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The Week in Review: US Clinical Trial of China Diabetes Drug

publication date: Aug 29, 2009
 | 
author/source: Richard Daverman, PhD
This week’s news from the world China life science included an important step forward: a first FDA approval to begin clinical trials of a China-discovered, synthesized drug. Also, experts estimated the size of this year’s China pharmaceutical sales; vaccines figured prominently in the news, and a new relationship was established between a China biopharma and a university.

Jiangsu Hengrui Medicine (SHA: 600276) is the company behind the first the drug given FDA approval to begin clinical trials (see story). The drug, Retagliptin, is an improved version of Merck’s (NYSE: MRK) Januvia, a member of the DPP-4 inhibitor class of drugs prescribed for type 2 diabetes patients who are not on insulin. No trials have begun with Retagliptin in China. The other China drugs in US tests are derived from TCMs. Unlike metformin and pioglitazone, two drugs widely used by the same patient population, DPP-4 drugs do not cause weight gain.

According to a new report from Wicon International, the total amount of revenue generated by drug products in China during 2009 is expected to grow by 16% to reach 563 billion RMB ($82 billion) (see story). Experts think a variety of factors may move the final number much higher, closer to a 20-25% increase. The official PRC government statistics for the first five months of 2009 show total pharmaceutical sales reached 322 billion RMB ($47.4 billion) for the period, implying full-year 2009 would equal 773 billion RMB ($113.7 billion) if the industry keeps up its early-year pace.

Sinovac Biotech (NYSE: SVA) (北京科兴生物制品有限公司) has been selected by the Public Health Bureau of Beijing to be one of four vaccine companies that will supply the city with seasonal flu vaccine for 2009 (see story). Sinovac will provide Beijing with its split viron vaccine, Anflu®. The city hopes the vaccine’s usefulness will spread beyond the seasonal flu to also protect its citizens from H1N1 swine flu. Sinovac did not disclose financial terms or its share of the contract.

The Mexican government announced a deal to purchase 10 million doses of H1N1 flu vaccine from China, though it was not specified which China pharmaceutical companies would supply the vaccine (see story). Mexico has already purchased 20 million doses of the vaccine from European sources. All deliveries will be in time for Mexico’s winter flu season.

Simcere Pharmaceutical Group (NYSE: SCR) (先声药业) and Sun Yat-Sen University Cancer Center of Guangzhou have established a strategic relationship to develop cancer drugs (see story). In addition, the two companies will build a joint program to train personnel in advanced R&D. The company did not disclose any specifics about the nature of the cancer drug investigation, though the research at Sun Yat-Sen University Cancer Center focuses on innovative drugs.

American Oriental Bioengineering (NYSE: AOB) (广西博科药业) reported it has SFDA approval to produce 61 of the products included in China's newly announced Essential Drug List, though the company is currently producing only six of them (see story). American Oriental markets 60 pharmaceutical products, and it has another 400 products that have been approved by the SFDA, but aren’t being produced at this point.

China Sky One Medical (NSDQ: CSKI) (中国天字一号医药公司) admitted that its financial reports filed with the State Administration for Industry and Commerce (SAIC) under-reported the income of China Sky One’s China-based subsidiaries (see story). The company said it expects the SAIC to assess a penalty for the misstatements, but it does not think the penalty will be “material to the company.”


Disclosure: none.

 

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