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The Week in Review: China’s 12th Five-year Plan for Medical Technology
Government and Regulatory
China has released its 12th Five-year Plan for Medical Technology, setting a long list of broad goals to be accomplished by the end of 2015 (see story). Those goals range from discovering world-leading medical technology to establishing robust means of diagnosing and treating China’s rural population. This Plan does not mention how much financial support each of the goals will receive, but it does detail the country’s agenda for 2011-15.
On March 1, 2011, the World Health Organization certified that the SFDA’s standards meet international criteria for vaccine supervision. Although other regulatory hurdles remain, the WHO certification means China vaccine makers will eventually be able to supply vaccines to resource-poor nations through UN-related agencies, a huge market (see story). Over time, the WHO action could transform China’s vaccine industry.
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 (see story). 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.
Deals and Financings
Zhejiang Huahai Pharma (SHA: 600521) announced it will stage a private placement of 100 million shares, raising as much as 1.3 billion RMB ($204 million) (see story). 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.
Big Pharma in China
Regeneron Pharma (NSDQ: REGN) and Bayer (XETRA: BAY) have begun a China Phase III trial of Eylea™ (aflibercept) Injection, a treatment for neovascular age-related macular degeneration (wet AMD) (see story). Earlier this month, Eylea was granted FDA approval for this indication in the US.
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 (see story). 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.
Jiangsu Sihuan Bioengineering (SHE: 000518) is suing Vitapharm Technology Co. of Australia (see story). 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.
Trials and Approvals
Shenzhen Haibin Pharma received a EU-GMP certificate from Germany allowing it to sell its meropenem bulk drug in Europe (see story). 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 (SHA: 600380).
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 (see story). LDR has been selling its artificial discs in China since 2009. The company has offices in Beijing and Shanghai.