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news.Simcere Pharmaceutical Group has received approval from the Chinese State Food and Drug Administration 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. 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.
Jinsheng Ren, chairman and CEO of Simcere, said: “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.”