SFDA Approves First-To-Market Generic Biapenem Injection Anxin

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Simcere Pharmaceutical Group has received approval from SFDA to manufacture and market a first- to-market generic Biapenem injection under the brand name Anxin.

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Anxin is the first Biapenem injection approved for sale in China, and will be used for the treatment of serious infections. Biapenem is a member of the fast-growing carbenicillin family, like Tienam from Merck & Co. Inc. and Mepem from Sumitomo Pharmaceuticals Co. Ltd., with a potential market in China of RMB1.6 billion. This family of drug has seen an approximate 30% year over year growth rate in China over the last three years.

As is the case with first-to- market branded generics in China, Anxin will enjoy an exclusive four-year market monitoring period, during which the SFDA will not accept further requests for approval of pharmaceuticals with the same chemical structure, dosage form and indication, that have not yet entered into clinical trial.

Mr. Jinsheng Ren, Chairman and Chief Executive Officer of Simcere, commented, "The approval of Anxin, a Simcere developed Biapenem injection, strengthens the company's antibiotic product portfolio in line with our strategy to focus on first-to-market generic and innovative drugs. More importantly, it provides a new and effective treatment for patients with serious infections who have experienced resistance to other antibiotics."

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