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中国政府调查国内最大乙肝疫苗生产商深圳康泰

来源:生物谷 2013-12-27 08:00

2013年12月27日讯 /生物谷BIOON/ --随着中国医药市场的不断发展,中国政府对相关领域企业监管也越来越严格。在最近爆出的婴儿接种乙肝疫苗死亡的新闻后,中国政府对两家涉事疫苗企业进行调查,其中一家就是中国国内最大的乙肝疫苗生产商深圳泰康生物技术公司。另外一家是北京天坛生物技术公司。

深圳泰康成立于1992年,其发展壮大受到了中国政府的资助和支持,同时美国默沙东公司也为深圳泰康提供了很多援助,例如提供乙肝疫苗生产中所需的许多专利用于帮助泰康公司建立乙肝疫苗生产线。当时中国每年有200万儿童感染乙肝疫苗。目前深圳泰康公司的疫苗市场占有率为60%。

中国市场目前已经成为了全球各大药企的必争之地,赛诺菲今年十月份已经获得批准在深圳建立疫苗制造厂。同时美国FDA对中国市场的安全问题也有高度警惕,FDA计划于明年在中国增派10名药物管理人员和9名食品管理人员专门负责出口到美国的药物和食品安全问题检查。而中国政府也对该领域药品安全管理投入巨大精力。今年已经有七人因为生产不合格药品而被判刑。(生物谷Bioon.com)

详细英文报道:

China, which has been trying to demonstrate adequate oversight of its growing drug industry, is investigating two of its key vaccinemakers after the deaths of 8 children were tied to their hepatitis B vaccines. One of those, Shenzhen Kangtai Biological Products, has become by far the largest producer of hepatitis B vaccines in China after getting its start two decades ago with the help of Merck & Co.

Chinese authorities put a hold on millions of doses of the vaccines from Shenzhen Kangtai Biological earlier this week, The New York Times reports, after 6 deaths were linked to its products. Since then two more children reportedly died after taking hepatitis B vaccines made by Beijing Tiantan Biological Products. Authorities said other vaccinemakers in the country could make up for the suspended products to maintain its vaccination program.

Shenzhen Kangtai Biological, which now has about 60% of the market, was started in 1992 with government support, The Times reports, as well as a big helping hand from Merck ($MRK). The U.S. drugmaker helped with the expertise for its first manufacturing facility and kicked in, royalty-free, the technology needed to make the hepatitis B vaccine to help the country deal with a condition that was infecting about two million children a year. China now has an early childhood vaccination program for the disease.

China is a key emerging market for Big Pharma, which sees great opportunity there. One example is French drugmaker Sanofi ($SNY), whose vaccine unit Sanofi Pasteur got approval in October to begin manufacturing influenza vaccines at a new plant in Shenzhen. But China has struggled to keep up with oversight on health and food issues. Five years ago, tainted Chinese heparin killed dozens of dialysis patients in the U.S., which made the FDA realize it needed to keep a closer look on production there. The FDA is currently investigating Chinese-made pet treats that have killed hundreds of dogs in the U.S.

To get in a better position to deal with China's growing place in the U.S. drug supply chain, the FDA is significantly adding to its own presence in China, planning to station another 10 drug inspectors and 9 food inspectors there over the next year. China has also been making strides with drug enforcement, sending 7 people to prison this year for their parts in making tainted drug capsules and just this month arresting hundreds of suspects in a crackdown on counterfeit drugs being made there and sold over the internet.

 

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