Simcere Pharmaceutical a Chinese company has received Chinese State Food and Drug Administration (SFDA) approval to manufacture and market a first- to-market generic Biapenem injection under the brand name Anxin.
Anxin is the first Biapenem injection approved for sale in China, which is 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 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.