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The Week in Review: FDA to Step Up Inspections of China Drugmakers

publication date: Aug 13, 2011
 | 
author/source: Richard Daverman, PhD
Government and Regulatory

The United States is finalizing details on a new law that will raise $299 million annually to fund greatly increased FDA inspections of foreign drugmakers (see story). The inspections will specifically target generic drug and API manufacturers that export to the US, especially India and China. To fund the initiative, drug manufacturers themselves will be assessed fees to raise the $299 million.

China’s National Development and Reform Commission ordered price cuts on 82 different drugs in 400 formulations, most of them from foreign drugmakers (see story). The reductions, which will average 14% and start September 1, will affect hormone, endocrine and nerve system medications. Many of the drugs previously enjoyed freedom to set their own prices because they were classified as innovative drugs.

Deals and Financings

Mingyuan Medicare Development (HK: 00233), a Hong Kong device maker that operates in the PRC, will pay $55 million to acquire a 70% stake in 18-month-old Shanghai Yuanqi (see story). 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.

Bohai Pharma (OTCBB: BOPH) paid $35 million to acquire Yantai Tianzheng Pharma (see story). Both companies produce and distribute modernized TCM products, and both are headquartered in Yantai City. Not only is Yantai Tianzheng profitable, but it is growing at a rapid rate.

China Medical Technologies (NSDQ: CMED), an in-vitro diagnostic company, will collaborate with Germany’s Leica Biosystems, which makes microscopes and scientific instruments (see story). The two companies will co-develop and market automated FISH kits for Leica’s BOND system that test for HER-2, EGFR and TOP2A genes. CMED will sell the automated FISH kits in China, and Leica will have an option to sell them in the rest of the world.

Company News

ShangPharma (NYSE: SHP), the Shanghai CRO, announced a share buyback program that may repurchase as much as $10 million of the company's stock over the next two years (see story). ShangPharma’s stock price has dropped from $15 in its October 2010 IPO to Thursday’s close of $7.70, a 49% haircut. Although buybacks often have little effect, ShangPharma’s ploy worked like magic: the company’s shares rose 28% by mid-session following the announcement, climbing $2.17 to $9.87.

ShangPharma also said its new biologics division is performing ahead of schedule on two projects, and the company hopes to sign several contracts for new biologics projects soon that will add more business (see story). ShangPharma expects the biologics division will have close to 100 employees on board by the end of 2011.

WuXi PharmaTech (NYSE: WX), the NY-listed CRO, reported Q2 revenues climbed 25% to $101.1 million, breaking the $100 million mark for the first time (see story). Although its mainstay Laboratory Services business was up a solid 10%, the big winner was Manufacturing Services. That segment leaped almost 150% ahead to $21 million in the quarter. All the numbers were slightly ahead of WuXi’s always conservative guidance.

Disclosure: none.

 

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