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Sunday, February 26, 2012

China Biotech In Review: Newsummit To Stage $80 Million IPO On NYSE

 by: ChinaBio Today February 26, 2012 Newsummit Biopharma Holdings, a Shanghai-based CRO offering pre-clinical drug development services, filed to raise up to $80 million in a New York Stock Exchange IPO (see story). The company has offices in five technology parks around China. Newsummit aims to be a one-stop solution for bringing a drug candidate or medical device through an IND (or NDA) filing, after the initial work on the product has been completed. The company uses a network of 99 service providers for most tasks. Pfizer (NYSE: PFE) and Zhejiang Hisun Pharma (SHA: 600267) will put $545 million of assets into their branded generics JV (see story). The investment will consist of off-patent drugs, manufacturing sites and cash. Hisun will contribute $295 million of these assets for a 51% stake in the JV, while Pfizer's portion will be $250 million for the remaining 49%. The two companies signed a MOU to set up the JV in June 2011, and they have now made progress by approving a framework agreement and releasing the financial commitments of each party. Pfizer wants to keep pursuing "opportunities" in China and India to expand its portfolio of generic drugs (see story). The company made the declaration soon after announcing its generic JV deal with Zhejiang Hisun Pharma. According to an unnamed Pfizer spokesperson, Pfizer is open to business development deals of all types, including partnerships, with China and Indian pharmas to help Pfizer attain this goal. Shanghai Fosun Pharma (SHA: 600196), a prolific dealmaker, bought an 18% stake in SD Biosensor, a Korean company that makes in-vitro diagnostic devices. Fosun will become SDB's China distributor as part of the deal. Fosun said SDB's products would add rapid diagnostic tests to its existing portfolio of diagnostic kits. SDB's major revenue-generators are tests for blood sugar and blood lipids. BGI, the China genomics sequencing giant, added another project to its expanding collection of global relationships. The latest collaboration is with Asia Cancer Research Group, a not-for-profit organization comprised of global heavyweights Eli Lilly (NYSE: LLY), Merck (NYSE: MRK) and Pfizer (NYSE: PFE). ACRG is seeking to discover new treatments for Asia's most common cancers. The organization will share its findings with the scientific community to advance treatment of these diseases.

Government and Regulatory As part of the 12th Five-Year Plan, China's ruling State Council will raise the healthcare insurance subsidy for farmers and non-working urban residents by 80%. The increase, which will be put in place by 2015, will take the subsidy up to 360 RMB ($57).

Trials and Approvals  Hutchison MediPharma, the drug discovery company subsidiary of Chi-Med [AIM: HCM], began a first-in-human Phase I clinical trial of a cancer drug, volitinib (HMPL-504), in Australia. Volitinib, the fourth cancer drug that the company has put into clinical trials, is a novel inhibitor of the c-Met receptor tyrosine kinase. In December 2011, Hutchison MediPharma entered a co-licensing agreement for the molecule with AstraZeneca (NYSE: AZN) in a $140 million deal. AstraZeneca assumed responsibility for developing volitinib outside of China. Access Pharma (ACCP.OB) announced that MuGard, its treatment for oral mucositis in cancer patients, received SFDA marketing approval. RHEI Pharma HK Ltd. handled the regulatory process for Access, and Jian An Pharma will market the product in China and Taiwan. Access out-licensed China rights for MuGard to RHEI Pharma in 2008. Dynex Technologies of Virginia received SFDA approval for its DS2R ELISA (enzyme-linked immunosorbent assay) machine. According to Dynex, the DS2 is a smaller, though still automated machine intended for clinics and research institutes with lower levels of demand. The DS2 handles two 96-well microplates and up to 12 different assays per assay run.

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