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Chinese Pharma & Biotech Press Review – N° 278

Feb
22
2013

Pharma and Biotech Press Review

HEADLINES

To begin with Universal Medica wishes you all a Happy Chinese New Year.

This week, we have had some 2012 results from the Ministry of Health as well as some SFDA moves to tackle distribution issues. They are planning to make changes to lower down the number of distributors, increasing their quality and intend to implement electronic monitoring all along the supply chain by 2016. So expect some news of distributors M&A in the coming months.

Meanwhile, we have Amgen willing to enter the market, stem cells research advances in Japan and still a very active medical device market. Have a nice read!

FOCUS

  • Celgene got SFDA’s approval for Revlimid
  • Chinese Guideline to Forbid Doctors’ Incomes Linked to Medical Expenses
  • SFDA: Newly-revised Rugulations on Drug Quality Monitoring : Electronic Monitoring During the Medication Manufacturing Process
  • Dyax and Cvie Therapeutics partner for Kalbitor’s commercialization in China, HK and Macau
  • Medtronic Rides Emerging Markets Growth to Strong Quarter
  • Amgen to Use Partnerships and M&A Strategies to Acess the Chinese Market

Healthcare News

Chinese Guideline to Forbid Doctors’ Incomes Linked to Medical Expenses
(新华网, 2013-02-20)
The Chinese government has released a guideline on its basic medicine system forbidding hospitals from linking doctors’ incomes with their patients’ medicine and medical exam expenses.
In fact, in China some hospitals adjust doctors’ salary depending on the revenues earned through medication sales and exam fees, creating greater economic burdens for patients in some cases.
The guideline, released by the health and reform office under the State Council, or China’s cabinet, is intended to consolidate and improve the basic medicine system and offer solutions for problems related to local-level healthcare.
Additionally, this guideline calls for efforts to train medical staff on the proper use of basic medicine, and also encourages non-governmental local medical institutions to use medications that are on the basic medicine list.
Moreover, this guideline aims to implement quality inspections for basic medicine and electronic monitoring during the medication manufacturing process. It also asks for inspection results to be released to the public regularly.

SFDA : Newly-revised Rugulations on Drug Quality Monitoring : Electronic Monitoring During the Medication Manufacturing Process
(Fiercepharma, 2013-02-19)
The State Food and Drug Administration (SFDA) has released a newly-revised regulation on Good Supply Practices (GSP) for drugs, urging greater risk-control abilities for drug distributors during the circulation stage.
According to Li Guoqing, a senior SFDA official, the article 187 of the GSP regulation stipulates detailed quality management standards for both wholesalers and retailers.
This revision of the GSP contains improvements related to purchase channels, storage temperatures, the keeping of receipts and other documents, cold-chain management and transportation. For example, according to these rules, invoices must be issued for drug procurement and the transportation of drugs must be accompanied by matching document records. Moreover, concerning transportation conducted by third-party groups, consigners should first review their transfer capacities and sign liability agreements in case the quality of the drugs cannot be maintained during the transportation process. These rules also define requirements concerning the storage and transfer of cold-chain drug products, with detailed stipulations on temperature monitoring, tracking and product checks upon reception.
These revised GSP regulations will take effect on June 1st, however, according to SFDA, related drug enterprises will have a three-year transition period to adjust to the new rules.
The companies not able to comply with these rules after 2016 will be banned from selling drugs.

14,000 Counterfeit Drug Cases have been Cracked by the Chinese Authorities in 2012
(中国网, 2013-02-20)
The State Food and Drug Administration and the Ministry of Public Security counted some 14,000 cases involving making and selling of counterfeit drugs, which represents an amount of more than RMB 16 billion.
Many of these cases included international trades and internet and television selling.
“The main pattern for these counterfeit drug cases involves underground manufacturing, online advertisements and express delivery. Their criminal method is becoming more technology-driven, group-based and covert,” the statement said.
The government plans to intensify efforts to crack down on counterfeiting.

98% of the Chinese Rural Population Covered by Medical Insurance
(人民日报, 2013-02-21)
A total of 805 million people, which represents 98% of the rural population, were covered by the rural medical insurance system by the end of 2012.
Under the new rural cooperative medical program, health funding for each countryside resident reached RMB 300 (48 U.S. dollars) last year.
According to Ministry of Health statistics, 1.5 billion people have received medical fee reimbursement through the program in 2012.
Hospital expenses added up to 24% of the annual per capita income.
Over 80% of rural areas have promoted payment method reforms. Moreover, measures have been taken to guarantee treatments for critical illnesses, with 990,000 patients receiving reimbursement for the treatment of serious diseases, according to the ministry.
The medical insurance system should also be enhanced to fully guarantee treatment for 20 serious diseases, such as child leukemia.

Pharmaceutical Industry

Celgene got SFDA’s approval for Revlimid
(BioSpectrum, 2013-02-12)
The Chinese State Food and Drug Administration (SFDA) gave its approval to Celgene for the registration of Revlimid (lenalidomide) in China. This approval was based on the safety and efficacy results in patients with relapsed or refractory multiple myeloma that have been proven through several phase III pivotal randomized international clinical trials.
Actually, the SFDA and Celgene are looking forward to making Revlimid available to patients in China as soon as late in the second quarter of 2013. Results from a large, phase II bridging study (MM-021) of lenalidomide and low-dose dexamethasone in 159 Chinese patients, who had relapsed or refractory multiple myeloma, also supported the submission and approval.
Celgene has received full approval for Revlimid from the SFDA including an Import Drug License for the use of Revlimid (lenalidomide) in combination with dexamethasone as a treatment for patients with relapsed or refractory multiple myeloma who have received at least one prior therapy.
As a matter of fact multiple myeloma is the second most commonly diagnosed blood cancer. According to the International Myeloma Foundation 750,000 people are estimated to suffer from multiple myeloma worldwide.
Revlimid will be made available only through a proprietary distribution program developed by Celgene. The company is working to supply Revlimid to the Chinese market as soon as possible. Certain standard government processes must be followed prior to launch.

Dyax and Cvie Therapeutics partner for Kalbitor’s commercialization in China, HK and Macau
(investor.dyax.com, 2013-02-08)
Dyax and Cvie Therapeutics (a subsidiary of Lee’s Pharmaceutical Holdings) have announced a strategic partnership for the development and commercialization of Kalbitor (ecallantide) in the treatment of hereditary angioedema (HAE) and other angioedema indications in China, Hong Kong and Macau.
Under the terms of this exclusive license agreement, Dyax will get an upfront payment and is eligible to receive future development, regulatory and sales milestones. Dyax is also eligible to receive royalty on net product sales.
Whereas CVie is responsible for all costs associated with development, regulatory activities, and the commercialization of Kalbitor in China, Hong Kong and Macau. Moreover, CVie will purchase the product from Dyax on a cost-plus basis for commercial supply.
Mr. Gustav Christensen, president and chief executive officer of Dyax said: “If approved, Kalbitor would become the first novel therapy available for HAE in China, where presently only steroids are used. We are pleased to have secured a new partnership for Kalbitor in this region and look forward to working with CVie toward its commercialization.”
Dr Benjamin Li, chief executive officer of CVie, added “As a novel therapeutic for acute HAE attacks, we anticipate that Kalbitor will allow us to provide a far more comprehensive disease management solution than is currently offered to HAE patients in China.”

China Shenghuo Pharmaceutical recieved proposal from Lan’s Int’l Medicine Investment Co.
(China Shenghuo Pharmaceutical Holdings, Inc, 2013-02-15)
China Shenghuo Pharmaceutical Holdings, Inc. announced that its Board of Directors received a preliminary, non-binding proposal from Lan’s Int’l Medicine Investment Co., Limited (LIMI), in which LIMI proposed China Shenghuo Pharmaceutical to go private through a transaction that will cash out the public shareholders of the company at a price of $0.15 per share, to be funded by LIMI if necessary. LIMI currently owns approximately 77.3% of the company’s outstanding common stock.
China Shenghuo is primarily engaged in the research, development, manufacture, and marketing of Sanchi-based medicinal and pharmaceutical, nutritional supplement and cosmetic products. Through its subsidiary, Kunming Shenghuo Pharmaceutical (Group) Co., Ltd., it owns thirty SFDA (State Food and Drug Administration) approved medicines, including the flagship product Xuesaitong Soft Capsules.
The Company’s Board of Directors formed a special committee of three independent directors: Jason Yuanxin Zhang, Yunhong Guan and Xiaobo Sun to evaluate LIMI’s proposal. The Special Committee has chosen Dorsey & Whitney LLP as legal advisor and National Securities Corporation as its independent financial advisor to assist it in the evaluation of the LIMI proposal.
No decision has been made by the Special Committee yet.

OxOnc to partner with Pfizer for a Xalkori phase III trial in China, Taiwan, Japan and South Korea
(Topix.com, 2013-02-11)
OxOnc Development LLP, an American company specialized in oncology. They have just signed a co-development agreement with Pfizer to conduct a Phase III clinical trial of a Pfizer cancer drug Xalkori® (crizotinib) in China, Taiwan, Japan and South Korea. This drug will be tested in patients with advanced Non-Small Cell Lung Cancer (NSCLC) with a ROS1 gene rearrangement (ROS1-positive). The drug is already approved in the US, Europe, China and Japan for NSCLC patients with the ALK genetic variation.

Luye Pharma Completed Phase II Trial of Cardiovascular TCM in the US
(BioPortfolio, 2013-02-18)
Luye Pharma Group, a leading specialty pharmaceutical company based on research and development based in Beijing, Nanjing, Yantai ,Sichuan and Singapore, has reported that Xuezhikang, a Traditional Chinese Medicine (TCM), used to lower cholesterol, proved its effectiveness in a US Phase II clinical trial.
According to the company, the drug “significantly” lowered low-density lipoprotein cholesterol while elevating beneficial high-density lipoprotein cholesterol.
Therefor, Xuezhikang is the only TCM included in the National Basic List as a treatment for blood lipids.

Tensys Medical Enters into Exclusive Agreement with Zhejiang Shanshi Medical Device for the Distribution of T-Line in China, Hong Kong & Taiwan :a 5-year Agreement Worth Up To $US 40 Million
(Business Wire, 2013-02-08)
Tensys Medical, Inc., a leader in the development and commercialization of continuous, non-invasive hemodynamic patient monitoring systems, has entered into a commercial agreement with Zhejiang Shanshi Medical Device CO., LTD (Shanshi) for the distribution of the company’s T-Line technology.
This agreement will allow Shanshi to market, pending final regulatory approvals, the company’s newest TL-300 throughout China, Taiwan, and Hong Kong. Under these terms the parties have agreed on cumulative orders of up to $US 40 million on a 5-year exclusive supply relationship.
“Our pre-marketing efforts have validated our belief that the T-Line can make a dramatic impact in the Asia-Pacific hemodynamic monitoring markets and Shanshi expects to begin full marketing efforts throughout China in 2013.”
Shanshi will initially target the T-line into the Chinese operating room (OR) and intensive care unit (ICU) markets. The T-Line technology platform accurately and continuously captures a patient’s beat-to-beat waveform and blood pressure in a completely non-invasive fashion, providing physicians with a stream of real-time hemodynamic data that is not possible using traditional non-invasive blood pressure devices. Avoiding the blind-time associated with a deflated or inaccurate cuff can enhance hemodynamic monitoring, which has been definitively linked to improved clinical outcomes.
Tensys Medical, Inc. is a leader in the development and commercialization of continuous, non-invasive, hemodynamic monitoring systems.

Medtronic Rides Emerging Markets Growth to Strong Quarter
(Fierce Medical Devices, 2013-02-19)
Medtronic’s CEO Omar Ishrak has said for a long time that he wants 20% of its revenue to come from emerging markets by 2016. And as a matter of a fact this medical device leading company has successfully reached $4 billion in total revenue in the last quarter, a step forward on the way to reaching its objective.
The company’s emerging markets revenue increased by 20% in the fiscal third quarter, partly thanks to a 3% sales jump that made $988 million in net earnings. Markets such as India and China now account for about 12% of Medtronic’s business, and the company aims to continue to focus on those high-growth areas.
On the emerging markets side, Medtronic has spent billions to build its presence overseas, buying Chinese orthopedics outfit Kanghui Holdings for $816 million in the fall and working to get its stents adopted in India. Kanghui is already meeting Medtronic’s performance expectations, Ishrak told investors on a conference call, and the company is preparing to jump into the Chinese structural heart market after buying a $66.2 million stake in local outfit LifeTech Scientific.
Here are a few figures of the Company:
– Revenue of $4.0 Billion, grew 4% on a Constant Currency Basis; 3% as reported
– International Revenue Grew 7% on a Constant Currency Basis; 5% as Reported
– Emerging Market Revenue Grew 21% on a Constant Currency Basis; 20% as Reported
– Non-GAAP Diluted EPS Growth of 11%; GAAP Diluted EPS Growth of 10%
– Free Cash Flow of $1.4 Billion; GAAP Cash Flow from Operations of $1.5 Billion

Chinese Divisional Patent Gives BioDiem an Additional patent Application for BDM-I while Keeping the Priority Rights from its Original Application
(BioSpectrum, 2013-02-21)
BioDiem received a grant of a Chinese divisional patent, expanding the patent position for its novel antimicrobial compound BDM-I. The parent patent was granted in China during 2010, BDM-I is a synthetic compound being developed by BioDiem as a treatment of serious infections. The divisional patent strengthens the company’s portfolio by granting BioDiem’s claims in China for BDM-I and compounds related to it chemically; for the use of BDM-I as a preventive and therapeutic compound against an array of infectious diseases. BDM-I’s effectiveness against a broad range of micro-organisms that cause serious human disease including tuberculosis, pneumonia, meningitis, malaria, sexually transmitted and many other diseases caused by bacteria, fungi and protozoa.

Biotechnologies

Amgen to Use Partnerships and M&A Strategies to Acess the Chinese Market
(WND, 2013-02-18)
Amgen plans to access the Chinese market through a combination of partnerships and M&A to gain a foothold in the country. Therefore Amgen expects and hopes to bring its own patented drugs on the China market by 2015.
Meanwhile, the company also announced it will establish a biosimilar capability that will manufacture versions of its competitors’ biologic drugs. Therefore, Amgen is currently building a plant in Singapore, which will be completed by 2017, in the plan to make these drugs.
The company expects to generate $1 billion of revenues from biosimilars in emerging market countries.

Events

China Healthcare Investment Conference in Shanghai, China on March 12-14
(Chinahic.com, 2013-02-22)
This will be the 4th edition of the Annual China Healthcare Investment Conference; it will take place in Shanghai on the 12th, 13th and 14th March 2013. Last year’s edition received 400 of the pharmaceutical industry’s most influential Chinese and global thought leaders. Leading Entrepreneurs, Investors, Government officials, legal and financial experts as well as other industry leaders in the rapidly growing China healthcare industry will attend this event.

Asia/Pacific news

Researchers in Japan move a step closer to stem cell trial with a hope of a solution for sight problems
(中国邮报, 2013-02-15)
Japanese Researchers have moved one step closer to clinical trials using adult stem cells in a therapy they hope will prove a cure for common sight problems.
The ethics committee at the Institute for Biomedical Research and Innovation in Kobe, west Japan, on Wednesday approved a trial treatment for age-related macular degeneration (AMD) using induced Pluripotent Stem (iPS) cells. The trial’s aim is to create retinal cells that can be transplanted into the eyes of patients suffering from AMD, a presently incurable disease that affects mostly middle-aged and older people and can lead to blindness.
The institute, together with the government-backed research institute Riken, “will submit an application for a clinical trial with Riken to the Health Ministry by the end of next month,” hospital official Kosuke Nagi told AFP.
If a clinical trial using iPS cells is approved, it “would be the first ever,” a health ministry official said, adding a trial using embryonic stem cells — harvested from human embryos — had been undertaken by a U.S. firm.
The ministry’s deliberation process will take a few months before approval, the official said.
Prime Minister Shinzo Abe said, last month, that his government will earmark 110 billion yen (US$1.18 billion) for research toward the clinical use of iPS cells.

Pfizer to lop off Asian Research Unit Amid Major R&D Downsizing
(Business Times, 2013-02-08)
As the drug giant, Pfizer, seeks to carve out more than $1 billion for its budget, the company has confirmed its plans to exit a clinical research operation in Singapore. The move shows that even research in the fast-growing Asia-Pacific region is subject to cutbacks.
In recent years Pfizer CEO Ian Read’s regime has been reducing R&D costs, mostly in the western countries, with the closure of programs in Sandwich, U.K., and the relocation of research away from Groton. The company revealed recently that the 2012 budget for exploring new treatments shrank to $7.8 billion from $9 billion in 2011.
The planned closure of Pfizer’s clinical research unit in Singapore comes as the company looks to chop off another $1.3 billion in R&D spending during 2013.
“This decision was made as part of Pfizer Worldwide Research & Development’s ongoing comprehensive effort to increase operational efficiencies and to create a more focused and sustainable R&D engine,” a Pfizer spokeswoman told a news service.
Indeed, New York-based Pfizer has pushed for more outsourcing of clinical research work at home and abroad.

Chinese Pharma & Biotech Press Review – N° 224

Feb
22
2011


HEADLINES

Dear customers,
We extend our sincerest wishes for a merry Christmas and a successful year 2012.
We will be happy to meet you again in January, with new reports and news on China.
Please, do not hesitate to contact us if you need any information: contact@universalmedica.cn
Merry Christmas!

FOCUS

  • China will continue its fight against counterfeit drugs
  • Boehringer Ingelheim Sets $91 Million Shanghai Expansion
  • Pfizer and GSK boost pneumonia vaccine price cuts for developing world
  • India, China boosting API: Companies & Markets

Healthcare News

Dehaier Medical Enters European Homecare Medical Product Market
(Market Watch, 2011-12-16)
Dehaier Medical Systems Ltd., an emerging leader in the development, assembly, marketing and sale of medical devices and homecare medical products in China, announced that it has signed on three Romanian companies to distribute Dehaier’s DHR-5L oxygen concentrators in Romania. This marks Dehaier’s first entry into the European homecare medical product market.

Chindex International, Inc. Announces Opening of Latest Premium Hospital in Tianjin
(Reuters, 2011-12-20)
Chindex International, Inc, an American health care company providing health care services in China through the operations of United Family Healthcare, a network of private primary care hospitals and affiliated ambulatory clinics, announced the official opening of its Tianjin United Family Hospital, one of the latest development projects of the United Family Healthcare network. The company held an opening and ribbon-cutting ceremony for Tianjin United Family Hospital in December, which was attended by distinguished guests including Mr. Gary Locke, the U.S. Ambassador to People’s Republic of China.

WHO warns Chinese public of misleading tobacco industry research
(Topix, 2011-12-19)
Research indicating that some cigarettes are less harmful is tobacco industry hype meant to mislead the public, a WHO official warned as a heated debate rages in China over the credibility of tobacco science. “Low-tar cigarettes, for example, don’t reduce the harm at all,” said Sarah England, a technical officer on tobacco control with the WHO Representative Office in China. She said tar, nicotine and other smoke emission yields derived from smoking-machine testing do not provide valid estimates of human exposure and there is no conclusive epidemiological or scientific evidence that cigarettes with lower machine-generated smoke yields are less harmful.

China will continue its fight against counterfeit drugs
(中国网, 2011-12-20)
China will continue next year its strong political fight against counterfeit drugs, announced the SFDA. Shao Mingli, director of the SFDA spoke at a national conference on the supervision and management of food and pharmaceutical products. China launched a special campaign of two years on the safety of pharmaceuticals (between July 2009 and July 2011), during which the authorities have investigated more than 42,000 cases and closed 1,093 illegal websites. The SFDA will control the information and transactions online related to pharmaceuticals and establish a monitoring network covering all the prefectures of the country, added Shao.

Pharmaceutical Industry

Sihuan Pharma Building $110 Million Facility in Beijing
(Scoop.pharma-digital, 2011-12-15)
Sihuan Pharmaceutical broke ground on a new 700 million RMB ($110 million) campus that will house production, R&D and offices. The 175 acre site is located in the Zhangwan Development Area, Tongzhou District, Beijing. Founded in 2001, Sihuan claims to have the largest market share of cardio-cerebral drugs in China. After completing its IPO last year, the company has been very busy, completing several M&A deals and investing in new facilities.

Boehringer Ingelheim Sets $91 Million Shanghai Expansion
(Asian Scientist, 2011-12-16)
Boehringer Ingelheim announced a $91 million expansion of its Shanghai manufacturing facility, which is located in Zhangjiang High-Tech Park. The German company positioned the investment as a “for China” strategy. The latest boost to BI’s China facilities follows a $149 million investment two years ago at the same site, aimed at increasing the company’s offerings in vaccines and animal health.

DSM Sinochem JV Building Second China Anti-Infective Facility
(Bioportfolio, 2011-12-20)
DSM Sinochem Pharma announced plans to build a manufacturing facility, located in Shandong province, to produce semi-synthetic cephalosporins (SSC). The facility will use DSM Sinochem’s efficient biotech manufacturing process. The JV was formed earlier this year when Sinochem Pharma paid $291 million for a 50% stake in Royal DSM‘s global anti-infectives unit.

Pfizer and GSK boost pneumonia vaccine price cuts for developing world

(Fiercepharma, 2011-12-20)
Pfizer and GlaxoSmithKline said they are selling an additional 360 million doses of their pneumonia vaccine to a global health organization at a discounted $3.50 a dose. The Global Alliance for Vaccines and Immunization (GAVI) is buying the doses, split evenly between Pfizer’s Prevenar GlaxoSmithKline’s Synflorix. Both corporations will supply the vaccines through 2023. The GAVI, raised $4.3 billion in pledges from donors in June to help fund its effort to immunize children against pneumococcal disease, which kills over 500,000 children annually, mostly in the developing world, and causes pneumonia, meningitis and sepsis. GAVI hopes to prevent 7 million deaths by 2030.

Hua Medicine In-licenses Diabetes Drug Candidate from Roche
(ChinaBio Today, 2011-12-21)
Hua Medicine has in-licensed global rights to Roche’s glucokinase activator program (GKA), a potential treatment for diabetes. GKA is a novel, small molecule activator of the glucokinase enzyme, which helps to regulate carbohydrate metabolism. The product, Hua’s first in-licensing, is ready to start clinical trials. In return for exclusive global development, manufacturing and marketing rights, Hua has agreed to pay an upfront payment, milestones and royalties.

Hengrui Gains FDA Approval for Cancer Drug
(Chinese Life Science Professionals Association, 2011-12-21)
Jiangsu Hengrui Medicine has been granted FDA approval for Irinotecan, an anti-cancer drug that is usually prescribed as part of a drug cocktail for colon cancer. According to Hengrui, the approval is the first given to a China company for an injected drug. The company said it plans to use the experience of its first FDA approval to accelerate plans for US and European acceptance of other drugs in its portfolio.

Biostar Pharmaceuticals Signs 12-Month Distribution Agreement With Huikang Pharmaceuticals
(Medindia.net, 2011-12-20)
Biostar Pharmaceuticals, Inc, a developer, manufacturer and marketer of pharmaceutical and health supplement products for a variety of diseases and conditions, announced that its newly acquired subsidiary, Shaanxi Weinan, signed a 12-month distribution agreement with Shaanxi Huikang Pharmaceuticals Co. effective January 1, 2012. Huikang Pharmaceuticals is distributor of pharmaceutical products in 11 provinces in Northwest and North China and has annual sales over RMB 300 million. Huikang Pharmaceuticals has a network of over 300 drugstores and hospitals, where, for the most part, Biostar products are not currently sold.

Biotechnologies

China Sky One Partners Up to Form New Stem Cell Company
(Devicespace, 2011-12-17)
China Sky One Medical, together with three partners, will invest $36.3 million to create a stem cell company, which will be called Harbin Tian Xin Biological Engineering. Besides providing umbilical cord cell banking, the new company will perform the clinical applications of bone marrow stem cells, intercord mesenchymal stem cells and other human stem cells.

Mindray Medical to Acquire a Controlling Stake in Hunan Changsha TDR Biotech
(PR Newswire, 2011-12-20)
Mindray Medical International Limited, a developer, manufacturer and marketer of medical devices worldwide, announced an agreement to acquire a controlling stake of Hunan Changsha Tiandiren Biotech Co., Ltd. TDR is a domestic manufacturer of microbiology analysis solutions that specialize in microbial identification and antibiotic susceptibility testing (ID/AST) and the blood culture system. Last year, the market for ID/AST and blood culture system was estimated at approximately $139 million in China. It is expected to grow 15-20% annually. Internationally, the market was estimated at $2.25 billion in 2010 and is expected to grow 5% annually.

Scientific News

Chinese doctors find way to detect liver cancer earlier
(新华网, 2011-12-19)
A simple test using just one milliliter of a patient’s blood can tell whether the patient has liver cancer — even if the tumor is less than two centimeters in diameter, new medical research in Shanghai shows. Doctors at the Zhongshan Hospital, a major medical institution affiliated with Fudan University, have found that seven microRNAs, or ribonucleic acid molecules, are strongly related to liver problems. This discovery can raise the accuracy of tests for early-stage liver cancer to almost 90 percent. Each test will cost a patient only about 100 yuan (15.9 U.S. dollars), said Dr. Fan Jia, vice president of the hospital and one of the country’s leading liver surgeons. China sees half of the world’s new liver cancer cases each year. More than 60 percent of Chinese liver cancer patients are diagnosed too late to be cured, according to the medical paper written by Fan’s team.

Asia/Pacific news

India, China boosting API: Companies & Markets
(BioSpectrum, 2011-12-16)
According to London based analysis company, Companies & Markets, the Development in the High Potency Active Pharmaceutical Ingredient (HPAPI) and Biogeneric drugs is boosting the growth of the Active Pharmaceutical Ingredient (API) market. There has been a paradigm shift in the use of innovative drugs to that of low-cost API drugs after the economic recession, thereby causing a positive impact on the overall growth of the API market. The Active Pharmaceutical Ingredient (API) forms the most vital part of every formulated end product, and is an important part of the whole pharmaceutical industry. The overall API market was valued at $101.08 billion in 2010, and is expected to grow at a CAGR of 7.9 percent from 2011 to 2016. There has been an increase in influence of API players from emerging economies such as India and China after the economic recession. The recession restricted the growth of Innovative sector in developed economies such as the U.S and Europe, as the Innovative sector requires huge investments. This has helped fuel the growth of Generics market in Asian countries such as India and China.

Chinese Pharma & Biotech Press Review – N° 223

Feb
15
2011


HEADLINES

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Get the report for only 1.500€ (single user license) by sending us this special promotional code: UMCNDS
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FOCUS

  • China warns against cancer-fighting medication of Caelyx and Velcade
  • China faces severe plasma shortage: health minister
  • 98% of Chinese Physicians Use Internet
  • China Will Regulate TCM Products to Improve Their Purity
  • Bayer bracing for profit-margin drop
  • Simcere and Bristol-Myers Squibb Enter Innovative Partnership to Develop Cardiovascular Compound

Healthcare News

Mindray Medical Invests in Healthcare IT Company
(Bioportfolio, 2011-12-10)
Mindray Medical agreed to buy a controlling interest in Zhejiang Greenlander Information Technology Co, a Hangzhou company that specializes in healthcare IT. Greenlander has developed software that archives medical images and combined it with a database tailored for the needs of radiology departments. Mindray makes numerous medical imaging devices. Terms of the transaction were not disclosed.

China warns against cancer-fighting medication of Caelyx and Velcade
(China SFDA, 2011-12-09)
China’s State Food and Drug Administration (SFDA) warned of safety risks related to the use of the AIDS-related cancer-fighting medication Caelyx and Velcade, drugs used for treating myeloma and lymphoma. The warning came after European Medicines Agency gave interim recommendations to deal with shortcomings in the quality of the two medications produced at Ben Venue Laboratories. The agency launched a precautionary recall for the remaining batches of Velcade and stopped new patients from being treating with Caelyx after an inspection found several shortcomings in relation to the aseptic filling process. The inspection was launched by medicine regulatory bodies from Britain, France and the United States from Nov. 7 to 11 this year at the Ben Venue facility. The SFDA has ordered the Xi’an-Janssen Pharmaceutical LTD, the import agent of the two products, to recall all Caelyx on the market and to stop selling Velcade. The company should inform doctors and patients of the potential risks and advise patients to replace Caelyx with alternatives.

China faces severe plasma shortage: health minister
(China MOH, 2011-12-11)
China is faced with severe challenges in collecting enough blood plasma to produce medicines, Health Minister Chen Zhu said. Blood plasma is needed to make blood products like prothrombin complex which is vital for hemophiliacs. The total volume of blood plasma collected last year was 4,180 tonnes, while the volume needed to produce enough medicines was 8,000 tonnes, said a statement from the ministry. The situation became even worse this year. Donations of blood plasma in China fell dramatically in recent years, as a result of safety concerns from donors and the government’s efforts to regulate blood collection after contamination triggered HIV infection scandals. In an overhaul of plasma collection services in 2004, the ministry closed 262 donation centers, leaving only 138 in operation, resulting in the plasma donations falling at least one-third from 5,000 tonnes in 2003. Blood plasma are currently collected at 144 designed stations across the mainland. The stations, as requested by law, are all owned by major manufacturers of blood products.

ICON Builds China Presence by Acquiring BeijingWits, a Clinical CRO
(Pharma Times, 2011-12-13)
ICON plc, a global CRO based in Ireland, made good on a promise to increase its China presence by acquiring a China clinical-stage CRO, BeijingWits Medical Consulting. Founded in 1997, BeijingWits offers Phase I-IV clinical trial services and claims expertise in China’s regulatory processes. ICON said the transaction would add 100 experienced personnel to its China staff. Terms were not disclosed.

98% of Chinese Physicians Use Internet
(News Maker, 2011-12-12)
Ninety-eight percent of physicians in China use the Internet, and they spend 5.1 hours a week on activities related to their practice and on specialty-related activities, according to a new study by Kantar Health, a healthcare-focused global consultancy company, and DXY, the largest online academic portal for Chinese physicians and life sciences professionals. According to the Digital Life Physician China survey, Chinese physicians spend about 42% of their online time, or 2.6 hours a week, on knowledge-based activities, including searching for articles, books or disease information; hospital/department information; and conferences and exhibitions. Continuing medical education (CME) takes up 1.9 hours a week, and they spend approximately 1.4 hours a week connecting with their peers online, including writing blogs, articles and reviews. Physicians spend only 0.6 hours a week interacting with their patients online, including answering patients’ questions and participating in patient education and support programs.

China Will Regulate TCM Products to Improve Their Purity
(Gov.cn, 2011-12-14)
China’s State Council has ordered measures that will more tightly regulate the production of TCM products. The goal is to increase the safety of TCM drugs and also improve their efficacy. The new rules will affect both how TCM raw materials are grown and how companies extract their active ingredients for botanical sources.

Quintiles, a Clinical-Stage CRO, will Double China Headcount
(Biospace, 2011-12-14)
Quintiles, a global clinical-stage CRO based in North Carolina, will launch a new company, named Kun Tuo, to build its China presence. The new company, like its predecessor, Quintiles China, will offer clinical trial services. Although Quintiles employs 20,000 people worldwide, it currently has just 300 staff in its two China offices. Kun Tuo plans to double Quintiles’ China’s staffing over the next year.

Lab tests confirm 86 hepatitis C cases in central China towns: ministry
(China MOH, 2011-12-13)
Laboratory tests indicate that a total of 86 people have been infected with hepatitis C in central China’s townships of Maqiao and Dancheng, a Health Ministry spokesman said. Spokesman Deng Haihua made the remark at a press conference while answering a question regarding a suspected outbreak of hepatitis C that was reported in two central China provinces since late October. A preliminary epidemiological probe conducted by the ministry and provincial authorities has confirmed 23 hepatitis C cases in Dancheng of Anhui province and 63 cases in Maqiao of Henan province, Deng said. The patients’ infections were all confirmed through lab tests and they are now receiving treatment at local clinics, Deng said.

China Medical Technologies Intends to Implement Debt Restructuring
(The Street, 2011-12-13)
China Medical Technologies, Inc, a leading China-based advanced in-vitro diagnostic (IVD) company, announced that the company intends to implement a debt restructuring plan to improve its balance sheet. The plan may include, without limitation, a debt-for-debt exchange with existing holders of the company’s convertible notes maturing in August 2013 and December 2016, which may potentially involve holders receiving new debts with different interest rates, maturities and principal amounts compared to the existing debts or other alternatives to be agreed.

Pharmaceutical Industry

AstraZeneca Buys China Generic Drug Firm; Announces US Layoffs
(ChinaBio Today, 2011-12-09)
AstraZeneca announced it will increase its China presence by acquiring Guangdong BeiKang Pharmaceutical, a drug maker with five generic injectible anti-infective products. The purchase price for BeiKang, a privately held company, was not disclosed. At the same time, AstraZeneca is laying off 1,150 members of its US-based sales force.

Beijing SL Pharma Buys Stake in Forwell Biopharm
(Silobreaker, 2011-12-10)
Beijing SL Pharmaceutical will invest 90 million RMB ($14 million) to buy new shares of Forwell Biopharm Co, giving Beijing SL an 18% stake in Forwell. Forwell’s major product is a human Adsorbed Rabies vaccine, which is administered before or after exposure to rabies. The transaction is the second investment Beijing SL has made in a vaccine company this year.

Bayer bracing for profit-margin drop
(Fiercepharma, 2011-12-13)
Bayer‘s profit margins are dropping as a result of the European debt crisis. The German drug giant is responding as any cautious drug company would–by stocking up on cash. Bayer CEO Marijn Dekkers is warning that delinquent payments, particularly in Greece, Italy and Spain, plus an overall cost-cutting trend on medicines, is forcing its profit margins in drugs and plastics to plunge. And Dekkers said Bayer continues to look toward growth in China, sustained by booming demand. We’ll see about growth in China. But in November it was warned that both the Chinese central and provincial government are pursuing policies that have led to substantial price cuts. As far as plastics? Dekkers suggested this year that Bayer’s plastics division could be ripe for M&A.

Simcere and Bristol-Myers Squibb Enter Innovative Partnership to Develop Cardiovascular Compound
(Pharma&Medical Packaging, 2011-12-13)
Bristol-Myers Squibb Company and Simcere Pharmaceutical, a leading pharmaceutical company in China, announced that the companies have expanded the strategic partnership formed last year to include a second collaboration in a different therapeutic area. The companies agreed to co-develop BMS-795311, Bristol-Myers Squibb’s preclinical small molecule inhibitor of the Cholesteryl Ester Transfer Protein (CETP). Inhibiting CETP could potentially raise HDL (good cholesterol) levels and help prevent cardiovascular disease. This collaboration is expected to accelerate the delivery of clinical Phase IIa proof-of-concept by leveraging the complementary strengths of a premier Chinese pharmaceutical company and a global biopharmaceutical company. Under the terms of the agreement, Simcere will receive exclusive rights to develop and commercialize BMS-795311 in China while Bristol-Myers Squibb will retain exclusive rights in all other markets. The companies will together determine the strategic development plan to explore the potential of BMS-795311 to treat and prevent progression of cardiovascular disease. Simcere will run and fund initial development work. Financial terms were not disclosed.

Biotechnologies

TaiGen obtains the worldwide rights for Nemonoxacin
(PRNewswire, 2011-12-09)
TaiGen Biotechnology, a leading development stage pharmaceutical company based in Taiwan with a wholly-owned subsidiary in Beijing, announced that Warner Chilcott will transfer the worldwide rights for nemonoxacin, a novel non-fluorinated quinolone antibiotic under development for treatment of antibiotic-resistant infection to TaiGen. With the transfer of the compound, a complete regulatory package and related intellectual property rights, TaiGen will hold the worldwide exclusive rights for development, manufacture, commercialization and sub-licensing of nemonoxacin.

Kane Biotech Issued New Patents in China and USA
(Marketwire, 2011-12-08)
Kane Biotech Inc, a biotechnology company engaged in the development and commercialization of products that prevent and remove microbial biofilms announced the issuance of Patent No. ZL 200680024157.1 entitled “Antimicrobial compositions for inhibiting growth and proliferation of microbial biofilm on medical devices” by the State Intellectual Property Office of the P.R. China. This patent covers the synergistic combination of Protamine Sulfate and Chlorhexidine (Trademark: Aledex®) developed for antibiofilm-antimicrobial coating of medical devices to prevent hospital-acquired infections. In addition, the company was recently issued Patent No. 7,989,604 entitled “DispersinB® polynucleotides and methods of producing recombinant DispersinB polypeptides” by the United States Patent and Trademark Office.

Chinese Pharma & Biotech Press Review – N° 222

Feb
9
2011


HEADLINES

Dear Suscribers,
Universal Medica China is glad to inform you that our new market analysis report “Drug Safety in China” has now been published.
Be aware of the new MoH rules from July 1st, 2011 tightening the ADR reporting and monitoring environment; for your company to be in line with the Chinese SFDA requirements.
As a special reward for our subscribers to the newsletter, we are glad to offer you an exceptional 25% discount on the price of the report, for any order before Dec. 20th, 2011.
Get the report for only 1.500€ (single user license) by sending us this special promotional code: UMCNDS
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FOCUS

  • China probes outbreak of Hepatitis C, unclean needles blamed
  • PRC Increases Goals of Healthcare Reform
  • UN official lauds China’s HIV/AIDS progress
  • HIV/AIDS infections soaring in China general population: experts
  • China’s AIDS control experience can be shared elsewhere: UNAIDS
  • Merck Will Build Beijing R&D Center; Invest $1.5 Billion in China

Healthcare News

China probes outbreak of Hepatitis C, unclean needles blamed
(Daily News, 2011-12-02)
Health authorities are investigating an outbreak of Hepatitis C in east and central China in which the reuse of needles by an unlicensed doctor is suspected as the cause. A group of experts dispatched by the Ministry of Health are tracing the outbreak in Anhui and Henan provinces after more than 100 people in two neighboring townships were found infected with the Hepatitis-C virus, according to provincial health officials. Guocheng County of Anhui has reported 76 infection cases, while 104 people in Yongcheng City in Henan have also tested positive for the virus in a preliminary screening. Investigators are focusing on an unlicensed village clinic doctor in Maqiao Township of Yongcheng who is suspected of having caused the outbreak by reusing needles. Residents said Wu Wenyi, the clinic doctor, seldom changed needles, and he is known as the “miracle doctor” for his ability to alleviate patients’ fever and diarrhea through injections and a few tablets.

PRC Increases Goals of Healthcare Reform
(Bioportfolio, 2011-12-01)
China wants to increase the benefits of healthcare reform. To accomplish that, the PRC will seek to implement measures that increase the per-person allowance in medical insurance plans and extend the essential medicine system to public clinics in villages and private clinics. The initiative was announced by the PRC’s Vice Premier, Keqiang Li, in a meeting convened by the State Council that was devoted to health care.

UN official lauds China’s HIV/AIDS progress
(Women of China, 2011-12-02)
China has made “fantastic progress” combating HIV/AIDS in recent years, according to a senior UN official in the country. “Over the last eight years, there has been a reduction in mortality due to AIDS of about 60 percent,” said Mark Stirling, UN Country Coordinator for AIDS in China, who emphasized the progress was “fantastic.” Stirling said about 60 million people were tested for HIV last year in China and roughly half the people in China who need antiretroviral therapy now get it. By 2015, China plans to reduce AIDS deaths by 30 percent and reduce new infections by 25 percent. To achieve these goals, Stirling said China needs to double its HIV testing rate and increase its antiretroviral therapy rate to 80 percent.

HIV/AIDS infections soaring in China general population: experts
(CNTV, 2011-11-30)
Chinese experts say an increasing number of old people and college students in the country have become infected with HIV/AIDS through unsafe sexual intercourse in recent years. Figures revealed Wednesday by the Chinese Center for Disease Control and Prevention (CDC) show that the number of HIV positive men in their 60s and above soared from 483 in 2005 to 3,031 in 2010, accounting for 8.9 percent of the total. In 2005, the group only took up 2.2 percent. Chinese men 60 and above with AIDS also skyrocketed from 237 to 2,546, accounting for 11 percent of all AIDS cases, up 5.6 percentage points from 2005. “As a result of improved living standards and health conditions, the sexually active period of old people, especially males, has been prolonged,” said Wu Zunyou, director of the CDC HIV/AIDS prevention and control center. “With considerable sex drive even after retirement and the death of spouses or their lack of interest, some elderly have resorted to sex services.” “Many tended to choose secluded and low-end venues and didn’t use condoms, which made them highly vulnerable to HIV infections,” Wu added. Also, a total of 1,252 HIV/AIDS-infected students were discovered as having the virus between January and October, accounting for 21 percent of all student cases. Infection has been especially obvious in the past two years among male college students aged between 20 to 24, according to the CDC.

China’s AIDS control experience can be shared elsewhere: UNAIDS
(The Body, 2011-11-30)
China’s efforts to fight AIDS are impressive and its experience can be shared, according to Michel Sidibe, executive director of the Joint United Nations Programme on HIV/AIDS (UNAIDS). “We have seen progress in terms of new infections. The number of people going into treatment is increasing and the mortality rate is going down very quickly in China,” Sidibe said during an interview with Xinhua. Sidibe said he was impressed by the country’s political leadership and commitment to controlling AIDS. According to UNAIDS, the country has reported a 60-percent reduction in deaths due to AIDS over the past eight years. New HIV infection cases in China have been reduced from 70,000 people annually in 2005 to around 48,000 in 2011, according to the country’s health department. “However, China’s success will not only be measured by what it has done for the Chinese people,” Sidibe said. China has successful experience in reducing new HIV infections among intravenous drug users, which can be shared with the rest of the world, particularly east Europe and south Asia where HIV infections among drug abusers is a major challenge, he said.

LDR Given China Approval for Two Medical Devices
(Business Wire, 2011-12-03)
LDR, a medical device company headquartered in Texas, received SFDA approval to market two spinal device systems in China: the ROI-C® Cervical Cage and the ROI-A® ALIF Cage. LDR has been selling its artificial discs in China since 2009. The company has offices in Beijing and Shanghai.

China’s Cabinet approves plan to strengthen drug safety
(新华网, 2011-12-07)
The State Council, or the Cabinet, approved a blueprint to establish a credit rating system and intensify monitoring for pharmaceutical groups to boost the country’s drug safety over the next five years. “Our country’s pharmaceutical companies are experiencing various problems such as the lack of an integrated credit system, inadequate supervision and a weak technical foundation. Medicinal safety is in a high-risk stage,” according to a statement released after a State Council executive meeting presided over by Premier Wen Jiabao. The 2011-2015 plan set the general goal of “sharply” increasing the level of safety and people’s satisfaction toward drugs by ensuring all pharmaceutical products meet the standards of a newly revised regulation on the quality management of medical products as of the end of 2015, said the statement. According to the plan, the country will also step up efforts to improve its standards for chemical medicines and biological products in line with the international level and take the lead in making international standards for traditional Chinese medicine (TCM). While strengthening the quality management in all phases of the drug manufacturing and medical apparatus, the plan also urges improvements in labs’ and health organizations’ capabilities to inspect drugs across the country, especially at the county and city levels. “We should improve the monitoring for adverse effects and drug abuse as well as the re-evaluation system for medicines after they enter the market, with a special focus on new and high-risk medicines and TCM injections,” said the statement. According to the statement, those who manufacture or sell counterfeit drugs should be severely punished, and business people with a history of serious misconduct should be banned from working in the pharmaceutical industry.

Pharmaceutical Industry

Haibin Pharma Announces European Approval for Bulk Antibiotic
(Biospace, 2011-12-02)
Shenzhen Haibin Pharma received a EU-GMP certificate from Germany allowing it to sell its meropenem bulk drug in Europe. Meropenem is a broad spectrum antibiotic. Haibin said it is the first China company to be granted European approval for meopenem bulk medicine. Currently, Haibin supplies almost 50% of China’s meropenem needs, and it exports to many areas of the world as well. Haibin is a subsidiary of Joincare Pharma.

Taiantang Pharma Pays $21.4 Million for Stake in TCM Company
(Devicespace, 2011-12-06)
Guangdong Taiantang Pharma will pay 136 million RMB ($21.4 million) for a 52% stake in Guangzhou Hongxing Group, a company that has a portfolio of 94 patented TCM medicines. Taiantang, which makes skin and cardiovascular drugs, acquired the stake by buying Shanyan Investment.

Foci Pharma to IPO in Shenzhen
(Bioportfolio, 2011-12-06)
Lanzhou Foci Pharma will issue 20.2 million shares in its IPO on the Shenzhen Small and Medium Enterprise Exchange. The expected date is December 13th. The new shares will comprise 25% of the company’s post-IPO capitalization of 80.8 million shares. Founded in Shanghai in 1929, Foci Pharma mainly sells and distributes patented TCMs, although it also deals in western drugs and raw herbs.

Merck Will Build Beijing R&D Center; Invest $1.5 Billion in China
(Europe.chinadaily, 2011-12-07)
Merck announced plans to build an Asia Research & Development headquarters in Beijing, which will be devoted to innovative drug discovery and development. The new initiative is part of a broader $1.5 billion investment in China R&D that Merck will make over the next five years. Merck said the investment has two goals: building its own capabilities and fostering relationships with outside researchers. It expects the center to provide new drugs and vaccines that meet global needs.

Aoxing Pharma Secures $3.2 Million from Bank Loan
(Dailymarkets, 2011-12-07)
Aoxing Pharma announced a new 20 million RMB ($3.2 million) bank loan, arranged with the help of a city-government owned investment firm. The one-year loan features a high 15% interest rate. Last month, Aoxing received $315,000 from Heibei Province to pay interest on its existing $12 million of debt. Aoxing reported cash of $2.5 million at the end of its most recent reporting period, and a negative cash flow of $2 million over the previous 12 months.

Conba Buys 84% of Yunnan Xiogye Pharma
(Silobreaker,  2011-12-07)

Zhejiang Conba Pharma bought an 84% stake in Yunnan Xiongye Pharmaceutical Ltd., a company that makes both TCMs and western drugs. Last year, Xiongye lost 4.7 million RMB ($739,000) on 7.8 million RMB ($1.2 million) of revenue. Founded in 1969, Xiongye has a portfolio of over 40 products, the ostensible reason for Conba’s interest. Terms of the transaction were not disclosed.

Events

Ascletis Nominated for Financing Deal of the Year
(ChinaBio Today, 2011-12-01)
China biopharma Ascletis was nominated as the initial contender for InVivo Blog’s contest that will choose the best Exit/Financing Deal of the Year from around the globe. Ascletis was chosen because its $100 million Series A funding was one of the highest ever for a biotech. Most Series A rounds are in the $5-$10 million range, and only 10% of this year’s initial fundings surpassed $40 million, making Ascletis’s accomplishment a standout performance.

Chinese Pharma & Biotech Press Review – N° 221

Feb
1
2011


HEADLINES

Dear Suscribers,
Universal Medica China is glad to inform you that our new market analysis report “Drug Safety in China” has now been published.
Be aware of the new MoH rules from July 1st, 2011 tightening the ADR reporting and monitoring environment; for your company to be in line with the Chinese SFDA requirements.
As a special reward for our subscribers to the newsletter, we are glad to offer you an exceptional 25% discount on the price of the report, for any order before Dec. 20th, 2011.
Get the report for only 1.500€ (single user license) by sending us this special promotional code: UMCNDS
Any inquiries, please contact us: info@universalmedica.cn

FOCUS

  • Number of diabetes patients nearly doubled in China over past decade: medical expert
  • 24 slimming products may cause strokes, heart attacks
  • Medical companies fined 7mln yuan for monopoly
  • Mother-to-child HIV/AIDS infection plunges in China: ministry
  • Shortage of emergency doctors
  • China’s HIV/AIDS-infected population estimated at 780,000

Healthcare News

Number of diabetes patients nearly doubled in China over past decade: medical expert
(World Navigator, 2011-11-26)
The number of Chinese diabetes patients nearly doubled over the past decade, with 9.7 percent of the country’s 1.3 billion people suffering from the disease, according to a Chinese medical expert. Ji Linong, director of the Chinese Medical Association (CMA)’s Diabetes Society, announced the statistic at an inauguration ceremony for a story-collecting activity entitled “I and Insulin” which is being co-sponsored by the society and an international pharmaceutical manufacturer. Only 36.1 percent of Chinese aged 18 and older are aware of diabetes, according to Ji. He added that only 35 percent of the diabetes patients has normal blood sugar levels, a key diagnostical indicator for diabetes.

24 slimming products may cause strokes, heart attacks
(Shanghai SFDA, 2011-11-24)
The city’s food and drug watchdog banned the sales of 24 diet products as they contain harmful ingredients that could cause heart attacks and strokes. The Shanghai Food and Drug Administration said the banned products, mostly capsules, were produced by 12 companies, including Guangzhou-based Kangmeiyuan Biological Technology Ltd which used sibutramine and phenolphthalein. Sibutramine is likely to increase the risk of strokes and heart attacks, while phenolphthalein may raise blood sugar levels. Under the Chinese law, these can only be used under the guidance of doctors. Although these chemicals can help reduce body fat, they are likely to cause side effects and life-threatening complications in some extreme cases, said officials.

Medical companies fined 7mln yuan for monopoly
(China NDRC, 2011-11-24)
The National Development and Reform Commission (NDRC)has fined two medical companies in Eastern China’s Shandong province nearly seven million yuan. The firms are accused of controlling raw materials of compound reserpine, a anti-hypertensive drug and increasing its bid prices. Seven million yuan – It’s the first heavily fined anti-monopoly case. So far, more than 10-million hypertensive patients rely on this medicine, with an annual consumption of nine billion tablets. Most of the consumers are from middle and low income groups.

Mother-to-child HIV/AIDS infection plunges in China: ministry
(China MOH, 2011-11-28)
The rate of HIV/AIDS infection from mother-to-child in China dropped from 34.8 percent at the start of 2009 to 7.9 percent in 2010, according to Vice Minister of Health Ma Xiaowei. In 2009 and 2010, the central government allocated 8.3 billion yuan (1.3 billion U.S. $) to carry out a series of health projects for women in the rural areas, including child delivery in hospitals, tests for cervical cancer and breast cancer, and mother-to-child HIV/AIDS infection prevention, said Ma at a meeting on women and children. According to Ma, 13.9 million pregnant women in rural areas received HIV/AIDS-related consultations and examinations in the two-year period. Figures from the ministry show that the country had 429,000 registered AIDS patients and HIV carriers as of the end of September, up by nearly 60,000 over the past 11 months. Although growth in the registered HIV/AIDS population has declined in recent years, previous research also indicated that a large group was not covered in the official count.

Shortage of emergency doctors
(上海日报, 2011-11-28)
Shanghai is suffering from a shortage of emergency doctors as demand for ambulances grows and medics quit due to tough working conditions. The local ambulance service has seen calls increase by 10 to 15 percent annually in recent years – reaching 500,000 last year. This is attributed to Shanghai’s aging population putting growing pressure on the ambulance service. Shanghai had planned to increase the number of emergency doctors to 1,000 by the end of year, but had only 579 as the deadline nears, according to a report issued by the Shanghai Medical Emergency Center. And many emergency doctors quit after a year or two, due to “pressure of work, low income and poor career development,” the report said.

AIDS on increase in Shanghai
(中国网, 2011-11-29)
Health experts warned that AIDS was on the increase in Shanghai with many more ordinary families affected by the disease. Lu Hongzhou, an AIDS expert of the Shanghai Public Health Center, told at a forum at Fudan University that in the first half of the year he received 50 to 70 more AIDS patients month by month, and during the second half he dealt with about 70 to 100 more cases each month. Most of the patients showed symptoms indicating the disease had reached an advanced stage, he said. “We have seen the increase in AIDS being controlled in 2009 globally, but in China, it may still increase for a long time,” he said. “Some experts have predicted that the country will need another 8, 10 or even 15 years to change the situation. However long it will take it’s clear that the trend will last not for a short period.”

China’s HIV/AIDS-infected population estimated at 780,000
(新华网, 2011-11-29)
China currently has 346,000 registered HIV carriers and AIDS patients, although the actual number is predicted to hit 780,000 by the end of 2011, according to an expert panel. Consisting of members from China’s Ministry of Health (MoH), the WHO UNAIDS, the expert panel estimated that the country will have 154,000 AIDS patients by the end of 2011, with 48,000 new infections and 28,000 deaths this year, according to a statement released by the MOH. China has been boosting distribution of HIV/AIDS tests among spouses of carriers and others who have close contact with them, the statement said, adding that a total of 67.45 million HIV tests were conducted across the country between January and October, up 16.5 percent year-on-year. These tests found 61,000 HIV carriers and AIDS patients. “HIV/AIDS remains a mildly prevalent disease in China, with the number of HIV carriers and AIDS patients in the country accounting for roughly one-fiftieth of the world’s total,” said the statement. The Chinese Center for Disease Control and Prevention (CDC) noted that the HIV/AIDS incidence rate in certain groups and parts of the country has become relatively high through infection by sexual intercourse, especially homosexual intercourse. China has registered the first case found in the country in 1985.

Mindray Announces Partnership with Epiphany Cardiography Products, LLC
(Medindia.net, 2011-11-28)
Mindray Medical International Limited, a developer, manufacturer and marketer of medical devices in Shenzhen, announced a strategic North American partnership with Epiphany Cardiography Products, LLC, Virginia. Under this partnership, Mindray’s 12-Lead cardiac monitoring data will be integrated into Epiphany’s pure web browser-based, user-friendly Cardio Server application, which receives, manages and exports diagnostic test results from over 100 devices to Electronic Medical Records (EMRs).

Pharmaceutical Industry

Fosun Pharma to Float up to $470 Million in Bonds
(Biospace, 2011-11-26)
Shanghai Fosun Pharma received permission from the China Securities Regulatory Commission (CSRC) to offer up to 3 billion RMB ($470 million) of corporate bonds. The bonds will be issued in installments. Half of the total must be offered in the first six months, and the remaining amount can be issued during the next 18 months. Fosun Pharma did not disclose how it intends to use the capital.

Kunming and ZBD to Collaborate on TCM Injection
(Bioportfolio, 2011-11-26)
Kunming Pharmaceutical will partner with Heilongjiang ZBD Pharmaceutical to develop Sanqi Panax Notoginseng for Injection (freeze-drying), a TCM used for blood disorders. Each party will contribute IP that they own or “are about to own” to the collaboration. The reason behind the “about to own” phrase was not made clear. Panax Notoginseng is prescribed to promote hemostasis, blood production and blood thinning.

Zhejiang Huahai Pharma to Raise $204 Million
(ChinaBio Today, 2011-11-29)
Zhejiang Huahai Pharma announced it will stage a private placement of 100 million shares, raising as much as 1.3 billion RMB ($204 million). The company will use the proceeds to produce what was described as “blood thinning” APIs and finished drugs. Huahai is the world’s largest supplier of the antihypertensive class of drugs known as ACE (Angiotensin Converting Enzyme) inhibitors.

Regeneron/Bayer Start China Trial of Wet AMD Drug
(Pharma Times, 2011-11-29)
Regeneron Pharma and Bayer have begun a China Phase III trial of Eylea™ (aflibercept) Injection, a treatment for neovascular age-related macular degeneration (wet AMD). Earlier this month, Eylea was granted FDA approval for this indication in the US.

Sihuan Bioengineering Sues Vitapharm to Unwind Deal
(Silobreaker, 2011-11-30)
Jiangsu Sihuan Bioengineering is suing Vitapharm Technology Co. of Australia. Last year, Sihuan bought China rights to Vitapharm’s sublingual drug delivery technology, but Sihuan now claims Vitapharm did not have an effective patent for the technology. Sihuan is asking a Beijing court to set aside the transaction.

Biotechnologies

Roche NimbleGen and BGI Develop Advanced MHC Region Capture Technology for Human Disease and Biomedical Research
(Free Library, 2011-11-28)
Roche NimbleGen, Inc and BGI, the world’s largest genomic organization, announced that they have developed a Major Histocompatibility Complex (MHC) region capture technology based on NimbleGen SeqCap EZ Choice Library, a revolutionary process for the enrichment of the MHC region. This newly developed approach allows easy capture and enrichment of these highly repetitive regions and enables the generation of deep sequencing coverage of the human MHC region. This new sample preparation approach overcomes the limitations of traditional methods of PCR and genomic enrichment used for disease and drug research.

Scientific News

Traditional Chinese medicine provides new remedy for aplastic anemia
(Medical Wesrch, 2011-11-26)
Chinese scientists have worked out a new herbal remedy for aplastic anemia, a potentially fatal disease that can significantly reduce patients’ risk of infection and bleeding. The herbal granules, jointly developed by specialists from 16 medical institutions in Beijing, Tianjin, Hangzhou and Guangzhou, effectively relieves anemia and enhances patients’ immunity, said Dr. Zhou Yuhong, a specialist on blood diseases with Zhejiang Hospital of Traditional Chinese Medicine (TCM). In addition, the new drug has not shown any side-effects that are common in prevalent Western therapies, said Dr. Zhou, head of the research project known as “TCM intervention in chronic aplastic anemia treatment.”

Chinese Pharma & Biotech Press Review – N° 220

Feb
24
2011


HEADLINES

Dear customers,
Universal Medica is proud to present you the 220th number of its weekly press review “Chinese Pharma and Biotech Press Review” dedicated to the fastly growing Chinese biotechnology and pharmaceutical market.
Wishing our newsletters keep you in touch with the finest news about Chinese healthcare market.
For more information, please contact: info@universalmedica.cn

FOCUS

  • SFDA Will Inspect Foreign Drug Makers
  • China’s police forces take group action in combating fake medicines
  • Chinese Vice Premier visits HIV/AIDS medical personnel
  • China holds forum to leverage on generic market
  • China will train 35,000 professionals in emergency medicine by 2015

Healthcare News

SFDA Will Inspect Foreign Drug Makers
(China SFDA, 2011-11-18)
The SFDA has announced it will begin inspecting foreign drug makers whose products are imported into China. The initial batch, mainly volunteers, will consist of five to ten foreign drug makers from five different countries. These companies signed up because they want to help the SFDA refine its inspection skills. The move reflects China’s desire to bring its drug regulation system up to international standards.

BGI Forms Children’s Disease Partnership with Philadelphia Hospital
(Biospace, 2011-11-19)
BGI, formerly known as the Beijing Genomics Institute, though it is now located in Shenzhen, has established a joint institute with the Children’s Hospital of Philadelphia. The partnership, which will be called BGI@CHOP, will seek to determine genetic causes of both rare and common pediatric diseases using the Philadelphia Hospital’s biobank and expertise in clinical phenotyping.

China’s police forces take group action in combating fake medicines
(新华美通, 2011-11-17)
Police forces in China’s different regions launched a group action as part of a campaign to combat the production and sale of fake medicines, the Ministry of Public Security said. Police in 29 province-level regions will work under the command of the ministry and cooperate with the food and drug administrative authorities in raiding sites linked to criminal activity by investigations, the ministry said in a statement. According to the statement, the campaign has investigated 790 cases of medicines counterfeiting nationwide and targeted over 1,000 suspects involved.

Chinese Vice Premier visits HIV/AIDS medical personnel
(中国日报, 2011-11-21)
Chinese Vice Premier Li Keqiang visited HIV/AIDS medical personnel, volunteers of non-government organizations (NGOs), and people living with HIV ahead of the World AIDS Day which falls on Dec. 1. In the voluntary testing clinic of the Beijing Diseases Prevention and Control Center (CDC), Li said counseling and testing are crucial to the early detection and early treatment of HIV/AIDS, and encouraged the clinic staff to work hard on the very front-line of HIV prevention and control. Li greeted people living with HIV and volunteers, shaking hands with them. He recognized the role of NGOs in keeping the disease at bay, particularly in terms of HIV/ AIDS awareness education and intervention. Li said HIV prevention and control is a systemic project that takes the entire society to carry out, calling for establishing a mechanism to involve “social forces” into HIV prevention and control. Li asked health authorities at all levels to keep close contact with HIV-related NGOs, providing assistance needed to these organizations and their volunteers. “Care, respect and assistance are the best pain relievers for people living with HIV,” Li said.

Chinese pharmacologist awarded 1 mln yuan for discovery of malaria drug
(CNTV, 2011-11-21)
A prize of one million yuan (157,500 U.S. dollars) was awarded to 81-year-old pharmacologist Tu Youyou and her team for their discovery of Qinghaosu, which has become a standard regimen for malaria. Tu, a scientist with the China Academy of Chinese Medical Sciences, was presented with the “outstanding contribution” award at a meeting held by the academy for her contribution to the discovery. During an interview on the sidelines of the meeting, the scientist described the discovery as “an honor that would help traditional Chinese medicine go global.” Tu also gave credit to her research team, saying the discovery of Qinghaosu could not have been accomplished without the help of her colleagues.

China holds forum to leverage on generic market
(China Biospectrumasia, 2011-11-18)
The Chinese pharmaceutical industry is accelerating its expansion into major global markets. For that reason, the China Centre for Pharmaceutical International Exchange (CCPIE) of the SFDA, is holding its second International Forum on Generic Drugs in Shanghai. This year’s Forum is host to about 300 attendees, including the key management of major Chinese pharmaceutical companies and senior officials of the SFDA. According to one of the speakers, Stravencon’s CEO Mr Douglas B Andrews, “This Forum will provide the senior management of Chinese companies with the necessary information to emulate in pharmaceuticals what Chinese firms have already accomplished in many other industrial fields.”

China will train 35,000 professionals in emergency medicine by 2015
(China MOH, 2011-11-18)
More than 35 000 health professionals who specialize in emergency care will be trained between 2011 and 2015 to strengthen the capacity of the country to respond to disasters and emergencies in public health, health authorities said. This program funded by the government, which details a plan for large-scale training for the next five years, was unveiled at a press of the Ministry of Health. The Ministry states that the courses offered include the management of medical emergencies, prevention and control of acute infectious diseases and the emergency treatment of poisonings and severe radiation.

Pharmaceutical Industry

Tiantan Biological Receives $24 Million from Gates Foundation
(Topix, 2011-11-17)
Beijing Tiantan Biological Products has received an offer from the Bill & Melinda Gates Foundation for $23.73 million in backing to develop oral polio vaccines. Tiantan will supply the oral polio vaccine to UNICEF (United Nations Children’s Fund), after the vaccine has been certified by the WHO.

Novartis Will Invest $25 Million in Zhongshan Facility
(Bioportfolio, 2011-11-18)
Novartis will spend $25 million to enlarge a manufacturing facility in Zhongshan city, Guangdong Province. The plant, which produces drugs for Sandoz, Novartis’ generic subsidiary, will be the largest facility devoted to generics in China. Novartis signed a MOU with the government of Zhongshan this week.

Tasly Pharma Selects ICON for Global Phase III Trial of TCM Heart Drug

(Contractpharma.com, 2011-11-22)
Tasly Pharmaceuticals has chosen ICON, the Dublin-based CRO, to conduct a global Phase III trial of Tasly’s oral TCM treatment for angina. The drug, known alternately as T89, Dantonic® and Cardiotonic, could be the first TCM to win FDA approval in the US. In June of this year, Tasly announced it would invest $40 million into a US facility to support Dantonic.

Lilly Blames Weak China IP Protection for its Low China Investment
(ChinaBio Today, 2011-11-23)
Lilly remains worried about IP theft in China, even though the company is upping its investment in the China market in an attempt to increase its market share. In a recent interview, CEO John Lechleiter said China has made “remarkable progress” against counterfeiting, and “The importance of intellectual property protection is understood by the highest levels of government in China.” Nevertheless, IP theft remains a problem, according to Lechleiter.

Daiichi Sankyo establishes China subsidiary
(BioSpectrum, 2011-11-18)
Daiichi Sankyo announced the establishment of its 100 percent owned China subsidiary Daiichi Sankyo China in Shanghai. Daiichi Sankyo China will manage the operations of Daiichi Sankyo Pharmaceutical (Beijing) and Daiichi Sankyo Pharmaceutical (Shanghai), promoting quick decision making and strategic investment to ensure further growth and greater presence for the Daiichi Sankyo Group in China.

A Second Life for Bayer’s Diabetes Drug in China

(Chinese Life Science Professionals Association, 2011-11-24)
China offers many different opportunities to global pharma – inexpensive APIs, drug development, a large market, to name a few very broad categories. For Bayer, China has given a second life to a 17-year-old diabetes drug, Glucobay. Glucobay, long off patent, is almost forgotten in the US. But it provided Bayer China with $283 million in revenues last year, an increase of 22% over the year before.

Biotechnologies

China Plans $1.7 Trillion Investment in Hi-Tech, including Biotechnology
(Biotechnologyheadlines.com, 2011-11-22)
China will invest 10 billion RMB ($1.7 trillion) over the next five years into five strategic industries – one of which is biotechnology. The program and the amount were announced by US Commerce Secretary John Bryson, who is visiting China on an official trade mission. The program was reported for the first time one year ago in a Reuters report, but it was never officially confirmed.

Asia/Pacific news

Italian Pharma Menarini Buys Invida of Singapore
(Pharma Times, 2011-11-17)
Menarini, the largest pharmaceutical company in Italy, has bought Invida, a drug commercialization company headquartered in Singapore that operates in Asia Pacific. Invida, whose revenues top $220 million annually, was established in 2005 by three companies: Temasek, Singapore’s official investment arm; Quintiles, an international CRO; and the Zuellig Group, a large Asia Pacific drug distribution company. Invida offers services from sales to contract manufacturing. Terms of the transaction were not disclosed.

Chinese Pharma & Biotech Press Review – N° 219

Feb
17
2011


HEADLINES

Dear customers,
Universal Medica is proud to present you the 219th number of its weekly press review “Chinese Pharma and Biotech Press Review” dedicated to the fastly growing Chinese biotechnology and pharmaceutical market.
Wishing our newsletters keep you in touch with the finest news about Chinese healthcare market.
For more information, please contact: info@universalmedica.cn

FOCUS

  • China’s Health Ministry promises reform after hospital scandals
  • Beijing curbs antibiotic addiction overdose
  • Infectious diseases kill 1,360 on Chinese mainland in Oct.
  • Almost 9 percent of Beijingers suffer from the illness diabetes
  • Experts say childhood diabetes on the rise in China

Healthcare News

China’s Health Ministry promises reform after hospital scandals
(新华网, 2011-11-11)
The Ministry of Health has promised measures to improve patient’s confidence in doctors after a number of scandals, said ministry spokesman Deng Haihua. Moreover, the ministry has ordered a thorough investigation into one particular recent accusation of medical negligence, said another senior official of the Health Ministry, Zhao Minggang, who also called on all medical workers to be extremely careful and prudent when treating patients. The case under investigation concerns a baby mistakenly diagnosed as stillborn in October in a hospital in south China’s Guangdong province. Medical workers wrapped the infant in a plastic bag and discarded it, only for relatives to later discover it was still alive. Huang Lichuan, director of the hospital’s department of obstetrics and gynecology, confessed that the nurses had made a wrong diagnosis due to a “shortage of experience.” Zhao called for more understanding from the public as there are in-built risks in medical treatments and the results might fall short of patients’ expectations. If patients have doubts, they can negotiate with the hospitals or ask health administrative authorities to solve them, Zhao said, or they can resort to court or mediation procedures.

Beijing curbs antibiotic addiction overdose
(Global Times, 2011-11-11)
Beijing authorities will launch a citywide campaign to regulate the overuse of antibiotics in public hospitals from now to the end of this year, a move to ensure safe medical practices. The overuse of antibiotics causes many of the drugs to become ineffective, which means drug-resistant infections may develop, such as MRSA, known as the “superbug.” If hospitals fail the assessment, their ranking may be downgraded, which may affect the hospital’s reputation. Beijing Municipal Health Bureau revealed they will evaluate antibiotic use in 165 second and third-class hospitals, the Beijing Times reported. “We’ll check the types and doses of antibiotics hospitals use. Hospitals which fail won’t be able to participate in hospital grade assessments,” said Ma Yanming, the bureau’s spokesperson.

Infectious diseases kill 1,360 on Chinese mainland in Oct.
(China MOH, 2011-11-11)
Infectious diseases killed 1,360 people on the Chinese mainland in October, the Ministry of Health said. More than 530,000 infections were registered in the month, including two cholera infections that resulted in no deaths, according to a statement posted on the ministry’s website. Cholera is categorized as a Class A infectious disease — the most serious class under China’s Law on the Prevention and Treatment of Infectious Diseases. Nearly 298,000 cases of Class B diseases were reported in the month, with 1,318 of them resulting in death. Viral hepatitis, tuberculosis, syphilis, dysentery, and gonorrhea were among the five most frequently reported cases in the month, accounting for 96 percent of all Class B cases, the statement said. The death toll due to Class C disease was 42. The top three Class C diseases were hand-foot-mouth disease, infectious diarrhea and mumps, which accounted for 96 percent of cases in this category.

Almost 9 percent of Beijingers suffer from the illness diabetes
(新华美通, 2011-11-12)
Some 8.6 percent of Beijing’s permanent residents between 18 and 79 years old are diabetes sufferers, the Health Bureau of Beijing Municipality has revealed. Diabetes has become one of the most serious threats to health in Beijing, said Mao Yu, deputy chief of the bureau. And the aging population is expected to develop more diabetic cases in the coming years, Mao added. Aside from confirmed patients, the bureau classes 5.1 percent of Beijing’s permanent population as potential diabetes patients. As well as genetics, diabetes can also be triggered by inadequate exercise, a poor diet, drinking, smoking and other unhealthy life styles, said Mao, with obesity the major cause of diabetes among children and adolescents. To promote awareness around World Diabetes Day on Nov. 14, the bureau has launched a campaign of free diabetes tests.

Lepu Medical Buys Controlling Interest in Dutch Device Maker
(Cafe Pharma, 2011-11-16)
Lepu Medical Technology (Beijing), which makes medical devices for coronary artery intervention and anesthesia delivery, will spend $6.6 million to purchase a 70% share in Comed, a Dutch company that makes medical devices used to treat cardiovascular diseases. Lepu Medical also announced it will spend $7.5 million to establish a Dutch Cooperative (Coop) in the Netherlands, which will presumably own the Comed stake.

RNL Opens the World’s Largest Stem Cell Medical Center in Beijing

(PRNewswire, 2011-11-15)
RNL BIO, South Korea’s premier adult stem cell firm has just founded the world’s largest stem cell medical center in Beijing. Beijing RNL Stem Cell Medical Center is located in Beijing’s “Yanda International Medical Research Institute“. Beijing RNL Stem Cell Medical Center facility occupies 41,600 square footage of Yanda International Medical Research Institute’s 297 acres gross area. RNL is proud to present the world’s largest stem cell medical center which has a capacity to store 20,000 patients’ stem cells.

Experts say childhood diabetes on the rise in China
(CNTV, 2011-11-14)
Medical experts called for more effective methods for diabetes prevention, as more children and teenagers in China are suffering from the disease. Diabetes has become one of the most commonly seen chronic diseases in children and teenagers, said Kuang Hongyu, a doctor at the No. 1 Affiliated Hospital of Harbin Medical University. About 10 percent of all diabetes patients the hospital receives are people under 20 years of age, according to Yang Aige, a doctor at the No. 1 Hospital of Hebei Medical University. He said the hospital’s youngest diabetes patient is only four years old. Genetics, inadequate exercise and poor diets are the main reasons behind the rising number of childhood diabetes patients, Yang said. Hospitals across China have been offering free diabetes tests as part of a national diabetes awareness campaign.

Pharmaceutical Industry

BMS plans shot in the arm for aging Chinese
(中国日报, 2011-11-09)
The international pharmaceutical company Bristol-Myers Squibb Co (BMS) has announced that it will focus on the development of drugs to fight chronic diseases in China, and will launch at least five new products by 2020. Jean-Christophe Pointeau, president of BMS (China) Investment Co Ltd, said that the company’s concentration on diabetes, hepatitis, cardiovascular and metabolic conditions, and cancer, is based on the fact that China has seen a rapid rise in the incidence of these chronic diseases. Ranked the world’s sixth-largest drugmaker by Fortune magazine in 2010, BMS launched a new diabetes medicine in China earlier this month. It will also launch new cardiovascular medication under joint development with Pfizer next year. Two more new diabetes drugs are expected to come on to the market between 2013 and 2014, and there are plans to launch a range of cancer and anti-viral medicines between 2015 and 2016.

China Resources Medications Forms $158 Million JV with Pientzehuang
(Biospace, 2011-11-12)
China Resources Medications Group will form a one billion RMB ($158 million) joint venture with Zhangzhou Pientzehuang Pharma. China Resources will own 51% of the entity, while Pientzehuang Pharma will be the minority partner. Pientzehuang will contribute eight products to the JV, which plans to build a 200,000 square meters pharmaceutical industrial park in Zhangzhou, Fujian province.

Fosun Pharma Buys 6.5% Stake in Simcere for $30 Million
(Bioportfolio, 2011-11-12)
Shanghai Fosun Pharma has purchased a 6.5% stake in Simcere Pharmaceutical, paying $30.3 million to buy 3.48 million of Simcere’s ADRs in open market transactions. Fosun has a history of buying stakes in US-listed China biopharmas. In 2009-10, Fosun slowly amassed a 32% stake in Tongjitang Chinese Medicine Company, another NYSE company. Then, Fosun and Tongjitang’s CEO/Chairman took the entire company private in November of last year.

WuXi PharmaTech to Form $50 Million Venture Fund
(Fiercebiotech, 2011-11-12)
WuXi PharmaTech has formed a $50 million corporate venture fund. The company listed a number of objectives behind the initiative, the first of which is to fund technologies that will increase WuXi’s service capabilities. The fund also hopes to help innovative scientists bring their breakthroughs to realization, and not surprisingly, WuXi expects to make money from the investments. The profits will come, said WuXi, as the investments grow in value and through the company’s access to new revenue-generating technologies.

Hutchison MediPharma Starts Clinical Trial of Cancer Drug
(Evaluate Pharma, 2011-11-15)
Hutchison MediPharma, the drug discovery arm of Chi-Med, has begun a first-in-human Phase I clinical trial of epitinib (HMPL-813), the third of MediPharma’s oncology compounds to enter clinical testing. Epitinib is a novel, second generation, orally active, small molecule inhibitor targeting the epidermal growth factor receptor (EGFR). MediPharma hopes epitinib will prove to be effective against brain tumors that have EGFR mutations, either primary brain tumors or tumors metastasized to the brain.

Pfizer’s Shanghai Anti-Infectives Research Unit Delayed
(ChinaBio Today, 2011-11-16)
Pfizer said it will extend the timeline on the build out of its Shanghai Anti-Infectives Research Unit. Earlier, an internet report stated the China research program had been cancelled. In February of this year, Pfizer announced it would close its Anti-Infectives unit in Groton, Conn. and transfer the operation to Shanghai. The move was supposed to take up to two years. Now, Pfizer says the timeline is extended, though the company has not announced a new schedule.

Intergraph® Technology Enables Bayer Technology Services to Engineer New Plant in China

(The Street, 2011-11-14)
Bayer Technology Services successfully implemented advanced process technology for a new Bayer Material Science production site at Caojing in Shanghai, using Intergraph® integrated design and engineering solutions. The new process technology significantly reduces solvent and energy consumption as well as operating costs and carbon dioxide emissions. Report said these results are achieved, among other factors, thanks to the engineering efficiency, quality and integration provided by the Intergraph SmartPlant®.

Scientific News

Chinese scientists identify a predisposing gene to schizophrenia
(Chine-informations, 2011-11-12)
Chinese scientists have identified a gene that increases the susceptibility of its carriers to be schizophrenic, announced the Anhui Medical University. The researchers analyzed the genes of 12 000 healthy individuals and schizophrenia patients and found the gene tspan-18. It is located on chromosome 11 and increases the risk of mental illness. Chinese researchers also validated the effect of another gene linked to schizophrenia, located on the sixth chromosome and discovered by their foreign colleagues. Schizophrenia is characterized by a dissociation of personality, affecting the patient’s connection with reality. Scientists from everywhere in the world are now trying to discover, through genetic analysis, the cause of mental illness and a permanent cure. The discovery of the scientists was published in the scientific magazine “Nature Genetics“.

Chinese Pharma & Biotech Press Review – N° 218

Feb
10
2011


HEADLINES

Dear customers,
Universal Medica is proud to present you the 218th number of its weekly press review “Chinese Pharma and Biotech Press Review” dedicated to the fastly growing Chinese biotechnology and pharmaceutical market.
Wishing our newsletters keep you in touch with the finest news about Chinese healthcare market.
For more information, please contact: info@universalmedica.cn

FOCUS

  • China to launch massive survey on TCM resources
  • China faces huge lack of hearing aid specialists: ministry
  • China warns against use of a diabetes drug in light of bladder cancer risks
  • Hundreds of hospital staff stage strike
  • Sanofi Says China Sales Grew 47% to $370 Million in Q3
  • Former Head of Shanghai Pharma Given Death Sentence for Accepting Bribes

Healthcare News

China to launch massive survey on TCM resources
(SATCM, 2011-11-06)
China will soon launch its fourth national survey on Traditional Chinese Medicine (TCM) resources to secure the industry’s sustainable development. The preparatory work has been completed and a pilot program for the survey will commence soon, covering six provinces and regions, including Anhui, Hunan, Hubei, Sichuan, Xinjiang and Yunnan, said Wang Guoqiang, vice minister of health. Wang, also director of the State Administration of TCM, made the remarks at the annual gathering for the country’s pharmaceutical professionals. The last survey on this subject, conducted between 1983 and 1987, indicated that the country had over 12,000 types of TCM resources with the majority in the wild. TCM generally refers to the comprehensive Chinese medical system based upon the body’s balance and harmony. Among the components of TCM are traditional herbal drugs and inherent therapies, including acupuncture, physical exercise, and remedial massage.

China Nuvo Solar Energy, Inc. Announces Third-Party Distribution Agreement With Bluewater Surgical, Inc.
(13abc.com, 2011-11-05)
China Nuvo Solar Energy, Inc. (CNUV) announced that SurgLine, Inc.has signed an agreement with Bluewater Surgical, Inc. to a western distributorship. Bluewater Surgical plans to offer SurgLine products for spine surgery, sports medicine, trauma surgery and more to acute care hospitals and physician owned surgery centers as an alternative to the high priced medical device providers in the marketplace.

China faces huge lack of hearing aid specialists: ministry
(China MOH, 2011-11-07)
China is faced with a huge lack of hearing aid specialists who can examine and evaluate people’s hearing problems and recommend suitable aid devices for them, the Ministry of Health said. A total of more than 60,000 hearing aid specialists are needed to serve China’s 27 million people with moderate or severe hearing problems, but the country’s number of available professionals is less than 20 percent of the total figure needed, according to the ministry. China currently has only around 10,000 such technical professionals, the ministry said in a statement, adding that there needs to be one hearing aid specialist for every 400 hearing-impaired people. China still has a long way to go in the training and selecting of enough qualified hearing aid specialists, said the ministry. The ministry recently organized a national professional competition in hearing recovery in a bid to create a favorable atmosphere for training of hearing aid specialists.

Hundreds of hospital staff stage strike
(South China Morning Post, 2011-11-08)
500 of auxiliary staff at a top Shanghai hospital went on strike, demanding a pay rise and full social welfare insurance. They gathered in a passageway leading to the emergency department at the Xinhua Hospital Affiliated to Shanghai’s Jiaotong University Medical School at about 7am. The staff, known as care workers, does most of the cleaning and basic patient care, leaving medical matters to nurses. They are managed by hospitals through subcontractor company, earning about 40 to 80 yuan (HK$48 to HK$97) a day. The hospital authority said it had called in medical staffs that were off to fill in for the striking care workers. The strikers left the passageway after 10am to negotiate with the subcontractor company. While many internet users expressed sympathy for the low-paid care workers many others criticized them. A man whose young son was to have surgery said they should uphold their rights in an open space, not in a passageway leading to the emergency room.

China warns against use of a diabetes drug in light of bladder cancer risks
(China SFDA, 2011-11-08)
China’s State Food and Drug Administration (SFDA) warned doctors and patients of increased bladder cancer risks related to the use of the diabetes drug pioglitazone. The SFDA advised bladder cancer patients to avoid using pioglitazone or to use it in the smallest dose possible, and asked medical experts to weigh pros and cons before prescribing the medication and to work out rational, safe treatment plans for patients. The warning came after statements made by drug safety watchdogs in the United States and Europe said patients treated with drugs containing pioglitazone were more likely to develop bladder cancer. Pioglitazone was first used by the United States and Japan for treating type-II diabetes mellitus in 1999, and was approved for use in China in 2004. It has been sold in more than 100 countries worldwide. The SFDA said that it and relevant departments are conducting analysis and assessment to the safety of pioglitazone.

Pharmaceutical Industry

Aslan Pharma In-licenses China Rights to BMS Cancer Drug
(World Pharma News, 2011-11-05)
Aslan Pharmaceuticals, a pharmaceutical startup based in Singapore, has entered a strategic partnership with Bristol-Myers Squibb. Aslan will fund development of a BMS oncology candidate, BMS-777607, following a pre-agreed BMS program. BMS-777607 is a small molecule inhibitor of the MET receptor tyrosine kinase for treatment of solid tumors. The compound is expected to target gastric and lung cancer.

Global Pharm Holdings Group, Inc. Completes Acquisition of Qingdao Likang Pharmaceutical Co., Ltd.
(Reuters, 2011-11-05)
Global Pharm Holdings Group, Inc. (GPHG), a China-based, integrated pharmaceutical company engaged in pharmaceutical-related products distribution, Traditional Chinese Medicine (TCM) herbs cultivation and processing business through its subsidiaries in Anhui, Jilin, Guangdong and Shandong provinces, announced that it completed the acquisition of the 100% equity interest of Qingdao Likang Pharmaceutical Co., Ltd (Qingdao Likang), a city-level pharmaceutical distributor located in Qingdao, Shandong Province. With the completion of this acquisition, Qingdao Likang becomes an indirect wholly owned subsidiary of GPHG.

TPI to Develop New Formulation for Flagship Product Gingko Mihuan
(The Free Library, 2011-11-03)
Tianyin Pharmaceutical Co., Inc. (TPI), a pharmaceutical company that specializes in patented biopharmaceutical medicine, modernized traditional Chinese medicine (TCM), branded generics and active pharmaceutical ingredients (API) announced the formulation expansion program for its flagship product Gingko Mihuan Oral Liquid (GMOL). GMOL, the proprietary prescription medicine for TPI with averaged annual revenue of $22 million, is used nationwide in China to treat brain ischemia and infarction, coronary heart diseases, memory dysfunction and other neurological disorders. Major components in the Gingko extracts are flavonoids and terpenoids.

Sanofi Says China Sales Grew 47% to $370 Million in Q3
(Topix, 2011-11-08)
Sanofi reported its China revenues climbed 47% in Q3 to $370 million, a gain of $119 million. About one-third of that rise can be attributed to Sanofi’s acquisition of BMP Sunstone, whose sales were running about $40 million per quarter when the company was still an independent entity. The quarter puts Sanofi at an annual run rate of $1.5 billion for China revenues.

Jennerex/Lee’s Pharma Report Positive Phase II Data for Cancer Drug
(Evaluate Pharma, 2011-11-09)
Jennerex, a San Francisco clinical-stage biotech focused on cancer therapies, released positive data on its novel treatment for liver cancer, JX-594. Lee’s Pharma of Hong Kong has in-licensed China rights to the drug, and will conduct the China portion of a global Phase III trial. About 600,000 cases of hepatocellular carcinoma are diagnosed each year, of which 350,000 are in China. The US reports only 20,000 new cases every year.

Yabao Pharma Raises $74 Million in Secondary Offering
(Biospace, 2011-11-09)
Yabao Pharmaceutical Group announced a 470 million RMB ($74 million) private placement. The proceeds will be invested in a GMP production facility, quality control systems for Safflower production, a production line for solid preparations and other projects. In February 2011, Yabao announced a $50 million collaboration with Frontage Labs of Pennsylvania to develop sustained release versions of more than 20 products.

Former Head of Shanghai Pharma Given Death Sentence for Accepting Bribes
(Peace Times, 2011-11-10)
Jianwen Wu, the former head of Shanghai Pharmaceutical Group, received a death sentence from a Shanghai court for accepting bribes, embezzling public funds and other charges of graft. However, the sentence was suspended for two years, and most likely, Wu will see the sentence changed to life imprisonment if he exhibits good behavior over the next two years.

Biotechnologies

China National Biotechnology to IPO on the Hong Kong Exchange
(Bioportfolio, 2011-11-05)
China National Biotechnology Group (CNBG) plans a Hong Kong IPO, according to Zhiping Song, Chairman of its parent, China National Pharmaceutical Group Corporation (SinoPharm Group). CNBG, which will change its name to China Biotech, is comprised of six institutes of biological products. According to two people with knowledge of the matter, CNBG plans to seek as much as $2 billion in an initial public offering.

ImmBio Strikes China Deal with CNBG Unit for TB Vaccine
(ChinaBio Today, 2011-11-05)
ImmunoBiology Ltd (ImmBio), a Cambridge, UK vaccine company, has joined with Sinopharm Vaccine Institute, a part of China National Biotechnology Group (CNBG), to co-develop T-BioVax, ImmBio’s proprietary TB vaccine. The goal of the partnership is to bring the T-BioVax vaccine through SFDA approval and market it in China initially.

Sinovac Biotech’s EV71 Vaccine Passes Phase II Test
(International Business Times, 2011-11-10)
Sinovac Biotech announced positive top-line results from a Phase II clinical trial of the company’s inactivated vaccine for human enterovirus 71 (EV71), which causes hand, foot and mouth disease (HFMD). The vaccine showed good immunogenicity and a favorable safety profile with no vaccine-related serious adverse events.

Chinese Pharma & Biotech Press Review – N° 217

Feb
3
2011


HEADLINES

Dear customers,
Universal Medica had the pleasure to be a speaker during the 6th Shanghai Pharmacoepidemiology and Clinical Use of Drugs International Symposium. We introduced the French and European pharmacovigilance systems.
For more information, please contact: info@universalmedica.cn

FOCUS

  • China, Canada to build research center for child development, Alzheimer’s disease
  • China’s cabinet approves emergency vaccine provision plan
  • Gates Foundation and China Form $300 Million Drug and Agriculture Partnership
  • Chinese pharma eyes opportunity in U.S., U.K.

Healthcare News

China, Canada to build research center for child development, Alzheimer’s disease
(人民日报, 2011-10-27)
A Chinese-Canadian research center for child development and the study of Alzheimer’s disease will be built at Chongqing Children’s Hospital in southwest China. The center will be jointly funded by the Chinese hospital and the University of British Columbia (UBC) in Canada with a total investment of over 30 million yuan (4.8 million U.S. dollars). Medical researchers at the center will carry out research on diseases such as Down syndrome, Alzheimer’s, epilepsy, cerebral palsy, autism, and learning dysmnesia. The center, to be operational within two or three years, has invited chemistry Noble laureate Aaron Ciechanover as a consultant.

The FDA Improves Tracking of Foreign-Sourced Drugs
(ChinaBio Today, 2011-11-03)
The US FDA is instituting a new IT system that tracks the source of drugs to help control the risks of drugs manufactured in foreign countries. For countries like China, the new system asks companies to increase their cooperation with the US pharmaceutical regulator. Drug companies whose products are well documented will be rewarded with expedited customs clearance.

China’s cabinet approves emergency vaccine provision plan
(China.org, 2011-10-26)
The State Council, or China’s Cabinet, approved a plan to create a national vaccine provision system in order to boost the country’s ability to cope with epidemic emergencies. The plan was passed at a regular meeting held by the State Council and presided over by Premier Wen Jiabao. “Our country’s vaccine reserves can meet the basic demands of regular epidemic prevention, but our ability to research, manufacture and preserve supplies for emergencies are inadequate,” said a statement released after the meeting. Although acknowledging vaccination as “one of the most economic and effective measures” to prevent infectious diseases, the statement said that the actual vaccination rate in the country is still comparatively low. According to the plan, a vaccine provision system that can supply regular use and at the same time greatly boost the country’s ability to cope with emergencies should be set up by 2015. By 2020, the system should be able to cope with emergencies and major epidemic situations as quickly and effectively as those found in developed countries, said the plan. According to the statement, the country will improve its epidemic monitoring network, strengthen research and development of vaccines against major and new diseases and boost the quantity and quality of vaccine production.

Lepu Medical Invests $15.6 Million to Increase Medical Device Capacity
(Bioportfolio, 2011-10-27)
Lepu Medical Technology (Beijing), a coronary artery intervention and anesthetics device maker, will transfer 99 million RMB ($15.6 million) into a subsidiary, Shanghai Shape Memory Alloy Material. Shape Memory Alloy will use the money to expand production of its coronary occlusion products.

Gates Foundation and China Form $300 Million Drug and Agriculture Partnership
(Seekingalpha, 2011-10-29)
China’s Ministry of Science and Technology (MOST) will collaborate with the Bill & Melinda Gates Foundation in a $300 million initiative to support innovative R&D that advances global health and agriculture. The two groups will select promising China projects. For every dollar the Gates Foundation grants to support the project, MOST will contribute two $.

PM Group establishes in China
(PrimeNewswire, 2011-10-28)
The international engineering, architecture and project management firm, PM GROUP has announced the opening of an office in China to service its multinational biopharma and food clients, as it continues to increase its international footprint. PM Group chose China to capitalise on future opportunities in what is one of the fastest growing regions in the world, according to Dave Murphy, CEO of PM Group.

Alios Signs Flu Treatment Deal with Univ. of Hong Kong
(Topix, 2011-11-01)
Alios BioPharma of South San Francisco has licensed technology that targets influenza to Versitech Limited, the technology transfer arm of the University of Hong Kong. The technology may lead to novel medications that treat the flu through a “novel chemical matter that targets a unique component of the influenza virus life cycle.”

China reports about 60,000 new HIV/AIDS cases
(中国日报, 2011-11-01)
China reported about 429,000 registered AIDS patients and HIV carriers as of the end of September, up by nearly 60,000 over the past 11 months, according to official figures released. Chen Zhu, China’s Minister of Health, revealed at a conference that since the 1980s, the country had seen over 164,000 registered AIDS patients and 86,000 recorded deaths attributable to the disease. Although growth in the registered HIV/AIDS population has declined in recent years, previous research also indicated a large group not covered in the official count. A joint research project conducted in 2009 by the MoH and the WHO estimated the total to be 740,000 as of the end of that year. With more HIV carriers turning into AIDS patients and more deaths reported, the spread of the disease will project a growing influence on the social and economical development of affected regions, Chen said.

Chinese police seized 30 million $ of counterfeit medicines
(新华网, 2011-11-01)
The police in Henan province (central China) said it had seized 190 million yuan (29.9 million $) of counterfeit drugs during an investigation into production and sales network of illegal drugs. The public safety office in Kaifeng said in a statement that they had discovered the network in a robbery case in which a woman had replaced real drugs by fake ones, claiming to have purchased them in a pharmacy in April. After a four-month investigation, authorities in Kaifeng stormed the production and sales sites of 117 counterfeit drugs and arrested 114 members of the network, based in the city of Anyang. During this campaign the police seized more than 65 million bottles of counterfeit drugs.

Healthgen, a China Startup, Announces Rice-Derived Human Serum Albumin
(Biospace, 2011-11-02)
A China startup is on the verge of producing human serum albumin (HSA), a plasma protein, from rice. According to a report in the Proceedings of the National Academy of Sciences, their process produces HSA that is functionally equivalent to blood-derived albumin, a substance that is always in short supply. The lead author of the study, Daichang Yang, PhD of Wuhan University, has co-founded Healthgen Biotechnology Co., Ltd. to commercialize the breakthrough.

12,000 arrested for selling drugs online
(South China Morning Post, 2011-11-02)
Mainland police arrested 12,125 suspects and confiscated more than 300kg of illicit drugs in a nationwide crackdown on narcotics sold through online chat rooms. It is the first time authorities have smashed a nationwide drug distribution system which used the online media as its main transaction platform. In the campaign, which started in March, police busted 144 drug rings involved in narcotics trafficking and 22 drug-making plants. The report did not specify what drugs had been seized. Via the webcam of the chat rooms, members were taking drugs together, sharing their drug-taking experiences and buying and selling drugs. Many mainland internet services host video chat rooms. Their sizes vary, with some holding 10 people and some up to 500. Drug-taking activities usually took place in the chat rooms holding around 10 people.

Is FDA’s strategy outdated in China?
(CNTV, 2011-10-27)
The U.S. FDA seems to have disappointed Chinese citizens and many domestic enterprises over the past three years, after opening its first branch in China in late 2008. An obvious expectation of many was that the FDA could help improve safety standards and quality control of foodstuffs and consumer goods, while some Chinese enterprises hoped it would simplify the export routine and find them quicker access to the U.S. market. However, many are now questioning whether the existence of the branch is meaningful to the Chinese side. On September 20, 2011, the FDA’s China Office organized its first training session on food safety in Zhanjiang on aquatic product breeding and export. The attendees, Chinese government officials and enterprises leaders were treated like pupils from underdeveloped countries. While in fact, the FDA’s aquaculture supervision experience was not rich enough to tutor the Chinese enterprises, as American aquatic products mainly come from ocean fisheries and its aquaculture industry is not large-scale. Li Xiaofeng (alias), an official from a local Bureau of the China Inspection and Quarantine, noted that since the FDA has reached out its hand to China, it will not retreat. But China needs a better FDA branch to remove the questions domestic enterprises have about export policy and help ensure food safety around the world.

Pharmaceutical Industry


Novo Nordisk Rejects China M&A; Will Grow through Innovation

(Reuters, 2011-11-03)
Novo Nordisk A/S, the Danish pharma that specializes in diabetes drugs, does not want to grow in China through M&A. It plans to continue its emphasis on developing its own innovative drugs. To that end, Novo Nordisk has previously announced investments in its Beijing R&D center and Tianjin manufacturing plant, while it is also working to increase diabetes education in China.

Lansen Pharma Inlicenses China Rights to Rheumatoid Drug
(Biospace, 2011-10-28)
Lansen Pharmaceutical Holdings obtained exclusive China rights to a rheumatoid treatment from Ethypharm SA, a French pharma. Headquartered in Hong Kong, Lansen manufactures and distributes western-style drugs in mainland China, with a focus on disease-modifying anti-rheumatic drugs (DMARDs). The license gives Lansen the right to distribute ketoprofen/omeprazole slow-release capsules for more than ten years.

Chinese pharma eyes opportunity in U.S., U.K.
(Fiercepharma, 2011-10-28)
Big Pharma’s stampede into China is well documented. But Chinese drugmakers appear to have an appetite for sales in Big Pharma’s home markets. As China Daily reports, a group of Chinese pharma executives and industry investors made a foray into the U.S. to check out the prospects. They met with Amgen, Pfizer, Ernst & Young‘s pharma group and healthcare-investment specialist Warburg Pincus. “We are here to learn from the major international pharmaceutical entrepreneurs,” Buchang Pharmaceuticals President Zhao Chao told the Daily, “and to also look for cooperation possibilities.” Meanwhile, a Chinese drugmaker is said to be scouting sites for operations in the U.K. Company officials have checked out AstraZeneca‘s ($AZN) 69-acre site in Loughborough, which is slated for closure later this year, and Pfizer’s ($PFE) Sandwich facility, which is also up for sale, the Leicester Mercury reports. Thing is, the pharma growth that has foreign drugmakers salivating has also fattened up Chinese pharma’s purse. Investment in Chinese pharma is up by almost 38% so far this year to $19.7 billion, government statistics show. Chinese companies already have a sizable share of the U.S. market for APIs and raw materials, but to grow substantially, analysts say, they’ll need to supply finished doses.

Chinese Pharma & Biotech Press Review – N° 216

Feb
27
2011


HEADLINES

Dear customers,
Universal Medica is proud to present you the 215th number of its weekly press review “Chinese Pharma and Biotech Press Review” dedicated to the fastly growing Chinese biotechnology and pharmaceutical market.
Wishing our newsletters keep you in touch with the finest news about Chinese healthcare market.
For more information, please contact: info@universalmedica.cn

FOCUS

  • Health experts warn antibiotics heavily overused in China
  • Traditional Chinese medicine to establish in Middle East
  • UC Davis and BGI Announce Partnership to Establish State-of-the-Art Genome Center in Sacramento
  • BioBay, Roche and Harvard Form Novel Cancer Drug Partnership
  • Novartis Transferring Jobs from Europe/US to China and India

Healthcare News

Health experts warn antibiotics heavily overused in China
(Global Times, 2011-10-19)
Chinese medical experts have warned that antibiotics have been “heavily overused” at hospitals, which might cause serious side-effects for the health of an entire generation. The average annual consumption of antibiotics per capita in China amounts to 138 grams, ten times the level in the United States, said Xiao Yonghong, an expert with the Institute of Clinical Pharmacology of Peking University, in the Beijing-based Guangming Daily. Penicillin is the most overused. According to a report from the Ministry of Health, the average dose of Penicillin that each Chinese has taken annually is almost three times higher than the international level. According to the ministry, 70 out of 100 Chinese inpatients have received antibiotics while the maximum number set by the WHO is 30. About 97 percent of patients in the surgical department in China used antibiotics but research showed that a large number of surgical patients would not need antibiotics if hospitals conducted proper sanitation measures, the ministry report said. Particularly, antibiotics are overused in the treatment of children. Nearly one third of the daily 10,000 outpatients at the Beijing Children’s Hospital take intravenous drips that largely contain antibiotics, said Yang Yonghong, a doctor with the hospital. The ministry launched a nationwide campaign over the past six months to regulate the use of antibiotics in the latest effort to ensure safe medical practice. Although progress has been made, Vice Health Minister Ma Xiaowei admitted that the government faces great challenges as quite a few public hospitals have loosened supervision on prescription safety under heavy pressure from patients. Insiders also noted that the overuse of antibiotics was partly driven by profit-seeking pharmacy firms. There are more than 6,000 pharmacy companies in China that produce more than 1,000 sorts of antibiotics. About 60 percent of the newly approved medicines by the State Food and Drug Administration (SFDA) last year were antibiotics. According to the SFDA, the country reported 690,000 cases of adverse drug reactions caused by abuse of medicine, including 600 deaths in 2010. The SFDA announced a regulation on the clinical application of antibiotics last week, reportedly the strictest ever.

Traditional Chinese medicine to establish in Middle East
(French.people.com.cn, 2011-10-19)
Tongrentang, an international renowned group specialized in traditional Chinese pharmacopoeia, opened a clinic in Dubai offering treatments based on Chinese medicine, the first of its kind in Middle East. The new facility, owned by Beijing Tongrentang Gulf Co. Ltd, is located in Dubai healthcare center. The clinic has its own pharmacy, offering more than 70 medicinal plants-based products 100% natural, certified by internationally recognized companies and in accordance with World Health Organization (WHO) standards.

UC Davis and BGI Announce Partnership to Establish State-of-the-Art Genome Center in Sacramento
(PRNewswire, 2011-10-25)
The University of California, Davis, and BGI, the world’s largest genomic institute, based in China, have signed a historic agreement that will change the landscape of genomic sciences in California and the Western states, and foster critical breakthroughs in the areas of food security and human, animal and environmental health. The new partnership will establish a state-of-the-art BGI sequencing facility for immediate use on the UC Davis Health System campus in Sacramento, and initiate planning for a permanent BGI@UC Davis Joint Genome Center.

BEYOND Dental & Health Opens 19th Regional Office in China
(ABC 12, 2011-10-25)
BEYOND Dental & Health, global leader in the design and manufacture of professional teeth whitening systems and aesthetic dentistry products announced the opening of its 19th regional office in Mainland China, completing a plan to open 12 offices this year across the country. “We’re excited by the growth in the Mainland China market, each office now has a fully trained sales and technical support team that can reach dental hospitals, private practices, and dental students directly – this direct reach is unique in China where most companies rely on regional distributors for product sales and support” says Joshua Granson, Vice President and International Marketing Director for the company.

Life Technologies Launches 3500 Dx Series Genetic Analyzers for In Vitro Diagnostic Use in China
(Pharmainfo.net, 2011-10-25)
Life Technologies Corporation announced that its Applied Biosystems 3500 Dx / 3500xL Dx Genetic Analyzer has been approved by China’s SFDA for diagnostic use in China. The 3500 Dx is a capillary-based Sanger Sequencer intended for use in the analysis of human DNA or RNA for the detection of genetic changes that may lead to disease presence or susceptibility. “Approval by SFDA means that hospital laboratories and patients across China will benefit from the accuracy and reliability of the 3500 Series platforms,” said Siddhartha Kadia, President of Life Technologies, Greater China. “A number of diagnostic applications could be developed for the 3500, such as infectious disease and virus detection, genetic disease and cancer mutation identification for targeted drug therapies, as well as prenatal chromosome disorder detection.”

Pharmaceutical Industry

Simcere Partners Up with Suzhou NeuPharma on Cancer Drug
(Bioportfolio, 2011-10-21)
Simcere Pharma signed a strategic cooperation agreement with Suzhou NeuPharma to develop and produce novel drugs. The first candidate is a cancer drug. Simcere will contribute its production and marketing expertise, while NeuPharma will be responsible for developing drug candidates. Simcere is a China biopharma that is expanding from its base of branded generic drugs by entering numerous innovative research collaborations.

Medicilon to Complete Pre-Clinical Work on South Korean Anti-Depressant
(Clinica Space, 2011-10-21)
Medicilon, a Shanghai CRO, has agreed to complete the pre-clinical development of a new anti-depressant developed by SK Biopharmaceuticals of South Korea. Medicilon will prepare the work for both China and US approval of the small molecule, known as SKL-PSY, which is being developed as a treatment of depression and bipolar disorder.

Hepalink Pharma Posts Lower Q3 Results
(Business Week, 2011-10-20)
Shenzhen Hepalink Pharma, a maker of heparin products, reported its Q3 profits fell 58% to 148 million RMB ($23 million). Hepalink blamed the shortfall on a drop in the price of heparin API. In the past, Hepalink was the only China heparin API company whose products were certified by the FDA. It lost that advantage when a competitor was also granted FDA certification.

Amerigen Finds Partner to Develop Cancer Drugs in the US and China
(ChinaBio Today, 2011-10-20)
Amerigen Pharma signed a collaboration agreement with Stason Pharma to develop generic oral oncology drugs. Both companies are located in the US. Amerigen also has a China subsidiary, located in Suzhou, and according to Amerigen’s business plan, the company develops drugs for both markets.

ShangPharma Buys Charles River’s Shanghai Lab
(Chinasourcing.org.cn, 2011-10-25)
ShangPharma acquired the Shanghai research facility formerly owned by Charles River Labs. The purchase will allow ShangPharma’s main subsidiary, Shanghai ChemPartner, to expand its GLP tox study capacity. The lab comprises 31,990 square feet of in-vivo research facilities, which were designed for GLP tox studies, plus another 13,885 square feet of lab and office space.

WuXi PharmaTech Makes Clinical-Stage CRO Acquisition
(Seekingalpha, 2011-10-25)
WuXi PharmaTech will acquire two related China clinical-stage CROs so that the company can expand its offerings to include clinical-stage services for its clients. Previously, WuXi’s offerings were limited to pre-clinical drug development and contract manufacturing. In August, Dr. Ge Li, CEO of WuXi, announced the company would move into clinical-stage services through a “combination of organic growth and acquisitions.” Positioning the expansion as a natural outgrowth of its pre-clinical work, Dr. Li said clients were requesting help in obtaining SFDA approval for their new products.

BioBay, Roche and Harvard Form Novel Cancer Drug Partnership
(Biobay, 2011-10-25)
BioBay, the Suzhou life science park, announced a drug research collaboration with Roche and Harvard University. Harvard scientists will contribute a novel research approach to the project for a cancer drug that is built around autophagy, the degradation of cell components. BioBay will add expertise in medicinal chemistry and preclinical development, and Roche will provide access to its drug discovery, development and commercialization capabilities. The project will be implemented and managed by the newly established Nimbus Innoworks, a joint-venture between BioBay and Wen Associates.

Modern Hasen Pharma Building $43.6 Million Essential Drug Facility
(Biospace, 2011-10-26)
Shanghai Modern Hasen (Shangqiu) Pharmaceutical, a subsidiary of Shanghai Modern Pharmaceutical, announced to invest 277 million RMB ($43.6 million) to build a production facility in Shangqiu, Henan province. The new plant will produce drugs that are listed on the essential drug list.

Scientific News

Chinese scientists make breakthrough in leprosy treatment
(Dermatologymdreviews.com, 2011-10-24)
Chinese scientists have made a breakthrough that could lead to more effective treatments for leprosy. A team from Shandong Provincial Institute of Dermatology and Venereology in east China has identified two new risk variants near IL23R and RAB 32 genes that are responsible for the disease, according to a report published online in the scientific journal Nature Genetics. Knowing that the two gene variants influence susceptibility to leprosy could allow doctors to diagnose the disease in sufferers earlier in its outset, as well as to develop new treatments. A genetic database could now be built up to predict those people particularly susceptible to leprosy, said Zhang Furen, the leader of the research team. The study involved more than 10,000 samples being taken from leprosy sufferers and healthy test subjects and analysed. Leprosy is a chronic nerve-killing disease that leads to problems with patients’ skin, feet, hands, legs and eyes. More than 200,000 newly-contracted leprosy cases are reported worldwide every year, and China has around one tenth of the world’s sufferers.

Asia/Pacific news

Novartis Transferring Jobs from Europe/US to China and India
(Internet Drug News, 2011-10-26)
Novartis, the Swiss multinational pharma, plans to eliminate 2,000 jobs, about 1,100 of them in Switzerland and the remaining 900 in the US. Meanwhile, the company will raise its headcount in China and India. Apparently, Novartis plans to increase its clinical trial activity in the two Asian countries, because it will add 700 positions there in data management and trial monitoring. Many of the jobs being eliminated elsewhere are in those same fields.

Chinese Pharma & Biotech Press Review – N° 215

Feb
20
2011


HEADLINES

Dear customers,
Universal Medica is proud to present you the 215th number of its weekly press review “Chinese Pharma and Biotech Press Review” dedicated to the fastly growing Chinese biotechnology and pharmaceutical market.
Wishing our newsletters keep you in touch with the finest news about Chinese healthcare market.
For more information, please contact: info@universalmedica.cn

FOCUS

  • China’s essential medicine costs down by 25 pct in two years: official
  • 1.28 billion Chinese covered by healthcare medical insurance
  • Western lifestyle leads to rise in breast cancer rates
  • Chinese no faith in local clinics
  • China demands stricter drug management in hospitals

Healthcare News

China’s essential medicine costs down by 25 pct in two years: official
(China Human Rights, 2011-10-12)
Prices for essential medicine in community-level clinics dropped by 25 percent over the last two years, according to an official from the Ministry of Health. Zheng Hong, director-general of the ministry’s department of pharmaceutical policy and essential medicine system, said during a press conference that the drops came after the implementation of the essential medicine system in August 2009. Zheng said the system has been implemented in community-level healthcare institutions in all of China’s provinces, municipalities and autonomous regions. He said health insurance coverage has increased significantly over the last two years. Essential medicine, as defined by the World Health Organization (WHO), refers to medicine that satisfies the healthcare needs of the majority of a given population and should available at all time in adequate amounts. Chinese people have complained about the high cost of medicine in recent years, as doctors have attempted to generate income for hospitals by aggressively prescribing expensive and sometimes unnecessary drugs.

Western lifestyle leads to rise in breast cancer rates
(Asiaone.com, 2011-10-17)
Breast cancer has become the most lethal form of the disease among Chinese women, with city dwellers being hit harder than those in the countryside, medical experts said. In the past 30 years, the period covered by China’s large and rapid urbanization, the incidence of breast cancer increased about 6 percent annually, which was higher than the global average of 4 percent. The Chinese mainland reports 126,000 new cases of breast cancer and about 37,000 deaths from the disease each year, roughly one-tenth of the world’s total, the latest statistics from the Ministry of Health said. A more Western lifestyle, together with China’s opening-up, economic growth and a rising obesity epidemic, are mainly to blame, said Wang Ping, deputy director of the breast cancer center at Tianjin Cancer Institute and Hospital. Official studies showed that Chinese women aged 45 and above are most susceptible to the disease. This is about 15 years earlier than the average age in most developed countries. Women younger than 45 account for less than 20 percent of total patients on the mainland. By 2010, more than 1.8 million had been screened and nearly 900 cases diagnosed, official statistics showed.

Chinese no faith in local clinics
(Channelnewsasia.com, 2011-10-13)
Hospitals in China are notorious for their long waiting times, but many Chinese would still rather wait at hospitals than go to the local doctor or community clinic. Industry experts have said they cannot be blamed for such a mindset. Treating common cold and fever at the community clinic in China costs about US$10. In the hospital, the cost could go up to about US$30 because of additional specialist fees. Additionally, patients would have to wait for at least half an hour. Even though it may be cost- and time-saving to go to a polyclinic, many Chinese still rather flock to the hospitals to treat a common cold because they do not trust the medical standards at the community level. Xiamen Municipal Health Bureau deputy director Jiang Jie said: “The community clinics used to be small sub-district health centres. The staff were under-qualified, with some graduating from technical schools while some had no professional training or formal education at all.” To attract more young doctors, healthcare centres have been working to create more opportunities for career advancements, as well as better salaries.

China Medical Technologies Announces the Approval of the Renewed High and New Technology Enterprise Status for a Major Subsidiary in China
(Wltz.com, 2011-10-17)
China Medical Technologies, Inc., a leading China-based advanced in-vitro diagnostic company, announced that its wholly-owned subsidiary Beijing Yuande Bio-Medical Engineering Co., Ltd has passed the examination by the relevant government authorities and renewed its high and new technology enterprise status for another three year period from January 2011 to December 2013. With this status, Beijing Yuande is qualified for a preferential corporate income tax rate of 15%, which is lower than the statutory corporate income tax rate of 25%, as well as other government incentives for high and new technology enterprises.

1.28 billion Chinese covered by healthcare medical insurance
(人民日报, 2011-10-13)
Basic healthcare insurance programs in China currently cover 1.28 billion people, or 95.5% of the national population, said the Chinese government. The number of beneficiaries of health insurance for urban employees, the insurance program for unemployed urban residents and the new rural cooperative health insurance has increased by 154 million compared with 2008, stated an official from the reform of medical Office care of the State Council of China in a press release. In April 2009, the Chinese government has accelerated its healthcare reform by unveiling a three-year program with an investment of 850 billion yuan to provide affordable fair and high quality medical services. This reform gives priority to the large rural population, especially farmers, whose annual income is about 1, 595 yuan (250 $). According to the press release, the system, largely funded by donations and government grants, has collected this year 16.6 billion yuan funds, an increase of 75% compared to 2008. Nearly 100 million people have benefited from this support system, mostly poor, disabled and elderly people.

China demands stricter drug management in hospitals
(CNTV, 2011-10-17)
China’s top drug watchdog has demanded stricter drug management in medical institutions to provide better protection for consumers. In a statement issued, the SFDA said it recently issued a circular urging all hospitals and clinics to standardize their purchases, storage, allocation and use of pharmaceutical drugs. Medical institutions should keep a detailed account of information regarding the drug’s supplier, manufacturer, batch number, amount and price for at least three years, the administration said. Hospitals should establish systems to ensure drugs are well-stored for quality protection and to closely monitor expiry data information, according to the statement. Drugs made by hospitals should be strictly used within the institution and never circulated to other hospitals without prior approval from drug administration agencies, it said.

Boston Scientific Launches Promus Element™ Stent System In China
(Fierce Medical Devices, 2011-10-17)
Boston Scientific Corporation has begun a phased launch of its PROMUS Element™ Everolimus-Eluting Platinum Chromium Coronary Stent System in China. The launch campaign will be expanded within the country based upon receipt of subsequent provincial reimbursement approvals. The Company previously received registration approval for the PROMUS Element™ Stent System from the SFDA of China. “The PROMUS Element Stent represents a true next-generation DES technology and its unique platinum chromium alloy addresses many of the limitations found in older stent alloys,” said Runlin Gao, M.D., of the Cardiovascular Institute and Fu Wai Hospital in Beijing, and Principal Investigator of the PLATINUM China trial.

Zhuhai Hokai Medical Instruments Completes ChiNext IPO
(ChinaBio Today, 2011-10-19)
Zhuhai Hokai Medical Instruments, a medical device maker, offered 33.35 million shares at 20 RMB each on the ChiNext Exchange. The shares, which have begun trading, were priced at a PE ratio of 62 times earnings. The company provides minimally invasive cancer treatment technology and equipment.

Metabolon and Shanghai Jiao Tong University open Metabolomics Lab in China
(Business Wire, 2011-10-18)
Metabolon, a diagnostics and services company offering the industry’s leading biochemical profiling technology, announced that it has opened a new metabolomics lab in Shanghai in collaboration with Shanghai Jiao Tong University (SJTU). The SJTU-Metabolon Joint Metabolomics Laboratory is a partnership with Shanghai Jiao Tong University, one of the oldest and most prestigious public research universities in China. Metabolon has licensed its proprietary metabolomics platform technology to SJTU to enable a world class biochemical profiling laboratory at the university. SJTU has funded the laboratory and personnel already trained by Metabolon and will work with academic and commercial scientists within China or other Asian countries to perform biochemical profiling experiments with Metabolon’s technology.

Pharmaceutical Industry

BeiGene In-Licenses Two Potential Cancer Drugs from Janssen
(Fiercebiotech, 2011-10-15)
BeiGene, based in Beijing’s Zhongguancun Life Science Park, has acquired China rights to two clinical-stage compounds, both of them oncology drug candidates, from Janssen Pharmaceutica NV, a division of Johnson & Johnson. Founded last year, BeiGene has an ambitious two-pronged business plan that combines in-licensing of five clinical stage drug candidates with developing its own novel drugs. The two drug candidates, intetumumab and MTKi-327, are the first acquisitions the company has made.

Sinocom Pharma Withdraws Nasdaq IPO
(Ewallstreeter.com, 2011-10-15)
Sinocom Pharmaceutical withdrew its plans for an IPO on the Nasdaq exchange, blaming poor market conditions. Sinocom is a drug distributor in East-Central China that has expanded to growing TCM herbs. The shares were being offered by selling shareholders, who received them as part of a $15 million financing that allowed Sinocom to build a warehouse. The company planned to raise as much as $58 million.

Lundbeck Sets Up Research Center in Shanghai
(Pharmaphorum.com, 2011-10-18)
Lundbeck A/S, a Danish biopharma that specializes in CNS drugs, has established a research center in Shanghai. The center will do some of Lundbeck’s own work – work that is currently being performed by China CROs – and the center will also serve as a means of building Lundbeck’s relationships with innovative academic and pharma company researchers in China.

Biotechnologies

ViroMed’s Gene Therapy Drug Given SFDA Approval for Phase II Trial
(Biospace, 2011-10-14)
ViroMed of Korea has been given SFDA approval to begin a China Phase II clinical trial of a gene therapy drug. VM202-PAD will be tested as a treatment for Critical Limb Ischemia (CLI). The drug candidate is a biologic drug based on Hepatocyte Growth Factor (HGF), a gene that stimulates the growth of arteries. Trials of VM202-PAD for this indication are already underway in Korea and the US.

HUYA Bioscience International and Tianjin International Joint Academy of Biotechnology and Medicine Form Alliance
(Bioportfolio, 2011-10-18)
HUYA Bioscience International, a leader in globalizing China’s biopharmaceutical innovations, announced a strategic alliance with the Tianjin International Joint Academy of Biotechnology and Medicine (TJAB). The alliance will unite the strength and resources of both parties to accelerate the development of China’s biomedical innovation and industrialization. TJAB, a state of the pharmaceutical research & development platform, was jointly established by the Ministry of Science and Technology, the Ministry of Commerce, the Ministry of Health, the SFDA, and Tianjin Municipality. It was established with the vision of creating China’s International Innovation Zone of Biotechnology and Medicine (BioMed Zone) to boost China’s biomedical industry. Situated at the heart of the Tianjin Binhai New Area, TJAB has attracted more than 100 research & development groups, focusing in the areas of infectious diseases, cancer, diabetes, and hypertension.

Asia/Pacific news

Eurofins opens central laboratory in India
(Pharma Times, 2011-10-13)
The Global Central Laboratory operation of France’s Eurofins food, pharmaceutical and environmental testing group has opened a new central laboratory in Bangalore, India as part of its support network for clinical trials worldwide. The ‘Knowledge Hub’ in Bangalore gives Eurofins Global Central Laboratory a total of three central laboratories in the Asia Pacific region. The global central laboratory network now includes wholly-owned facilities in India, the United States, Europe, Singapore and China. The network supports clinical trials in more than 50 countries spanning six continents.

Chinese Pharma & Biotech Press Review – N° 214

Feb
13
2011


HEADLINES

Dear customers,
Universal Medica is proud to present you the 214th number of its weekly press review “Chinese Pharma and Biotech Press Review” dedicated to the fastly growing Chinese biotechnology and pharmaceutical market.
We continue to publish our weekly review for our numerous customers this week after the Chinese National Day.
Wishing our newsletters keep you in touch with the finest news about Chinese healthcare market.
For more information, please contact: info@universalmedica.cn

FOCUS

  • China to slash leprosy cases by half by 2020
  • China approves 1,000 drugs in 2010
  • Infectious diseases kill nearly 1,400 on Chinese mainland in Sept.
  • Beijing residents face rising cancer threat
  • China starts nationwide drug safety check

Healthcare News

China to slash leprosy cases by half by 2020
(English.gov.cn, 2011-10-03)
China plans to reduce the rate of leprosy cases by 50 percent over the next ten years in a bid to eradicate the infectious disease in the country, the Ministry of Health (MoH) has announced. The prevalence rate is targeted to be brought down to one case per 10,000 people by 2015, down by 20 percent compared to 2010, and the rate will further shrink to one in every 100,000 people by 2020, down 50 percent from 2010, according to a national leprosy-control plan (2011-2020) published by the MOH. A total of 500,000 leprosy patients have been reported and given free treatment across the country since the founding of the People’s Republic of China in 1949. The number of leprosy cases has plummeted over the past 62 years, but the country still faces challenges fighting the epidemic, the MOH said. Leprosy, an infectious disease that has affected humanity for over 4,000 years, is primarily characterized by skin lesions and progressive physical debilitation, and can cause permanent nerve damage. The government has divided the country’s 32 provinces, municipalities and autonomous regions into three categories in accordance with the situation regarding the epidemic, with the first-grade areas being the most affected by leprosy and the third-grade areas being least affected.

China approves 1,000 drugs in 2010
(新华网, 2011-10-10)
China’s food and drug watchdog said it approved 1,000 drug registration applications in 2010, 26.2 percent more than in 2009 due to an increase in the approval of generic chemicals. Among the approved drugs, chemicals represent the highest proportion at 89 percent, while Chinese traditional medicine accounts for less than 10 percent of the total, according to a report released by the SFDA. The report said more than 124 new drugs were approved in 2010. Domestic applications made up roughly 89 percent of the approved, among which 73 percent were generic, the report indicated. Most of these approved drugs purportedly fight infection, diabetes and diseases concerning the respiratory system and tumors. The total number of drug registration applications in 2010 was 6,294, according to the report.

Infectious diseases kill nearly 1,400 on Chinese mainland in Sept.
(China MOH, 2011-10-10)
A total of 1,390 people were killed by infectious diseases in September, the Ministry of Health (MoH) said. The ministry said in an online statement that one person died from bubonic plague, while seven cases of cholera resulted in no deaths. Plague and cholera are categorized as Class A infectious diseases, the most serious classification under China’s Law on the Prevention and Treatment of Infectious Diseases. A total of 317,564 cases of Class B diseases were reported last month, resulting in 1,353 deaths. No cases of severe acute respiratory syndrome (SARS), human H5N1 or class B diphtheria were reported. According to the statement, viral hepatitis, tuberculosis, syphilis, dysentery and gonorrhea were the five most frequently reported Class B diseases in September. There were 229,360 cases of Class C disease infections, causing 36 deaths. Foot-and-mouth disease, diarrhea and parotitis accounted for 95 percent of all reported cases of Class C diseases.

Beijing residents face rising cancer threat
(中国日报, 2011-10-12)
About 105 people were diagnosed with cancer every day in the capital last year, with the disease responsible for one in four deaths, a recent study shows. The figures were released by the Beijing Institute for Cancer Research during a news conference to mark the 35th anniversary of the Peking University Cancer Hospital, a partner organization. Lung and breast cancer are the major threats, said Li Pingping, co-author of the report. Research found that, between 2000 and 2009, instances of lung cancer rose 56 percent, while breast cancer cases went up 127 percent. Less common cancers such as thyroid cancer and uterine body cancer have also seen rapid increases over the past decade, the report added.

China starts nationwide drug safety check
(China MOH, 2011-10-12)
Six government departments started a nationwide drug safety check and assessment, according to the Ministry of Health (MoH). The MOH, the Ministry of Public Security and four other departments are working together to conduct the assessment, which will primarily focus on establishing order in the medical market and curtailing illegal activity in the medical industry. Eliminating the manufacture and sale of counterfeit drugs and stopping the spread of illegal medical advertisements are the most significant aspects of the campaign, according to Bian Zhenjia, deputy head of the State Food and Drug Administration (SFDA). Beginning in south China’s Guangdong Province, the inspection will be conducted in ten provinces and municipalities by ten panels consisting of experts and officials from the six departments.

Pharmaceutical Industry

Newsummit Launches $100 Million Fund for US Medical Device Makers
(Avcj.com,  2011-09-29)
Newsummit Pharmaceutical Group teamed up with the Cleveland Bio Fund in a $100 million effort to help US biomedical device companies to commercialize their products in China. The funds were raised in China, where Newsummit is located. Cleveland Bio Fund will identify Cleveland-area medical device companies with US-approved products. These companies will be small-to-medium sized entities that have not been able to bring their products to China. Once all the candidates in the Cleveland area have been examined, the fund will widen its search to include companies from elsewhere in the US.

Nycomed/Takeda Adds Antihistamine to China Portfolio
(ChinaBio Today, 2011-10-01)
Upon receiving government approval, a new Company based in China called Tasly-SemBioSys Pharmaceuticals, Ltd., will be incorporated in Tianjin, the third largest city in China. This Agreement is the most comprehensive partnering commercialization endeavor in SemBioSys ‘ history. SemBioSys is a biotechnology company that utilizes its renewable, patented plant seed oil body and protein expression technology platforms to develop and make high value proteins and oils and drug candidates for health and wellness products. Tasly is one of China’s largest pharmaceutical companies and is China’s second largest producer of traditional Chinese medicines (TCM). Its lead drug, Tasly Cardiotonic pill, is the number one selling TCM in China and has held that position for the last seven years.

SciClone Announces $20 Million Stock Buyback
(Bioportfolio, 2011-10-06)
SciClone Pharma announced a share repurchase program of up to $20 million over the next 24 months. SciClone, headquartered in California, commercializes and markets Western drugs in China. In addition to boosting the company’s stock price, the repurchase program will partially offset the 8.3 million shares that may be offered by the previous owners of NovaMed, which SciClone acquired in April of this year. Despite its solid financial performance, SciClone’s stock price remains low.

China’s Pharma Output Climbed 30% in First Seven Months of 2011
(China NDRC, 2011-09-29)
For the first seven months of 2011, the production value of mainland China’s pharmaceutical industry was up 29.6% compared to the same period last year, according to the National Development and Reform Commission. Total output was 802.4 billion RMB ($125 billion). All the sectors of the industry showed healthy gains. If the industry continues at its present pace, full-year 2011 output would equal 1.375 trillion RMB ($215 billion).

AstraZeneca to Build $200 Million Manufacturing Plant in China Medical City
(Pharma Times, 2011-10-11)
AstraZeneca will spend $200 million to build a major new manufacturing facility in Taizhou’s China Medical City. The plant, which will produce both IV and solid oral medications for the China market, is the largest investment AstraZeneca has ever made in a single manufacturing site. China is becoming increasing important to AstraZeneca. In the first half of 2011, the company’s revenues in the PRC grew 22% to $624 million.

Sembiosys and Tasly Pharmaceuticals Sign Multi-Product Commercialization and Platform Collaboration Agreement
(BiomedReports, 2011-10-11)
Upon receiving government approval, a new Company based in China called Tasly-SemBioSys Pharmaceuticals, Ltd., will be incorporated in Tianjin, the third largest city in China. This Agreement is the most comprehensive partnering commercialization endeavor in SemBioSys ‘ history. SemBioSys is a biotechnology company that utilizes its renewable, patented plant seed oil body and protein expression technology platforms to develop and make high value proteins and oils and drug candidates for health and wellness products. Tasly is one of China’s largest pharmaceutical companies and is China’s second largest producer of traditional Chinese medicines (TCM). Its lead drug, Tasly Cardiotonic pill, is the number one selling TCM in China and has held that position for the last seven years.

Biotechnologies

Rosetta Genomics Announces Exclusive License with Avatao Biotech for Distribution of miRview Tests in China
(PR Newswire, 2011-10-11)
Rosetta Genomics, a leading developer and provider of microRNA-based molecular diagnostic tests, announced that it has executed a license agreement with Avatao Biotech, a leading biotechnology company developing and distributing cutting-edge diagnostic products in China, for the exclusive rights to market miRview® mets and miRview® mets(2) , Rosetta’s microRNA-based diagnostic tests, in The People’s Republic of China. Avatao will also have the exclusive rights to market one additional Rosetta Genomics’ product in China which will be selected by Avatao within a year. Avatao is supported by Kunshan microRNA Institute, a leading research institute focused on microRNA technologies.

Biostar Announces $9.6 Million China Acquisition
(Dailymarkets, 2011-10-11)
Biostar Pharmaceuticals will pay 61 million RMB ($9.6 million) in cash to acquire Shaanxi Weinan Huaren Pharmaceuticals, Ltd. For Biostar, the attraction of Shaanxi Weinan is a portfolio of 86 approved drugs and one health product. Shaanxi Weinan reported revenues of $3.3 million in 2009 and $4.4 million in 2010, with net income of at least 15%.

Events

University of Hong Kong and Sinopharm Sign Cooperation Agreement
(Quamnet.com, 2011-10-11)
The University of Hong Kong and China National Pharmaceutical Group Corporation (Sinopharm), the largest pharmaceutical company in China, have signed a Strategic Cooperation Framework Agreement. It was the first time HKU has formed a cooperation partnership with a major state-owned pharma in Mainland China. The partnership between HKU and Sinopharm is vital to the industrialization of research output as well as the internationalization of Mainland pharmaceutical enterprises, and both parties are looking forward to benefiting mutually from the alliance.

Asia/Pacific news

GSK Seeking Up to $2B Bolt-on Acquisitions in India
(Smartbrief.com, 2011-10-05)
GlaxoSmithKline is looking to complete “smaller” acquisition targets in India in the $500 million to $2 billion range, according to the company’s CEO Andrew Witty. He characterized these transactions as bolt-on additions rather than transformative ones. GSK does not need a large acquisition, he said, because the company already has a well-established presence in India with a recognizable brand name. His comments would seem to apply equally to China, where GSK has been involved in several “smaller” M&A transactions.

Chinese Pharma & Biotech Press Review – N° 213

Feb
29
2011


HEADLINES

Dear customers,
The 2011 Universal Medica Market Access Conference held in Paris was a great success, Universal Medica Group thank all its participants and partners.
In the coming Chinese National day, the 1st October, Universal Medica wish you a happy holiday! We will continue to provide you with latest news on the Chinese healthcare market from October 13th.

FOCUS

  • 300,000 children aged under 5 die each year
  • Citywide checks after polio outbreak in Xinjiang
  • AstraZeneca Remains Committed to Partnering in China
  • Daiichi Sankyo Given OK for Prostatic Hyperplasia Drug in China

Healthcare News

Tech-Bank secures production approval for blue-ear pig vaccine
(ANDANH, 2011-09-22)
Leading domestic animal feed producer Ningbo Tech-bank Co. Ltd. (Tech-Bank) has obtained production approval from the Ministry of Agriculture (MoA) for a live vaccine for Porcine Reproductive and Respiratory Syndrome Virus (PRRSV). Also known blue-ear pig disease, PRRSV is a pandemic disease that causes reproductive failure in swine, as well as respiratory illnesses in young pigs. Tech-Bank expects to launch the vaccine, which targets the PRRS-CH-1R strain of the virus, as early as October this year. The product will be manufactured by Chengdu Tech-Bank Biological Products Co. Ltd. (Tech-Bank Bio), a vaccine maker Tech-Bank acquired in August 2008. The production approval is valid for five years.

300,000 children aged under 5 die each year
(新华网, 2011-09-22)
Almost 300,000 children aged under 5 on the Chinese mainland die every year, with more than 36 percent dying at home with poor access to healthcare, official statistics show. The Report on Women and Children’s Health Development, which was released by the Ministry of Health and is the first of its kind, lists five main causes of child mortality, including premature birth, congenital heart disease and accidental asphyxia. “China still faces daunting challenges to further reduce the sheer number of child deaths and to better address health equality,” said Qin Huaijin, director of maternal and child healthcare for the ministry. By 2010, the mortality rate of under 5-year-olds was 1.64 percent, down 73.1 percent and 58.7 percent on 1991 and 2000, said Qin, who put the change down to continuous efforts by the government to improve children’s health.

China sees first polio outbreak in 12 years
(Shanghaiist.com, 2011-09-22)
For the first time in 12 years, an outbreak of polio has struck China, infecting nine people in Xinjiang and inciting a furious scramble to vaccinate Xinjiang’s at-risk migrant children. The vaccination campaign targets 3.8 million children under 15 in the outbreak area, and children younger than five in other areas of Xinjiang. Recent tests conducted on the Xinjiang polio virus have linked it to a strain currently ravaging Pakistan, which has seen over 80 confirmed cases just this year. Interestingly, China’s last polio epidemic spawned when a man from another neighbor, India, carried the virus into the country in 1999. According to Oliver Rosenbauer of the World Health Organization, the strain’s rapid spread can be attributed to its extreme virulence. And if that isn’t fear-inducing enough, this particular virus also poses a higher risk of paralysis than other strains.

Citywide checks after polio outbreak in Xinjiang
(China.org, 2011-09-22)
Shanghai has stepped up screening to identify children who have missed polio vaccinations after an outbreak, was reported in Xinjiang earlier this month. “Migrant children are the main targets of the campaign in the wake of the polio outbreak in Xinjiang,” said the Shanghai Health Bureau’s Li Shanguo. “Local parents are strictly following the vaccination schedule by taking their children for vaccination in time, while migrant children may miss the injection due to low awareness and their removal from home town to the city.” He said each subdistrict will check all the children in its communities and require eligible children to get the free vaccination. In Beijing, according to a photograph posted online of a notice at a residential community, all Xinjiang people younger than 40 and migrant children younger than six were required to register for checks and vaccinations. In Shanghai, Li said, “we only screen children and give vaccines to children who were not vaccinated. Adults are so far not covered.”

Gov’t to further standardize Tibetan medicine
(CNTV, 2011-09-28)
The government will further accelerate the pace of standardizing the traditional Tibetan medicinal herbs and pharmacy in the next five years, according to a national conference on supporting the development of Tibetan medicine. The SFDA will step up its efforts to stipulate new standards or amend existing standards for Tibetan medicine, by giving greater policy support and more financial assistance to Tibet Autonomous Region, said Shao Mingli, director of the administration. Furthermore, the administration will help the regional government in building up local assessment institutions and train professional workers in this field. Great efforts have been done in the past years to standardize Tibetan medicine. The autonomous region has accomplished the drafts of 100 standards on Tibetan pharmacy.

Pharmaceutical Industry

Daiichi Sankyo Given OK for Prostatic Hyperplasia Drug in China
(Bioportfolio, 2011-09-23)
Daiichi Sankyo received SFDA approval for silodosin, a treatment of painful or difficult urination (dysuria) associated with benign prostatic hyperplasia. In 2008, Daiichi Sankyo paid $4.8 billion to buy a majority stake in Indian generic drugmaker v, combining Ranbaxy’s strength in generic drugs with its own expertise in patented cardiovascular and cancer drugs.

AstraZeneca Remains Committed to Partnering in China
(ChinaBio Today, 2011-09-24)
AstraZeneca plans to continue an emphasis on partnership in China drug development, rather than outright acquisition of China biopharmas with promising technology, according to Steve Yang, PhD, AstraZeneca vice-president and head of R&D for Asia and emerging markets. “In China, our collaboration strategy is to forge partnership with leading academic and medical institutions that already have in-depth expertise in Asia-specific diseases,” said Yang.

Zhongsheng Pharma Commits $3 Million to Three Novel Drugs
(BiospecGlobal, 2011-09-27)
Guangdong Zhongsheng Pharma will spend 20 million RMB ($3.1 million) to develop three new drugs to treat pulmonary fibrosis, diabetes and solid-tumor cancers in cooperation with Sichuan University and Guangdong South China Center for Innovative Pharmaceuticals. Zhongsheng Pharma owns the IP for the drugs, which have completed their pre-clinical development.

Cardinal Health Seeking to Acquire China Drug Distributors
(Seekingalpha, 2011-09-28)
Cardinal Health, the US drug distribution company, is still hunting for M&A opportunities in China’s drug distribution sector. Late last year, Cardinal Health made its first purchase in China, paying a sizeable $470 million to acquire the China drug distribution business of Zuellig Pharma. In the future, Cardinal wants to combine organic growth with acquisitions to expand its presence in China.

Biotechnologies

ProMetic Sells Biotech Product in China
(Biospace, 2011-09-23)
ProMetic Life Sciences, a Montreal-area biopharma, has made its first sale in China. The company said an unnamed large China pharma purchased a proprietary Mimetic Ligand™ affinity adsorbent to be used in a biomanufacturing process, which it will use for scale-up manufacturing of a biosimilar. If the biosimilar product is eventually approved, ProMetic expects a long-term supply agreement could yield the company between $3 million and $5 million per year.

China Grand Pharma Pays $17 Million for Wuhan Kernel Biotech
(Cafe Pharma, 2011-09-24)
China Grand Pharmaceutical and Healthcare Holdings will pay 110 million RMB ($17.2 million) to acquire an 81% stake in Wuhan Kernel Biotechnology. Wuhan Kernel develops and sells bio-pesticides (most of which are exported) and feed additives. China Grand Pharma, headquartered in Hong Kong, makes drugs and APIs in its PRC-based subsidiaries, with a specialty in cardiovascular and ophthalmology drugs.

Sinovac Given Final Go-Ahead for Animal Rabies Vaccine
(BioSpectrum, 2011-09-28)
Sinovac Biotech received a production license for RabEnd, its inactivated animal rabies vaccine, from China’s Ministry of Agriculture, the final step in the approval process for the vaccine. Sinovac has already assembled a sales force to help launch the product. The vaccine will be the first of Sinovac’s planned foray into animal health vaccines.

Events

BioBay Investor Forum 2011 Selects Chiva Pharma and Suzhou Biologix Medical Technology as Most Promising Companies
(Market Watch, 2011-09-23)
BioBay Investor Forum 2011 concluded a successful meeting, after selecting Chiva Pharmaceuticals, Inc. and Suzhou Biologix Medical Technology as the two “Most Promising” of the presenting companies. The event brought together more than 240 investors, entrepreneurs and industry experts to hear presentations from 19 of China’s young life science companies. The event was the fourth annual BioBay Forum. It was organized by ChinaBio LLC and Suzhou BioBay life science park.

Three American scientists honored for their promotion of the Sino-US medical cooperation
(人民日报, 2011-09-26)
Three American scientists of a prestigious cancer center in Houston were awarded by the local Chinese community during a gala, the prize of “Distinguished Friend of China” for their efforts to promote medical cooperation between the United States and China. The gala is one of the numerous activities organized by the Chinese community in Houston, the fourth largest city in the United States to celebrate the 62nd anniversary of the People’s Republic of China foundation. The three scientists are all working at the oncology Center MD Anderson of Texas University. The President of the center Ronald DePinho, his Vice Executive President Raymond N. Dubois and the physician Lynda Chin have all played a positive role in the development of Sino-American while working for collaboration among various U.S. and Chinese institutions for research, including drug, education, training and medical care in the field of cancer.

Scientific News

New study links high BPA level with type II diabetes
(Health-news-today, 2011-09-21)
Local doctors found a high level of bisphenol A (BPA) in blood can increase the risk of type II diabetes. The discovery was published in the latest issue of Annals of Internal Medicine published in the United States. Shanghai Ruijin Hospital said the discovery can help the research on BPA, an organic compound used in many consumer products, but its negative effects on human health have not been proven with any solid evidence so far. Currently, many countries including the US and China have banned the use of BPA in feeding bottles and food containers for babies. As concern rises about BPA’s potential hazard to child health, people also began to discuss its effects on adults. Ruijin Hospital doctors carried out a research to study the relationship between exposure to BPA and type II diabetes. The research found 87.7 percent of Chinese over 40 have BPA in their urine, averaging 0.81ng per milliliter. When the BPA level reaches 1.43ng per milliliter, the risk of diabetes grows significantly.

Chinese Pharma & Biotech Press Review – N° 212

Feb
22
2011


HEADLINES

Dear customers,
The China pharmaceutical market is expected to hit $200 billion by 2020, making it the 2nd largest in the world, before Japan.
The 2011 Universal Medica Market Access Conference to be held on September 28th, 2011 in Paris, will focus on China current challenges and future evolution, and will explore the key drivers to successfully access the market:

  • APIs sourcing
  • Off-Shore Production
  • Clinical Trials
  • Licensing

Take the chance to assess new business opportunities, and make the right choices!
For more information, please contact: info@universalmedica.cn

FOCUS

  • China Scientist Given Lasker Award for TCM-based Malaria Drug
  • Shanghai firm to solve national heart drug crisis
  • Pfizer Signs Jointown to Distribute its Drugs in China
  • West China Hospital of Sichuan University, China Wins Two Golds at the Asian Hospital Management Awards 2011
  • Indian, Chinese drug makers target cheap, accessible biosimilars
  • China is committed to the prevention and treatment of non-communicable diseases

Healthcare News

Hua Medicine Raises $50 Million to Develop and Commercialize Drugs
(Bioportfolio, 2011-09-21)
Hua Medicine, an innovative drug development and commercialization company in China announced in conjunction with the BioBay Investor Forum organized by ChinaBio LLC and Suzhou BioBay, that it has secured $50 million in new financing commitments from a prestigious group of US and Chinese healthcare investors. The funds will be used to further Hua’s internal development programs as well as provide financial resources for the acquisition, development and commercialization of additional programs.

Hitachi Medical breaks ground on Suzhou plant
(Sipac.gov.cn, 2011-09-20)
Hitachi Medical System (Suzhou) Corp., a unit of Japanese medical device maker Hitachi Medical Corp., has started construction of a second plant in Jiangsu Province’s Suzhou City. Located in Suzhou Industrial Park, the 130,000-square-meter facility will cost a total of $107 million and is intended to expand the Suzhou subsidiary’s capacity for x-ray fluoroscopic radiography systems and diagnostic ultrasound imaging equipment. It will also include a research and development (R&D) center. Hitachi Medical furthermore plans to use the plant to manufacture products it currently makes in Japan, and will target the output at emerging markets.

Avenue Capital Plans $313 Million Fund for China Medical City
(ChinaBio Today, 2011-09-17)
Avenue Capital Group, a New York-based hedge fund and private equity investor, has teamed up with China Medical City in Taizhou to form a healthcare industry investment fund. It plans to raise $313 million, of which $157 million will be available by the end of this year. The PE fund will invest in CROs, biopharmas, drug distributors, medical device makers and hospital companies – all of them located in China Medical City.

China is committed to the prevention and treatment of non-communicable diseases
(新华网, 2011-09-20)
Chinese Minister of Health Chen Zhu declared in New York that China would strive to find ways to prevent and treat non-communicable diseases (NCDs), taking into account the Chinese specificities while participating in the sharing of experiences with the international community and making a contribution. Chen made the remarks at a meeting of the UN General Assembly on NCDs. He pointed out that NCD had become the primary threat to health in the Chinese population with more than 260 million patients. It is therefore crucial in his view to strengthen the prevention and treatment of NCDs.” The Chinese government is implementing a global scientific concept of comprehensive development, sustainable and coordinated” said Chen, adding that the National Master Plan of China for five years to come had as an indicator of increased average life expectancy of one year. The UN General Assembly, which represents all 193 member countries, began a high-level meeting unprecedented NCD to draw attention to these diseases and to develop an action plan to combat them. Chinese Minister of Health stressed that the effective prevention and treatment of NCDs was one of the key measures. The universal health coverage for 1.3 billion Chinese people is a goal that is the core of the healthcare reform that is currently developing in China.

TCM watchdog unveils development plan for Hainan Province
(SATCM, 2011-09-21)
The State Administration of Traditional Chinese Medicine (SATCM), China’s TCM industry watchdog, has agreed to work with authorities in south China’s Hainan Province to promote the local TCM sector during the 12th Five-Year Plan (2011-2015). The agreement comes after the SATCM in June signed a similar deal with authorities in west China’s Gansu Province, which paved the way for future cooperations between the regulator and local governments. Like Gansu, the island of Hainan has a small population and is rich in natural TCM resources – some 3,080 native medicinal herbs grow there and more than 3,000 marine creatures with medicinal properties are found in the surrounding seas. But its TCM sector remains underdeveloped compared with most places on the mainland.

MicroPort to acquire orthopedic implant maker
(Business Highbeam, 2011-09-13)
MicroPort Scientific Corp. (MicroPort), a leading vascular device maker in China, will strengthen its orthopedics operations with the acquisition of a Suzhou City-based producer and distributor of orthopedic implants. MicroPort’s orthopedics unit, Shanghai MicroPort Orthopedics Co. Ltd. (MicroPort Orthopedics), has agreed to acquire Suzhou Best Co. Ltd., the shell company that owns the implant firm, for RMB 110 million ($17.23 million). The announcement did not disclose the name of the implant maker, which has two workshops producing eleven product lines of trauma and spinal orthopedic devices. The deal is intended to shore up MicroPort’s position in China’s fragmented orthopedics sector after the industry recently showed signs of consolidation, the company said.

Pharmaceutical Industry

Lingrui Pharma plans private placement to fund relocation, expansion
(Interfax.cn, 2011-09-19)
Traditional Chinese medicine (TCM) maker Henan Lingrui Pharmaceutical Co. Ltd. (Lingrui Pharma) hopes to raise RMB 386 million ($15.67 million) in a private placement to fund the relocation and expansion of its main production plant for oral drugs. Authorities in Henan Province’s Xinyang City ordered the company to relocate the facility to the suburban Xinyang Science and Technology Park from its current downtown location, said Ye Qiang, an investor relations representative. The firm is set to receive compensation from the city government for vacating the 100-mu (66,667 square meter) site, but Ye declined to disclose further details. The new plant is slated for completion in early 2014.

Hepalink to inject $12 mln into HK unit
(ANDANH, 2011-09-16)
Shenzhen Hepalink Pharmaceutical Co. Ltd. (Hepalink), China’s largest producer of heparin sodium active pharmaceutical ingredient (API), plans to inject HKD 95 million ($12.18 million) into its wholly-owned Hong Kong subsidiary and develop it into a platform for overseas expansion. Hepalink has yet to establish a subsidiary abroad, despite exporting 99 percent of its heparin sodium active pharmaceutical ingredient (API) output. Part of the injection will be used to double the registered capital of the subsidiary, Hepalink (Hong Kong) Co. Ltd., from HKD 5 million ($641,000) to HKD 10 million ($1.28 million).

Shanghai firm to solve national heart drug crisis

(上海日报, 2011-09-15)
The main producer of a drug whose short supply has forced major hospitals in China to stop heart operations since late July, promised to increase production. Protamine sulfate injection is used to reduce bleeding after heart surgery. Officials from Shanghai Pharmaceutical (Group) Co, whose Shanghai No. 1 Biochemical & Pharmaceutical Co was until recently the only domestic producer of the drug, said it was aware of the shortage and would be expanding production. It said it had reduced production early this year due to a shortage of raw materials. Protamine sulfate is extracted from the sperm of salmon and other species of fish and is used after surgery to help control bleeding. Doctors said it had been in use since the 1960s and cost just 11.2 yuan (US$1.75) per pack. There is no alternative product on the market. Hospitals in Shanghai said the shortage of protamine sulfate had not had any effect on heart surgeries so far but couldn’t promise that would continue. Hospitals in other provinces have been seriously affected, however, with some having had to cancel heart surgery. The SFDA said it was coordinating drug production and would give the green light to other companies applying for a production license. An SFDA official said the reason for the shortage was complicated, involving raw material supply and pricing and the government would be carrying out research to help solve the problem.

Pfizer Signs Jointown to Distribute its Drugs in China

(Current Partnering, 2011-09-19)
Pfizer has signed a China drug distribution deal with Jointown Pharmaceutical Group. The agreement will give Pfizer entry into Jointown’s network of provincial hospitals, OTC outlets and other rural markets. As a result of the arrangement, Pfizer is shutting down its own network that distributed drugs to pharmacies. Financial details of the relationship were not disclosed.

Shanghai to attack medicine shortages
(Shanghai.gov.cn, 2011-09-16)
Shanghai has set up a mechanism to help solve the shortage of cheap but effective medicines, which are disappearing from the market due to meager profit margins, authorities said. The government will give subsidies and take other actions to encourage production, according to officials of the Shanghai SFDA. In recent years, there have been repeated shortages of many key medicines because their low prices that have removed the incentive for firms to produce them. Some 342 kinds of cheap medicine are hard to find or are disappearing completely. They range from skin creams to anti-viral drugs to allergy medications. Eleven cheap, classic medicines that are under shortage or have run out of stock will reappear in Shanghai with the same price at 10 outlets of Huashi Pharmacy. One such drug is chlortetracycline hydrochloride eye ointment, which saw a halt in production early this year due to its price of only 2.4 yuan (38 US cents). Shanghai a mis en place un mécanisme pour aider à résoudre la pénurie de médicaments bon marché mais efficaces, qui disparaissent du marché en raison de marges bénéficiaires faibles, ont ainsi annoncé les autorités. Le gouvernement va accorder des subventions et prendre d’autres mesures pour encourager la production, selon des responsables de la SFDA de Shanghai. Ces dernières années, il y a eu des pénuries répétées de nombreux médicaments essentiels parce que leur bas prix avait supprimé l’incitation des entreprises pour les produire. Quelques 342 sortes de médicaments bon marché sont difficiles à trouver ou disparaissent complètement. Cela va des crèmes pour la peau aux médicaments antiviraux contre les allergies. Onze médicaments bon marché classiques qui sont en pénurie ou rupture de stock vont réapparaître à Shanghai au même prix dans 10 points de vente des pharmacies Huashi. Un de ces médicaments est la pommade ophtalmique chlortétracycline chlorhydrate, qui a vu sa production arrêtée en début d’année en raison d’un prix de 2,4 yuans seulement (38 cents américains).

Events

West China Hospital of Sichuan University, China Wins Two Golds at the Asian Hospital Management Awards 2011
(Fox Wilmington, 2011-09-19)
The Hospital Management Asia 2011 Conference kicked off a grand opening in Singapore Resorts World Conference Center. Two projects of West China Hospital of Sichuan University from China won the Gold Awards. The Executive Vice President Mr. Zhang Wei received the trophies on behalf of the hospital. This year, West China Hospital submitted 6 projects for the Awards assessment. Among them, “The Project of Epilepsy Prevention and Control in Tibet” led by the Department of Neurology and “The Project of Platform Construction for New Medical Services Model and The Treatment Technology for Hemorrhagic Stroke” led by the integrated nerve ward / neurosurgery, won the Gold Awards in the field of Corporate Social Responsibility and Clinical Services Improvement after fierce competition, making it the only medical institution that won two Gold Awards this year.

Scientific News

China Scientist Given Lasker Award for TCM-based Malaria Drug
(CNTV, 2011-09-17)
Dr. YouYou Tu of the China Academy of Chinese Medical Sciences in Beijing was given the 2011 Lasker Award for work that led to the discovery of artemisinin, the world’s foremost treatment for malaria. Dr. Tu’s investigations, conducted 40 years ago, scoured ancient literature for TCM recipes that would be effective against the deadly disease. One of these, described originally 2000 years ago, seemed especially promising. It became the world’s most effective treatment for malaria, artemisinin.

Asia/Pacific news

Takeda scouts for M&A in India, plots Chinese growth
(Fiercepharma, 2011-09-16)
India and China are on most expansion-minded drugmakers’ shopping lists. So, it’s not a huge surprise that top Japanese drugmaker Takeda Pharmaceutical is eyeing M&A in India. Takeda is looking for Indian partnership and joint venture opportunities. It’s also looking at buying Indian companies. The company hasn’t reached any “specific agreements” but it’s “actively” shopping around. Meanwhile, the Japanese company is also pumping up its operations in China. Takeda is aiming for $1 billion in Chinese sales in four to five years. It’s in the process of recruiting 650 reps, enough salespeople to more than triple its current force of 250. Takeda’s motivation for expanding in these countries is the same as Big Pharma’s: Growing generic competition for key branded drugs, as well as pricing pressures in and slowing growth in mature markets. The Japanese company’s top-selling drug, the diabetes treatment Actos, faces generic rivals in August 2012, and its current financial forecasts include lower profits over the next several years. So, it has plenty of ground to make up.

Indian, Chinese drug makers target cheap, accessible biosimilars
(Fiercebiotech, 2011-09-19)
Over the past few years some of the most influential groups in biotech have been hammering away at the argument over biosimilars, effectively shaping discussions around the core notion that complex biologics can’t be knocked off like the traditional small molecule. Now a group of Indian and Chinese companies have invested hundreds of millions of dollars into new facilities that could rock, if not help topple, which has been influencing the FDA as it slowly ramps up a new regulatory structure to deal with follow-ups. As Gardiner Harris reports in The New York Times, pioneers like Dr. Yusuf Hamied says that they can copy a number of biologics and sell them for a third of their regular price. And that’s just for starters. “Once we recover our costs, our prices will fall further,” he told The Times. Some UN officials insist that the developing world will need to get these drugs–classic blockbuster biologics like Herceptin, Avastin, Rituxan and Enbrel–at a low cost before they can effectively fight cancer and other non-communicable diseases. And that’s a big focus in countries like India and China, where pharma giants have been investing big bucks as they position themselves to reap the rewards found in emerging markets. Provided these upstart developers can deliver as promised, without presenting a host of new safety issues in their wake, the FDA could find itself under siege to explain why biosimilars will arrive in the U.S. slowly, with price tags that are still substantial.

Cipla, with Plants in China and India, Goes After Biosimilar Market
(ChinaBio Today, 2011-09-22)
Cipla, the Indian generic drugmaker, revealed it has invested $165 million to build facilities in China and India to produce biosimilars. The company is working on developing copies of at least a dozen biotech drugs with a goal of charging only one-third their current price. Last year, Cipla paid $25 million to buy a 25% stake in BioMab, a Shanghai maker of biotech drugs. Cipla and BioMab both contributed to the $165 million investment, though details were not disclosed.

Chinese Pharma & Biotech Press Review – N° 211

Feb
16
2011


HEADLINES

Dear customers,
The China pharmaceutical market is expected to hit $200 billion by 2020, making it the 2nd largest in the world, before Japan.
The 2011 Universal Medica Market Access Conference to be held on September 28th, 2011 in Paris, will focus on China current challenges and future evolution, and will explore the key drivers to successfully access the market:

  • APIs sourcing
  • Off-Shore Production
  • Clinical Trials
  • Licensing

Take the chance to assess new business opportunities, and make the right choices!
For more information, please contact: info@universalmedica.cn

FOCUS

  • China needs half a million more traditional medicine professionals in next 5 years
  • China Red Cross trains doctors from rural China
  • AIDS intervention programs reduce mother-to-fetus transmission in China
  • China lowers maternal death through subsidizing hospital delivery
  • Pfizer Starts China Animal Health JV with Jilin Guoyuan
  • Merck Partners with China’s BGI on Genomics

Healthcare News

China needs half a million more traditional medicine professionals in next 5 years
(China Human Rights, 2011-09-14)
China needs over half a million professionals trained in Traditional Chinese Medicine (TCM) over the next five years, according to a government report published. The report, released by the State Administration of Traditional Chinese Medicine, said that about 517,600 more TCM personnel are needed for the country’s hospitals, community healthcare centers and rural clinics. The report also highlighted major problems, such as TCM resource imbalances among the country’s different regions and lack of TCM service institutions and workers in rural areas. The report is based on a national investigation, which was launched by the administration in May last year, of the basic situation of TCM development. According to the report, China now has about over 500,000 TCM workers and about 21 percent of the country’s qualified medical staff have TCM service qualifications.

China Red Cross trains doctors from rural China
(中国日报, 2011-09-14)
Eighty “village doctors” from minority groups in northwest China’s Xinjiang Uygur Autonomous Region started a 14-day medical training program in Beijing sponsored by China Red Cross Foundation. The program covers prevention and treatment of gynecology, paediatric and orthopedic diseases as well as legal issues that the so called village doctors may encounter in their work and theories concerning communicating with patients. The training program, initiated in 2006, has trained 3,266 doctors of 25 ethnic groups at the village level in 26 provinces. “Households are sparsely scattered in the vast territory of Xinjiang. The training aims to improve the medical service of village doctors and better serve the farmers and herdsmen in the region,” said Wang Zhi, a senior official with the foundation.

HealthLinx and CytogenDx to Develop New Ovarian Cancer IVD for China
(ChinaBio Today, 2011-09-13)
HealthLinx, an Australian IVD company, has struck a deal with China CRO CytogenDx to seek SFDA approval for OvPlex, a HealthLinx clinical-stage diagnostic test for ovarian cancer. OvPlex measures plasma levels of anterior gradient protein 2 (AGR2), a new ovarian cancer biomarker. In a recent test, OvPlex was more accurate than CA125, the current IVD tool for ovarian cancer.

AIDS intervention programs reduce mother-to-fetus transmission in China
(Cdcnpin.org, 2011-09-09)
AIDS intervention programs have reduced HIV transmission from pregnant women to their unborn fetuses, said a senior health official. In the areas covered by the programs, 7.9 percent of HIV-positive mothers transmitted the virus to their babies, down 33 percent prior to the programs being initiated in 2003, said Fu Wei, a senior official with the Ministry of Health, at a press conference. China started a pilot program of providing free HIV tests and follow-up health counselling for pregnant women in 2003 in eight counties of five provinces and expanded it to 1,156 counties in 31 provincial divisions in 2010. In 2010, the country added free syphilis and hepatitis B testing in the intervention programs. In 2010, about 839 million yuan (129 million U.S. dollars) from the central budget was spent in the programs that covered 6.4 million pregnant women, accounting for about 44 percent of the total expectant mothers in China.

China lowers maternal death through subsidizing hospital delivery
(新华网, 2011-09-09)
The maternal mortality rate in China has notably dropped as the country provided expectant mothers in rural areas with subsidies to deliver at hospitals, said a health official. The maternal mortality rate stood at 30 out of 100,000 in 2010, said Fu Wei, a senior official with the Ministry of Health, at a press conference. The figure was 34.2 out of 100,000 in 2008, and Fu attributed the reduction directly to the subsidies. Since 2009, each pregnant woman in the countryside has received 500 yuan (77 US dollars) for hospital delivery, Fu said. From 2009 to July, the central government allocated 7.9 billion yuan for the program and subsidized 22.62 million expectant mothers. Under the program, 96.7 percent of rural expectant mothers gave birth to their children at hospitals, up 4.4 percentage points from the level in 2008. Hospital delivery also reduced the infant mortality. The infant mortality rate in China, 13.1 out of 1,000 in 2010, dropped by two thirds from the 1990 level, which met the goal set by the United Nations in its Millennium Development Goals.

Imported polio virus leaves 1 infant dead in Xinjiang
(人民日报, 2011-09-09)
One of the nine infants in northwest China’s Xinjiang Uygur Autonomous Region diagnosed with polio, a disease that can cause irreversible paralysis, has died of the disease, said a spokesman for the Ministry of Health. The other eight infants are still receiving treatment but are out of danger, said Deng Haihua, a ministry spokesperson. The nine patients were all from Xinjiang’s Hotan Prefecture, Deng said, adding that the disease has not been found in other parts of the country. The MOH has reported the cases to the World Health Organization (WHO). According to the Chinese Center for Disease Control and Prevention, the WHO has confirmed that the virus came from Pakistan. The center said the WHO confirmed this after gene sequencing showed that the virus had a 99 percent resemblance to the wild poliovirus that caused an outbreak in Pakistan in 2009. The MOH has sent three teams of experts, headed by Health Minister Chen Zhu and Chen’s deputy, Yin Li, to Xinjiang to inspect the situation, Deng said. The ministry also dispatched 90 experts from other parts of China to assist in disease prevention tactics in Xinjiang, including active search and immunization.

Opening of an exhibition of traditional Chinese medicine in Vienna
(新华美通, 2011-09-09)
The exhibition of traditional Chinese medicine (TCM) opened for three days in the Hirschstetten Botanical Garden in Vienna, aiming to introduce traditional Chinese medicine to the Austrians and their interest for the culture of Chinese medicine. Traditional Chinese medicine in recent years found a growing recognition and acceptance in Austria. Now it is not only studied in the classroom but also in hospitals and clinics. Some private insurance companies in Austria have begun to include traditional Chinese medicine treatments among the services they cover. Proprietary Chinese medicines are already available in many pharmacies in Austria. However, traditional Chinese medicine continues to experience a number of general limitations in Austria, and is not taken into account by the public health insurance system. Some Austrians still have reservations about Chinese medicine, particularly medicinal plants. All these factors still limit the development of traditional Chinese medicine in this country.

China’s Push for Low Prices Causes Drug Shortages
(Fiercepharma, 2011-09-15)
China’s policy of forcing drug costs lower has caused a major problem: shortages. The price of an important drug used following cardiac surgery, protomine sulfate, dropped to the point where companies could not make a profit. Not surprisingly, pharmas stopped producing protomine sulfate, and several areas of China are in short supply of the vital medication. Even though the situation first surfaced three months ago, it still persists.

China to support development of traditional medicines in Xinjiang
(中国日报, 2011-09-14)
China’s State Food and Drug Administration (SFDA) signed an agreement with the local government of far western Xinjiang Uygur Autonomous Region to support the development of traditional medicines of ethnic minorities. Shao Mingli, director of the SFDA, said at a conference in Urumqi, the capital of Xinjiang, that the agency will provide professional guidance and technological support for the research and development of traditional medicines in Xinjiang. The administration will also help establish quality standards and assessment systems for the traditional medicine of Uygurs, the dominant ethnic minority in Xinjiang, Shao said. The agency will also allocate funds for the development of the traditional medicine industry, he said without elaborating.

Pharmaceutical Industry

Pfizer Starts China Animal Health JV with Jilin Guoyuan
(CBS News, 2011-09-10)
China’s policy of forcing drug costs lower has caused a major problem: shortages. The price of an important drug used following cardiac surgery, protomine sulfate, dropped to the point where companies could not make a profit. Not surprisingly, pharmas stopped producing protomine sulfate, and several areas of China are in short supply of the vital medication. Even though the situation first surfaced three months ago, it still persists.

Merck Partners with China’s BGI on Genomics
(Bioportfolio, 2011-09-14)
Merck, known as MSD outside North America, has formally launched a collaboration with BGI, the Shenzhen-based genomics powerhouse. The two companies will seek to discover and develop biomarkers as a means toward drug discovery, drug development and diagnostics applications. In September 2010, the two entities signed an agreement to explore ways to work together, and this partnership is the result.

Covidien to Build Medical Device R&D Center in Shanghai
(Fierce Medical Devices, 0000-00-00)
Covidien will build a medical device R&D center in Shanghai’s Caohejing Hi-Tech Park that will be operational by July 2012. The company’s R&D staff in China will jump from 25 at present to over 300 when the 100,000 square foot facility is finished. Covidien, which is headquartered in Dublin, but has most of its managing operations in the US, is comprised of three life science divisions: medical devices, pharmaceuticals and medical products.

ShangPharma Forms mAb Partnership with Hengrui Medicine
(PRNewswire, 2011-09-16)
ShangPharma, a Shanghai CRO, announced it will partner with Jiangsu Hengrui Medicine Co. to develop novel therapeutic monoclonal antibodies (mAbs). The partnership will focus on a specific therapeutic area, which was not disclosed. The agreement was signed between Hengrui and ChemPartner, a ShangPharma subsidiary that also has staff dedicated to pharma projects with Lilly.

Wanbei Pharma clinches EU GMP for antibiotic API
(Interfax.cn, 2011-09-14)
Privately held antibiotic producer Anhui Wanbei Pharmaceutical Co. Ltd. (Wanbei Pharma) has won European Union (EU) Good Manufacturing Practice (GMP) certification for lincomycin hydrochloride active pharmaceutical ingredient (API), opening the door for exports to Europe. The antibiotic producer currently holds a 30 percent share of the domestic market for the API, and also exports the ingredient to southeast Asia. The firm last year won GMP certification for lincomycin hydrochloride in the U.S., becoming the first drug maker in its home province of Anhui to obtain U.S. GMP.

Honz Pharma to buy antibiotic injection rights for $11 mln
(ANDANH, 2011-09-09)
Honz Pharmaceutical Co. Ltd. (Honz Pharma), a manufacturer of pediatric drugs in China, plans to purchase the rights and production technology for an exclusive antibacterial injection from Hainan Guoruitang Pharmaceutical Co. Ltd. (Guoruitang) for RMB 73 million ($11.44 million). The firm has sought to expand its portfolio after China’s drug watchdog in May tightened restrictions on its main product, nimesulide, banning the use of the fever drug on children below the age of 12. Nimesulide contributed about 72 percent of the company’s sales revenue in 2010. The compound ceftazidime sodium and tazobactam sodium injection from Guoruitang will compliment Honz Pharma’s existing portfolio of antibiotics, which includes ceftazidime injection, norfloxacin capsule and cefminox sodium injection.

Chinese Pharma & Biotech Press Review – N° 210

Feb
8
2011


HEADLINES

Dear customers,
The China pharmaceutical market is expected to hit $200 billion by 2020, making it the 2nd largest in the world, before Japan.
The 2011 Universal Medica Market Access Conference to be held on September 28th, 2011 in Paris, will focus on China current challenges and future evolution, and will explore the key drivers to successfully access the market:

  • APIs sourcing
  • Off-Shore Production
  • Clinical Trials
  • Licensing

Take the chance to assess new business opportunities, and make the right choices!
For more information, please contact: info@universalmedica.cn

FOCUS

  • Efforts to ease medical costs take effect
  • Orphans from quake-hit province receive free insurance to cover critical illnesses
  • Public medical insurance system benefits 93 percent of Chinese: health official
  • China launches rehab medicine pilot program
  • China completes grassroots essential drug system roll-out
  • GlaxoSmithKline to Use Three Vaccine Distributors to Cover China
  • Merck Serono Opens Beijing Lab

Healthcare News

Orphans from quake-hit province receive free insurance to cover critical illnesses
(人民日报, 2011-09-01)
About 42,000 orphans from quake-hit Sichuan Province received renewed insurance contracts to cover the treatment of 12 critical illnesses. An insurance fund created through donations will be accessible for one year, according to Dr. Heidi Hu, managing director of the China Children Insurance Foundation (CCIF). “It’s the second year that we have been able to offer insurance to registered orphans in Sichuan, including those whose parents passed away in the devastating quake three years ago,” Hu said. The foundation launched a joint program in cooperation with the Ministry of Civil Affairs in 2009 to give free medical insurance to 712,000 orphans, according to the CCIF. According to Hu, each insured child is covered for 100,000 yuan (15,474 U.S. dollars) at a premium of 50 yuan a year.

Efforts to ease medical costs take effect
(中国日报, 2011-09-01)
Medicine prices at public clinics have been notably reduced thanks to a policy that promotes basic medicine, an office of the State Council said. Current price levels of basic medicine used by government-funded township hospitals and community clinics have been reduced an average of 25 percent from the levels two years ago when the policy started, according to a statement from the State Council office in charge of reforming the country’s healthcare program. Provincial governments will purchase basic medicine through public bidding and distribute them to local clinics. These clinics must not raise the prices of listed medicine and in return, the government will provide them with subsidies. The policy has been implemented at all township and community clinics in all the 31 provinces, municipalities and autonomous regions in the Chinese mainland, the statement said.

Public medical insurance system benefits 93 percent of Chinese: health official
(China.org, 2011-09-04)
The public medical insurance system on the Chinese mainland currently covers over 1.25 billion people, or about 93 percent of the mainland’s total population, according to a health official. The Chinese mainland’s rural cooperative medical system has provided 835 million people with health care, while another 421 million are covered by basic medical insurance systems for urban dwellers, said Zhang Zongjiu, director of the Department of Medical Service Supervision of the Ministry of Health. Zhang made the remarks at an ongoing health forum of hospitals from the mainland and Taiwan, which was held in Hangzhou, the capital city of eastern Zhejiang Province. In the first half of 2011, the Chinese government spent more than 245 billion yuan (about 38.4 billion U.S. dollars) on health care, up 61.4 percent year-on-year, according to a report submitted to the country’s top legislature, the Standing Committee of the National People’s Congress, in late August.

China charity group offers help to needy children with hearing defects
(新华网, 2011-09-05)
China Soong Ching Ling Foundation (CSCLF), a Beijing-based charity group, launched a program offering free treatment to children with hearing defects from needy families. The first group of ten children will receive free artificial cochlear implant surgeries, which is an effective way of treating deafness early in babies, said a statement from the foundation. About 27.8 million people experience some level of deafness in China, which is one fifth of the world’s total hearing deprived population, among whom nearly 140,000 are under six years old. The foundation will arrange a 1.5 million yuan (about 235,000 U.S.dollars) start-up fund, the statement said.

South China villagers turn to music to prevent spread of AIDS
(新华美通, 2011-09-01)
In south China’s Guangxi Zhuang Autonomous Region, an area renowned for its history of musical folklore, local residents have found a unique way to spread knowledge regarding AIDS prevention. The songwriting campaign has been effective because folk songs are a traditional artform in the region, making them more readily understandable and acceptable for local residents. Guangxi has been one of the hardest-hit areas in China in terms of the number of AIDS infections discovered there, ranking only after central China’s Henan Province. More than 76 percent of the infections are sexually transmitted, according to Ge Xianmin, an official from the AIDS prevention office of the Guangxi regional government.

China launches rehab medicine pilot program
(Interfax.cn, 2011-09-06)
China has launched a pilot program to expand and integrate rehabilitation medicine services in its health care system in a bid to meet growing needs for chronic disease therapy among its rapidly aging population, the Ministry of Health announced. The two-year program will experiment with different rehab care models in preparation for a nationwide roll-out of the scheme, and involves 14 administrative regions – Beijing and Shanghai, the provinces of Heilongjiang, Jiangsu, Fujian, Shanxi, Shandong, Henan, Hubei, Hunan, Guangdong, Sichuan and Yunnan, as well as the Xinjiang Uyghur Autonomous Region. Each of the regions have selected two districts or cities to establish an integrated rehab care model involving grassroots, Grade II and Grade III medical institutions. The MoH advised local governments to make funding provisions and set pricing policies for rehab services, as well as establish training programs to boost rehab therapist numbers. The ministry also encouraged private investment in the sector.

China completes grassroots essential drug system roll-out
(ANDANH, 2011-09-02)
China has completed the nationwide roll-out of a basic essential drugs system to all its grassroots medical institutions two years after the scheme kicked-off, the State Council‘s health care reform office said. All 31 administrative regions in mainland China have established a centralized tender platform for essential drug supply contracts. Thirteen regions have already completed the tender for next year’s contracts, including Anhui, Shandong, Sichuan and Heilongjiang provinces, while bidding is underway in a further seven regions, including Jiangsu. China revived its essential drug system as part of the health care reform, releasing a revised list for grassroots medical institutions in 2009. It is comprised of 307 basic drugs that are reimbursable under the national medical insurance scheme and that grassroots institutions must stock and sell without price markups.

HK officials to attend meeting on infectious diseases in Macao
(SINA, 2011-09-07)
Hong Kong’s Director of Health will lead a delegation to attend the Eleventh Tripartite Meeting of Guangdong, Hong Kong and Macao on the Prevention and Control of Infectious Diseases in Macao on Sept. 8 and 9, according to local government website. During the two-day meeting, experts from the three places will review the latest situation of communicable diseases, the prevention and control of scarlet fever, anti-microbial resistance, laboratory surveillance of infectious diseases and exchanges in laboratory technology. Participants of the meeting will include key medical and public health officials and professionals from Guangdong, Macao and Hong Kong.

China Nuvo Solar Completes Acquisition of SurgLine
(MarketWatch, 2011-09-06)
China Nuvo Solar Energy, Inc. announced that it has completed the acquisition of 100% of the common stock of SurgLine, Inc. Pursuant to the terms of the Share Exchange Agreement, SurgLine will become a wholly owned subsidiary of China Nuvo. The company will continue to trade under the symbol CNUV. At the appropriate time the company will seek to change its name and symbol to reflect the business of SurgLine. SurgLine’s product lines include trauma, orthopedic, spine and ENT medical and surgical products selling into hospitals and surgery centers. China Nuvo Solar Energy, Inc. is a development stage company that owns unique patent pending solar and photovoltaic related technology.

Pharmaceutical Industry

GlaxoSmithKline to Use Three Vaccine Distributors to Cover China
(Biospace, 2011-09-06)
GlaxoSmithKline signed up three companies to distribute its portfolio of vaccines in China. Each of the three companies will be responsible for a specific geographical region of the PRC. GSK is committed to offering a complete portfolio of vaccines in China, but it has recently backed away from using China partners to accomplish to develop and manufacture vaccines, preferring to depend on its own expertise.

Merck Serono Opens Beijing Lab
(ChinaBio Today, 2011-09-02)
Merck Serono, the biopharmaceutical division of Merck KGaA, has opened a China lab as part of its planned R&D hub in Beijing. The lab, which has $5.8 million of equipment, will pursue individualized treatments for cancer, neural degenerative disease and autoimmune and inflammatory disorders.

AllCells Expands Primary Cell Services in Shanghai
(Business Wire, 2011-09-07)
AllCells, LLC, a San Francisco-area lab that provides biotech researchers with primary cell types, has relocated and expanded its Shanghai facilities. AllCells-Shanghai is now operational in Ju Ke Park. The purpose of the new facility will be to serve global big pharma clients that have established R&D centers in China, according to Jack Zhai, Head of Marketing for AllCells.

Fosun Pharma and Lonza to Start Generic Drug JV
(SinoCast, 2011-09-08)
Shanghai Fosun Pharmaceutical (Group) and Lonza Group of Switzerland will form a generic drug JV with 100 million RMB ($15.6 million) in capital. The JV will take advantage of the strengths of each parent: Lonza in APIs and intermediates; Fosun in finishing and China distribution. The JV will be owned equally by the two partners.

Excipient maker Er-Kang Pharma gets nod for Shenzhen GEM IPO
(Hdlns.com, 2011-09-06)
Hunan Er-Kang Pharmaceutical Co. Ltd., a leading producer of pharmaceutical excipients, has received approval to launch an initial public offering (IPO) to raise up to RMB 500.46 million ($78.37 million) on the Shenzhen Stock. The firm plans to issue 184 million shares, accounting for 25 percent of its total equity after the issuance, according to its listing prospectus. The proceeds will be used to fund production expansion for excipients including pharma grade glycerin and propylene glycol, as well as the establishment of a research and development (R&D) center and the extension of its China sales network.

Biotechnologies

SinoCubate Signs on Biotech Startup Veteran for Incubator
(Bioportfolio, 2011-09-03)
SinoCubate announced its launch as an incubator/investor in privately held companies located in mainland China. To begin operations, SinoCubate has signed up Wei Wei Zhang, MD, PhD as a director and member of senior management. Dr. Zhang is a serial China-US entrepreneur who has been instrumental in eight biotech startups, a background that indicates SinoCubate will be interested in biopharmas. Previously a shell company, SinoCubate will now start operating with $5 million in share-based capital.

Chinese Pharma & Biotech Press Review – N° 209

Feb
1
2011


HEADLINES

Dear customers,
The China pharmaceutical market is expected to hit $200 billion by 2020, making it the 2nd largest in the world, before Japan.
The 2011 Universal Medica Market Access Conference to be held on September 28th, 2011 in Paris, will focus on China current challenges and future evolution, and will explore the key drivers to successfully access the market:

  • APIs sourcing
  • Off-Shore Production
  • Clinical Trials
  • Licensing

Take the chance to assess new business opportunities, and make the right choices!
For more information, please contact: info@universalmedica.cn

FOCUS

  • Eight Chinese nurses win Florence Nightingale Medal for outstanding contributions
  • Rule to keep sane out of hospital
  • China: four imported cases of polio reported in Xinjiang
  • China’s expenditures on health care surge 61.4 pct: report
  • Fosun Pharma eyes Aohong Pharma stake
  • Simcere Obtains SFDA Approval for Rheumatoid Arthritis Treatment
  • Vasomedical Buys Two China Medical Device Manufacturers

Healthcare News

Eight Chinese nurses win Florence Nightingale Medal for outstanding contributions
(RCSC, 2011-08-26)
Eight Chinese nurses were awarded the Florence Nightingale Medal for their outstanding contributions to health care. President Hu Jintao, who is also the honorary president of the Red Cross Society of China (RCSC), presented the medals to the nurses at a ceremony held in the Great Hall of the People in downtown Beijing. China has made great strides in humanitarian causes and will continue to boost the development of humanitarian efforts around the world, Hu said. The Chinese government will continue its support by strengthening the RCSC’s cooperation with the International Committee of the Red Cross (ICRC) and make positive contributions to world peace and development, according to Hu. Vice Premier Li Keqiang attended the awarding ceremony. A total of 39 nurses from 19 countries won the Florence Nightingale Medal this year. The Florence Nightingale Medal, the highest international honor for nurses, was introduced in 1912. A total of 62 Chinese nurses have won the award since the country began to recommend candidates in 1983. “The Florence Nightingale Medal recognizes the extraordinary commitment, courage, compassion and innovation of nurses and nursing aides who have helped people survive natural disasters and armed conflicts,” a post on the ICRC’s website says. The award is named after Florence Nightingale (1820-1910), an English nurse known for her pioneering work in improving medical care for sick and wounded soldiers during the Crimean War (1853-1856).

Rule to keep sane out of hospital
(Official Wire, 2011-08-27)
Shenzhen doctors will see their licenses suspended and face fines of up to 50,000 yuan ($7,824) if they are found guilty of sending someone who isn’t mentally ill into a mental hospital for treatment. A proposed Rule on Mental Hygiene in Shenzhen also stipulates that hospitals and medical institutions found to have assisted doctors in admitting such people would be fined 100,000 yuan and lose their operating licenses. And doctors who deliberately misdiagnose a mental illness would be held criminally responsible. The rule is expected to be passed by the Shenzhen People’s Congress. Zhou Rongsheng, deputy director of the congress’s legal affairs committee, said the rule would help to ensure that hospitals, medical institutions and doctors conform to a set of standards. “The rule requires mental hospitals and doctors to clearly inform their patients, or their patients’ guardians, of the rights they have, as well as to inform them of their medical treatment plans and the possible future results and side effects of that treatment,” Zhou said. “Mental patients would only be given treatment when that has been approved by the patients themselves or, if the patients aren’t capable of controlling their own actions, by their guardians,” he said. The proposed rule also forbids hospitals and medical institutions from forcing mental patients to work unless that work is part of their treatment.

China: four imported cases of polio reported in Xinjiang
(人民日报, 2011-08-27)
Four babies in the Xinjiang Uygur Autonomous Region were confirmed to have polio, a disease that can cause irreversible paralysis, announced the department of health in the region. These four patients, aged from four months to two years old, are all from Hotan Prefecture, the department said in a press release. According to an assessment made, two of the patients recovered and were allowed to leave the hospital, while two others remain hospitalized but are in stable condition. The Chinese Center for disease control and prevention reported at midnight on its website that the World Health Organization confirmed that the virus was imported from Pakistan. According to the center, the WHO confirmed after gene sequencing, that the virus was 99% similar to the wild poliovirus that appeared in Pakistan in 2009. The Chinese Ministry of Health ( MoH ) sent a team of experts in Xinjiang in order to help to prevent the disease. Polio, also known as poliomyelitis, is a viral disease of the brain and spinal cord that often affects children under five years old. On 200 infections, one leads to irreversible paralysis, especially of the legs. Of the four countries endemic for polio in the world, namely Afghanistan, India, Nigeria and Pakistan, Xinjiang shares a border with three of them. Before the outbreak of the disease in Hotan, China had been free of polio for 11 years.

China’s expenditures on health care surge 61.4 pct: report
(Latest-health-news, 2011-08-25)
The Chinese government spent over 245 billion yuan (about 38 billion U.S. dollars) on health care in the first half of this year, according to a report submitted to China’s top legislature. The government’s expenditures on health care during the period represented a sharp increase of 61.4 percent year-on-year. The Standing Committee of the National People’s Congress (NPC), China’s top legislature, is convening in Beijing for a three-day legislative session. Finance Minister Xie Xuren spoke to the committee about the implementation of the government’s health care budget. According to Xie’s report, the central government had spent 76 billion yuan on improvements to the country’s new rural cooperative medical system, as well as its urban basic medical insurance system. The per capita medical treatment allowance from government fiscal assistance increased from 120 yuan to 200 yuan, Xie said. The central government also spent 28.7 billion yuan to improve local health care infrastructure and facilities and narrow the gap of health care services during the first half of this year. Xie said China’s basic medical care system for urban and rural residents currently covers 1.28 billion people, or more than 90 percent of the country’s total population.

Two die in northwest China of suspected food poisoning
(中国日报, 2011-08-24)
Food poisoning is the suspected cause of two deaths and dozens of sick in northwest China’s Gansu Province, said local authorities. According to the government of Longxi county, 30 people had been sent to hospitals, of which six were in critical condition. Two died early Wednesday morning after medical treatment failed. All of patients were found to have had a kind of local snack made of bean jelly and roast chicken at a store. Police have detained the stall owner and collected the remaining food for testing. The Gansu Provincial Health Department has sent a team of experts to the county to look into the case.

Vasomedical Buys Two China Medical Device Manufacturers
(Genetherapynet, 2011-08-25)
Vasomedical announced it has purchased two China-based medical device companies: Life Enhancement Technology and Biox Instruments Co. Both companies currently serve as manufacturing partners for Vasomedical. The purchase price was $1 million in cash plus 7.4 million shares of stock (a $2 million value) plus an unspecified number of warrants, some of which are performance related. Vasomedical is a US maker of external cardiovascular devices and also a distributor of GE diagnostic imaging equipment.

Pharmaceutical Industry

Fosun Pharma eyes Aohong Pharma stake
(Interfax.cn, 2011-08-30)
Leading domestic pharmaceutical firm Shanghai Fosun Pharmaceutical (Group) Co. Ltd. (Fosun Pharma) plans to acquire a 70 percent controlling stake in Jinzhou Aohong Pharmaceutical Co. Ltd. (Aohong Pharma) in a bid to strengthen its presence in the central nervous system (CNS) and cerebro-cardiovascular drug sectors. The total consideration for the deal will amount to a maximum of RMB 1.36 billion ($213.11 million) and it will be conducted by Fosun Pharma’s investment unit, Shanghai Fosun Pharmaceutical Development Co. Ltd. (Fosun Development), said the announcement. Aohong Pharma’s current largest shareholder, Xinjiang Bozhe Equity Investment Co. Ltd. (Bozhe Equity), will see its stake diluted from 98.14 percent to 28.14 percent following the acquisition.

TCM maker Xinbang Pharma turns to nutritional supplements
(Congoo, 2011-08-29)
Guizhou Xinbang Pharmaceutical Co. Ltd. (Xinbang Pharma), a manufacturer of cardiovascular and digestive traditional Chinese medicines (TCM), is pinning future growth on nutritional supplements as it plans to move into the sector via a RMB 10 million ($1.56 million) subsidiary. The subsidiary is still at the planning stage and what exactly it will produce has yet to be decided, said Xiao Yue, a securities representative from the Guiyang City-based company. Shenzhen Stock Exchange-listed Xinbang Pharma recently reported sluggish first-half growth from its core business, with revenue up 5.55 percent year-on-year at RMB 167.96 million ($26.28 million). The firm’s existing nationwide distribution network, meanwhile, is suited to marketing nutritional supplements according to the company.

Simcere Passes EU-GMP Inspection for OTC Diarrhea Treatment
(Clinica Space, 2011-08-25)
Simcere Pharma reported that Biqi, the company’s branded generic anti-diarrhea drug, has passed EU-GMP inspection. The certificate was issued following an audit that covered product formulation, manufacturing process, facilities and quality management systems. In 2010, Simcere’s manufacturing facility for diosmectite, the API in Biqi, successfully passed EU-GMP inspection. Simcere makes innovative cancer treatments and branded generics, all of which are distributed in China. Simcere should now be able to market Biqi in Europe, though it did not announce any plans to do so.

Simcere Obtains SFDA Approval for Rheumatoid Arthritis Treatment
(Rttnews, 2011-08-25)
Simcere Pharma was granted SFDA approval for Iremod, an oral iguratimod drug classified as belonging to the category of Disease Modifying Anti-rheumatic Drugs (DMARDS). It will be indicated to treat active rheumatoid arthritis. Iremod, which was developed by Simcere, will be the first global iguratimod offering. Simcere expected SFDA approval of the drug as long ago as 2009. However, the drug inhibits COX-2, which may have complicated the regulatory process.

Epitomics Plans Taiwan IPO Later in 2011
(Antibody Chain, 2011-08-25)
Epitomics, the San Francisco-area biopharma with two major facilities in China, intends to IPO on the Taiwan Stock Exchange before the end of the year. Epitomics’ business model is based on the company’s proprietary RabMAb® monoclonal antibody technology, which the company says provides better antigen recognition than the more common mouse models. Because the company is still awaiting approval from the Taiwan Stock Exchange for the IPO, the company has not released details of the transaction.

Biotechnologies

Royal DSM and Sinochem Close Antibiotics JV Deal
(Biospace, 2011-09-01)
Royal DSM, the Dutch life sciences and materials company, and Sinochem received regulatory approval for their antibiotic JV. The JV, announced last December, called for Sinochem to buy a 50% stake in DSM’s anti-infectives unit for a price of $291 million. The JV combines DSM’s expertise in anti-infective APIs with Sinochem’s experience in China marketing. The JV will be headquartered in Hong Kong.

NexBio Reports Positive Data from Test of Biologic Flu Drug
(Bioportfolio, 2011-08-31)
NexBio, a San Diego biotech startup, has released positive data from a Phase II trial of a novel biologic that aims to both treat and prevent infection by all flu strains. The drug works by inhibiting entry of the virus into cells. NexBio was formed by a China husband-wife team who did their early academic work in China, and then moved to the US to earn biology PhDs. NexBio has been in the news recently because the FBI conducted a very public raid on the company’s offices, though neither the FBI nor the company has explained the object of the raid.

Nycomed Says Growth in China Helped Revenues
(ChinaBio Today, 2011-08-30)
Nycomed, a privately owned Swiss biopharma, said its recent acquisition of Guangdong Techpool Biopharma and a direct sales model in China boosted the company’s revenues in Q2. Nycomed announced it spent $210 million to purchase a 51% stake in Techpool, a biologics company. Asia-Pacific, Africa and Middle East saw revenues climb by 81%, though Nycomed did not break out China sales separately.

WuXi AppTec Certified by European Authorities for Bioanalytical Services
(Pharm Pro, 2011-08-25)
WuXi AppTec reported it has been given a certificate of Good Laboratory Practice (GLP) for its Bioanalytical Services (BAS) unit from European regulatory authorities. With the new certificate WuXi is authorized to carry out European-approved ADME (absorption, distribution, metabolism, and excretion) studies, toxicokinetic and pharmacokinetic studies, and hERG assay and biomarker studies. The company also made an attempt to clear up the confusion of its name — whether it is called WuXi PharmaTech or WuXi AppTec.

Chinese Pharma & Biotech Press Review – N° 208

Feb
25
2011


HEADLINES

Dear customers,
The China pharmaceutical market is expected to hit $200 billion by 2020, making it the 2nd largest in the world, before Japan.
The 2011 Universal Medica Market Access Conference to be held on September 28th, 2011 in Paris, will focus on China current challenges and future evolution, and will explore the key drivers to successfully access the market:

  • APIs sourcing
  • Off-Shore Production
  • Clinical Trials
  • Licensing

Take the chance to assess new business opportunities, and make the right choices!
For more information, please contact: info@universalmedica.cn

FOCUS

  • Two confirmed anthrax infection cases reported in NE China
  • Hong Kong reports 101 HIV cases in second quarter
  • China to tighten restrictions on popular antibacterials in coming months
  • China’s elderly care lagging in face of aging population, low funding
  • China Nepstar Chain Drugstore Announces Share Repurchase Program
  • Fragmented governance holding back health reform
  • Medical device SMEs set to benefit from relaxed clinical trial rules

Healthcare News


Two confirmed anthrax infection cases reported in NE China

(Global Times, 2011-08-23)
Two people have been confirmed infected with cutaneous anthrax, while 33 others were suspected as having the disease in Liaoning Province, health authorities said. Wang Tianyu, an official with the emergency response office of the Liaoning Health Bureau, said the two patients — both locals in Niuzhuang Township, Haicheng City — were diagnosed after their cell samples tested positive for the disease by state-level labs. Suspected anthrax infection cases were first reported in Haicheng on Aug. 6. All those 35 people either confirmed or suspected to have the disease have been hospitalized. “No new suspected anthrax infection cases have been reported for the past 11 days,” said Wang. He said the patients were suspected to have been infected with the cutaneous anthrax through skin contact with diseased cattle. So far, local authorities have slaughtered 551 cattle and seized 2,450 beef products on the market. No one has died from the disease after the epidemic was discovered in the province, said Wang.

Hong Kong reports 101 HIV cases in second quarter
(China Economic, 2011-08-23)
Hong Kong’s Department of Health announced that 101 cases of Human Immunodeficiency Virus (HIV) infection were recorded in the second quarter of 2011 in the city. The newly reported cases, comprising 78 males and 23 females, have brought the cumulative total of reported HIV infections to 5,036 since 1984. The department’s consultant Dr. Wong Ka-hing said sexual transmission continued to be the major mode of HIV transmission in Hong Kong. Of the 101 HIV cases reported, 34 acquired the infection via heterosexual contact, 33 via homosexual or bisexual contact, four through drug injection. The routes of transmission of the remaining 30 cases were as yet undetermined due to inadequate information.

China to tighten restrictions on popular antibacterials in coming months
(ANDANH, 2011-08-23)
China is set to tighten restrictions on some best-selling antibacterial drugs in coming months as part of an ongoing campaign to curb overuse. The restrictions are the latest development in a campaign launched in April to ratchet up China’s regulation of antibacterial drugs in the period up to 2013. The changes are likely to come into effect in September, Ma Xudong, a health official said. Of last year’s top 20 best-selling antibacterial drugs, the list placed nine in the restricted category – mostly new products including cefotiam, cefminox, piperacillin sulbactam, cefoxitin, moxifloxacin. The nine medicines accounted for 22.81 percent of anti-infective drug sales last year, according to figures from the China Pharmaceutical Association (CPA).

China’s elderly care lagging in face of aging population, low funding
(Interfax.cn, 2011-08-23)
China’s health care system is struggling to meet the needs of its rapidly aging population in the face of insufficient government funding and a weak medical insurance system, experts said at the recent 2011 China Health Forum in Beijing. China’s population is aging at an exponential rate – the country became an “aging society” in 2000 when the proportion of the population over the age of 60 passed 10 percent. This figure rose to 13.3 percent in the 2010 national census, and is expected to rise to 20 percent by 2020. The problem has been exacerbated by the one-child policy, said Wang Yanzhong, a researcher with Chinese Academy of Social Sciences (CASS). Poor access to health services for China’s elderly is reflected in their low per capita medical expenditure, compared to three to five times in other countries. Insufficient funding has moreover made elderly care an important source of revenue for public hospitals, leading to over-prescription of medication and a ballooning hospitalization rate.

Fragmented governance holding back health reform
(Rsssearchhub, 2011-08-22)
Ineffective government structure is a major barrier to the progress of China’s health reform, and in particular the improvement of public hospitals, an expert told an industry forum in Beijing. “Authority over China’s health care system, and in particular the public hospital reform, is too fragmented. Responsibilities for fiscal management, staff recruitment and policymaking are dispersed among at least eight different agencies,” William C. Hsiao, K.T. Li Professor of Economics at the Harvard School of Public Health, said at the 2011 China Health Forum organized by the Ministry of Health (MoH). China is currently pilot testing public hospital reform in 17 cities. The changes are intended to improve hospital management and reduce the dependence of medical institutions on income from drug revenue. But such goals will be difficult to achieve when there are four different agencies responsible for allocating health care funding, the professor noted. The Ministry of Finance (MoF) allocates general health care funding.Meanwhile, the MoH and the Ministry of Human Resources and Social Securities (MOHRSS) are in charge of funding medical insurance for rural and urban residents, respectively, and the Ministry of Civil Affairs (MoCA) provides subsidies for low-income patients.

Disputes heat up over essential drug system
(Global-Report, 2011-08-17)
As China progresses with pilot tests of its essential drug system, debate is heating up regarding the role of regional drug lists and how the new system will affect drug procurement, industry insiders told the press recently. “Given the variance in additions by provincial authorities, the central government ought to increase its control over regional lists to ensure that the national list remains authoritative,” Ye Hua, an associate professor of at Fudan University’s Shanghai Medical College said. “Regional differences increase the likelihood that drugs from provincial lists will be used in place of those on the national list,” Liu Yuan, pharma analyst from Guoyuan Securities, told the press. To date, only seven administrative regions have adopted the double-envelope model since the State Council recommended the system last December, Zheng Hong, director of the essential drug policy at the Ministry of Health (MoH) said in Beijing.

Narcolepsy and Influenza: Onset of Narcolepsy Appears to Follow Seasonal Patterns of H1N1
(Science Daily, 2011-08-22)
The onset of narcolepsy appears to follow seasonal patterns of H1N1 and other upper airway infections, according to a new study of patients in China that was led by Stanford University School of Medicine narcolepsy expert Emmanuel Mignot, MD. The findings, which will be published online in Annals of Neurology, show that a peak in narcolepsy cases occurred five to seven months after a peak in flu/cold or H1N1 infections in the country. “Together with recent findings, these results strongly suggest that winter airway infections such as influenza A (including H1N1), and/or Streptococcus pyogenes are triggers for narcolepsy,” Mignot, a professor of psychiatry and behavioral sciences, and his colleagues wrote in the paper. The study follows recent reports that a particular H1N1 vaccine, not one used in the United States or China, seemed to lead to narcolepsy. This new paper, however, found no correlation between vaccination and narcolepsy among the patients studied in China. “The new finding of an association with infection, and not vaccination, is important as it suggests that limiting vaccination because of a fear of narcolepsy could actually increase overall risk,” the authors wrote in the report.

Chinese liver surgery broadcasts live to U.S. surgeons
(新华网, 2011-08-17)
Chinese surgeons had a chance to impress their U.S. counterparts with their surgical techniques, as two liver resection operations in an east China hospital were broadcasted live at the UCLA Medical Center. Via video-conferencing, liver surgeons with the Medical Center of University of California, Los Angeles, watched the surgeries on two patients with severe liver cancer, which was led by Zheng Shusen, president of The First Hospital affiliated with the School of Medicine, Zhejiang University, in Hangzhou City. Ronald Busuttil, chief of the division of liver and pancreas transplantation at UCLA, described the procedures as “perfect,” saying that he was impressed by the skillfulness of the Chinese surgeons. In China, liver surgery was started in the late 1950s and has witnessed a rapid development during the past 60 years. In some big hospitals in the cities of Beijing, Shanghai and Hangzhou, the rate of bleeding during the surgery and post-operative complications is now the lowest in the world. The UCLA Medical Center and The First Hospital affiliated with Zhejiang University’s School of Medicine, have signed an agreement to strengthen their cooperation in the study of pathogenesis, diagnosis, and treatment of liver diseases.

Chinese herbal medicine effective in treatment of H1N1 Influenza
(China.org, 2011-08-19)
A controlled trial has found that Chinese herbal medicine decoction maxingshigan-yinqiaosan has a similar efficacy to oseltamivir in reducing time to fever resolution in people suffering mild H1N1 influenza virus infections. Carried out by a group of Chinese researchers, headed by Prof. Wang Chen with Beijing Chao-Yang Hospital under the Capital Medical University, the study was published by the famous internal medicine journal Ann Intern Med. Participants of the trial were 410 young adults aged 15 to 59 years with laboratory-confirmed H1N1 influenza. The researchers concluded that both active intervention, alone and in combination, were effective in reducing time to fever resolution in young adults with H1N1 flu, and therefore suggest that maxingshigan-yinqiaosan may be an alternative to oseltamivir.

China medical dressing industry grapples with development bottlenecks – insiders
(Interfax.cn, 2011-08-19)
China’s medical dressing manufacturers are advised to boost research and development (R&D) spending and move up the value chain to overcome rising production costs and intensifying pressure on the global stage, according to industry insiders. “Rising production costs driven by a hike in cotton prices and growing labor costs have shrunk profit margins for China’s medical dressing manufacturers over the last two years,” Cao Gang, deputy director of medical device department of China Chamber of Commerce for Import & Export of Medicines & Health Products said. The value of China’s medical dressing industry surged 35.81 percent in 2010 to reach RMB 49.93 billion ($7.80 billion). China-produced dressings were exported to about 130 countries and regions, accounting for more than 50 percent of the global market, according to figures from the chamber. “China faces competition in this sector from other emerging markets such as India, Pakistan, Thailand, Vietnam and some eastern European countries,” Cao said. “In order to break these bottlenecks on development, China’s manufacturers must invest more in developing high-end medical dressings [that use synthetic and biological materials],” Cao said.

Pharmaceutical Industry

China Nepstar Chain Drugstore Announces Share Repurchase Program
(Red Orbit, 2011-08-23)
China Nepstar Chain Drugstore Ltd., the largest drugstore chain in China based on the number of directly operated stores, announced that its board of directors has authorized a share repurchase program. Under the terms of the approved program, China Nepstar may repurchase up to US$20 million worth of its issued and outstanding American Depositary Shares (ADSs) from time to time over the next 12 months. The timing and extent of any purchases will depend upon market conditions, the trading price of the ADSs, the nature of other investment opportunities presented to the company, the company’s cash flows and expected cash flows, general economic conditions and other factors. The company’s board of directors will review the share repurchase program periodically, and may authorize adjustment of its terms and size accordingly. Nepstar plans to fund repurchases made under this program from its available cash balance.

Medical device SMEs set to benefit from relaxed clinical trial rules
(Hdlns.com, 2011-08-18)
China’s small and medium-sized medical device makers are set to benefit from clinical trial exemptions for more than 100 different devices, an industry insider said. The State Food and Drug Administration (SFDA) is currently seeking public consultation on a list of more than 100 Class II medical devices that will be exempt from the tests, including mercury blood pressure meters and sterile scalpel blades, said Emily Yuan, general manager of medical device consulting firm Beijing Green Binwood Medical Technology Co. Ltd. The deadline for input is Aug. 31. “Small and medium-sized medical device makers that typically produce Class I and Class II devices stand to benefit,” said Yuan, adding that such a list is a first for the SFDA.

Shanghai Pharma inaugurates Shanghai Pharmaceuticals Shanhe Wuxi
(Bioportfolio, 2011-08-22)
Shanghai Pharmaceuticals, the only integrated pharmaceutical company in China that has leading positions in both pharmaceutical product and distribution markets, invested $53.7 million (RMB344 million) to set up Shanghai Pharmaceuticals Shanhe Wuxi Holdings, a joint venture company, with Jiangsu Wuxi Shanhe Group. Shanghai Pharmaceuticals beat many rivals in this acquisition and completed an integrated distribution network covering six provinces and one city in eastern China.The acquisition of Wuxi Shanhe will strengthen the leading position of the Group’s distribution business in eastern China and at the same time, integrate the strategic network of the Group in other provinces including Zhejiang, Jiangxi and Anhui to penetrate into the southern and central southern parts of China. Furthermore, the collaboration provides huge potential for the consolidation of pharmaceutical manufacturing resources in Shanghai and realizes the gradient transfer of product offerings. This is part of the Group’s major development strategy to consolidate resources in the industry, optimize its network and boost its core competitiveness.

China pharmacy takes edible bird’s nest off shelf amid safety concerns
(Silobreaker, 2011-08-21)
Beijing Tongrentang Co., a retailer of traditional Chinese medicine, has pulled all edible bird’s nests off the shelf after excessive amounts of chemical nitrite were found in Malaysia-imported products in the eastern Zhejiang Province. The sales ban became effective at all Tongrentang stores in China and abroad on Aug. 17, a day after State Administration for Industry and Commerce, the market watchdog, demanded retailers to tighten quality inspection of bird’s nests, the company said in a statement. The industry and commerce administration in Zhejiang Province said on Aug. 15 that excessive amount of sodium nitrate was found in edible bird’s nests imported from Malaysia. The Malaysian government later clarified that the problematic products were fake and were not endorsed by its food safety departments. Sodium nitrate is a kind of chemical that is commonly used to produce food preservative and fertilizers.

Biotechnologies

China draws expats from U.S. to launch biotechs
(Fiercebiotech, 2011-08-19)
With China’s government planning to pump hundreds of billions into its biotech sector, the country is motivating scientists from the U.S. and within its own borders to start biotechs. China is now safely in the U.S. biotech industry’s rear view mirror, but the Chinese government reportedly has a 5-year plan to pour more than $300 billion into the country’s life sciences sector to to create more than a million biotech jobs. And Chinese expatriates like Duan Peng, a research assistant professor at Rutgers University in New Jersey, are seizing the opportunity to open biotechs in their native country. Generous tax policies and government investments in start-ups are propelling new biotech activity in China. With these benefits in mind, Duan and his partners have started a diagnostics company in the city of Nantong in China’s Jiangsu province. And more expats like Duan are expected to do the same.

Chinese Pharma & Biotech Press Review – N° 207

Feb
19
2011


HEADLINES

Dear customers,
The China pharmaceutical market is expected to hit $200 billion by 2020, making it the 2nd largest in the world, before Japan.
The 2011 Universal Medica Market Access Conference to be held on September 28th, 2011 in Paris, will focus on China current challenges and future evolution, and will explore the key drivers to successfully access the market:

  • APIs sourcing
  • Off-Shore Production
  • Clinical Trials
  • Licensing

Take the chance to assess new business opportunities, and make the right choices!
For more information, please contact: info@universalmedica.cn

FOCUS

  • Immunization protects 80 mln Chinese from hepatitis B infection, ministry
  • Survey shows malaise among China’s doctors
  • Infectious diseases kill over 1,400 on Chinese mainland in July
  • Doctors could do better at reducing irregular heartbeat risks
  • Compensation plan for vaccine victims
  • China lowers prices of 82 medicines by 14%
  • Simcere Plans to Triple Headcount in New R&D Facility
  • Kangwei Bio to commercialize H. pylori vaccine

Healthcare News

Luye Pharma completes Baoguang Pharma acquisition
(Interfax.cn, 2011-08-17)
Shandong Luye Pharmaceutical Co. Ltd. (Luye Pharma) has completed the acquisition of Sichuan Baoguang Pharmaceutical Co. Ltd. (Baoguang Pharma) for a total consideration of RMB 300 million ($46.95 million), marking its entry into the diabetes drug market. Based in north China’s Shandong Province, Luye Pharma aims to gain a foothold in southwest China through the move, as well as diversify its portfolio with gastroenterological and orthopedic drugs. Baoguang Pharma is based in southwest China’s Sichuan Province and mainly produces western drugs and traditional Chinese medicine (TCM) for diabetes, gastroenterological and orthopedic diseases.

Duyiwei Bio to branch into western medicine via JV
(Silobreaker, 2011-08-17)
Gansu Duyiwei Biological Pharmaceutical Co. Ltd. (Duyiwei Bio), a traditional Chinese medicine (TCM) maker, plans to set up a western medicine joint venture (JV) with Hong Kong investment firm Heracles International Investment Co. Ltd. (Heracles). The JV will focus on developing production technology for biological medicines and small-molecule chemical drugs that will facilitate Duyiwei Bio’s entry into the western drug sector. The venture will have a registered capital of RMB 5 million ($783,500), with Duyiwei Bio contributing RMB 3 million ($470,100) for a 60 percent stake and Heracles RMB 2 million ($313,400) for the remaining 40 percent.

Virus may cause of high blood pressure: Chinese study
(中国邮报, 2011-08-16)
High blood pressure could be caused by a common virus, according to a study carried out by a team of Chinese doctors which has possible implications for millions of people around the world. The human cytomegalovirus (HCMV) infects most adults but is repressed by the body’s immune system and rarely causes any symptoms. But a team from Beijing Chaoyang Hospital’s cardiology center has found the first evidence of a link between HCMV and essential hypertension, according to a report published on the website of the U.S. medical journal Circulation. The findings “demonstrate a novel link between HCMV infection and essential hypertension,” according to the report. “These findings may reveal important insights into the pathogenesis of essential hypertension”. Former Circulation chief editor James Willerson posted comments that the findings of the study “might present a new strategy for preventing and treating cardiovascular disease.”

China medical trade soars 40 pct in H1
(Cccmhpie.org.cn, 2011-08-11)
China’s trade in medical products surged 39.93 percent year-on-year to hit RMB 34.55 billion in the first half (H1), according to figures released by the China Chamber of Commerce for Import & Export of Medicines & Health Products. Exports during the period rocketed 36.62 percent to $21.39 billion, while imports shot up 45.67 percent to $13.16 billion, according to the figures. Active pharmaceutical ingredients (API) exports were worth $11.04 billion, up 28.63 percent, while medical devices exports soared 57.34 percent to $7.13 billion. “Exports started to rebound in 2009, mainly driven by strong demand for APIs and medical devices. But the present debt crisis in Europe and the U.S. might dampen this trend,” Tan Shengcai, deputy secretary-general of the chamber, told the press.

Hospital management requires increased independence – experts
(Interfax.cn, 2011-08-11)
Hospital management bureaus require greater independence from health authorities to ensure their success, health officials said at the recent Health Economic Forum 2011 in Beijing. China introduced separate bureaus to oversee hospital management on a trial basis as part of its ongoing health care reforms. The initiative is intended to improve management efficiencies and help attract private investment in health services. “Poor management is the biggest impediment to the development of China’s hospitals, and introducing independent oversight is necessary to make improvements,” Mao Yu, deputy director of Beijing Hospital Management Bureau, said at the conference. The Beijing bureau also hopes to see increased interest in the city’s medical services sector from large health care providers from outside the city, said Mao.

Women’s rights guidelines set health care targets
(Rsssearchhub, 2011-08-15)
China’s State Council issued 10-year guidelines for the improvement of women’s rights that set a range of health care goals and are set to improve medical provision for women, an industry insider said. The document, “Guidelines for the development of Chinese Women (2011-2020),” focuses on seven areas, namely health, education, social security, the environment, and the legal, political and economic standing of women. One of the main targets of the guidelines is a reduction in the death rate of pregnant and lying-in women to below 20 per 100,000 by 2020. The rate was 32 per 100,000 in 2009, according to data from IMS Consulting Group. “The government will need to increase spending on maternal and child care to reach this target, and will need to focus on rural areas in particular,” Wang Mengliang, an engagement manager with IMS said.

Six people die of heart disease per minute in China
(中国网, 2011-08-12)
About 230 million people in China suffer from cardiovascular disease, and about six people die from it per minute in the country, according to a report released at the 7th China Heart Congress. The report, delivered by the Ministry of Health ‘s National Center for Cardiovascular Disease at the four-day congress, indicates that nearly three million people died of cardiovascular disease, such as coronary heart disease, cerebral apoplexy, heart failure and hypertension, in China each year. The report listed insufficient physical exercise, unhealthy eating habits, such as excessive salt and fat intake, and smoking as causes of cardiovascular disease, and the number of people suffering from it is increasing each year, it said. The death rate of coronary heart disease and myocardial infarction in rural areas exceeds that in small- and medium-sized cities, according to the report.

Warning that new tick disease is highly infectious
(China MOH, 2011-08-15)
A newly discovered tick-borne disease may endanger people in close contact with carriers of the lethal virus, the Ministry of Health warned. The warning came amid a promise to upgrade blood-testing facilities nationwide. The emerging tick-borne disease, known as “fever-thrombocytopenia syndrome”, is caused by an offshoot of the Bunia virus. This virus may cause victims to suffer from liver and kidney failure and can result in internal bleeding. The body fluids of people who fall victim to the disease are highly infectious. Patients should be treated in isolation wards, according to a guideline on the ministry’s website. Unless adequate precautions are taken, people in close contact with carriers need to be put under a 14-day quarantine regime. If there are any signs of fever a doctor or the health authorities should be immediately informed and given as much detailed information as possible. More than 280 cases of the tick-borne disease have been reported in central and eastern provinces, including Henan, Hubei, Shandong, Anhui and Jiangsu, according to statistics from the Chinese Center for Disease Control and Prevention (CDC). The disease has already claimed the lives of more than 10 people. Ninety percent of the victims of the disease were more than 40 years old and farmers accounted for 90 percent of these cases, the CDC said. The CDC said that most of the victims suffered nausea, fatigue and a lack of appetite. The disease reduces white blood cell and platelet counts, which can lead to organ failure and death.

Pharmaceutical Industry

Beijing SL Pharma Forms Canadian Vaccine JV
(ChinaBio Today, 2011-08-16)
Beijing SL Pharmaceutical will invest 130 million RMB ($20 million) in a Canadian JV, which it will form with PnuVax, an Ontario startup. Beijing SL Pharma will own 85% of the new entity. PnuVax, which specializes in vaccine manufacturing processes, will own the rest. The JV’s initial focus will be on 23-valent pneumococcal polysaccharide vaccines (PPSVs) that are intended for the China market.

Sinopharm Acquires Wuhan Zhongliang Pharma
(Bioportfolio, 2011-08-16)
Sinopharm, the Beijing State-Owned pharmaceutical giant, has apparently won the bidding for another state-owned company, the troubled Wuhan Zhongliang Pharmaceutical Group. There were several companies interested in acquiring Zhongliang, and one contender apparently offered 500 million RMB ($78 million) for the company. The size of Sinopharm’s bid is not yet known, though it was speculated that Sinopharm prevailed because of its previous commitment to invest 5 billion RMB ($780 million) in Hubei Province (Wuhan is the capital of Hubei) over the next few years.

Is China preparing to challenge the U.S. for biotech supremacy?
(Fiercebiotech, 2011-08-17)
It appears that the answer to that question is yes. China’s 5-year plan for biotech calls for $308 billion in spending and the creation of a million new biotech jobs. “The opportunity for the Chinese–and, of course, for the U.S.–is to learn from this overemphasis on the “R” in the “R&D” equation, and to focus more on the “D”, the reporter said.”The other opening for China is to take the mass of basic research bought by America’s trillion-dollar investment, which is readily available in journals and databases, and turn it into products–and into gold.” China’s biotech industry is light years behind U.S. companies. But with its rep for lightning advances, the Asian nation could be on our heels before we know it, according to reporter.

Abbott Expanding Manufacturing Capacity in China to Meet Demands of Fast-Growing Nutrition Market
(MarketWatch, 2011-08-16)
Abbott announced that it will invest $230 million (USD) to build a state-of-the-art nutrition manufacturing facility in Jiaxing. The facility represents Abbott’s largest investment in China to date and will manufacture premium powdered milk products for Chinese infants and children. More than 17 million infants are born each year in China and rising incomes and a growing middle class have created increased demand for high-quality nutrition products. To meet the needs of this dynamic market, Abbott anticipates launching a number of new product innovations over the next three years across the pediatric nutrition category in China. The plant, when operational in 2013, will employ approximately 300 people.

Concord Medical and GE Healthcare Sign MOU for Preferred Partnership in China
(ABC 12, 2011-08-11)
Concord Medical Services Holdings Limited, the operator of the largest network of radiotherapy and diagnostic imaging centers in China, announced that it has signed an MOU with GE Healthcare (GEHC), through its subsidiaries General Electric International Operations Company, Inc. and GE Medical Systems Trade & Development (Shanghai) Co., Ltd., to form a preferred strategic partnership in China. Under the MOU, Concord Medical and GEHC have agreed to cooperate in academic and marketing programs, and plan to jointly organize new seminars and conferences in China to create more opportunities for scientific exchanges. Concord Medical will partner with GEHC to enter and expand into rural and primary care markets in China, through financial leasing or other mutually beneficial business strategies.

Biotechnologies

Sinovac Receives GMP Certificate in Mexico for Seasonal Flu Vaccine and Hepatitis A Vaccine
(PRNewswire, 2011-08-11)
Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, announced that it has obtained the GMP certificate for its seasonal flu vaccine and hepatitis A vaccine from the Mexican regulatory authority, the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) of Mexico Ministry of Health. Sinovac is the first Chinese vaccine manufacturer to be granted GMP certificate by COFEPRIS. The GMP certification follows the onsite inspection by COFEPRIS at Sinovac’s Beijing headquarters in September 2010. The GMP certificate is effective for 30 months with an expiration date of January 12, 2014, at which time a new GMP inspection shall be applied for the renewal of GMP certificate.

Scientific News

North East China reports more cases of cutaneous anthrax infection
(新华网, 2011-08-11)
Nine more people are suspected of being infected with cutaneous anthrax in northeast China’s Liaoning Province, bringing the total number of reported cases to 30, local health authorities said. Among the reported cases, three have been confirmed and 27 others are still being investigated, the Liaoning Provincial Health Department said in a statement. Twenty-nine of the patients are receiving treatment at an infectious disease hospital in the city of Anshan, while the other one has been transferred to a hospital in the provincial capital of Shenyang. An initial investigation by local health authorities indicated that the patients contracted the disease after coming into direct contact with diseased cattle. Cutaneous anthrax is an infection of the skin caused by direct contact with infected animals or animal products. It is rarely fatal if treated.

Chinese Pharma & Biotech Press Review – N° 206

Feb
18
2011


HEADLINES

Dear customers,
The China pharmaceutical market is expected to hit $200 billion by 2020, making it the 2nd largest in the world, before Japan.
The 2011 Universal Medica Market Access Conference to be held on September 28th, 2011 in Paris, will focus on China current challenges and future evolution, and will explore the key drivers to successfully access the market:

  • APIs sourcing
  • Off-Shore Production
  • Clinical Trials
  • Licensing

Take the chance to assess new business opportunities, and make the right choices!
For more information, please contact: info@universalmedica.cn

FOCUS

  • Immunization protects 80 mln Chinese from hepatitis B infection, ministry
  • Survey shows malaise among China’s doctors
  • Infectious diseases kill over 1,400 on Chinese mainland in July
  • Doctors could do better at reducing irregular heartbeat risks
  • Compensation plan for vaccine victims
  • China lowers prices of 82 medicines by 14%
  • Simcere Plans to Triple Headcount in New R&D Facility
  • Kangwei Bio to commercialize H. pylori vaccine

Healthcare News

Luye Pharma completes Baoguang Pharma acquisition
(Interfax.cn, 2011-08-17)
Shandong Luye Pharmaceutical Co. Ltd. (Luye Pharma) has completed the acquisition of Sichuan Baoguang Pharmaceutical Co. Ltd. (Baoguang Pharma) for a total consideration of RMB 300 million ($46.95 million), marking its entry into the diabetes drug market. Based in north China’s Shandong Province, Luye Pharma aims to gain a foothold in southwest China through the move, as well as diversify its portfolio with gastroenterological and orthopedic drugs. Baoguang Pharma is based in southwest China’s Sichuan Province and mainly produces western drugs and traditional Chinese medicine (TCM) for diabetes, gastroenterological and orthopedic diseases.

Duyiwei Bio to branch into western medicine via JV
(Silobreaker, 2011-08-17)
Gansu Duyiwei Biological Pharmaceutical Co. Ltd. (Duyiwei Bio), a traditional Chinese medicine (TCM) maker, plans to set up a western medicine joint venture (JV) with Hong Kong investment firm Heracles International Investment Co. Ltd. (Heracles). The JV will focus on developing production technology for biological medicines and small-molecule chemical drugs that will facilitate Duyiwei Bio’s entry into the western drug sector. The venture will have a registered capital of RMB 5 million ($783,500), with Duyiwei Bio contributing RMB 3 million ($470,100) for a 60 percent stake and Heracles RMB 2 million ($313,400) for the remaining 40 percent.

Sinopharm Acquires Wuhan Zhongliang Pharma
(Bioportfolio, 2011-08-16)
Sinopharm, the Beijing State-Owned pharmaceutical giant, has apparently won the bidding for another state-owned company, the troubled Wuhan Zhongliang Pharmaceutical Group. There were several companies interested in acquiring Zhongliang, and one contender apparently offered 500 million RMB ($78 million) for the company. The size of Sinopharm’s bid is not yet known, though it was speculated that Sinopharm prevailed because of its previous commitment to invest 5 billion RMB ($780 million) in Hubei Province (Wuhan is the capital of Hubei) over the next few years.

Biotechnologies

Beijing SL Pharma Forms Canadian Vaccine JV
(ChinaBio Today, 2011-08-16)
Beijing SL Pharmaceutical will invest 130 million RMB ($20 million) in a Canadian JV, which it will form with PnuVax, an Ontario startup. Beijing SL Pharma will own 85% of the new entity. PnuVax, which specializes in vaccine manufacturing processes, will own the rest. The JV’s initial focus will be on 23-valent pneumococcal polysaccharide vaccines (PPSVs) that are intended for the China market.

Is China preparing to challenge the U.S. for biotech supremacy?
(Fiercebiotech, 2011-08-17)
It appears that the answer to that question is yes. China’s 5-year plan for biotech calls for $308 billion in spending and the creation of a million new biotech jobs. “The opportunity for the Chinese–and, of course, for the U.S.–is to learn from this overemphasis on the “R” in the “R&D” equation, and to focus more on the “D”, the reporter said.”The other opening for China is to take the mass of basic research bought by America’s trillion-dollar investment, which is readily available in journals and databases, and turn it into products–and into gold.” China’s biotech industry is light years behind U.S. companies. But with its rep for lightning advances, the Asian nation could be on our heels before we know it, according to reporter.

Scientific News


Virus may cause of high blood pressure: Chinese study

(中国邮报, 2011-08-16)
High blood pressure could be caused by a common virus, according to a study carried out by a team of Chinese doctors which has possible implications for millions of people around the world. The human cytomegalovirus (HCMV) infects most adults but is repressed by the body’s immune system and rarely causes any symptoms. But a team from Beijing Chaoyang Hospital’s cardiology center has found the first evidence of a link between HCMV and essential hypertension, according to a report published on the website of the U.S. medical journal Circulation. The findings “demonstrate a novel link between HCMV infection and essential hypertension,” according to the report. “These findings may reveal important insights into the pathogenesis of essential hypertension”. Former Circulation chief editor James Willerson posted comments that the findings of the study “might present a new strategy for preventing and treating cardiovascular disease.”

Chinese Pharma & Biotech Press Review – N° 205

Feb
11
2011


HEADLINES

Dear customers,
The China pharmaceutical market is expected to hit $200 billion by 2020, making it the 2nd largest in the world, before Japan.
The 2011 Universal Medica Market Access Conference to be held on September 28th, 2011 in Paris, will focus on China current challenges and future evolution, and will explore the key drivers to successfully access the market:

  • APIs sourcing
  • Off-Shore Production
  • Clinical Trials
  • Licensing

Take the chance to assess new business opportunities, and make the right choices!
For more information, please contact: info@universalmedica.cn

FOCUS

  • Immunization protects 80 mln Chinese from hepatitis B infection, ministry
  • Survey shows malaise among China’s doctors
  • Infectious diseases kill over 1,400 on Chinese mainland in July
  • Doctors could do better at reducing irregular heartbeat risks
  • Compensation plan for vaccine victims
  • China lowers prices of 82 medicines by 14%
  • Simcere Plans to Triple Headcount in New R&D Facility
  • Kangwei Bio to commercialize H. pylori vaccine

Healthcare News

Immunization protects 80 mln Chinese from hepatitis B infection, ministry
(China MOH, 2011-08-09)
China credited its national immunization program which protected about 80 million people from being infected with the Hepatitis B virus (HBV) in the 19 years after 1992, when the virus was first brought into the program. Wang Bin, deputy director of the disease prevention bureau under the ministry, said inoculations also helped prevent 19 million additional children from becoming carriers of hepatitis B surface antigen (HBsAg) in the same period. HBsAg is an early indicator of acute hepatitis B.
About 93 million Chinese are HBV carriers, accounting for more than a quarter of the world’s total. Chinese job hunters have long complained of discrimination on the grounds of them having Hepatitis B. In 2005, the government issued a health standard that included Hepatitis B carriers among eligible candidates for the civil service. According to the standard, Hepatitis B carriers are eligible to work for the government so long as the infection does not progress to the disease stage.

Survey shows malaise among China’s doctors
(China CMDA, 2011-08-10)
Large numbers of doctors in China are unsatisfied with their work environment, in particular senior doctors and those working in rural areas, according to the results of a survey released. The study was carried out by the Chinese Medical Doctor Association (CMDA) in 11 provinces and municipalities during March and April this year. Of the 3,704 health workers surveyed, 48.54 percent said they were not satisfied with their work environment, 55.47 percent of whom were senior doctors. Medical disputes, heavy workloads and high patient expectations were cited as sources of pressure by 70.67 percent of doctors, with senior doctors more likely to be affected by these factors. Some 96 percent of doctors thought their salary did not match their contribution, and 78.01 percent said they did not want their children to follow their career path. The CMDA advised the government to increase investment in the health care system and to boost doctor salaries while cracking down on kickbacks.

Infectious diseases kill over 1,400 on Chinese mainland in July
(中国日报, 2011-08-10)
Notifiable infectious diseases killed 1,419 people on the Chinese mainland in July, the Ministry of Health said. More than 770,129 cases of infections were reported last month, including six cases of cholera resulting in no deaths, a ministry statement said. Cholera is categorized as Class A infectious disease — the most serious class under China’s Law on the Prevention and Treatment of Infectious Diseases. A total of 349,524 cases of Class B diseases were reported last month, resulting in 1,320 deaths. No cases of severe acute respiratory syndrome (SARS), poliomyelitis, human infection of H5N1, or diphtheria under class B were reported. According to the statement, viral hepatitis, tuberculosis, syphilis, dysentery, and gonorrhea were the five most frequently reported Class B diseases in July. There were 420,599 cases of Class C diseases infections, causing 99 deaths. Foot-and-mouth disease, diarrhea and parotitis accounted for 97 percent of all reported cases of Class C diseases.

Doctors could do better at reducing irregular heartbeat risks
(新华网, 2011-08-03)
About 10 million people on the Chinese mainland suffer from atrial fibrillation (AF), the most common type of irregular heartbeat, a leading cause of stroke, experts warn. Among the population, the disease’s prevalence now stands at 0.77 percent but the risk increases with age, says Hu Dayi, director of the Center of Cardiology at Peking University People’s Hospital in Beijing. To improve the situation national health authorities and academic societies have published clinical guidelines instructing medical doctors on how to deal with AF. Hu adds that financial incentives among doctors are also to blame. “Warfarin is cheap and carries certain risks without proper follow-up services, including regular blood tests, so many medics don’t bother to administer it,” Hu notes. A practical compromise for AF patients at relatively lower risk of a stroke is aspirin, another anti-clotting drug, expert suggests. It is not as effective as warfarin, but is less likely to cause serious bleeding. “It takes time to improve the situation,” Hu says, adding improving the ability of doctors, particularly at community level clinics, is the first step to address the problem.

Compensation plan for vaccine victims
(China Stock, 2011-08-03)
Families of patients who die or are left disabled due to vaccines may soon receive massive payouts from the government, as the capital looks to close a major loophole in its health system. Currently, compensation claims can only be made against clinics and manufacturers if tests prove the medicine that was administered did not comply with the national standard. However, a Beijing Health Bureau draft regulation now open to public consultation aims for the first time to ensure help for those seriously affected by any of the 16 vaccines in the city’s immunization program. The proposal states that families of the deceased will receive for 20 years an amount equal to the previous year’s per capita disposable income of Beijing urban residents. Authorities will also cover the cost of funerals and autopsies.

Online marketing growing trend for health products – industry insiders
(Interfax.cn,  2011-08-05)

There is a growing trend for online marketing of health care products as Internet connectivity increases in China, industry insiders said at the 13th Chinese Medical Elite Salon. The Internet is changing marketing strategies in the health care industry as third generation (3G) mobile networks roll out and mobile newspapers gain in popularity, said Zhang Jiming, chief consultant of Sidea Consulting Co. Ltd., which organized the conference. China’s Internet users numbered 485 million at the end of June, according to figures from the China Internet Network Information Center figures. About 65.5 percent of these have used mobile phones to access the Internet, and microblog user numbers have reached 195 million.

China lowers prices of 82 medicines by 14%
(China NDRC, 2011-08-05)
China will lower the retail price ceiling of 82 kinds of pharmaceutical drugs by an average 14 percent in a move to reduce people’s medical bills, the top economic planner announced. The price adjustment, the second cut this year, will come into effect on September 1, the National Development and Reform Commission (NDRC) said in a statement. The regulation aims to maintain the production and supply of cheap drugs and ease the financial burden for families, according to the statement. In March, the commission lowered the retail price ceiling of 162 kinds of medicines by an average of 21 percent, which was expected to save the Chinese consumers nearly 10 billion yuan (1.55 billion U.S. dollars).

Pharmaceutical Industry

Mingyuan Medicare Buys Diagnostic Company for $55 Million
(Genome Web, 2011-08-10)
Mingyuan Medicare Development, a Hong Kong company that operates in the PRC, has agreed to buy a 70% stake in 18-month-old Shanghai Yuanqi for 354 million RMB ($55 million). Both companies provide cancer screening kits to the PRC. Shanghai Yuanqi has developed molecular diagnostic kits for leukemia, lymphoma, and individualized cancer therapy. Minyuan’s best selling product is its C-12 protein chip, which tests blood samples for 12 tumor markers that detect 12 types of cancer.

Huahai Pharma reaps rewards from global demand for sartans APIs
(Interfax.cn, 2011-08-10)
Zhejiang Huahai Pharmaceutical Co. Ltd., a leading producer of active pharmaceutical ingredients (API) in China, saw net profit in the first half (H1) surge 122 percent year-on-year to RMB 133 million ($20.7 million) on the back of high global demand for sartans active pharmaceutical ingredients (API). Sales of sartans APIs during the period soared 130 percent year-on-year to RMB 258 million ($40.1 million), driven in particular by demand from developed markets. Global demand for sartans APIs has risen recently as generic drug makers gear up in anticipation of patent expiries for various innovative sartans products in coming years. From 2012 to 2014, patents are set to expire on Diovan (valsartan) by Novartis and Avapro (irbesartan) by Bristol-Myers Squibb, among others. Generic drug makers in developed markets typically procure sartans APIs six months prior to production, meaning Huahai Pharma will likely continue to benefit from the patent expiries for the rest of this year and in 2012.

YaoPharma to invest $155 mln in high-end plant
(Global-Report, 2011-08-09)
Chongqing-based drug maker YaoPharma Co. Ltd. has signed an agreement with the municipal government to invest RMB 1 billion ($155 million) in a production plant for high-end drugs, a representative of the firm’s controlling stakeholder said. The facility will make finished drugs for export and provide contract manufacturing services for international drug makers, said a public relations representative with Shanghai Fosun Pharmaceutical Group Co. Ltd. (Fosun Pharma). YaoPharma is controlled by Fosun Pharma, a leading pharma firm in China, which owns a 51 percent stake. The remaining 49 percent is held by Chongqing Chemical & Pharmaceutical Holdings (Group) Co. Ltd, which is owned by the Chongqing government. The new plant is expected to generate yearly sales revenue of RMB 3 billion ($466 million) once operational in 2013, without specifying what products will be manufactured at the plant.

VWR Buys China’s LabPartner, a Fellow Lab Products Supplier
(Bioportfolio, 2011-08-04)
VWR International, LLC, a US-based distributor of laboratory supplies and services, announced plans to acquire LabPartner (Shanghai) Co., Ltd. Located in Zhangjiang Hi-Tech Park, LabPartner supports China’s biopharma labs with premium products and integrated services and a focus on chemicals. The price of the transaction was not disclosed.

Simcere Plans to Triple Headcount in New R&D Facility
(Topix, 2011-08-03)
Simcere Pharmaceutical will increase its R&D staff to 1,000 in the next three or four years, up from its present headcount of 300. The company recently announced it would build a new R&D center in Beijing’s Zhongguancun Innovation Park, where it recently bought rights to 65,300 square meters of land. The company is headquartered in Nanjing, but Simcere said it wanted to access Beijing’s talent pool. The company says it needs R&D to increase its product portfolio.

Shionogi deal reflects renewed interest in China among Japan’s drug makers – analyst
(Rsssearchhub, 2011-08-03)
Leading Japanese drug maker Shionogi & Co. Ltd. unveiled plans to enter China on Aug. 1 in a move that reflects renewed interest in the market among Japan’s pharma firms, an industry analyst told the press. The Japanese firm has agreed to acquire a 24.17 percent stake in Nanjing City-based C&O Pharmaceutical Technology (Holdings) Co. Ltd. (C&O), and later plans to increase its holding to gain control of the company. The deal is expected to be worth a total of 14.3 billion yen ($185 million), Shionogi said. Shionogi plans to operate C&O in partnership with Japanese conglomerate Sumitomo Corp., which already holds a 29 percent stake in the firm. C&O will retain its current executive director, Gao Bin. “Shionogi is eying C&O’s extensive sales network in China, especially in hospitals. Firms that distribute imported drugs like C&O typically have good connections with big hospitals,” Bian Chenguang, a pharma analyst with Beijing-based Anbound Consulting, told the press.

Global Pharm acquires Pacific Asia Pharm
(Sun Herald, 2011-08-05)
Global Pharm Holdings, a China-based pharmaceutical company, has announced that the company entered into a share purchase agreement and completed the acquisition of Pacific Asia Phram Investment Group. Pursuant to the acquisition agreement, the sellers agreed to sell and the company agreed to purchase the aggregate of 50,000 ordinary shares in Pacific Asia Pharm, a company incorporated and existing under the laws of the British Virgin Islands, representing the entire issued share capital of Pacific Asia Pharm. The consideration for the sale shares is $42 million. With the completion of this acquisition, Pacific Asia Pharm becomes a wholly owned subsidiary of the company.

Abbott Expanding Manufacturing Capacity in China to Meet Demands of Fast-Growing Nutrition Market
(MarketWatch, 2011-08-16)
Abbott announced that it will invest $230 million (USD) to build a state-of-the-art nutrition manufacturing facility in Jiaxing. The facility represents Abbott’s largest investment in China to date and will manufacture premium powdered milk products for Chinese infants and children. More than 17 million infants are born each year in China and rising incomes and a growing middle class have created increased demand for high-quality nutrition products. To meet the needs of this dynamic market, Abbott anticipates launching a number of new product innovations over the next three years across the pediatric nutrition category in China. The plant, when operational in 2013, will employ approximately 300 people.

Biotechnologies

Kangwei Bio to commercialize H. pylori vaccine
(F-paper,  2011-08-10)
Vaccine developer Chongqing Kangwei Biotech Co. Ltd. (Kangwei Bio) plans to commercialize its long-awaited oral recombinant Helicobacter pylori (H. pylori) vaccine at a new facility in Anhui Province’s Wuhu City, the firm’s second-largest shareholder, Yueyang Xingchang Petrochemical Co. Ltd. (Xingchang Petrochemical) announced. Kangwei Bio recently signed an agreement with the Wuhu government to invest RMB 1 billion ($155 million) in a plant for the vaccine with a designed annual production capacity of 12 million units. A new subsidiary named Wuhu Kangwei Biotech Co. Ltd. (Wuhu Kangwei) will be formed to oversee the project. The H. pylori bacterium is a major cause of diseases of the upper gastrointestinal tract, including gastritis, gastric ulcers and gastric cancer. The infection rate in China stands at more than 50 percent.

Chinese Pharma & Biotech Press Review – N° 204

Feb
4
2011


HEADLINES

Dear customers,
The China pharmaceutical market is expected to hit $200 billion by 2020, making it the 2nd largest in the world, before Japan.
The 2011 Universal Medica Market Access Conference to be held on September 28th, 2011 in Paris, will focus on China current challenges and future evolution, and will explore the key drivers to successfully access the market:

  • APIs sourcing
  • Off-Shore Production
  • Clinical Trials
  • Licensing

Take the chance to assess new business opportunities, and make the right choices!
For more information, please contact: info@universalmedica.cn

FOCUS

  • Reforms lure global medical device makers to grassroots market – analyst
  • China to consult with EU on X-ray scanner based on WTO rules
  • Hospital management bureau opens in Beijing, focusing on public hospital reform
  • Over 300 doctors sent to Tibet to help children with congenital heart disease
  • China bans poorly edited healthcare books
  • Sichuan Pharma float reflects management issues of state-owned drug makers – analyst
  • Oral Interferon May Prevent and Control Avian Influenza Virus Infection

Healthcare News

Reforms lure global medical device makers to grassroots market – analyst
(Interfax.cn, 2011-07-27)
GE Healthcare ‘s plan to move the headquarters of its global X-ray business from the U.S. to Beijing reflects growing interest among multinational medical device makers in China’s grassroots market, an analyst told press. “Multinational medical device makers such as GE Healthcare, Philips Healthcare and Siemens Healthcare are increasingly attracted to China’s grassroots market due to ongoing health reforms that aim to improve primary care. Previously they have focused more on the high-end market,” Xu Qing, a pharmaceutical analyst with Soochow Securities said. GE Healthcare hopes low-end products will account for 50 percent of its China sales within three to five years, compared with the current 20 percent, the company’s China CEO, Rachel Duan, told press. Furthermore, the U.S. firm announced plans last year to invest $2 billion in its China operations, including $500 million for six “customer innovation centers.” It also deployed 500 sales representatives to rural China to assist doctors in grassroots medical institutions. Meanwhile, some leading domestic players are trying to boost their share of the high-end market, but continue to lag behind foreign competitors in terms of technology and brand status, the analyst said.

Hokai Medical gets nod for Shenzhen IPO
(Global-Report, 2011-07-28)
Privately-owned medical device maker Zhuhai Hokai Medical Instruments Co. Ltd. (Hokai Medical) has got the green light for an initial public offering (IPO) on the Shenzhen Stock Exchange Growth Enterprise Market (GEM) to fund a major expansion. The firm intends to issue 33.35 million shares, or 25 percent of its total equity after the issuance, according to its listing prospectus. A stock valuation has yet to be carried out. The company plans to expand capacity for its two main products – non-invasive thermotherapy devices (NITD) used to treat cancers and molecular sieve oxygen generators (MSOG) – with respective investments of RMB 30 million ($4.65 million) and RMB 48.54 million ($7.52 million).

China to consult with EU on X-ray scanner based on WTO rules
(新华网, 2011-07-27)
China’s Ministry of Commerce said that it will consult with the European Union with respect to the WTO rules after the latter filed a complaint against China over levying anti-dumping duties on X-ray scanners. On July 25, the EU requested consultations with China under the dispute settlement system concerning China’s anti-dumping duties on X-ray scanners imported from the EU, the WTO said on its website. The EU and China have 60 days to reach an agreement, otherwise the EU could ask the WTO to rule on the matter. Starting Jan. 23, China imposed anti-dumping duties between 33.5 percent and 71.8 percent on scanners imported from the EU with a time span of five years.

Hospital management bureau opens in Beijing, focusing on public hospital reform
(En Radio, 2011-07-28)
Beijing established a new medical authority as part of an ongoing project to change the way the nation’s public hospitals operate. The creation of the Beijing Hospital Management Bureau will help the country to reform its public hospitals and create a modernized hospital management system, Health Minister Chen Zhu said at the bureau’s opening ceremony. The bureau will be in charge of asset management and supervision, management recruitment and training and operational reforms for the city’s 22 major public hospitals. Beijing has been approved to be the 17th city to test government-run hospital reform programs, according to the Ministry of Health. The reform programs are aimed to ease the public’s concern over rising medical costs.

Over 300 doctors sent to Tibet to help children with congenital heart disease
(CNTV, 2011-07-28)
More than 300 doctors from about 20 provincial regions across China left for Tibet, where they will offer free surgery to children with congenital heart disease and people with cataracts. Aside from providing surgery, the medical specialists are expected to pair up with local doctors and offer them short-term training. In an effort to help impoverished newborns with congenital heart disease to have access to medical services, the United Front Work Department of the CPC Central Committee has organized doctors to preform free operations on more than 100 children since 2008. Most of these children were from China’s hinterland regions of Sichuan, Ningxia and Inner Mongolia, according to a statement from the department.

Guang’anmen Hospital Improves Medical Waste Disposal Control With Ekahau RTLS System
(Fox Carolina, 2011-07-28)
Guang’anmen Hospital in Beijing, one of the leading hospitals affiliated with China Academy of Chinese Medical Science, focusing on clinical practice, scientific research and education, has chosen Ekahau ‘s RTLS system to monitor hazardous medical waste disposal. HKC Technology Co., as the local IT integrator is responsible for installation and support the system at the hospital. “A secure disposal of medical waste is important for safety and compliance reasons, for this purpose, our hospital personnel will carry Ekahau T301BD personnel badgets, and the medical waste truck will be equipped with the Ekahau T301A asset tags.” said Ms. Jie Wang, head of disposal control.

China bans poorly edited healthcare books
(中国日报, 2011-07-30)
China’s General Administration of Press and Publication (GAPP) has halted the publication of 104 healthcare books as many self-proclaimed experts spread their pseudoscientific methods for longevity. “Through a variety of means, some phony doctors and experts have been writing books and misleading the public by spreading their unscientific healthcare methods for quite some time,” said GAPP head Liu Binjie. During a spot check of 50 healthcare books, the GAPP found 24 with substandard editing. According to Liu, publication administrative departments were urged to strengthen the supervision of healthcare projects regarding authors’ professional background, abilities of editing staff and related statistics.

Guizhou guidelines shake blood products sector
(CHINA NATIONAL RADIO, 2011-08-02)
Recently issued regulations for blood plasma stations in Guizhou Province are set to result in a wave of closures that will significantly reduce China’s national output of blood plasma, insiders have said. The guidelines, announced July 15, stipulate that the province’s 20 blood plasma stations will be slashed to four by 2014. No details of which operators will be affected were given. The move is expected to reduce the supply of blood plasma in China by roughly 20 percent, Zhao Bing, pharmaceutical analyst from Shanghai Securities said.

Pharmaceutical Industry

Sichuan Pharma float reflects management issues of state-owned drug makers – analyst
(Interfax.cn, 2011-07-28)
The recent floatation of Sichuan Pharmaceutical Co. Ltd., a state-owned manufacturer of antibiotic active pharmaceutical ingredients (API), on the Southwest United Equity Exchange reflects the management problems plaguing medium-sized state-owned drug makers, an analyst told press. “Most medium-sized state-owned drug makers in China are plagued with management problems and struggle to maintain profitability,” Zhang Hongbin, an industry analyst from Datong Securities, said. Official figures show that in the first quarter (Q1) this year, 32 of China’s 132 state-owned pharma firms, or 24.24 percent, incurred losses – higher than the overall figure for state-owned companies of 14.62 percent. Sichuan Kelun Pharmaceutical Co. Ltd. (Kelun Pharma) initially showed interest in acquiring Sichuan Pharma, it later backed off. The Board Chairman of Kelun Pharma said that Sichuan Pharma was an unsuitable target and Kelun Pharma would concentrate on its own API projects instead.

Hisun Pharma to increase US focus with PharmTak investment
(Global-Report, 2011-08-02)
Drug maker Zhejiang Hisun Pharmaceutical Co. Ltd. (Hisun Pharma) plans to acquire a minor stake in U.S. startup PharmTak Inc., a specialist in generic drug formulations, in a bid to speed up its entry into the finished dosage market in the U.S.. The firm plans to invest $2 million for a 24.69 percent stake. Hisun Pharma hopes to benefit from the Californian firm’s advanced formulation technology for high-end generics as well as its experience of the U.S. regulatory environment.

Shionogi of Japan to Take Control of China’s C&O Pharma
(ChinaBio Today, 2011-08-01)
Shionogi & Co., a Japanese pharma, will pay $185 million to obtain a controlling interest in C&O Pharmaceutical Technology. C&O Pharma, a company that produces antibiotics and other drugs for the China market, is headquartered in Hong Kong, but listed in Singapore. Shionogi said it wants to establish a major presence in China for its own drugs.

Merck Reduces Workforce Globally while Building in China
(Bioportfolio, 2011-08-01)
Merck announced it will be cutting another 13,000 jobs, about 14% of its current headcount, while at the same time continuing to build its China workforce. About 35%-40% of the cutbacks will be in the US, especially in administrative and support personnel. Meanwhile, Merck reported China revenues rose in Q2 by 30% to $208 million, driven mainly by its products in the infectious disease and respiratory sectors.

Hepalink Pharma to acquire control of finished dosage JV
(人民日报, 2011-08-01)
Shenzhen Hepalink Pharmaceutical Co. Ltd. (Hepalink), China’s leading producer of heparin sodium active pharmaceutical ingredient (API), plans to acquire control of its finished dosage joint venture (JV), Chengdu Haitong Pharmaceutical Co. Ltd. (Haitong Pharma). Hepalink plans to increase its holding in the JV to 85 percent by acquiring a 36 percent share from its partner Chengdu Tongde Pharmaceutical Co. Ltd. (Tongde Pharma) for a total consideration of RMB 7.2 million ($1.12 million). The move is intended to strengthen Hepalink’s finished dosage operations and make up for dwindling revenue and profit from its core API business.

Biotechnologies

BGI and GT Life Sciences, Inc. Report Genome Sequence of CHO-K1
(ABC 12, 2011-08-01)
BGI, the world’s largest genomics organization, and GT Life Sciences, Inc., a privately held biotechnology company that utilizes a proven metabolic modeling and experimental platform to drive the discovery and design of new products and processes for the life sciences field, announced that their collaborative study on the genomic sequence of the Chinese hamster ovary (CHO) K1 cell line was published July 31 online in Nature Biotechnology. The CHO-K1 genome is the first published cell line genome decoded by de novo sequencing and assembly. The study yields a better understanding of the genetics of CHO cells and will accelerate the discovery and development of new recombinant protein therapies.

Scientific News

Oral Interferon May Prevent and Control Avian Influenza Virus Infection
(Science Daily, 2011-07-29)
Avian influenza virus is a threat to the commercial chicken industry and, with its recent rapid spread across China, has also shown the ability for transmission from chickens to humans and other mammals. In an article in Journal of Interferon & Cytokine Research, Chinese researchers report that oral chicken interferon-alpha may significantly reduce influenza virus levels when given either preventively or therapeutically. Shanshan Meng and colleagues from the Chinese Academy of Sciences(CAS), Beijing, and Shandong Academy of Agricultural Sciences, Jinan, present the results of a study in which healthy chicks 7 or 33 days old were given chicken interferon-alpha either before or after exposure to AIV. The level of virus in their respiratory tracts was then measured and compared. The authors report their findings in the article “Recombinant Chicken Interferon-α Inhibits H9N2 Avian Influenza Virus Replication In Vivo by Oral Administration.”

Chinese Pharma & Biotech Press Review – N° 203

Feb
28
2011


HEADLINES

Dear customers,
The China pharmaceutical market is expected to hit $200 billion by 2020, making it the 2nd largest in the world, before Japan.
The 2011 Universal Medica Market Access Conference to be held on September 28th, 2011 in Paris, will focus on China current challenges and future evolution, and will explore the key drivers to successfully access the market:

  • APIs sourcing
  • Off-Shore Production
  • Clinical Trials
  • Licensing

Take the chance to assess new business opportunities, and make the right choices!
Order now and get a special pre-publication price !
For more information, please contact: info@universalmedica.cn

FOCUS

  • Bailout of grassroots medical institutions won’t restore financial health – sources
  • TCM regulator issues clinical trials guidelines
  • Antibody sector set to benefit from gov’t support – expert
  • The Chinese group Simcere and Merck will create a joint venture
  • MoH expands multi-site practicing for doctors
  • PolyGel Signs Long Term Exclusive Agreement with China’s Largest Distributor of Healthcare Products
  • Aeras and China National Biotech Group Sign Memorandum of Understanding for TB Vaccine R&D Collaboration

Healthcare News

Bailout of grassroots medical institutions won’t restore financial health – sources
(Interfax.cn, 2011-07-20)
China’s recent decision to bailout its indebted grassroots medical institutions (GMIs) is unlikely to solve their financial problems, industry insiders said. The bailout plan requires local governments to settle the long-term debts of GMIs under their authority within two years, according to a joint circular issued July 12 by the National Development and Reform Commission (NDRC), the Ministry of Finance (MoF) and the Ministry of Health (MoH). GMIs in China, which include township clinics and community health institutions, have amassed debts of RMB 5.85 billion ($905.14 million), according to MoH figures. “Authorities at county-level will conduct audits, while governments at provincial-level and below will allocate funds to pay off the debts. Priority will be given to GMIs that have implemented the essential drug system,” said Sun Zhigang, deputy director of the NDRC. Furthermore, the central government plans to allocate extra funding to help local governments in central and western China carry out the directive, the circular said, without providing further details.

TCM regulator issues clinical trials guidelines
(SATCM, 2011-07-20)
The State Administration of Traditional Chinese Medicine (SATCM) issued preliminary guidelines for clinical trials of traditional Chinese medicines (TCM). TCM clinical trials previously lacked specific regulations and were obliged to comply with China’s Good Clinical Practice (GCP) standards and clinical trial regulations for western medicines. SATCM’s preliminary guidelines covers basic clinical trial procedures, but largely focus on a network of 16 TCM clinical trial laboratories started in 2008 to help formulate a set of national standards. The labs will receive total government spending of RMB 4 billion ($618.24 million) in the period up to 2015. The guidelines require each lab to set up a database and formulate a set of detailed clinical trial regulations, as well as recruit at least one employee to process data for each of the 14 key diseases the program is focused on.

Ascletis Adds Support to $100 Million in Startup Capital
(World Market Media, 2011-07-21)
Ascletis, a US-China drug development startup, announced new support from the two cities in which it will do business – Hangzhou, China, and Research Triangle Park, US. One feature of the new agreements is clear: Ascletis will house a US-based R&D center in the Research Triangle’s Hamner Institutes. Beyond that, there aren’t many specifics in the agreements, beyond access to the networks of The Hamner and Hangzhou Hi-Tech Industry Development Zone.

China Nuvo Solar to acquire medical products company
(The MiamiHerald, 2011-07-22)
China Nuvo Solar Energy has announced that it has signed a definitive agreement to acquire US-based medical and surgical supply company SurgLine. Pursuant to the terms of the agreement, China Nuvo Solar would acquire one hundred percent of the outstanding common stock of SurgLine. The closing of the transaction is subject to customary closing conditions, including among other things, the completion of the schedules, the certified audit of SurgLine, accompanying due diligence as well as any necessary approvals. Industry experts estimate the healthcare sector consumes over 16 percent of the economy and is growing, combined with the 70 million baby boomers that have entered or will be entering retirement age putting additional pressure on the healthcare system.

Guangdong Province establishes independent medical pricing committee
(Rsssearchhub, 2011-07-25)
South China’s Guangdong Province has set up an independent pricing committee for drugs and medical services, the provincial pricing bureau announced. The committee will initially play an advisory role but this may be expanded in the future, the bureau’s director, Su Qi, said in the announcement. The move is the latest in a series of medical pricing reforms implemented by Guangdong in recent years that included markup regulations and price caps for different dosage forms of the same drug. It comes after the province announced plans to expand the role of non-government organizations in policymaking and the provision of public services. While the provincial bureau will continue to exercise the final say over price caps on some medicines, the committee will play an important advisory role, Zhao Zhendong, deputy secretary-general of the China Pricing Association said. The China Pricing Association is a semi-official pricing organ under the National Development and Reform commission (NDRC), China’s state economic planner.

Antibody sector set to benefit from gov’t support – expert
(Global-Report, 2011-07-22)
China’s monoclonal antibody (mAb) drug industry will see rapid development in coming years on the back of strong government support, the director of China’s national antibody drug research center said at the Antibody Engineering Summit 2011. A government committee will finish reviewing applications for 22 grants for mAb research projects, each of between RMB 5 million ($775,640) and RMB 20 million ($3.10 million), Guo Yajun said at the conference held in Shanghai. Antibody drug development has been a key focus area of four long-running government research programs, Guo noted, namely the State High-tech Development Plan (also known as the 863 Program), the National Basic Research Program (Program 973), the Key Innovative Drug Creation Program, and a program funded by the National Development and Reform Commission (NDRC). The main barrier to the development of the industry in China remains lack of mass production technology, China has only four mAb drug workshops, each with a capacity of less than 1000 liters, while in developed economies there are a total of 33 mAb drug workshops each with a capacity of over 10,000 liters.

MoH expands multi-site practicing for doctors
(China MOH, 2011-07-26)
China will further expand a pilot program that allows doctors to practice in up to three different medical institutions, the Ministry of Health (MoH) announced. The move comes as part of China’s ongoing health reform launched in 2009, and aims to free up talent and increase opportunities for doctors by ending a rule that binds them to a single institution. The change was introduced in 2009 to 47 cities selected to pilot test China’s public hospital reform, and will now be extended to a further two cities in each province starting from Aug. 15. Furthermore, mid-level doctors will now be involved in the program, which was previously limited to senior physicians.

Pharmaceutical Industry

The Chinese group Simcere and Merck will create a joint venture
(新华网, 2011-07-22)
The Chinese pharmaceutical group Simcere concluded an agreement with Merck & Co. on the creation of a joint venture in order to meet the growing demand for medical services in China. The strategic partnership will combine the extensive resources and expertise of a transnational company specializing in health care with those of leading Chinese pharmaceutical company, to support their common goal in terms of development, registration and manufacturing and sales force, according to the agreement. The cooperation will focus initially on manufacturing of branded pharmaceutical products for cardiovascular and metabolic diseases. Merck is proud to partner with Simcere and is committed to make medical care advancing in China. This innovative partnership is accelerating the expansion of Merck’s business, while complying with Chinese government’s efforts to facilitate access to qualitative medicines, said the president of “Global HumanHealth” of Merck during the signature ceremony in New Jersey.

TPI Ships Macrolide API Samples for International Sales Standard Testing
(ABC 12, 2011-07-22)
Tianyin Pharmaceutical Co., Inc. (TPI), a pharmaceutical company that specializes in the research, development and sale of patented biopharmaceutical medicine, modernized traditional Chinese medicine, branded generics and active pharmaceutical ingredients (API) announced that the Company has shipped the first batch of Azithromycin API sample to RELATIONS International Ltd. for Bangladesh export standard test. This is the first step for the development of macrolide international export business for TPI following the signing of the sales and marketing agreement with RELATIONS International Ltd., a Bangladesh corporation that specializes in API product sales in the People’s Republic of Bangladesh.

PolyGel Signs Long Term Exclusive Agreement with China’s Largest Distributor of Healthcare Products
(KPHO, 2011-07-26)
PolyGel, the manufacturer of Orthopedic, Therapy and Skin Care Products, has signed a long term exclusive distribution agreement with China National Pharmaceutical Foreign Trade Corporation (Sinopharm Foreign Trade). Based in Beijing, Sinopharm Foreign Trade is a wholly-owned subsidiary of China National Pharmaceutical Group Corporation (Sinopharm Group). The Sinopharm Group is the largest distributor of pharmaceutical and healthcare products in China, with 2010 revenues of over 69.2 billion RMB (10.45 billion $). An important part of the PolyGel program will focus on the growing population of diabetics in China. According to a study published in the New England Journal of Medicine, China now has more people with diabetes than any other country in the world, with more than 92 million adults diagnosed with diabetes and another 150 million more are on their way to developing it.

Meheco Corp. to acquire controlling stake in licorice TCM maker
(Interfax.cn, 2011-07-26)
State-owned drug distributor China Meheco Corp. plans to acquire a 51 percent controlling stake in Xinjiang Tianshan Pharmaceutical Industrial Co. Ltd. (Tianshan Pharma), a leading manufacturer of licorice-based traditional Chinese medicine (TCM). The transaction is worth RMB 44.15 million ($6.86 million) and is intended to shore up Meheco’s position in the market for licorice, a common TCM ingredient. Beijing-based Meheco currently owns one of China’s largest exporters of licorice and related products, Genertec Meikang Pharmaceutical Co. Ltd. Tianshan Pharma’s licorice supply channels and extensive portfolio of licorice-based drugs is consistent with Meheco’s ambitions in the sector.

China’s pharm industry sees 27% rise in output value in Jan- May
(China NDRC, 2011-07-26)
China’s pharmaceutical industry realized RMB 569.3 billion in output value in the first five months of this year, 27% more than in the corresponding period of last year, said the NDRC in a statement published on its website. The output value of the chemical original drug manufacturing sector jumped 24.2% year on year to RMB 120 billion, and that of the chemical preparation manufacturing sector grew 24% year on year to RMB 157.1 billion. The Chinese traditional patent medicine generated RMB 121.8 billion in output value in the first five months, up 30.9% year on year, and the medical equipment and appliance sector grew 23.4% year on year to RMB 48 billion. During the period from January to May, the value-added output of China’s pharmaceutical industry increased 16.2% year on year on average. During the period from January to April, the industry completed RMB 54.12 billion of fixed-asset investment, 33.7% more than in the same period of last year. There was a 48.6% increase in biomedicine sector.

Boston Scientific to Spend $150 Million in China
(Buzz Box, 2011-07-27)
Boston Scientific Corporation, the cardiovascular medical device maker, announced plans to spend $150 million over the next five years to increase its China presence. Specifically, the company will build a manufacturing facility in the PRC to serve local markets, and it will also establish a training center, complete with virtual learning systems, to teach the latest procedures. At the end of the five years, Boston Scientific expects its China operations to be producing $500 million in revenue each year.

Chi-Med Forming an OTC Drug Distribution JV
(Biospace, 2011-07-25)
Hutchison China MediTech will expand its business plan by adding third-party OTC drug distribution to its activities. The company announced a JV that will distribute its own TCM drugs and offer similar services to other companies. Chi-Med, as the company is popularly known, expects the new venture will add “substantially” to its profits. Chi-Med was allowed previously to distribute its own products, but not those of other companies.

Biotechnologies

Aeras and China National Biotech Group Sign Memorandum of Understanding for TB Vaccine R&D Collaboration
(The Street, 2011-07-26)
Aeras and the China National Biotech Group (CNBG) announced the signing of a memorandum of understanding for the organizations to pursue opportunities to jointly develop tuberculosis (TB) vaccines in China and potentially other parts of the world. The partnership is intended to leverage both organizations’ capabilities to support the development of TB vaccines. TB is a major public health priority in China, where there are more than one million new TB cases every year. The scope of potential activities will cover the full spectrum of product development, including pre-clinical development, process development and manufacturing, and clinical development in TB and potentially other disease areas. Details of the specific activities and areas of focus of the collaboration will be set forth in a future definitive agreement.

Chinese Pharma & Biotech Press Review – N° 202

Feb
21
2011


HEADLINES

Dear customers,
Drug safety in China is rapidly gaining attention owing to the westernization of the pharmaceutical culture. In addition, due to an increasing number of clinical trials being held right here in China, the risks of serious adverse events and adverse drug reactions have never been greater.
The 2011 “Drug Safety in China” market analysis report of Universal Medica provides you with a comprehensive examination of the Chinese safety system versus the western world.
Key contents: ADR reporting & monitoring, Comparison with the European safety principles, Interviews of global safety KOLs…
Order now and get a special pre-publication price !
For more information, please contact: info@universalmedica.cn

FOCUS

  • China Takes Dramatic Step to Curb TCM Speculation
  • Clinical Research in Asia Shifting Focus to New Emerging Markets
  • Health reform stifling pharma retail industry – insiders
  • China pharma firms diversify marketing strategies
  • China Pharmacopoeia 2015 set to raise TCM quality standards
  • MoH to roll out electronic booking for medical appointments
  • China API exports surge 31 pct in first five months

Healthcare News

China Takes Dramatic Step to Curb TCM Speculation
(Biospace, 2011-07-18)
China’s National Development and Reform Commission (NDRC), which has responsibility for controlling prices in China, decided on a dramatic course of action to lower the high cost of TCM raw materials. The NDRC told anyone who has a supply of codonopsis pilosula, an important TCM herb more popularly known as radix, that they must sell their supplies – and then set a low price as the ceiling at which the transactions must take place. To show that it means business, the NDRC ordered the worst offenders to sell their stockpiles within one week.

Clinical Research in Asia Shifting Focus to New Emerging Markets
(Pr-Inside, 2011-07-19)
Clinical development teams increasingly consider a new group of smaller Asian nations instead of defaulting to established markets, such as India and China, to host sites for clinical research in Asia, according to a new study by pharmaceutical consulting firm Cutting Edge Information. The research details clinical development trends and data from China and India as well as trials in Malaysia, Hong Kong, Taiwan, Thailand, Singapore, South Korea and the Philippines. The study, “Emerging Markets Clinical Trials: Asia,” examines strategies and best practices for addressing intellectual property concerns and benefiting from strong patient-physician relationships in these emerging markets. “India and China opened the door for pharma companies to consider focusing on Asia for large parts of their clinical development strategy,” said Adam Bianchi, chief operating officer at Cutting Edge Information.

China Pharmacopoeia 2015 set to raise TCM quality standards
(China ChP, 2011-07-13)
The next edition of the China Pharmacopoeia, due to be issued in 2015, is expected to focus on raising quality standards for traditional Chinese medicine (TCM), helping to strengthen the competitiveness of major players in the sector, according to industry insiders. The pharmacopoeia will in particular expand the system of “multi-component quality indicators” (MCQI), Zhou Fucheng, deputy secretary of the Chinese Pharmacopeia Commission said in Guangdong Province’s Shenzhen City. MCQI refers to the use of multiple chemical and biological agents to detect the presence of component ingredients in TCMs. This method increases scientific control over the process, producing more accurate and comprehensive results than the use of a single agent.

MoH to roll out electronic booking for medical appointments
(China MOH, 2011-07-14)
China’s Ministry of Health (MoH) has urged local health authorities to press ahead with the roll-out of electronic booking systems for medical appointments, a health official declared. Cities will each set up their own integrated platform, said Zhang Zongjiu, director of the MoH medical service supervision division. The move is intended to ease pressure on the country’s overcrowded hospitals, where hour-long waits for doctors are commonplace, as well as improve access for patients living in remote areas and streamline patient transfers. Top-level hospitals must introduce the system by year-end, and at least 50 percent of revisits to these institutions should be pre-booked. Local health authorities are urged to step up efforts to publicize the platform and improve uptake, while hospitals are required to report more regularly to health authorities on the status of their booking services, Zhang said.

China API exports surge 31 pct in first five months
(Cccmhpie.org.cn, 2011-07-14)
China’s exports of active pharmaceutical ingredients (API) were worth $9.23 billion in the first five months of this year, up 30.64 percent from a year earlier, according to figures released by China Chamber of Commerce for Import & Export of Medicines & Health Products. India remained the largest export destination, with shipments surging 32.12 percent year-on-year to reach $1.31 billion. Exports to ASEAN(Association of Southeast Asian Nations)countries rocketed 51.26 percent to $886.14 million, while exports to South America saw similarly strong growth of 51.09 percent, hitting $731.14 million. “Exports to ASEAN countries have been helped by the region’s zero-duty policy on China imports that took effect Jan. 1, 2010. This growth is expected to continue,” Du Hong, a researcher from the chamber said. In terms of product types, exports of macrolide APIs soared 78.57 percent to $158.58 million, while tetracycline API exports grew 50.52 percent to $125.35 million. Meanwhile, vitamin API exports dipped to $788.77 million, down 25.4 percent, and exports of antipyretic and analgesic APIs plummeted 45.09 percent to $192.76 million.

China: 400, 000 children receive free insurance in case of serious illness
(新华网, 2011-07-17)
Over 400, 000 orphans and children from disadvantaged families in China have benefited from free insurance covering twelve major serious diseases, announced the China Children Insurance Foundation (CCIF). In cooperation with the Ministry of Civil Affairs, the foundation initiated in 2009 a program to provide free health insurance to 712, 000 orphans under the age of 18, and listed on the Ministry list. Heidi Hu, director of the foundation, said that her organization has managed to collect over 21 million yuan in donations and helped to cover 300, 000 orphans in 19 provinces and regions, including Sichuan, Tibet and Qinghai . “Orphans are our priority, but we have also included on the list of beneficiaries, children from families with financial problems,” she said. According to the director, each insured child is covered for 100, 000 yuan (15, $ 474) for an annual premium of 50 yuan.

Beijing Municipality tests TCM in chronic disease prevention
(SATCM, 2011-07-18)
Beijing Municipality launched a program to test the use of a traditional Chinese medicine (TCM) skin patch in the prevention of chronic diseases, the State Administration of Traditional Chinese Medicine (SATCM) announced. The program will distribute Sanfu patches, a heat-giving remedy administered during summer to improve the body’s ability to fend off chronic conditions that normally occur during winter, in particular respiratory and bone diseases. The initiative is intended to improve chronic diseases care at grassroots level, and involves some 446 medical institutions, including community health centers (CHC) and Grade II and Grade III hospitals. Sanfu patches are a traditional preventative remedy in China, and a course of treatment usually lasts about three years, a representative of Shichahai Community Health Center surnamed Wang said.

Pharmaceutical Industry

Health reform stifling pharma retail industry – insiders
(Rsssearchhub, 2011-07-19)
China’s pharmaceutical retail industry is at low tide due to changes brought about by the health care reform and regional differences in policies and markets, business insiders said at the 2011 China Chain Drugstore Annual Meeting in Nanjing. Drugstore operators stand to see little benefit from the ongoing health care reform, which is mainly concerned with improving medical insurance coverage and implementing the essential drugs system to improve primary health care. Moreover, the zero markup policy on essential drugs in grassroots medical institutions is driving consumers away from drugstores towards dispensaries. “The health reform seems to have forgotten the retail industry,” said Zhang Xuan, general manager of Nanjing Sinopharm Medicine Co. Ltd. The sector did feature in the 12th Five-Year Plan (2011-2015) for the industry issued by the Ministry of Commerce in May this year, concrete policies have yet to be set, he added. A recent list of the top-performing chain drugstores in 2010 saw just 10 chain drugstores each achieve annual sales revenue of over RMB 2 billion ($309.12 million) in 2010, only two more than the figure for 2009. In light of this, drugstore operators will need to make improvements in certain areas if they are to rise to the challenge, Zhang noted.

China pharma firms diversify marketing strategies
(Interfax.cn, 2011-07-19)
China’s pharmaceutical firms are increasingly focused on marketing to gain a competitive edge rather than concentrating solely on R&D, industry insiders said at the sixth China Top 100 Pharmaceutical Manufacturers Press in Hunan. “Many pharma firms in China are weak in R&D and it is difficult for them to win a competitive advantage in the short-term by developing innovative products,” Li Jiuxiang of China Nuokang Biopharmaceutical Inc. (Nuokang Bio), said at the conference. Nuokang Bio recently started outsourcing marketing to contract sales organizations (CSO) in some provinces. Meanwhile, Guangzhou Pharmaceutical Holdings Co. Ltd. (Guangzhou Pharma) has decided to replicate the successful marketing strategies of its subsidiaries throughout the 11 companies it owns. “China could become the second largest pharmaceutical market in the world in the period from 2011 to 2015, and innovation will be the key to thriving in this competitive environment,” Lin Jianning, director of SFDA Southern Medicine Economic Research Institute said at the conference.

Huaren Pharma to establish blood purification R&D center

(First Rain, 2011-07-14)
Qingdao Huaren Pharmaceutical Co. Ltd., a leading domestic manufacturer of infusions, plans to establish a RMB 68.36 million ($10.57 million) research and development (R&D) center for blood purification products, a major growth area for the company. The center will primarily focus on peritoneal dialysis (PD) solutions, as well as developing hemofiltration solutions, said Xia Hua, an investor relations representative with the firm, adding that the company plans to expand its 50-member research team once the facility is on-line. PD uses a patient’s peritoneum, part of the abdomen, as a membrane across which fluids and dissolved substances are exchanged from the blood. The technique is much less costly than conventional hemodialysis (HD).

Humanwell Healthcare to take control of US distribution JV
(Hdlns.com, 2011-07-15)
Wuhan Humanwell Healthcare (Group) Co. Ltd. (Humanwell) has signed a letter of intent (LoI) to inject $15.08 million into its New Jersey-based distribution joint venture (JV) to gain a controlling stake in the company. The firm hopes to enter the U.S. market in the first quarter (Q1) next year with generic drugs in soft capsule dosage form, a representative of Humanwell’s board of directors who wished to remain anonymous said. The representative declined to disclose which drugs the firm plans to export. The JV, Puracap Pharmaceutical LLC (Puracap), was set up to distribute Humanwell’s generic drugs in the U.S., and the capital deployment will increase its stake in the venture from 45 to 75 percent. Its U.S. partner Enspire Group LLC, a pharma consultancy based in New Jersey, will see its controlling 55 percent stake diluted to 23 percent.

Stratos Product Development and Response Biomedical Partner to Develop Internationalized Diagnostic Device for Distribution to China and Other Markets

(Einnews, 2011-07-14)
Stratos Product Development LLC announced its continued partnership with Response Biomedical in the development of an internationalized version of the RAMP® 200 clinical diagnostic system, building on the success of the North American version of the product released in 2008. In April, Response Biomedical announced it received product registration from China’s SFDA to sell the RAMP® 200 Reader in the Chinese market. The market potential for diagnostic products in China is rapidly expanding and Response Biomedical has the necessary resources and partnerships in place to meet the growing market demand for the RAMP® 200 and cardiac diagnostic tests. Stratos Product Development and Response Biomedical have distribution agreements in place to support product representation in China for the next two years.

China BCT Expands its Retail Pharmacy Footprint in Guangxi with the Opening of 21 New Stores
(PRNewswire, 2011-07-20)
China BCT Pharmacy Group, Inc., a leading pharmaceutical distributor, retail pharmacy, and manufacturer of pharmaceutical products in Guangxi Province, announced that the company is in the process of launching 21 new retail pharmacy stores in Guangxi, bringing the total number of “Baicaotang” branded stores to 208. The new stores will offer a full range of pharmaceutical products and are located in areas of Liuzhou city, the administrative counties around Liuzhou, Yizhou City. Upfront capital investment to complete site renovation for the new stores, which have an average size of roughly 73 square meters, totaled approximately RMB 12.6 million ($1.9 million). Management estimates that the pay back period on this investment will be approximately 4 years and believes that the 21 new stores, as a group, will generate annual revenues of approximately RMB 18.9 million ($2.63 million). The company expects all of the new locations, upon receipt of required government business licenses, to be fully operational by the end of the third quarter of 2011.

Hong Kong forces second GSK recall
(Fiercepharma, 2011-07-19)
Hong Kong isn’t happy with GSK. Regulators there have ordered the drugmaker to recall an antibiotic roughly a month after they found powdered forms of the drug contaminated by chemicals known as “plasticizers.” The new recall order applies to Augmentin tablets, which also were found to be tainted by the chemicals. Health officials tested the tablets as a follow-up to last month’s recall of the powdered Augmentin, which is reconstituted into a liquid for dosing. The substances detected in the Augmentin tablets include diisodecyl phthalate (DIDP) and diisononyl phthalate (DINP), the Hong Kong government said. Health officials say the amounts found in the powdered and tablet forms are “unlikely to cause acute harmful effects if taken according to the recommended dosage.”

Biotechnologies

Chongqing Zhifei Nixes Plan to Buy Bilthoven Biologicals
(ChinaBio Today, 2011-07-19)
Chongqing Zhifei Biological Products announced it will not pursue a plan to acquire Bilthoven Biologicals, a Dutch vaccine maker, explaining that the transaction was too risky. According to Zhifei, Bilthovern’s plans and operational methods were not what it expected. In May of this year, Zhifei announced a $93 million takeover of Bilthoven’s operations, which it positioned as a means of giving itself a foothold in Europe.

Chinese Pharma & Biotech Press Review – N°201

Feb
14
2011


HEADLINES

Dear customers,
Drug safety in China is rapidly gaining attention owing to the westernization of the pharmaceutical culture. In addition, due to an increasing number of clinical trials being held right here in China, the risks of serious adverse events and adverse drug reactions have never been greater.
The 2011 “Drug Safety in China” market analysis report of Universal Medica provides you with a comprehensive examination of the Chinese safety system versus the western world.
Key contents: ADR reporting & monitoring, Comparison with the European safety principles, Interviews of global safety KOLs…
Order now and get a special pre-publication price !
For more information, please contact: info@universalmedica.cn

FOCUS

  • TCM regulator unveils development plan for Gansu Province
  • China Taobao.com asked to stop selling drugs
  • China will set up its general practitioners system by 2020
  • HK to unveil new health plan
  • Foreign pharma firms continue to eye essential drug market
  • MoF announces $2.8 bln to support health reform
  • Novartis eyes international board listing

Healthcare News

TCM regulator unveils development plan for Gansu Province
(SATCM, 2011-07-06)
The State Administration of Traditional Chinese Medicine (SATCM) has agreed to help develop traditional Chinese medicine (TCM) health care services in west China’s Gansu Province. The agreement with the government of Gansu, which has a small population and abundant TCM resources, is likely to pave the way for similar initiatives involving the SATCM and China’s local authorities. According to the announcement, the SATCM has earmarked RMB 200 million ($30.91 million) in funding for TCM-based services in the province. It will help Gansu set up two major TCM hospitals and a national TCM clinical trial facility, as well as four facilities to provide public education in TCM in a bid to strengthen local TCM brands. Meanwhile, all township clinics and community health centers (CHC) in Gansu will be required to set up TCM departments and dispensaries within the next two years. The SATCM also plans to send 50 TCM practitioners from Gansu to study overseas each year, and dispatch 20 experts to the province each year to conduct training. Furthermore, the SATCM plans to conduct a survey of Gansu’s TCM resources from 2011 to 2015.

China Taobao.com asked to stop selling drugs
(新华网, 2011-07-08)
Taobao.com, the largest platform for e-commerce in China, was asked to stop selling drugs, because the website has not obtained the related official certificates, according to the SFDA. The retailers must first obtain the approval from the administrative departments of food and drug products in order to sell drugs on Internet. They must also publish their certificate number on their website’s home page. Taobao has a certificate enabling to provide information about medicines on Internet, but not the certificate required for selling the drugs. Official figures from the administration show that China counts 69 drugs trade groups certified on internet, 39 of them are allowed to sell drugs to individuals.

China will set up its general practitioners system by 2020
(新华美通, 2011-07-08)
A system of general practitioners (GPs) will be set up in China by 2020, in order to ensure better medical care for the 1.3 billion people, according to a document published by the State Council, Chinese cabinet. This document, entitled “Guidelines on the establishment of the general practitioners system”, highlights the importance of establishing the GPs system in order to meet the people’s needs in terms of health. The GP system is widely used in developed countries, where general practitioners are “guardians” of the residents’ health in small districts. They are responsible for the treatment of acute and chronic diseases, disease prevention and health education. The establishment of the GPs system will inevitably bring changes and reforms in health care services of the country, and the Council of State Affairs will learn from international experiences, while striving to develop a system of GPs with Chinese characteristics, says the document. According to the document, there will be two or three GPs per 10 ,000 urban and rural inhabitants. The government will provide an allowance for general practitioners who choose to work in remote areas in central or western regions.

HK to unveil new health plan
(中国日报, 2011-07-11)
A working group will be set up to formulate health insurance proposals and frameworks for the city’s Health Protection Scheme, Secretary for Food and Health of HongKong York Chow said. In a briefing to the city’s Legislative Council’s Panel on Health Services, Chow said that the working group on the scheme aims to regulate private health insurance and private healthcare services under the scheme to strengthen protection for the public. “Members of the public supported regulating private health insurance and healthcare services through introducing the scheme to enhance market transparency and promote healthy competition, and strengthen protection to the public,” Chow said. Apart from establishing the working group, a high-level steering committee will be set up to conduct a strategic review of healthcare manpower planning and professional development.

MoF announces $2.8 bln to support health reform
(China MoF, 2011-07-12)
China’s Ministry of Finance (MoF) announced a RMB 18.4 billion ($2.84 billion) spending package to boost ongoing health care reforms, bringing total government spending on the health care overhaul this year to RMB 171.7 billion ($26.54 billion). Grassroots health care is the biggest beneficiary in the latest round of spending, with RMB 7.2 billion ($1.11 billion) earmarked to improve maternal and infant care, emergency care, and infectious and occupational disease centers. As part of the latest package, county hospitals specializing in traditional Chinese medicine (TCM), ethnic minority medicine and pediatrics are set to receive a total of RMB 5.9 billion ($912.14 million) to fund new equipment. Meanwhile, the ministry allocated a further RMB 3.4 billion ($525.64 million) to subsidize serious disease treatment for low-income patients, while RMB 1.5 billion ($231.9 million) will be used to fund telepathology services in some 500 county-level hospitals in remote areas.

China Pharma Events Attract Over 27,000 Visitors
(PR Newswire, 2011-07-12)
Leading events organiser UBM Live, a division of UBM Plc, announced that its pharmaceutical ingredients event, CPhI China 2011 and co-located events ICSE China for contract and outsourced services, P-MEC China for pharmaceutical machinery and equipment and BioPh China to cater to the biopharmaceuticals market, held from June 21st to 23rd in Shanghai, experienced a 36% increase in attendance from the 2010 events. Over three days, ten exhibition halls and 4,500 square meters of temporary exhibition space were prepared to host a record of 27,198 attendees, including 5,479 international visitors. Exhibitor numbers also rose year over year. Together, the CPhI China, ICSE China and BioPh China events hosted 1,518 exhibitors, while P-MEC China and the newly introduced LABWorld pavilion for lab instrumentation and analysis hosted 386 exhibitors.

Pharmaceutical Industry

Foreign pharma firms continue to eye essential drug market
(Articles base, 2011-07-06)
Foreign pharmaceutical companies continue to target Shanghai’s essential drug market, confounding expectations that they would withdraw due to low profitability, according to industry insiders. Shanghai’s latest essential drug supply tender concluded last month and saw almost 30 multinationals and sino-foreign joint ventures (JV) win contracts for 150 products encompassing 60 different drugs. Some foreign firms cut their offer prices to secure contracts. AstraZeneca offered a price of RMB 6.97 ($1.08) for Betaloc (metoprolol tartrate tablets), a 4.73 percent reduction on the RMB 7.30 ($1.13) the U.K.-based firm offered in a tender in Jiangxi Province last year. And Shanghai Schering-Plough Pharmaceutical Co. Ltd cut the price of Eloson (mometasone furoate cream) to RMB 13.89 ($2.15), down 3.02 percent from the company’s Beijing 2010 tender price of RMB 14.31 ($2.21). A few companies cut prices by over 10 percent, including Pfizer, which reduced the price of Norvasc (amlodipine besylate tablets) to RMB 32.80 ($5.07), down 13 percent from the RMB 35.95 ($5.56) the firm offered in Beijing last year.

Zhejiang Medicine to develop novel asthma drug with partners

(Interfax.cn, 2011-07-07)
Zhejiang Medicine Co. Ltd. (Zhejiang Medicine) is to develop and commercialize a novel asthma drug in collaboration with U.S. biopharma firm MediciNova Inc. and Beijing Make-Friend Medicine Technology Co. Ltd. (MFM). The drug, MM-221, a highly-selective beta(2)-adrenergic receptor agonist, was discovered by MedicNova Inc. and will soon enter phase III clinical trials in the U.S. The three parties will establish a joint venture (JV) in Zhejiang’s provincial capital of Hangzhou to carry out the project. Named Zhejiang Senmai Medicine Biotechnology Co. Ltd., it will have a registered capital of RMB 14.29 million ($2.21 million), with Zhejiang Medicine contributing RMB 5.71 million ($882,766) for 40 percent stake, and MFM and MediciNova each investing RMB 4.29 million ($663,234) for 30 percent shares. Zhejiang Medicine hopes the JV will benefit from MFM’s experience in new drug registration and marketing in China, Zhu Qin, Zhejiang Medicine’s investor relations representative said.

Hikma Pharma Buys Stake in Hubei Haosun Pharma
(Manufacturing pharmaceutical, 2011-07-11)
Hikma Pharma, a Jordanian pharma with significant presence in the Middle East/North African region, paid $5 million to acquire a significant minority interest in Hubei Haosun Pharma. Haosun, which is privately held, develops and manufacturers difficult-to-make APIs with a specialization in oncology treatments. Hikma positioned the transaction as a means of gaining long-term access to high quality APIs.

Sagent Pharma Adds Lummy Pharma to its List of China Collaborators
(Bioportfolio, 2011-07-11)
Sagent Pharma of the US will add one more China collaborator to its list of 12 China companies with which it has relationships. Sagent, which specializes in generic injectable drugs, has announced a relationship with Chongqing Lummy Pharmaceutical Company, a company that is active in the injectable sector. Details of the agreement were not made public.

Novartis eyes international board listing
(Reuters, 2011-07-12)
Swiss drugmaker Novartis is considering a possible initial public offering in China, joining a growing list of multinationals eyeing a listing on Shanghai’s planned international board, two people with knowledge of the situation said. Novartis is studying the feasibility of a China IPO and has been consulting relevant government agencies, said the sources, who declined to be identified because the information is not public. Novartis spokesman Eric Althoff declined to comment. Selling shares in China would enable Novartis to raise money to fund rapid expansion in China and for potential acquisitions, as it competes fiercely with rivals such as Roche and Eli Lilly in the country. Having its shares traded on the Shanghai Stock Exchange could also help Novartis promote its brand in a country where concerns over food and drug safety constantly haunt consumers. China is among the six countries identified by Novartis as priority emerging markets for the company, where combined net sales grew 12 per cent last year to US$4.6 billion, accounting for 10 per cent of the firm’s global sales, its annual report said. Novartis expects that proportion to double in five years.

Nanjing Pharma signs LOI with retail giant Alliance Boots
(Interfax.cn, 2011-07-13)
Nanjing Pharmaceutical Group Co. Ltd. (Nanjing Pharma) and Switzerland’s Alliance Boots Plc have signed a letter of intent (LOI) to cooperate in drug retailing and distribution in China. As one of China’s largest pharma firms, Nanjing Pharma hopes Alliance Boots’ advanced logistics capabilities will enhance its distribution network. The deal is occurring at a time of growing concern in China’s health retail sector over changes ushered in by national health reform, such as stricter price controls and increasing competition from dispensaries in grassroots medical institutions. According to the LOI, the cooperation may take the form of a joint venture (JV), with the China firm holding a controlling 75 percent stake and the Swiss health retailer taking a 25 percent stake. Alternatively, Alliance Boots may become a strategic investor in Nanjing Pharma’s subsidiary.

Shanghai Pharma Spending to Build Drug Distribution Business
(Biospace, 2011-07-13)
Shanghai Pharmaceutical Holding plans to make a 2 billion RMB ($310 million) capital expenditure that will, among other things, solidify its drug distribution business in North China. The company will put 1 billion RMB ($155 million) of capital in its distribution subsidiary to bulk up its sales network. Another $80 million will go to establish a sales unit in North China, and it will spend 500 million RMB ($75 million) in an information technology venture.

Biotechnologies

3SBio Inc. Announces SFDA Approval of High-Dose EPIAO
(Wthr.com, 2011-07-11)
3SBio Inc., a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, announced that the SFDA has approved its 36,000 IU dosage formulation of EPIAO for the treatment of anemia associated with chemotherapy in cancer patients. High-dose EPIAO is the only dosage form of this kind available in China. The approval provides patients in China with an additional treatment option which has been available since 2004 in the United States and 2006 in the United Kingdom. High-dose EPIAO is designed for the rapid restoration of hemoglobin to normal levels among cancer patients. The 36,000 IU dosage is comparable to the standardized dose used globally for chemotherapy-induced anemia, allowing for less frequent administration than lower dosage forms, which in turn is expected to provide greater convenience for both patients and caregivers.

China Biologic to open plasma collection station in Shandong Province
(BioSpectrum, 2011-07-12)
China Biologic Products, one of the leading plasma-based biopharmaceutical companies in China, has announced that it has received the permit from the Shandong Province Health Department for the newly built plasma collection station in Ningyang, and expects to begin commercial plasma collection at the Ningyang station. The company received approval to build two new plasma collection stations in Yishui and Ningyang Counties in May 2010. The Yishui station began collecting plasma in December 2010. With the opening of the Ningyang station, China Biologic owns seven of the eight plasma collection stations in Shandong Province. “The Ningyang and Yishui stations have a combined designed annual capacity of about 80 metric tons of plasma. We expect to increase the volume of plasma collected there until we are at the designed annual capacity for those two stations, which we believe is likely to occur in 2014.” said Chief Executive Officer of China Biologic.

Chinese Pharma & Biotech Press Review – N°200

Feb
8
2011


HEADLINES

Dear customers,
Drug safety in China is rapidly gaining attention owing to the westernization of the pharmaceutical culture. In addition, due to an increasing number of clinical trials being held right here in China, the risks of serious adverse events and adverse drug reactions have never been greater.
The 2011 “Drug Safety in China” market analysis report of Universal Medica provides you with a comprehensive examination of the Chinese safety system versus the western world.
Key contents: ADR reporting & monitoring, Comparison with the European safety principles, Interviews of global safety KOLs…
Order now and get a special pre-publication price !
For more information, please contact: info@universalmedica.cn

FOCUS

  • MoH releases new guidelines for appraising community health institutions
  • MoH, CAS to jointly promote national health and pharma R&D
  • China plans to expand a project of health insurance for children in rural areas
  • China’s pharma exports face challenges despite swift growth
  • MoH, Shanghai sign cooperation agreement
  • Construction begins on Shanghai vaccine production base
  • China’s gastric cancer drug market will grow to $469 million in 2015

Healthcare News

Delivery delays for essential drugs in Anhui
(Interfax.cn, 2011-06-29)
The excessive number of drug distributors in Anhui Province is being blamed for delays in delivery of essential drug purchases. Anhui held auctions for essential drugs beginning in August of last year. From September 2010 to June 2011, the province’s 1,756 grassroots medical institutions purchased essential drugs with an aggregate value of RMB 1.03 billion ($159.19 million). To date, drugs valued at RMB 972 million ($150.23 million) have been distributed. However, some drug distributors are refusing to deliver essential drugs where the purchasing order is relatively small. There are over 600 drug distributors in Anhui, 270 of which were selected by pharmaceutical manufacturers to distribute essential drugs. County health departments are required to improve the supervision of the essential drug system and implement measures to rate the performance of drug distributors.

Golden Meditech acquires general hospital facility in Beijing
(PRNewswire, 2011-06-29)
China’s leading integrated-healthcare devices and service operator Golden Meditech has acquired a hospital facility in Beijing’s Haidian district. The acquisition target, with a site area of approximately 18,692 m2 and permissible construction area of 74,035 m2 will be completed in 2012. Upon completion of the acquisition, the GM Hospital Group will effectively own 57.91% of the new hospital. The new facility has obtained the relevant regulatory approvals for the construction of a 500-bed general hospital, five times the current capacity of 100-beds in the Group’s existing Daopei Hospital in Beijing, which will be able to relieve the shortage in bed spaces and cater to patients who are seeking to be admitted based on the hospital’s strong reputation. GM Hospital Group is the first foreign entity to be granted a nationwide hospital management license. It currently operates one of China’s most renowned haematology hospitals under the Daopei brand name, located in Beijing and Shanghai.

MoH releases new guidelines for appraising community health institutions
(China MOH, 2011-06-30)
The Ministry of Health (MoH) introduced new instructions for appraising the performance of community health centers and clinics in China. Community health institutions will be evaluated in terms of their management, public health services, basic medical services, traditional Chinese medicine (TCM) services, and patient and staff satisfaction. Grading will be done on a 1000 point scale, where a maximum of 350 points can be awarded for public health services and 230 points for basic medical services. On site examinations, questionnaires and interviews will be carried out during the appraisal process. Health institutions will be given a rating of excellent, pass or fail. The results will be used to determine the amount of government funding given and the directors of each institution. Those that fail will be issued with official warnings, or shut down if no improvements are made. There were 32,739 community health centers and clinics in China at the end of 2010, with a total of approximately 390,000 staff.

MoH, CAS to jointly promote national health and pharma R&D
(China MOH, 2011-07-01)
China’s Ministry of Health (MoH) and the Chinese Academy of Sciences (CAS) have signed a cooperative framework agreement to jointly promote national health and biopharmaceutical research and development (R&D). Under the agreement, the two sides will form a cooperative mechanism involving different government authorities, research institutes and medical institutions to promote new drug R&D for major infectious and chronic diseases, such as tumor and metabolic disorders, as well as advance stem cell and regenerative medicine research. The collaboration will also look to boost the biomedical device industry. The MoH-CAS cooperation will also include the establishment of research centers for the study of translational medicine, psychological health and food safety. China’s biopharmaceutical industry generated total sales revenue of RMB 75.3 billion ($11.6 billion) in 2009.

Technology from Varian Medical Systems dedicated during a special ceremony at Shantou University

(PR Newswire, 2011-06-30)
Shantou University (STU) Medical College’s Affiliated-Cancer Hospital has become the first cancer treatment center in China to acquire and install the TrueBeam™ system for image-guided radiotherapy. The system, which was made by Varian Medical Systems, was donated to the hospital by the Li Ka Shing (LKS) Foundation, a private charitable foundation established to nurture a culture of giving, support educational reforms and help advance medical research and services. The TrueBeam machine was dedicated in a special ceremony held at the affiliated hospital. Speaking at the ceremony, Professor Zhang Guojun, Director of the hospital, said: “This advanced technology, combined with our physicians’ expertise and commitment in patient care, will offer a new chapter of possibilities in our long and hard battle against cancer.” TrueBeam was designed to treat tumors with increased speed and accuracy, including tumors that move during treatment as the patient breathes in and out.

China plans to expand a project of health insurance for children in rural areas
(新华网, 2011-06-28)
China plans to expand a pilot project for medical care in all rural areas by September, to give more financial support to children with congenital heart disease and leukemia, announced the Health Minister Chen Zhu. By September, all rural children enrolled in the new rural cooperative medical care (a project of health insurance for rural residents), will receive a refund of up to 70% of expenses for the treatment of their disease. The government launched in June 2010 the pilot project in 15 provincial regions, to offer a higher reimbursement for rural children, victims of serious diseases such as congenital heart disease and leukemia. The project has reduced expenses by 60% of care, according to the MoH. According to the latest report in April, 9059 children benefited from this project. The new rural cooperative medical care in China currently covers 832 million Chinese, more than 96% of the country’s rural population.

MoH, Shanghai sign cooperation agreement
(China MOH, 2011-07-05)
China’s Ministry of Health (MoH) announced has signed a cooperation agreement with the Shanghai municipal government to partner on the promotion of healthcare services in the municipality. The agreement will see the two bodies jointly manage hospitals currently under the MoH’s control, and establish a chronic disease prevention system and a general practitioners-based community health service system. They will also promote traditional Chinese medicine (TCM) services and continue public hospital reform. Additionally, the parties will work together to set up a health record system for Shanghai residents, improve the adverse drug reaction (ADR) monitoring system, and develop globally competitive medical research institutions and medical talent. The MoH and the municipal government will also jointly manage Shanghai’s National Institute of Parasitic Disease Control and Prevention, and set up a tropical disease treatment and prevention center in the municipality before 2015.

Construction begins on Shanghai vaccine production base
(Rsssearchhub, 2011-07-05)
Construction began on a new vaccine production base in Shanghai’s State Biopharmaceutical Industry Zone in Fengxian District, the municipal government announced. The project requires a total investment of RMB 4 billion ($618.24 million) which will come from the Shanghai Institute of Biological Products (SIBP), a subsidiary of China’s largest pharmaceuticals company, China National Pharmaceutical Group Corp. (Sinopharm). The base will cover an area of 480 mu (320,002 square meters) and will include workshops, quality testing centers, and mid-test production lines. It will produce a total of 180 million vaccines each year, generating annual sales revenue of RMB 5.8 billion ($896.45 million). SIBP produces more than 200 biological products, such as vaccines, blood products and diagnostic reagents. Its flagship products include varicella vaccine, influenza vaccine, and measles-mumps vaccine.

China’s gastric cancer drug market will grow to $469 million in 2015
(Freshnews, 2011-07-06)
Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, has analyzed that China’s gastric cancer drug market will grow from $250 million in 2010 to $469 million in 2015. According to the report, Gastric Cancer in China, market growth will be driven by expansion of the diagnosed and drug treated population, greater access to chemotherapy agents used to treat gastric cancer, increased use of targeted therapies and improved patient spending power. The incidence of gastric cancer in China is one of the highest worldwide, surpassed only by Japan and Korea; gastric cancer incident cases will increase 1.6 percent annually in China between 2010 and 2015. Although not approved by the Chinese government for gastric cancer treatment, branded targeted therapies including Bristol-Myers Squibb /Eli Lilly/ ImClone Systems / Merck KGaA’s Erbitux, Roche’s Herceptin and Novartis’s Gleevec are currently prescribed off label by Chinese oncologists for gastric cancer treatment. Some targeted therapies, including Herceptin and two emerging agents, GSK’s lapatinib and Novartis’s everolimus, will be launched in China by the end of the study forecast period, further contributing to growth in this market.

Glory Medical signs agreement to rebuild earthquake-hit county hospital
(Interfax.cn, 2011-07-05)
Shenzhen Glory Medical Co. Ltd. (Glory Medical) has signed a framework agreement with Sichuan Province’s Tongjiang county government and Tongjiang County People’s Hospital to rebuild the hospital on another site in the county. The deal, worth RMB 270 million ($41.77 million), includes building construction, interior design and medical equipment procurement for the Grade II Class B public hospital. A formal contract for the project has yet to be signed. The rebuilt Tongjiang County hospital will cover an area of 114 mu (76,000 square meters) and have 600 beds, according to an earlier announcement by Tongjiang County Health Bureau. The current hospital was damaged in the 2008 Sichuan earthquake.

Jiaotong University opens hospital research institute
(F-paper, 2011-07-04)
Shanghai Jiaotong University opened a research institute focused on China’s public hospital reform, the centerpiece of the country’s ongoing healthcare overhaul. The Jiaotong University China Hospital Development Research Institute, will research theories and practices of hospital management both at home and abroad, covering hospital finance, payments, management systems and ownership structures. The institute will provide graduate programs for public health students as well as training for senior hospital management.

Zhejiang Medicine plans $309 mln private placement
(ChinaBio Today, 2011-07-05)
Zhejiang Medicine Co. Ltd. (Zhejiang Medicine) announced its plans to issue 70 million shares through a private placement in order to build a factory in Shaoxing City, Zhejiang Province. The company aims to issue the RMB 2 billion ($309.4 million) worth of shares to no more than 10 investors, excluding its largest shareholder, Xinchang Changxin Investment Development Co. Ltd., which holds a 25.59 percent stake in the firm. The factory will increase Zhejiang Medicine’s Vitamin E (VE) active pharmaceutical ingredient (API) production capacity from 15,000 tons to over 35,000 tons. Zhejiang Changhai Bio Co. Ltd., a fully-owned subsidiary of Zhejiang Medicine, will construct and operate the plant. Zhejiang Medicine is the world’s third largest VE API producer, after Dutch drug maker Royal DSM and German chemical giant BASF. VE API generated 51 percent, or RMB 2.32 billion ($358.9 million), of the company’s 2010 sales revenue.

Pharmaceutical Industry

China’s pharma exports face challenges despite swift growth
(Cccmhpie.org.cn, 2011-06-29)
China’s pharmaceutical exports showed signs of strong growth after the 2008 global economic downturn but are facing mounting pressure from low-priced competition, increased production costs and a lack of proprietary products, experts said at the 2011 China and the World forum in Shanghai. According to figures from the China Chamber of Commerce for Import & Export of Medicines & Health Products, the total value of China’s pharmaceutical exports from January to April of this year reached $13.95 billion, an increase of 40.75 percent year-on-year. Active pharmaceutical ingredient (API) exports in the same period accounted for 52.76 percent of this total, with a value of $7.36 billion. China is a global leader in various forms of API, such the APIs used in vitamin C, analgesics, and various cephalosporin. “China will not be overtaken any time soon, and will maintain swift annual growth in pharmaceutical exports” Tan Shengcui, deputy secretary of the chamber, said at the forum. Low cost APIs take up a large portion of the export market, however. In 2010, 47 percent of China’s API exports were priced at under $10 per kilogram, according to Tan. Despite the fact that the total API export volume grew 31.31 percent year-on-year, the average price of such exports dropped 5.89 percent, he added. Low-priced competition is common in China, creating price fluctuations. Figures from the chamber show that the average price for vitamin C API exports fell 31 percent on an annual basis last year, while its export volume increased 47 percent.

Kangmei Pharma prepares $386 mln bond issue
(Interfax.cn, 2011-07-04)
Kangmei Pharmaceutical Co. Ltd. (Kangmei Pharma) has its sights set on raising RMB 2.5 billion ($386.40 million) through a bond issuance. The bond will have an interest rate of six percent and will be redeemable on June 21, 2018. Of the funds raised, RMB 1.5 billion ($231.84 million) will be used to repay banks loans, while the remainder will go toward business expansion. Kangmei Pharma has deployed a total of RMB 1.99 billion ($307.57 million) for the development of 12 projects over the past two to three years. The projects, including a traditional Chinese medicine (TCM) distribution center and TCM production bases in Beijing and Sichuan Province, will require an additional RMB 5.58 billion ($862.44 million) in the course of the next five years. Also included are TCM trading markets in Guangdong Province and Hebei Province. Kangmei Pharma is one of China’s leading pharma firms, generating sales revenue of RMB 1.39 billion ($214.84 million) in the first quarter (Q1) of 2011, an increase of 99 percent year-on-year.

Gloria Pharma to acquire 51 pct stake in competitor
(Business highbeam, 2011-06-29)
Harbin Gloria Pharmaceutical Co. Ltd. announced plans to acquire a 51 percent stake in rival pharma firm Heilongjiang Dilong Pharmaceutical Co., Ltd. in a bid to increase its share of the domestic orthopedic drug market. Dilong Pharma is controlled by nine individual investors, seven of which have agreed to sell equity to Gloria Pharma. Gloria Pharma’s flagship product, cervus and cucumis polypeptide injection, accounted for 40 percent of the company’s sales revenue in 2009. Dilong Pharma and Heilongjiang Jiangshi Pharmaceutical Co. Ltd. are the only other domestic pharma firms approved to produce the injection.

Biotechnologies

Walvax Biotech to invest $112 mln in vaccine production
(Devicespace, 2011-06-29)
Walvax Biotechnology Co. Ltd. announced it will deploy RMB 727.34 million ($112.42 million) to construct vaccine workshops in Yunnan Province’s Yuxi City. Construction will begin in 2012 and is scheduled for completion in 2014. The workshops will cover a total area of 63,610 square meters and are designed to produce vaccines for haemophilus influenzae type B (Hib), pneumonia and meningococcal disease. The project remains subject to shareholder approval. Yunnan-based Walvax Biotech has applied for SFDA approval to begin clinical trials of its Hib and pneumonia vaccines. A total of 49 million vaccines will be produced each year, generating estimated annual sales revenue of RMB 1.57 billion ($242.66 million), and annual profit of RMB 466.89 million ($72.16 million).

Chinese Pharma & Biotech Press Review – N°199

Feb
30
2011


HEADLINES

Dear customers,
Drug safety in China is rapidly gaining attention owing to the westernization of the pharmaceutical culture. In addition, due to an increasing number of clinical trials being held right here in China, the risks of serious adverse events and adverse drug reactions have never been greater.
The 2011 “Drug Safety in China” market analysis report of Universal Medica provides you with a comprehensive examination of the Chinese safety system versus the western world.
Key contents: ADR reporting & monitoring, Comparison with the European safety principles, Interviews of global safety KOLs…
Order now and get a special pre-publication price !
For more information, please contact: info@universalmedica.cn

FOCUS

  • 13-fold increase in scarlet fever cases
  • Hospitals face antibiotics cuts
  • Shanghai CDC, Hutchinson establish breast health lab
  • MoH encourages retired physicians to set up clinics
  • China to spend $308B, gain 1M new jobs in 5-year biotech plan
  • Johnson & Johnson Medical opens Suzhou R&D center
  • Shanghai International Medical Center breaks ground
  • China is considering a draft amendment to the law on occupational diseases

Healthcare News

13-fold increase in scarlet fever cases
(上海日报, 2011-06-24)
Shanghai reported 771 cases of scarlet fever last month – more than 13 times the number recorded during the same period last year. The city began to see a rise in numbers in March, when there were 143 cases, followed by 270 cases in April, said the Shanghai Health Bureau. In February, there were only 28 cases of the disease that mainly affects children under 10, and 87 in January. In May 2010, 58 cases of scarlet fever were reported in the city. Bureau officials didn’t offer an explanation for the rise, but insisted numbers are stable and under control. Hong Kong has reported a high incidence of scarlet fever in recent weeks, with two children dying of the disease. Researchers there said the epidemic has been caused by a drug-resistant mutated bacteria that is easily spread. Health officials said Shanghai hasn’t found any genetic change in the bacteria causing scarlet fever, but the authorities will keep a close eye on the situation.

Hospitals face antibiotics cuts
(上海日报, 2011-06-27)
Some local hospitals are using almost three times as many types of antibiotics than will be permitted under strict regulations. According to regulations drafted by the MoH, city-level hospitals should offer no more than 50 types of antibiotics. District-level hospitals are permitted to use only 35 types of the drugs. But currently, some local hospitals offer more than 100 types of antibiotics and city-level hospitals still use around 60 types. The introduction of the new regulation will see nearly half of antibiotics types withdrawn from local hospitals. No introduction date has been confirmed, but it is widely thought to be July 1. The regulations also stipulate that antibiotics can be used on no more than 60 percent of hospitalized patients and only 20 percent of patients in out-patient service. The city bureau will carry out a fortnightly inspection on antibiotics use from July 4. Hospitals listed in the bottom 20 places will be inspected again after making corrections, officials said.

Shanghai CDC, Hutchinson establish breast health lab
(BioSpectrum, 2011-06-27)
The Shanghai Municipal Center for Disease Control and Prevention (Shanghai CDC) and the Breast Health Global Initiative (BHGI), headquartered at Fred Hutchinson Cancer Research Center, jointly will establish the Shanghai Breast Health Resource Center as BHGI’s first learning laboratory in China. The project marks the first such agreement between the Shanghai CDC and a U.S. cancer research center. Through this agreement, the Shanghai CDC and its partners will work with the BHGI on projects related to cancer control and will provide a comprehensive assessment of breast cancer early detection for the population of Shanghai and the region. The first project of the Shanghai Breast Health Resource Center, organized as a BHGI Learning Laboratory, will be an evaluation of the effectiveness of clinical breast exam (breast exam performed by a qualified health professional) for breast cancer early detection, based upon breast cancer screening conducted in Shanghai.

MoH encourages retired physicians to set up clinics
(China MOH, 2011-06-28)
The Ministry of Health (MoH) announced that pilot tests will soon begin for retired physicians to set up their own clinics. The tests will run from July 1, 2011, to June 30, 2012, and will take place in Tianjin Municipality, Shenyang City in Liaoning Province, Jilin Province’s Changchun City, Fuzhou Province’s Xiamen City and Kunming City in Yunnan Province. Qualified physicians must hold a senior academic title and have provided medical services for at least five years, including three years in a grade II or grade III hospital. They are encouraged to set up township and community clinics. Medical institutions are prohibited from restricting the opening of these new clinics.

Japan’s Nipro Medical breaks ground on Hefei City production center
(Interfax.cn, 2011-06-28)
Nipro Medical Corp., Japan’s leading medical device manufacturer, has broken ground on a production center in Hefei City, Anhui Province. Nipro Medical will deploy $300 million to build the center, which is scheduled for completion in September 2012. The facility will cover an area of 285 mu (190,000 square meters) and mainly produce hemodialysis products, including dialyzers, and blood tubing and syringes for the domestic market. The company expects the center to employ approximately 3,000 people, including a 150-member research team. Once operational, it is expected to generate annual sales revenue of RMB 2 billion ($308.8 million).

China to spend $308B, gain 1M new jobs in 5-year biotech plan
(Fiercebiotech, 2011-06-28)
While the economic development agencies in many states are trying to do more with less money, Chinese officials have mapped out ambitious plans to generate a million new biotech jobs by the end of 2015. And they’re backing those ambitious plans with $308 billion for science and technology. Ma Hongjian, the deputy director of the China National Center for Biotechnology Development, says that the government intends to reserve 20 billion yuan for new drug development and control of disease. “The development priorities of the 12th Five-Year Plan (2011-2015)–biopharmacy, bio-engineering, bio-agriculture and biomanufacturing–will bring benefits to Chinese people,” declared Chinese State Councilor Liu Yandong. And there are specific goals in mind, including an extra year of life expectancy and a lower infant mortality rate.

China to introduce GPs for grassroots-level clinics by 2012
(Interfax.cn, 2011-06-23)
China’s State Council announced it aims to introduce general practitioners (GPs) to grassroots medical institutions by 2012. Qualified GPs will begin working in urban community health centers and clinics and township clinics, according to the announcement. GPs will make up the majority of staff at grassroots medical institutions and will help to improve the accessiblity and affordability of medical services in China. Fifth-year medical students must receive three years of training before qualifying as a GP, the announcement added. Licensed physicians and assistant physicians in grassroots medical institutions are required to receive a maximum of two years training. GPs will also have the option of setting up their own practice. The private clinics will receive government subsidies based on the number of residents that each GP attends. The Ministry of Health (MoH) aims to create 180,000 GPs by 2015, or two to three GPs for every 10,000 residents, the ministry stated in development guidelines issued in April of this year. This number will increase to 300,000 by 2020, of which 100,000 will be licensed physicians and assistant physicians that have completed training.

MoH to expand clinical pathway trial
(China MOH, 2011-06-24)
China’s Ministry of Health (MoH) announced its plans to expand the ongoing clinical pathway trial this year to include all administrative regions in mainland China. The ministry will expand the trial to cover 1,406 Grade II and III hospitals across China from the original 50 hospitals in 12 provinces and municipalities designated in 2009. Grade III hospitals involved in the plan must implement a new clinical pathway in at least 10 medical specialties, including cardiology, neurovascular intervention and orthopedic joint implants, the announcement said. Grade II hospitals will begin clinical pathways covering at least five medical specialties, including orthopedic joint implants. The ministry aims to reduce medical cost this year through the trial, the announcement added.

Johnson & Johnson Medical opens Suzhou R&D center
(Fierce medical devices, 2011-06-24)
Johnson & Johnson Medical Ltd. has opened a research and development (R&D) center in Suzhou Industrial Park, located in Jiangsu Province’s Suzhou City. The 2,000-square meter Asia Pacific Innovation Center will focus on medical device R&D, including that for orthopedic products, blood glucose monitors and in vitro diagnostic (IVD) products. It will primarily target emerging markets in the Asian Pacific such as China and India. The center has already formed a R&D team of 45 members and expects to have between 100 and 200 researchers in the near future. Johnson & Johnson Medical Suzhou currently produces orthopedic implants under the brand DePuy for sale on both China’s and the global market.

Shanghai International Medical Center breaks ground
(上海日报, 2011-06-24)
Construction began on the Shanghai International Medical Center in Shanghai’s Pudong New Area, the local government announced. The center will include a hospital and several specialized treatment centers. It is designed to provide high-end, non-reimbursable medical services for Chinese and foreign nationals. The first phase of construction will focus on the main hospital and requires a total expenditure of approximately RMB 800 million ($123.65 million). Investment will come from Shanghai International Medical Center Investment Management Co. Ltd., a joint venture (JV) established in March 2010 by state-owned Shanghai International Medical Park and eight private investors. Singapore’s Parkway Medical Group, which already operates clinics in Shanghai, will be invited to manage the medical center.

China is considering a draft amendment to the law on occupational diseases
(新华网, 2011-06-27)
The Standing Committee of National People’s Congress (NPC) began to discuss a draft amendment to the law on occupational diseases, to improve the protection of rights and legitimate interests of workers. According to the draft amendment, health care facilities should not refuse the demands of workers regarding occupational diseases, said the Standing Committee of NPC, during a bimonthly legislative session. The symptoms described by sick workers can serve as a reference when healthcare institutions make a diagnosis. According to this amendment, patients will be considered affected by an occupational disease if there is no evidence from denying a link between their symptoms and the factors inducing those diseases. The draft amendment will also simplify procedures for arbitration of disputes in the workplace. More than 27,000 cases of occupational diseases were reported at the end of last year, according to statistics from the MoH.

Pharmaceutical Industry

Conba Pharma, Honz Pharma sign drug distribution agreement Conba Pharma
(ChinaBio Today, 2011-06-23)
Zhejiang Conba Pharmaceutical Co. Ltd. (Conba Pharma) announced it has signed a distribution contract for a generic fever medicine with Hainan Honz Medicine Distribution Co. Ltd. Honz Medicine is a wholly-owned subsidiary of leading domestic pediatric drug maker Hainan Honz Pharmaceutical Co. Ltd. (Honz Pharma). Under the terms of the contract, Honz Medicine has the exclusive five-year China distribution rights to over-the-counter (OTC) ibuprofen granules manufactured by Conba Pharma, effective July 1, 2011. The agreement requires Honz Pharma to sell a minimum 12 million boxes of the drug in the first year of cooperation, the announcement added. It is also aiming for a 10 percent year-on-year sales growth, with aggregate sales revenue reaching RMB 150 million ($23.21 million), over the five-year period.

Sihuan Pharma to enter TCM market via Smart Baskets acquisition
(Rsssearchhub, 2011-06-23)
Hainan Province-based Sihuan Pharmaceutical Holdings Group Ltd. announced it has signed an agreement to fully acquire Smart Baskets Investments Ltd. for RMB 775 million ($119 million). Smart Baskets is an investment company registered in the British Virgin Islands with two wholly-owned pharma subsidiaries in China, namely Vinise Pharmaceutical Co. Ltd., a traditional Chinese medicine (TCM) manufacturer in Tonghua City, Jilin Province; and Hainan Litzman Pharmaceutical Co. Ltd., a drug producer and distributor in Wanning City, Hainan Province. Vinise Pharma has several exclusive TCM injections to treat cardio-cerebral vascular diseases and production lines for large volume parenteral (LVP) injections. Sihuan Pharma currently lacks capability in both areas. Sihuan Pharma said it aims to enter the domestic TCM market through the acquisition, focusing on TCM treatments for cardio-cerebral vascular diseases.

Hybio Pharma to obtain commercialization rights CoSci Med-Tech sustained release drugs
(Interfax.cn, 2011-06-23)
Shenzhen Stock Exchange-listed Hybio Pharmaceutical Co. Ltd. (Hybio Pharma) announced that it plans to deploy RMB 90 million ($13.91 million) to purchase the commercialization rights for 21 sustained release drugs being developed by Beijing CoSci Med-Tech Co. Ltd. The products will be used in the treatment of various illnesses, including cardiovascular diseases, respiratory diseases, diabetes, gastric system diseases, rhinitis and insomnia. CoSci Med-Tech will transfer research and development (R&D) documents of the drugs to Hybio Pharma between 2011 and 2013, as well as provide support for the drugs preliminary production. Hybio Pharma will be responsible for the registration of these new drugs. Hybio Pharma expects to generate revenue of RMB 303.53 million ($46.91 million) in 2019 and RMB 822.29 million ($127.09 million) in 2026 from the sale of the drugs.

Sirnaomics Names China Partner for siRNA Therapeutic
(Biospace, 2011-06-23)
Sirnaomics, located in Maryland, USA, has partnered with Guangdong Zhongsheng Pharmaceutical Co. to develop its small interfering RNA (siRNA) ocular neovascularization therapeutic. The partnership will seek to develop and commercialize STP601, a Sirnaomics siRNA candidate for treatment of diabetic retinopathy and age-related macular degeneration. Zhongsheng Pharma is committing 63 million RMB ($9.8 million) to the partnership, including upfront and milestone payments.

Chinese Pharma & Biotech Press Review – N°198

Feb
23
2011


HEADLINES

Dear customers,
Drug safety in China is rapidly gaining attention owing to the westernization of the pharmaceutical culture. In addition, due to an increasing number of clinical trials being held right here in China, the risks of serious adverse events and adverse drug reactions have never been greater.
The 2011 “Drug Safety in China” market analysis report of Universal Medica provides you with a comprehensive examination of the Chinese safety system versus the western world.
Key contents: ADR reporting & monitoring, Comparison with the European safety principles, Interviews of global safety KOLs…
Order now and get a special pre-publication price !
For more information, please contact: info@universalmedica.cn

FOCUS

  • Gov’t program developed 27 biomaterials since 2006 – MOST
  • Harbin Pharma to relocate API production over environmental concerns
  • China orders recall of drug over toxic fears
  • China: 280 cases of disease caused by tick bites this year
  • Jiaotong University, SAEC to research adverse drug reactions
  • Boehringer Ingelheim launches OTC laxative in China
  • MoH opens pediatric kidney stone center in Shanghai
  • CRO ClinTec Making Push into China and Asia Pacific Region

Healthcare News

Gov’t program developed 27 biomaterials since 2006 – MOST
(China MOST, 2011-06-17)
China’s national biomaterials research program for the 11th Five-Year Plan period (2006-2010) helped develop 27 proprietary biomaterials for orthopedic, dental and ophthalmic use, the Ministry of Science and Technology (MOST) announced. The program, initiated by MOST and the Ministry of Education (MOE), received central government funding of RMB 30 million ($4.64 million), the announcement said. Total investment in projects under the scheme amounted to RMB 60 million ($9.27 million). Production lines have already been set up for 14 products developed under the program. Six of these have received production approval, including a calcium phosphate coating for artificial joints, an artificial bone repair material, and a rigid gas permeable (RGP) contact lens – a lens that helps oxygen transmission to the eye. Meanwhile, eight of the products are still undergoing clinical trials.

Sino Medical begins distributing second-generation stent
(Interfax.cn, 2011-06-17)
Sino Medical Sciences Technology Inc. has started distributing a proprietary second-generation drug-eluting stent (DES) to hospitals in north China’s Tianjin Municipality, the government of Tianjin’s Binhai New Area annonced. The firm intends to distribute the product, named the BuMA stent, in more than 1,000 hospitals across China, and has applied for a CE mark in the EU, the announcement said. A DES is a device inserted into problematic peripheral or coronary arteries that releases drugs to block cell proliferation and prevent fibrosis that could otherwise block the artery. Second-generation polymer-free DESs are believed to be more effective and safer than traditional versions.

Transplant center gets go-ahead in Inner Mongolia
(Silobreaker, 2011-06-16)
Health authorities in the Inner Mongolia Autonomous Region granted Baogang Hospital approval to set up a liver and kidney transplant center, the regional government announced. Located in Baotou City, the hospital is the first medical institution the region to gain approval for conducting such transplants. Classified as a Grade III, Class A hospital, Baogang has already set up facilities for transplant patients, including transplant matching and post-operation management systems, according to the announcement.

LabCorp Buys Clearstone Labs, Giving it Access to China
(Bioportfolio, 2011-06-16)
LabCorp (Laboratory Corporation of America) will acquire Clearstone Central Laboratories, a privately held central laboratory services company that will extend LabCorp’s reach into China and the greater Asia-Pacific region. Clearstone has a facility in Beijing and another in Singapore in addition to labs in Canada and Europe. Clearstone is headquartered in Toronto. LabCorp, which reported revenues of $5 billion in 2010, offers a broad list of tests that range from routine blood analyses to reproductive genetics to DNA sequencing.

China orders recall of drug over toxic fears
(上海日报, 2011-06-19)
Shanghai’s pediatric hospitals started to remove a GSK antibiotic treating children’s upper respiratory diseases and urinary tract infection from their pharmacies and inform parents that they will give full reimbursement if returning the drug. The emergency actions were launched after the SFDA issued a statement, requiring an immediate halt of sales and use of GSK’s amoxicillin and clavulanate potassium, and that products already on the Chinese market will be recalled. According to the statement, test results show that GSK’s amoxicillin and clavulanate potassium product contains traces of Di-isodecyl phthalate (DIDP), a cancer-causing plastic polymer. It’s the first time the plastic polymer was found in medicine after the country’s food industry has been plagued by the presence of the toxic chemical since Taiwan reported the first case in May. An official at Shanghai Children’s Medical Center said they took action immediately by informing doctors to stop prescribing the drug and removing all stocks from the shelves.

Chinese and British companies will develop jointly new drugs over the next decade
(新华网, 2011-06-18)
Chinese pharmaceutical companies and the UK will develop jointly 30 new drugs over the next decade, according to a partnership agreement. The news was announced by David Wilkinson, who represents the National Institute of Medical Education in the United Kingdom at the Convention on Biological Industry of China 2011 in Shenzhen of Guangdong Province. Mr Wilkinson said he had confidence in the “ambitious” plan, following the signing of the proposed China-UK partnership on health. The two sides will integrate their various advantages in bio-pharmaceutical industry, he said. This project, supported by both governments, involves nearly one billion yuan (154 million $) according to the estimations. About 12 million euros (about 17,13 million U.S. $), come from the British side.

China: 280 cases of disease caused by tick bites this year
(新华美通, 2011-06-17)
More than 280 cases of a disease caused by tick bites have been reported in the provinces of Henan, Shandong, Anhui and Jiangsu, according to the Chinese central control of disease and prevention. A dozen people have died as a result of tick bites. Of the total, 90% of cases occurred in people aged over 40 years. And farmers account for 90% of patients. This disease, called by the center “syndrome of thrombocytopenic fever,” is a kind of new infectious disease caused by a virus of the family Bunyavirus, from central regions of China. According to the center, the majority of victims suffered from nausea, fatigue and lack of appetite. In October 2010, the MoH issued a plan on the control and prevention of diseases that ticks are the vectors, asking local governments to report possible cases through a national network for disease control.

CRO ClinTec Making Push into China and Asia Pacific Region
(ChinaBio Today, 2011-06-17)
ClinTec International, a privately held clinical stage CRO based in Glasgow, Scotland, has opened four fully registered offices in China, Singapore and Thailand. Over the next three months, the company, which is bulking up its presence in Asia Pacific, will open additional offices in South Korea, Taiwan, Malaysia and Indonesia. ClinTec stresses its coverage of emerging markets, declaring it has operations in a UN-like 80 countries. ClinTec claims special expertise in oncology trials.

Biomatters Partners with Genewiz; Plans Entry into China
(Bioportfolio, 2011-06-20)
Biomatters, a New Zealand company that produces software for DNA analysis, has signed a strategic partnership with US-based Genewiz, a CRO offering DNA sequencing services. In addition to labs in the US, Genewiz has facilities in Beijing and Suzhou, China, which were opened in the last year. According to Biomatters, Genewiz is the largest private contract sequencing company in China and will, as a result, give it entry into the China marketplace.

MoH opens pediatric kidney stone center in Shanghai
(China MOH, 2011-06-21)
China’s Ministry of Health (MoH) has established a diagnosis and treatment center for pediatric kidney stones in Shanghai’s Xinhua Hospital, the municipal government announced. The center will formulate national diagnosis and treatment guidelines for kidney stones in children and conduct pathogenic research, the announcement said, as well as providing technical support to other medical institutions. The incidence of pediatric kidney stones has been rising rapidly in China since a scandal involving melamine-tainted infant milk powder erupted in 2008. The tainted milk adversely affected the health of an estimated 300,000 children as of November of 2008, according to official statistics.

Jiaotong University, SAEC to research adverse drug reactions
(Interfax.cn, 2011-06-22)
Shanghai Jiaotong University and the International Serious Adverse Events Consortium (SAEC) will begin to cooperate on research into drug-induced serious adverse events (SAE), the university announced. The research will focus on the role that genetics plays in drug safety in China and aims to enhance the development of personalized medicines for Chinese people, according to the announcement. The first phase of research is expected to last two years. Hospitals affiliated to Jiaotong University will also participate in the program. Based in Chicago, U.S., the SAEC is a nonprofit organization comprised of members from major pharmaceutical companies such as Pfizer, Novartis, Merck KGaA, Abbott Laboratories, GSK and Daiichi Sankyo, as well those from global academic institutes.

Dalian Medical University opens animal testing center
(Interfax.cn, 2011-06-17)
A breeding and testing center for specific pathogen free (SPF) laboratory animals has opened at Dalian Medical University in Liaoning Province’s Dalian City. The center provides lab animals and animal testing services to businesses, and hosts teaching facilities for use by academic institutions. Its animal breeding and experiment facilities cover 14,000 square meters and can raise up to 1 million animals, including 150,000 SPF mice. SPF animals are guaranteed to be free of particular pathogens, and are used to ensure specific diseases do not interfere with an experiment.

Pharmaceutical Industry

Harbin Pharma to relocate API production over environmental concerns
(Interfax.cn, 2011-06-15)
Environmental concerns have forced Harbin Pharmaceutical Group Co. Ltd. to relocate its primary active pharmaceutical ingredient (API) plant in Nangang District in central Harbin City to suburban Acheng District, the Acheng government announced. Local environmental regulators in March ordered the firm to curb production at its General Pharmaceutical Factory in Nangang District due to high pollution levels. The relocation comes after an investigation by state broadcaster China Central TV (CCTV) aired June 5 revealed that the chemical oxygen demand (COD) of waste water from the factory was still more than 10 times the legal limit. The new site will cover an area of 1.72 square kilometers, and the first phase will cost approximately RMB 2 billion ($308.64 million). Construction of the facility will take two to three years.

PKU Southwest Synthetic Pharma to Acquire 100% of Distribution Subsidiary
(ChinaBio Today, 2011-06-16)
PKU Southwest Synthetic Pharmaceutical received regulatory permission to issue 9.4 million shares to acquire the remainder of an affiliate, Beijing Pharmaceutical. Both companies are affiliated with the Founders Group, a high-tech conglomerate formed by Peking University in 1986. It is thought that Founders Group is gradually moving all of its pharmaceutical assets into PKU Southwest. Beijing Pharmaceutical is its principal drug distribution company based in North.

Boehringer Ingelheim launches OTC laxative in China
(Interfax.cn, 2011-06-22)
German pharmaceutical giant Boehringer Ingelheim announced that it has launched its top-selling laxative, Dulcolax, on the Chinese market. This is the second over-the-counter (OTC) drug that the company has introduced to China following the launch of the cough remedy Mucosolvan in 2006. Dulcolax, with the generic name bisacodyl, is sold in tablet form and helps to relieve the symptoms of constipation. The drug was developed by Boehringer Ingelheim and is sold in more than 90 countries. The incidence of constipation among Chinese adults is approximately 15 percent. Industry figures show that China’s laxative market generated RMB 1.1 billion ($170.02 million) in sales last year, up 8.1 percent year-on-year. The OTC constipation drug market in China is largely dominated by traditional Chinese medicines (TCM) and products marketed as health foods.

Chinese Pharma & Biotech Press Review – N°197

Feb
16
2011


HEADLINES

Dear customers,
Universal Medica Group and its renowned partners are pleased to organize the 2nd edition of the Innovation Days event to be held on 26, 27 September at the Cité Universitaire Internationale of Paris – France.
The only international event in France entirely dedicated to Innovation.
Over 600 participants expected to attend the 2nd edition!
New for 2011: a space dedicated to the “Partnering Deal” in order to promote networking and develop partnership opportunities.
For more information, please contact: info@universalmedica.cn

FOCUS

  • MoH announces grants for 2012 drug creation program
  • MoH urges expansion of rural subsidy scheme for serious illnesses
  • State Council approves plan for disability care
  • China calls for enhanced prevention and treatment mechanisms to fight against AIDS
  • Hong Kong yanks GSK drug on phthalate levels
  • BGI and U. of California Davis Announce Partnership

Healthcare News

MoH announces grants for 2012 drug creation program
(China MOH, 2011-06-10)
China’s Ministry of Health (MoH) announced details of government grants for drug research and development (R&D) projects under the Key New Drug Creation Program (KNDCP) in 2012. Launched in 2008, the KNDCP provides funding for research facilities and the development of drugs for major diseases including tumors, cardiovascular disease, diabetes and tuberculosis. According to the announcement, next year the program will provide funding for preclinical research, phase IV clinical trials and Good Clinical Practice (GCP) research facilities. It has previously focused on preclinical research and phase I-III clinical trials. Grants of RMB 10 million ($1.54 million) to RMB 15 million ($2.31 million) will be available for companies to set up Good Clinical Practice (GCP) centers. Preclinical research projects working on innovative drugs will be eligible for a grant of RMB 1 million ($154,083) to RMB 1.5 million ($231,125), while RMB 3 million ($462,250) to RMB 5 million ($770,416) will be available for phase IV clinical trials of new drugs.

MoH urges expansion of rural subsidy scheme for serious illnesses
(China MOH, 2011-06-10)
Local governments in China are urged to expand a program of subsidies for serious illness treatment in rural areas, Yang Qing, director of the Ministry of Health’s (MoH) Department of Rural Health Management. Under the program launched by the MoH and the Ministry of Civil Affairs in June last year, children with leukemia and congenital heart disease in rural areas are eligible for a special subsidy from local civil affairs bureaus that covers 20 percent of treatment costs, in addition to the 70 percent covered by basic rural medical insurance. “The MoH encourages local governments to extend the program this year to cover kidney dialysis and cervical and breast cancer therapy [for adults],” Yang said, adding that 13 administrative regions have already rolled out the changes. Inpatient coverage under the rural insurance program was increased this year to 70 percent of total expenses, up from 60 percent last year, while local governments are also starting to implement outpatient reimbursement programs.

State Council approves plan for disability care
(Interfax.cn, 2011-06-09)
China’s State Council approved guidelines for disability care that aim to extend rehabilitation services to all disabled citizens by 2015. According to the guidelines, specialist rehabilitation centers will work alongside other health care institutions to establish the comprehensive network. Grassroots medical institutions are required to set up rehabilitation units, while health authorities at provincial- and county-level are required to establish specialist rehabilitation centers and upgrade services in general hospitals. The measures also include special programs to provide care to 13 million disabled people, including deaf children, children under six years old, cataract patients, and the mentally disabled. A total of five million government-subsidized assistive devices will be handed out as part of these special programs, though no further details were given.

CAS institute to set up biotech park in Nantong City
(Rsssearchhub, 2011-06-09)
The Institute of Microbiology of the Chinese Academy of Sciences (IMCAS) plans to set up a biotech park in Jiangsu Province’s Nantong City, the CAS announced. The project will receive additional investment from Nantong Industry Holding Group Co. Ltd., a conglomerate owned by the city government, and the management committee of Gangzha Economic Zone, where the park will be located. Total investment in the 300,000 square-meter park could reach RMB 1 billion ($154.32 million), the Nantong government has said. The first project on the site will be the CAS National Engineering Research Center for Microbiology and Immunology Preparation, which will receive investment of about RMB 50 million ($7.72 million) over the next three years, according to CAS.

China: The Chinese health care system covers 96% of rural residents
(新华网, 2011-06-10)
The new rural cooperative medical care currently covers 832 million Chinese people, with larger refunds of medical expenses for people in rural areas, said Yang Qing, director of the department of health in rural of MoH. The new system brings to more than 96% of health insurance coverage in rural areas, said Yang Qing at a press conference. The remaining 4% are mostly farmers who became workers who work outside their places of residence. These can benefit from the health system for urban workers and residents, said Yang. He admitted that these efforts should be strengthened so that the entire rural population can benefit from the policy of health insurance. Under the new health insurance plan, the reimbursement cap for farmers rose from 30,000 yuan to 50,000 yuan (7,600 $), almost ten times the annual income of most farmers, revealed the director.

China calls for enhanced prevention and treatment mechanisms to fight against AIDS
(新华美通, 2011-06-10)
China called on governments, organizations and individuals to take active measures to strengthen solidarity and to establish a joint mechanism for prevention and treatment to meet the challenges posed by AIDS. In a speech in New York during the High-Level meeting of UN on HIV / AIDS, the Chinese Vice Minister of Health Yin Li said: “As a responsible developing country, the Chinese government has actively implemented its commitments to achieve universal access to prevention and treatment of AIDS, eliminate social discrimination and guarantee rights to the prevention, treatment and care of people with HIV / AIDS and their families, ” he said. Thanks to efforts in recent years, the spread of the AIDS epidemic in China has slowed, the mortality rate has significantly decreased and the living standards of people living with HIV / AIDS is greatly improved, has said Mr Yin.

US, China Pharmacopeia: Build stronger bonds
(BioSpectrum, 2011-06-14)
The Chinese Pharmacopoeia Commission (ChP) signed a memorandum with the United States Pharmacopeia (USP), exchanging appointments to serve as special councilors on international affairs to each other’s organization. The unprecedented step builds upon the already strong relationship that the organizations have shared over the past years and promises benefits to manufacturers, regulators, patients and consumers, who rely on quality standards for medicines. This new memorandum of understanding between the two nations has formalized and expanded several areas of cooperation between USP and ChP, including: joint work on documentary and physical standards for medicines that are suitable for either or both USP and ChP pharmacopeias; visiting scientists; translation of USP’s compendia of medicines and excipients into Chinese and joint scientific and standards meetings in China.

MoH launches telepathology program in Xinjiang county hospitals
(China MOH, 2011-06-14)
China’s Ministry of Health (MoH) launched a telepathology program in the Xinjiang Uyghur Autonomous Region, the regional government announced. Telepathology is the practice of pathology at a distance using telecommunications technology. The MoH has invested RMB 4.86 million ($750,000) in the project, which involves 43 hospitals in the autonomous region, as well as the Qilu Hospital of Shandong University, an MoH-managed Grade III institution in Shandong Province that is a leader in cardiovascular disease therapy.

Pharmaceutical Industry

Hong Kong yanks GSK drug on phthalate levels
(Fiercepharma, 2011-06-10)
A GSK antibiotic for kids has found itself under the microscope as Hong Kong authorities ordered a recall. The region’s Department of Health said lab tests found higher-than-allowable concentrations of a plasticizing agent in the drug, Augmentin powder for syrup. The newspaper reports GSK could face prosecution because of the contamination. The offending chemical, Diisodecyl phthalate, was found at two times the European limit, Hong Kong officials said. The government there has been routinely testing products with flavoring agents after products in Taiwan were found to contain plasticizers similar to–but more toxic than–the phthalate found in GSK’s product, the newspaper reports. No adverse events have been reported about the tainted product, so the recall order is a precaution. A government spokesman said that GSK hasn’t demonstrated the phthalate levels in its product are safe. Animal tests of the pure chemical have found that long-term consumption could damage the liver. “The threat to public health cannot be ruled out at this stage,” the spokesman said.

Suzhou Erye Pharmaceuticals’s New Production Line is Approved by the SFDA
(Dailymarkets,  2011-06-13)

NeoStem, Inc., an international biopharmaceutical company with product and operations in three business units – U.S. adult stem cells, China adult stem cells, and China pharmaceuticals, announced that its Suzhou Erye Pharmaceutical subsidiary has received approval from the SFDA for its sixth major production line which is responsible for the production of over 20 finished pharmaceutical products, 80% of which are on the National Insurance Drug List. The combined production lines now certified by the SFDA were responsible for approximately 99% of Erye’s 2010 revenues.

GSK to buy out partner in China vaccine JV
(ChinaBio Today, 2011-06-14)
U.K. pharma giant GlaxoSmithKline Pte Ltd. (GSK) has agreed to acquire full ownership of its vaccine joint venture (JV) with Shenzhen Neptunus Interlong Bio-Technique Co. Ltd. (Neptunus Interlong), the firm’s parent company Shenzhen Neptunus Bioengineering Co. Ltd. (Neptunus Bio) announced. GSK will acquire its Neptunus Interlong’s 51 percent stake in the JV, Shenzhen GSK-Neptunus Biologicals Co. Ltd., for $39 million, the announcement said. The JV develops influenza vaccines for the Greater China market, and was established in Guangdong Province’s Shenzhen City in August 2009 with a registered capital of $78.33 million. “The JV has no vaccines on the market yet, and may obtain marketing approvals later than expected due to tightening regulation,” an investor relations representative of Neptunus Bio said.

Nycomed to Market Roche Osteoporosis Drug in China and Asia-Pacific
(Biospace, 2011-06-15)
Nycomed, the Swiss biopharma, will market a Roche osteoporosis treatment, Bonviva, in China and other Asia Pacific markets. Boniva, a bisphosphonate, will be added to Nycomed’s existing portfolio of osteoporosis products. Nycomed, the 28th largest biopharma in the world, generates the highest proportion of its revenues from developing countries of any large or medium-sized global pharma – though China is not one of its top five markets.

Conba Pharma Forms Cancer JV with Kite Pharma, a US Startup
(Bioportfolio,  2011-06-14)

Zhejiang Conba Pharma announced plans for a JV with a development stage oncology startup, American Kite Pharmaceutical. The JV, which will be located in Hangzhou, will be funded with 8 million RMB ($1.2 million) of initial capital. Of the total, 70% will come from Conba and the rest from Kite. Kite is developing cancer immunotherapies using alpha fetoproteins (AFPs), with an initial indication of kidney cancer.

Biotechnologies

Agenix Discloses Plans for Clinical Trial of Hepatitis B Drug
(ChinaBio Today, 2011-06-09)
Agenix released a long-lead schedule for China approval of its new treatment for hepatitis B, AGX-1009. If everything goes according to plan, the company will apply in Q2 of 2012 to begin clinical trials of the drug. The trials themselves could start as early as late 2012. Agenix is developing the drug in partnership with the Institute of Medicinal Biotechnology, located in Beijing, a division of the Chinese Academy of Medical Sciences (CAS).

BGI and U. of California Davis Announce Partnership
(Bioportfolio, 2011-06-09)
BGI, the world’s largest genome sequencing institute formerly known as the Beijing Genomics Institute, has set up a partnership with the University of California, Davis. The two institutions will conduct large-scale genome sequencing and functional genomics programs, targeting the areas of food security, human and animal health and wellness, and biodiversity and environmental health. The new entity will be known as BGI@ UC Davis Partnership.

Chinese Pharma & Biotech Press Review – N°196

Feb
9
2011


HEADLINES

Dear customers,
Universal Medica Group and its renowned partners are pleased to organize the 2nd edition of the Innovation Days event to be held on 26, 27 September at the Cité Universitaire Internationale of Paris – France.
The only international event in France entirely dedicated to Innovation.
Over 600 participants expected to attend the 2nd edition!
New for 2011: a space dedicated to the “Partnering Deal” in order to promote networking and develop partnership opportunities.
For more information, please contact: info@universalmedica.cn

FOCUS

 

  • Novo plots China growth to protect market share
  • Pfizer and Zhejiang Hisun Sign MOU for Branded Generics JV
  • Tasly Pharma to Make $40 Million Investment in US Facility
  • D-Pharm Out-licenses China Rights for Epilepsy Drug to Nhwa Pharma
  • Dehaier Medical signs supply contract with PLA hospital
  • The outbreak of viral encephalitis under control in Fujian

Healthcare News

Anhui University of TCM launches diabetes research program
(ReportLinker, 2011-06-01)
Anhui University of Tradition Chinese Medicine will study the efficacy of traditional Chinese medicines (TCM) in treating diabetes, Anhui Province’s health department announced. According to the announcement, the three-year project aims to devise prevention and treatment pathways for impaired glucose tolerance (IGT). IGT is a pre-diabetic state of dysglycemia, or abnormal blood sugar levels, commonly associated with insulin resistance and increased risk of cardiovascular pathology. The study will involve 360 patients from five community health centers in Anhui’s provincial capital of Hefei.

Dehaier Medical signs supply contract with PLA hospital
(Interfax.cn, 2011-06-02)
Dehaier Medical Systems Co. Ltd., a medical equipment maker, has signed a supply contract worth $1.32 million with the People’s Liberation Army General Hospital in Beijing, the firm announced. The Grade III hospital, also known as 301 Military Hospital, is the largest general hospital under the auspices of China’s military, the People’s Liberation Army (PLA). Under the contract, Dehaier Medical will supply small animal in-vivo imaging (SAIVI) and laser capture micro-dissection (LCM) systems produced by German optical manufacturer, Leica Microsystems, as well as DNA sequencers from U.S.-based Applied Biosystems Inc., the announcement said.

China: 134.6 billion yuan to promote medical care since the beginning of the year
(新华网, 2011-06-01)
China has provided 134.6 billion yuan (about 20.76 billion U.S. $) in subsidies for medical services since the beginning of the year, said the Chinese MoH. According to a statement posted on the Ministry of Health’s website, in its efforts to promote medical services, the government allocated 23.5 billion yuan to finance a new rural cooperative medical care and 4.57 billion yuan to fund public health programs such as prevention of AIDS.

The outbreak of viral encephalitis under control in Fujian
(新华美通, 2011-06-02)
The outbreak of viral encephalitis that led to hospitalization of hundreds of children in the province of Fujian since the beginning of May is under control, local health authority officials said Thursday. Among the 117 hospitalized children in the district of Anxi, 87 were discharged and the remaining 30 children are still under treatment, said Wu Zhengxin, director of district health office. Fifty-two cases were reported in the District of Dehua and 23 in the city of Fu’an, according to a statement released by the Health Bureau of Fujian. All hospitalized children are in stable condition, outlines the Bureau. According to a survey conducted by experts from the MoH and local center for disease control, the disease is due to an intestinal virus, Echo 30, said Mr. Wu. Although not fatal, the virus can cause fever, headache and vomiting. The government of the Fujian province ordered the health authorities to closely monitor the epidemic to prevent further spread.

Hybridbio launches HPV database with MoH institute
(Interfax.cn, 2011-06-07)
Guangdong Hybridbio Biotech Co. Ltd. (Hybridbio) and the Development Center for Medical Science and Technology, an institute affiliated to the Ministry of Health (MoH), launched a national database for human papillomavirus (HPV) on June 5, Hybridbio announced. It is China’s first national HPV database, the firm said, and will collect data from about 40 general hospitals and maternal and child institutes across the country. The project will also give medical staff training in data collection. HPV infection is the leading cause of cervical cancer, and can also lead to cancers of the vulva, vagina, and anus in women, or cancers of the anus and penis in men. There are 130,000 new cervical tumor cases in China each year, and 30,000 deaths from the condition. The database will be used to inform government policy and research into the spread of HPV infection and cervical cancer in China, according to the announcement.

Medical Care Technologies to expand its service in China
(BioSpectrum, 2011-06-05)
China-based Medical Care Technologies, a rapidly growing children’s healthcare service provider, has announced that it is set to open its first of a string of planned pediatric health and wellness centre in China before the end of its fiscal year 2011. As China works towards a landmark healthcare reform program, to be fully implemented by 2020, one of its aims is to improve the supply of healthcare by the easing of government regulations for foreign investment in private healthcare services. This move was made to relieve some of the burden on state funding, with the private health sector catering for the more affluent of the country’s population. The new policies are crucial for ensuring that increased demand for medical services is met.

Pharmaceutical Industry

Novo plots China growth to protect market share
(Fiercepharma, 2011-06-01)
Novo Nordisk won’t cede its dominance in China so easily. The Denmark-based diabetes specialist will increase its investments in that country to keep hold of its No. 1 slot, COO Kaare Schultz said. “We don’t fear any competition,” Schultz avowed. Schultz was responding to news that Sanofi-Aventis, which is making inroads in many emerging markets, would train more than 10,000 doctors and diabetes-care experts in a Chinese government program designed to help contain the disease, Bloomberg reports. Novo won’t let that effort go unanswered, Schultz said. The Danish company will increase its numbers across the board, Schultz told the news service. Sales, production and patient care will all get a boost. “You will see more manufacturing,” he told Bloomberg. “You will see more education. You will see more training of patients. You will see more research locally.” China is one of the world’s fastest-growing drug markets. Diabetes also is growing fast there, and with government spending on healthcare on the rise, drugmakers are vying for their share of treatment. The market for diabetes drugs in China is expected to triple by 2019. Sanofi has been beefing up research there, while Novo most recently embarked on a major expansion of its insulin packaging plant. Novo won Chinese approval for its Victoza drug in March.

First China Pharma Progressing on Acquisition of Drug Distributor
(ChinaBio Today, 2011-06-01)
First China Pharmaceutical Group reported that due diligence has begun on its proposed acquisition of Shenzhen Ming HeTang Pharmaceutical Co., a drug distributor whose South China business will open new territory for First China. First China announced a MOU to buy Ming He Tang in March. First China also said its acquisition of Shandong Run Kang Pharma has now been put on hold.

Livzon Pharma to Spend $154 Million on New API Facilities
(Bioportfolio, 2011-06-01)
Livzon Pharma plans to invest one billion RMB ($154 million) to build two new fabrication facilities in a Ningxia Hui Autonomous Region industrial park. As a first step, Livzon will allocate 90 million RMB apiece to form two JVs, each of which will be formed with one of its subsidiaries. The JVs will increase production of each subsidiary’s APIs. First phase work in the park will cost 300 million RMB ($46 million).

Pfizer and Zhejiang Hisun Sign MOU for Branded Generics JV
(World Pharma News, 2011-06-02)
Pfizer and Zhejiang Hisun Pharma are in the process of forming a branded generics JV, a potentially significant initiative for gaining a larger position in China’s pharmaceutical market. About 60% of China’s drug spending goes to generics. Both companies would contribute products or other capabilities into the new JV, which is seen initially as a manufacturing venture. It will also commercialize and market drugs and conduct R&D on off-patent medicines.

Tasly Pharma to Make $40 Million Investment in US Facility
(ChinaBio Today, 2011-06-02)
Tianjin Tasly Pharma announced it will invest $40 million into a US facility that will support its TCM-based treatment for coronary disease, known as Compound Danshen Dripping Pills (CDDP). The company will build a 430,000 square foot production facility and training center near Washington DC, in a life sciences park located in Maryland. CDDP successfully completed a Phase II trial in early 2010. The company is planning a 2,000 patient Phase III trial that is expected to begin this year.

D-Pharm Out-licenses China Rights for Epilepsy Drug to Nhwa Pharma
(Bioportfolio, 2011-06-01)
D-Pharm, an Israeli biopharma, signed a deal giving Jiangsu Nhwa Pharmaceutical Company exclusive rights to develop its epilepsy treatment, DP-VPA, for China. Nhwa will be responsible for conducting the China clinical trials for the drug, which will be conducted following US FDA guidelines so D-Pharm can use the data to gain approval of DP-VPA in global markets. D-Pharm received $1 million up front, and it is due $1.4 million in milestone payments and 5% royalties on any sales over a specified threshold.

Conba Pharma to raise $92 mln in corporate bond issuance
(Rsssearchhub, 2011-06-03)
Zhejiang Conba Pharmaceutical Co. Ltd. (Conba Pharma) has been approved by the China Securities Regulatory Commission (CSRC) to issue corporate bonds worth a maximum RMB 600 million ($92.45 million), the company announced. The bonds will be issued on June 8 and have a five-year term, the announcement said. Of the funds raised, the firm will use RMB 125 million ($19.26 million) to repay loans to five banks by early 2012. The rest will be held in current capital to feed the firm’s increasing investments in brand-building, mergers and acquisitions (M&A), and drug research and development (R&D).

Huahai Pharma clinches US FDA approval for generic Alzheimer’s drug
(Interfax.cn, 2011-06-03)
Zhejiang Huahai Pharmaceutical Co. Ltd. has won marketing approval from the U.S. Food and Drug Administration (FDA) for a generic Alzheimer’s drug, a donepezil hydrochloride tablet, the firm announced. Donepezil hydrochloride is one of the best-selling treatments for Alzheimer’s disease globally. It was originally developed by Japan’s Eisai Co. Ltd., and was approved for the U.S. market in 1996. The first generic version of donepezil, developed by Indian generics maker Ranbaxy Laboratories Ltd., entered the U.S. market in November 2010. The firm obtained the approval via an Abbreviated New Drug Application (ANDA), a mechanism that allows firms to get marketing approval for generic drugs without having to go through the lengthy clinical trials process in the United States.

Kangmei Pharma acquires TCM commodity exchange in Puning City
(Interfax.cn, 2011-06-07)
Kangmei Pharmaceutical Co. Ltd. (Kangmei Pharma), a leading producer of processed traditional Chinese medicine (TCM) ingredients, will acquire and expand a commodity exchange for traditional Chinese medicine (TCM) materials in Guangdong Province’s Puning City, the firm announced. Under an agreement with the city government, Kangmei Pharma will purchase Puning Raw Traditional Chinese Medicinal Materials Trading Center for RMB 18.38 million ($2.84 million) and invest RMB 1 billion ($154.40 million) in expanding and upgrading the exchange, the announcement said. The Puning City-based firm aims to build the market into the main TCM raw material trading center in southern China. Construction will take two years and begin once the acquisition is approved by shareholders, the announcement said.

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