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The CFDA issues new regulations on medical devices

Mar
3
2014

The China Food and Drug Administration revised the Medical Device Supervision and Administration Regulations (MDR) and enforced it from June the 1st. As expected, this review, simplifies medical devices’ registration process, but some new regulations are in conflict with the new ones.

A notice has been published about issues bound to paradoxes between the former MDR and update one in which three points are clarified: manufacturers should rely on ‘currently effective provision’ as long as the new rules are not totally validated and effective and medical registrations issued after June 1st have a five year license term (vs 4 with the revised MDR); class II and III devices manufacturers and distributors will follow the current ‘administrative rules and guidance documents’; in case of illegal actions committed before June 1st, penalties will rely on the former MDR.

Source: National Law Forum                                              Date of Publication: 2014-07-03

WuXi PharmaTech gains the OECD’s certification

Mar
30
2014

The Suzhou toxicology facility of WuXi PharmaTech obtained the statement of Good Laboratory Practice (GLP) from the Organization for Economic Cooperation and Development (OECD). The inspection was conducted by the Belgium GLP Monitorate.

The inspection was made on 22 studies including toxicology, genetic toxicology, safety pharmacology, dermal irritation, skin phototoxicity, and immunology.

Dr. Ge Li, CEO of the company, said ‘with this recognition, WuXi has further solidified its leadership in offering the highest-quality toxicology service in China’.

Source: TrueblueTribune                                                       Publication Date: 2014-05-30

China to give up drug price regulation

Mar
19
2014

Drug price regulation has been an issue in terms of price quality and was a very hard move for global companies. The central government announced that a new regulation details will be published by July but the objective is already clear: free-market pricing for pharmaceuticals.
To Ms. Chen, partner and director of L.E.K Consulting, ‘it means the [commission] recognizes that forcing prices down and focusing purely on price does sacrifice drug safety, quality and availability’. Until now, the central government was encouraging provinces to reduce healthcare costs and prices to make healthcare services more affordable.

Source: The Wall Street Journal                                              Publication Date: 2014-05-19

Chinese scientists’ findings on the H7N9 virus

Mar
9
2014

A study published in the Nature Communication announced that Chinese scientist discovered in Hangzhou a human blood protein that would be associated with the H7N9 virus. Blood plasma levels of angiotensin II are higher in H7N9 patients and could be the root of physical deterioration.

According to Li Lanjuan, researcher at the Chinese Academy of Engineering and specialist in H7N9 prevention, this new finding may be a significant help in clinical practice and the executive editor of Nature Communication commented that ‘this study will provide a new perspective to H7N9 pathology and potential threatment for the future cases’.

Source: Shanghai Daily                                                                Publication Date: 2014-05-09

160 healthcare criminal gang members detained in Shanghai

Mar
21
2014

After seven months of investigation, Chinese authorities have arrested 160 members of a criminal gang in Shanghai for luring patients with overpriced drugs (10 times the original value). More than 500 victims were cheated through corrupt doctors for an amount reaching about CNY1.7.

On the other hand, 20 people have been arrested for selling more than 1.6 million fake Durex condoms and 19 detentions about counterfeit medical device in Henan province.

This large wave of ‘crack-downs’ is definitely highlighting the will of Xi Jinping’s government to drastly corruption and lures.

Source: Reuters                                                                     Publication date: 2014-04-21

WuXi PharmaTech manufactures ImmuFact IMP321

Mar
11
2014

The French biopharmaceutical company Immutep S.A and Eddingpharm started the production of their ImmuFact IMP321 product in WuXi AppTec facilities according to European, US and Chinese GMP standards.

Immutep will technically support the development of the production of the anti-cancer drug and was, as well as Eddingpharm, very satisfied by the Chinese manufacture’s quality as Dr. Triebel, Medical Director of Immutep said: ‘We have been very impressed by WuXi’s know how and motivation’.

Source: First Word Pharma                                                      Publication Date: 2014-04-11

 

China investing USD3.2 billion in drug development program and speeding up approvals

Mar
28
2014

A large investment program is launched by the China’s National Health and Family Commission (NHFPC) to enhance drug development against cancer, cardiovascular and cerebrovascular diseases, neurodegenerative disorder, mental disorders, diabetes, autoimmune disease, drug resistant pathogen, tuberculosis and others.

On the other hand, given to the still unmet medical needs of the Chinese population, the China Food & Drug Administration is speeding up innovative medical device approvals by creating a specific unique division. The objective is to shorten the whole approval process to 160 days.

Source: Seeking Alpha                                                                Publication Date: 2014-03-28

Call for Proposal for The Innovation Prize 2014

Mar
20
2014

For 6 years, The Innovation Prize® has become increasingly successful at an International scale and became a reference in biotechnology.

With the support of public organizations (The National Research Agency, The Pasteur Institute), the healthcare industry (Myriad Genetics, Ipsen, Servier and Pierre Fabre) and Universal Biotech, this prize awards biotechnology companies’ projects and academic research teams in life sciences.

The fields concerned are drugs, medical devices, medical technologies and e-health solutions.

Each year, 120 candidates apply from 25 countries to win the overall prize of 50.000 € including cash and consulting services provided by Universal Biotech and its partners.

The call for proposal of the Innovation Prize 2014 will be launched on February 3rd, 2014. The candidates will be able to register on the dedicated online platform: www.universal-biotech-prize.com

This key event for innovation projects is a real springboard for your cluster, institution, university… It is an international showcase for companies and innovative projects in the field of biotechnology.

The call for proposal will be launched on February 2014 but feel free to contact us now to relay information on your communication supports and to exchange logos and visuals so we can give you maximum visibility on our website.

Click to learn more

China healthcare sector among the most active industries in terms of investment opportunities

Mar
6
2013

Healthcare sector is one of the most active industries in terms of inbound M&A by foreign investors. With sales slowing in the West, the global drugs giants want a share of the booming profits in China. In particular, the biotechnology industry is part of the driving force behind this activity.

China remains a compelling story for global firms in the hunt for investment opportunities. As China’s global economy has moved to center stage, these opportunities have expanded into new sectors and new technologies. Among them pharmaceuticals and biotechnologies are driving the shift. They lead the increasing number of foreign interest and investors, and keep on developing new ranges of perspectives on the China inbound M&A market.

The Chinese government is specifically encouraging private investment in the medical industry. Taken together, these elements provide ample opportunities for cross-border integration of the pharmaceutical and health care industry. China is willing to keep on increasing domestic and foreign investments in healthcare services as part of restructuring the service sector.

Moreover, the value of mergers and acquisitions in China’s healthcare industry grew by 35% year over year to USD 7.4 billion in the first 8 months of 2013, according to Dealogic figures. The number of mergers and acquisitions rose by 8% during the same period to reach 178. In particular, USD 1.1 billion worth of deals involved American firms targeting Chinese healthcare firms.

Source: http://www.bbc.co.uk                                                    Publication Date: 2013-09-06

Diabetes & Digital in Emerging Markets

Mar
16
2013

The Asia Pacific market is a vast underserved market. With three quarter of the Chinese and Indian populations considered as diabetic, nearly 200 million people may use self monitoring of blood glucose products.

However no more than 45 percent of these patients have been diagnosed. Worst, inadequate education and awareness have led to a lack of use of self monitoring in the region, with less than 10 percent of the diabetic population using it.

As a consequence, the market is expected to reach $358.70 million in 2017 thanks to the development by equipment manufacturer, governmental and non-governmental organizations, and hospitals of camps and drives to awareness among patients.

In particular, regarding the China Diabetes market, it has been forecasted to expand by 20% annually to reach a value of around USD 3.2 billion by 2016, spurred by guidelines that set higher treatment standards. The rapid economic development has brought mass urbanization, changing diets and increasingly sedentary lifestyles. China has already the largest number of people with diabetes compared to any other country, with around 92.3 million adults suffering from the disease in 2013. Thus it represents a crucial issue for the central government as well as a booming market for pharma companies.

In deed, diabetes has become a rapidly growing public health problem in China over the past 20 years. Recently many pharma companies are deeply committing to developing a diverse range of innovative products for the growing type 2 diabètes population.

Source: http://www.biospectrumasia.com                                                     Publication Date: 2013-07-23

How to comply with new standard requierements in China?

Mar
9
2013

In a current atmosphere of system’s reform aiming at turning over a whole new leaf and accentuated by the media’s spotlights focus on the recent investigations and crackdowns on companies in China. Thus, the healthcare industry will have to operate with tougher compliance risks and more frequent interaction with the Central government.

Policies and procedures are changing in order to be simplified and more transparent, leading Big Pharmas and the other healthcare actors implement programs to ensure they will respect these and upgrade their activity processes to comply with the new regulations.

Among the main actions to implement and deal with the new standards, companies will first have to prepare a training courses for employees on how to handle investigations; they will also need to conduct compliance and legal risk assessment; financial and accounting practices have to be reviewed with internal control procedures; companies must conduct proactive internal audits and investigate on suspected violations, as well as detailed due diligence on third party intermediaries such as agents and sales representatives;

Globally, the current situation requires from every company to be able to take prompt action if faced with evidence or allegations of wrongdoing.

Chinese government authorities’ actions have led to new behavior requirements that can be reached only through compliant structural improvement.

Source: www.mondaq.com                                                                                     Publication Date: 2013-08-01

China’s biomedical sector transforming itself into an innovation hub

Mar
9
2013

China’s biomedical sector is rapidly transforming itself from a manufacturing base to an innovation hub. First, the government is investing billions of dollars and setting up innovation centers in a bid to catch up with the western countries by the end of its 12th Five-Year Plan. Thus, the R&D investments, reaching a cumulative $160 billion last year and close to surpassing Japan’s spending, are starting to pay off.

Moreover, the exponential increases in pharmaceutical related patent filings are catapulting the Asian giant over the U.S. and Japan. Also, the country’s five major provinces have formed “super clusters” thanks to the remarkable pace of establishment of 15 new drug innovation centers.

In particular, China’s biomedical sector is relying on sustained investment as its booster to rapid growth. The Major New Drug Innovation Program (MNDIP) has emerged as its main source of innovation since 2009 with a special focus on cancer, the leading cause of death in China. Timely changes in patent and related laws, since the nation joined the Trade-Related aspects of Intellectual Property rights (TRIPS) agreement in 1992, have also contributed to this growth.

Source: www.usa.chinadaily.com.cn                                                                        Publication Date: 2013-08-08

 

Highlights of the CFDA Restructuring Plan

Mar
1
2013

After the re-organization, the CFDA expanded its internal departments from 10 offices to 17, including the General Office, the Department of Policy, the Department of Legal Affairs, the Departments of Food Safety Supervision (I, II and III), the Department of Registration of Drugs and Cosmetics, the Department of Registration of Medical Devices, the Department of Drug and Cosmetics Supervision, the Department of Medical Device Supervision, the Bureau of Investigation and Enforcement, the Department of Urgency Management, the Department of Technology and Standards, the Department of Communications, the Department of Human Resources, the Department of Planning and Finance, and the Department of International Cooperation (Office of Hong Kong, Macao and Taiwan Affairs). Notably, the Department of Food Safety Supervision increased from 1 to 3, in order to exercise oversight over the entire supply chain and strengthen the vigilance system.

 

The CFDA retrieved legislative authority concerning food and drug laws, as well as qualifying authority for the food safety testing institutions from the Ministry of Health. The agency also retrieved the certification authority for medical devices as well as the manufacturing approval authority and compulsory inspection authority concerning cosmetics from the General Administration of Quality Supervision, Inspection and Quarantine (the “AQSIQ”).

Some of the CFDA’s approval authorities are delegated to the provincial Food and Drug Administrations (the “Provincial FDAs”), including:

  • GMP certifications for drugs and medical devices,
  • Renewal of drug registrations and supplementary applications relating to drug registration (excluding those changes affecting product quality),
  • Application for change of registration (excluding those changes affecting product quality) for locally-produced Class III medical devices,
  • Drug contract manufacturing, and
  • Approvals related to imported non-special-use cosmetic products.

Source: www.lexology.com                                                                                                Publication Date: 2013-05-21

China Plans to Boost Innovative Medical Device Industry

Mar
1
2013

China’s CFDA (China Food and Drug Administration) wants to boost the country’s innovative device industry. A response to new European legislation on medical devices. Recently the CFDA has released a draft, “Special Review and Approval Process for Innovative Medical Devices,” which makes the review and approval process for innovative devices more efficient.

To define “innovative” as part of the eligibility requirements, “The primary functioning mechanism of the medical device shall be the first of its kind in China, and the device’s efficacy or safety profile shall be fundamentally improved as compared with other similar products.”

Apart from the efforts to improve the efficiency of the review and approval process for medical devices, the CFDA also intends to simplify the application materials required in the license re-registration process for medical devices.

Source: http://www.china-briefing.com/news/2013/05/03/china-to-boost-innovative-medical-device-industry.html?src=mddionline

Publication date: 2013-05-03

China got ISO/TC150/SC7 Voting Rights

Mar
1
2013

According to the CFDA : “On March 26, 2013, the secretariat of Tissue Engineered Medical Products Subcommittee of National Technical Committee on Implants for Surgery and Orthopedic Devices of Standardization Administration of China received the notification of the International Organization for Standardization (ISO), declaring that China has registered as a P-member of the ISO/TC150/SC7 (International Organization for Standardization/ Technical Committee 150 for Implants for Surgery/ Sub Committee 7 for Tissue Engineered Medical Products) and obtained the ISO/TC150/SC7 voting rights”

Source : http://eng.sfda.gov.cn/WS03/CL0757/79617.html Publication Date : 2013-04-08

Import of Medical Devices in China Sees Rapid Growth

Mar
29
2013
“Recently, China’s Chamber of Commerce for Import & Export of Medicines and Health Products analyzed the customs statistics of 2012.   According to such statistics, the value of China’s import and export of medical device reached US$ 30.062 billion last year, increasing by 13.03%. The import value reached US$ 12.472 billion, increasing by 14.56% compared with the previous year.

Behind the growth, three features are notable:

1.         The import market is centralized.

China imported medical devices from over 100 countries during the last year, but, unsurprisingly, Europe and North America are the top two regions from which medical devices were imported into China.  Imports from Europe reached US $4.695 billion, representing 37.64% of the total imports, and imports from North America reached US $4 billion, representing 32.10% of the total imports.

2.         31 types of medical devices have import values exceeding US $100 million.

According to the statistics, the import values of 31 different types of medical devices, including, for instance, color ultrasonic diagnostic instruments, X-ray computed tomography apparatus and magnetic resonance imaging devices, exceeded US $100 million. The import value of orthopedic products has increased by 72.59%, representing the most rapid growth among all different types of medical devices.

3.         Shanghai has the largest share of the import market.

According to the statistics, 36.77% of the import value of medical devices is attributable to Shanghai, which has seen the largest import of medical devices in many years.  Among the importers in Shanghai last year, 69.51% of the companies are foreign invested.”

Source : www.insidemedicaldevices.com                           Publication Date : 2013-03-18

China Food and Drug Administration (CFDA) replaces the State Food and Drug Administration (SFDA)

Mar
29
2013

China’s 12th National People’s Congress has approved a plan to establish a ministry-level agency named China Food and Drug Administration (CFDA), which replaces the State Food and Drug Administration (SFDA).  The agency has started a reorganization under the leadership of a new commissioner, Mr. Zhang Yong.

Since March 22, 2013, SFDA replaced the sign on its headquarters with a new sign that has its new name in Chinese, and also began displaying the new name on the agency’s official Chinese and English websites, showing “China Food and Drug Administration” as its English name. The agency has announced that all of the previous functions of the SFDA have been merged into the new CFDA.

As a result of this restructuring, CFDA will be a full ministry agency reporting directly to the State Council, which is China’s highest administrative body.

This new development seeks “to strengthen regulation and boost people’s confidence in the country’s food and drug products” by eliminating “blind spots” and overlaps in regulatory authority, according to a Chinese official.

The Chinese government has also stated that this change will help to promote regulatory oversight and identify responsible parties, especially with respect to the regulation of food, which has been undertaken by SFDA and several other government ministries and agencies.

The newly elevated and expanded CFDA will integrate the functions of various agencies that regulate food, while also keeping its authority over drugs, devices, and cosmetics.  At present, the primary focus has been on the consolidated regulation of food products, so the impact of these structural changes on the regulation of medical devices in China is unclear.  Companies whose products are regulated by the agency should closely monitor the developments.

Source : http://www.sfda.gov.cn/WS01/CL0051/79254.html                             Publication Date : 2013-03-22

 

SFDA : Electromagnetic compatibility standard medical electrical equipment issued

Mar
18
2013

“In order to better ensure the safety of medical devices, the State Food and Drug Administration (SFDA) organized the National Medical Electrical Equipment Standardization Technical Committee to complete the drafting of the industry standard for medical devices YY 0505-2012 “Medical electrical equipment—Part 1-2: General requirements for safety—Collateral standard: Electromagnetic compatibility—Requirements and tests (IEC 60601-1-2: 2004, IDT)”. The Standard was issued on December 17, 2012 and will be put into practice as of January 1, 2014. As a basic general safety standard which is parallel with GB 9706.1 “Medical electrical equipment—Part 1: General requirements for safety”, YY 0505-2012 is a mandatory industry standard for medical electric equipment.”

Source : www.sfda.gov.cn                     Publication date : 2013-03-14

$183 Million Funding Destined to Transform China’s Diagnostic Market

Mar
18
2013

An aging population with unmet medical needs is driving the Chinese government to invest in the rapid development of innovative sensing technologies. China’s domestic Diagnostic Industry is still immature, with the current market structure dominated by Western companies and multinationals. However, emerging Chinese firms are gathering to challenge the Western players in the sensor and diagnostic market, according to Lux Research.

In fact, the government is planning to jump start a homegrown industry, with stated goals in the 12th Five Year Plan (FYP) to improve overall healthcare, especially in rural areas, and increase fundings in a number of key sensing and diagnostic research areas. In the 2011-2012 funding period, $82.9 million was distributed in molecular, biochemical, immunological, and physical diagnostic spaces, and China will aldo spend an additional $103 million on basic research in the sector during the 12th FYP.

In other words, Chinese domestic companies are switching strateg from a “me-too,” go-to-market strategy based on low cost production, to novel solutions requiring long R&D cycles.

In the $1.5 billion Chinese medical imaging market, Mindray, Wandong, and Neusoft have a rising market share of 10% based on sophisticated product development strategies.
Moreover the Beijing Genomics Institute, which is claimed to be the world’s largest genome sequencing organization, is eyeing a big payoff by developing drugs specifically designed for Chinese and non-Caucasian populations, filling a gap left by U.S. drugmakers, based on recognizing differences in response to marketed drugs between different populations.
University research in China is finding its way into the business value chain. Beijing Largev Instrumentation, a developer of dental CT, was founded by Tsinghua University and Nuctech, and is a major player funded under the “key technologies and product development of major digital medical equipment” mandate for the 12th FYP (Five Year Plan).

Source : www.businesswire.com         Publication date : 2013-03-05

Consolidation Guidance for Pharmaceutical Companies

Mar
18
2013

The People’s Republic of China’s (PRC) National Development and Reform Commission has issud a “Consolidation Guidance”, on the 22nd of January 2013, aiming to accelerate consolidation within the pharmaceutical sector.

The goals, to be achieved by 2015, set out by the Consolidation Guidance are :

  • Combined Sales Revenues from the top 100 pharmaceutical companies in China should account for more than half of the total PRC pharmaceutical sector sales revenue.
  • The top 20 pharmaceutical companies in China, selling “Essential Pharmaceuticals”, which are mostly generic pharmaceuticals listed in the Essential Drugs list published by the MoH (Ministry of Health) and are subject to price regulations, should account for 80% of all “Essential Pharmaceutical” sales in China.

Source : www.mondaq.com    Publication Date : 2013-02-28

Chinese Pharma & Biotech Press Review – N° 278

Mar
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.

Call for Proposals – Innovation Prize 2013

Mar
8
2013

The call for proposals Innovation Prize will be open from February 4 until April 15.

NEW: You will have to fill in your letter of intent on the Open Innovation Management© platform.
Our team will send you your personal username and password by email once you will have registered to the following form: APPLICATION FORM

Should you have any questions, do not hesitate to contact us using this e-mail: prix-innovation@universal-biotech.com

 

 

SFDA Unveils Regulatory Reform Plan

Mar
28
2013

The Chinese State Food and Drug Administration announced a reform plan concerning regulations. The SFDA is asking for public comments concerning the plan.

The key strategic priorities expressed in the plan are:

  • The will to accelerate technical reviews and regulatory approvals for innovative drugs. For this the SFDA has proposed to reward drug R&D capable of delivering better therapeutic effects on critical diseases. The reward results in indigenous intellectual property by accelerated technical reviews and regulatory approvals for the resulting innovative drugs. Moreover, innovative drugs whose R&D is sponsored by the Chinese government will be treated with high priority in technical reviews. Pre-clinical studies for innovative drugs were also mentioned, stating they should be risk-based ant that their technical evaluation should aim for a higher level of control of the quality risks. The SFDA might outsource pre-clinical studies’ technical review. They will also consider allowing the transfer of clinical trial authorizations.
  •  Technical reviews and regulatory approvals for high priority generics are also to be accelerated. In fact, the SFDA is going to define an evaluation mechanism for marketed generic drugs. “Generic drugs which fail to demonstrate sufficient clinical values will be discouraged from further development and manufacturing”. Generics which have a shortage in supply, insufficient competition, limited patient access and affordability, an indication for pediatric, rare or special diseases and have been evaluated as urgently required for clinical use will therefor receive high priority in technical reviews and regulatory approvals. “The quality consistency evaluation for generics will be a major policy initiative in the next couple of years and will lead to the formation of a Chinese Orange Book.” According to Mondaq.
  • Clinical studies’ quality control will be improved “SFDA will establish an information disclosure mechanism to enhance transparency of clinical studies and raise public awareness of the notion of, and need for, clinical studies.”
  • To boost development and manufacturing of pediatric drugs.

Source : www.mondaq.com    Publication Date : 2013-01-14

SFDA to Publish Excipient List for GMP

Mar
28
2013

In a plan to regulate manufacturing and use of pharmaceutical excipients, Chinese State Food and Drug Administration will publish, by next month, a list defining which excipients must be licensed or require a Drug Master File (DMF) under new quality reglementations due to be introduced. These risk-based assessments will lead to a master list of excipients requiring different levels of regulatory supervision.
“Provinicial SFDA will conduct on-site inspections and random tests according to Excipients GMP (good manufacturing practice).”
The list will specify which registration documents manufacturers will need.

Source : www.in-pharmatechnologist.com     Publication Date : 2013-01-22

Chinese Institute designed WHO collaborating center for biological products

Mar
28
2013

The State Food and Drug Administration (SFDA) announced that a Chinese institute has been designated to be a World Health Organization (WHO) Collaborating Center for the standardization and evaluation of biological products.
“The designation will help China become a major player in biological product standardization and evaluation and boost the country’s global competitiveness in the research and development of biotechnology,” said Wang Junzhi, director of the IBPC (Institute for Biological Product Control). In fact, the IBPC belongs to the National Institutes for Food and Drug Control (NIFDC) in China, it is the first WHO Collaborating Center for the standardization and evaluation of biological products located in an emerging country, and is the seventh in the world, according to the SFDA.
The WHO official website indicates that the work plan includes a various amount of activities that will contribute to the development of international standards for vaccines and other biological products, and also help their implementation into regulatory practice. Moreover, the initial period of designation is four years.

Source : www.xinhuanet.com – Publication date : 2013-01-17

Universal Medica Group – Best wishes for 2013!

Mar
10
2013

Universal Medica Group team wishes you the best for 2013!

See online wishes card

 

 

Newsletter : Lifescience e-novation

Mar
16
2012

To read the May edition articles : follow this link

15th International Workshop on Business Incubation

Mar
13
2012

The big chance to know investment and start-ups combined in China, especially Shanghai
September 2-6, 2012, Shanghai, China.

Shanghai International Business Incubator (SHIBI) International workshop is the premier event in the incubation industry in China, which has attracted more than 300 industry professionals from 20 countries and regions in the world attending it in the past 14 years.
The one-week workshop features keynote speech, incubator tours and networking opportunities.

Topics:
•    China’s innovation and entrepreneurship system
•    The innovation and entrepreneurial environment in Shanghai
•    Entrepreneurial pre-incubation promotes higher entrepreneurship success rate
•    Innovative practice of technological finance in the entrepreneurship
•    Developing way of business incubator combined by incubation and capital
•    Construction of professional incubation service system
•    Presentation and matchmaking with excellent start-ups in Shanghai.

To register, please click here: http://www.ypbase.com/Application.html

Innovation Days 2012

Mar
15
2012

About the Innovation Days 2012:

The leading meeting in Paris for early-stage biotech sector!

Innovation Days is designed to promote early-stage innovation biotech
and to enable Pharma and investors in their business development & licensing efforts
to source new platform technologies and innovative products.

Key figures of 2012 edition:

  • 450 attendees
  • 50 + speakers with conferences, workshops and presentations
  • 40 + exhibitors at the exhibition hall and the Innovation Gallery
  • 800 partnering meetings

Download the post event report.

 

Chinese Pharma & Biotech Press Review – N° 224

Mar
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.

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