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Simcere Phrama gets China regulator approval to market generic version of GSK’s Relenza

Simcere Pharmaceutical Group (NYSE: SCR), specializing in the development, manufacturing, and marketing of branded generic and proprietary pharmaceuticals in China, said its unit Nanjing Simcere Dongyuan Pharmaceutical Co Ltd has received new drug registration approval from the State Food and Drug Administration (SFDA) to manufacture and sell Zanamivir, a neuraminidase inhibitor inhalant used in the prevention and treatment of Influenza A and Influenza B.

Zanamivir is marketed globally by GlaxoSmithKline PLC (LSE: GSK) under the trade name Relenza.

Zanamivir is one of only two WHO approved drugs to which the new H1N1 strain of influenza A has been shown to be susceptible. GlaxoSmithKline granted a license to Simcere in 2006 to manufacture and sell Zanamivir and its formulations in China. Simcere is the only pharmaceutical company in mainland China that has such a license.

Disclosure: The author holds no positions in the company