China Biotech In Review: Deals, Trials And Regulations

July 15, 2012|includes: ALNY, OCLS Deals and TransactionsAscletis Pharma, a US-China JV that made headlines one year ago when it announced $100 million in initial startup capital, in-licensed China rights to its first drug candidate, an innovative RNAi molecule from Alnylam Pharma (NSDQ: ALNY) (see story). ALN-VSP is being developed for liver cancers including hepatocellular carcinoma (HC)). Ascletis will have exclusive rights for ALN-VSP in China, Hong Kong, Macau and Taiwan. Alnylam will retain rights to the drug for the rest of the world.Yunnan Walvax Biotech (SHE: 300142) obtained a 51% stake in Shanghai Fengmao Biotech. Walvax, previously known as a vaccine maker, will establish subsidiaries of Fengmao to produce five monoclonal antibodies and a sustained-release version of the anemia treatment EPO. Walvax will invest $16 million in cash, while other investors will contribute a monoclonal technology valued at $14.6 million.HAO Capital, a Beijing-headquartered private equity firm, teamed up with TCL Group, a consumer electronics company that has a medical device subsidiary, to form a JV called TCL Healthcare. The JV will target the high-end diagnostic imaging market in China. The capitalization of the JV was not disclosed.Siegfried Holding (SIX: SFZN), a Swiss CMO, is building an API and intermediates production facility in Nantong. The construction is being supported by the Nantong Economic and Technological Development Area (NETDA). Siegfried said additional land at the site may be used in the future for building a finished drug facility.

Trials and ApprovalsOculus Innovative Sciences (NSDQ: OCLS) of California received SFDA approval for Microcyn Hydrogel, a topical treatment for moistening, repairing and healing of acute and chronic wounds (see story). With the approval in hand, Shanghai Sunvic, the China partner of Oculus, will launch the product in Q3 of 2012, marketing Microcyn Hydrogel in both the OTC and professional healthcare markets in China.

Government and RegulatoryThe SFDA has issued new regulations governing the purity and safety of excipients, the pharmacologically inactive substances that drugmakers add to stabilize or deliver a drug's active ingredients. The new rules, which go into effect on October 1, place responsibility for the safety of the excipient on the drug company that uses it. The regulations also require excipient makers to test their products and prove they meet all specifications.

Disclosure: none.