Simcere Pharmaceutical Receives First Generic Biapenem Certificate

Simcere Pharmaceutical Group's first generic biapenem drug has received new drug certificate and production approval from China's State FDA. A newly launched generic drug enjoys a four-year assessment grace period during which SFDA declines applications of similar chemical compounds or drug administration routes whose R&D has not entered into clinical stages. Biapenem, like Merck's Tienam and Dainippon Sumitomo's Mepem, comes under carbapenem antibiotics. The drugs have a 1.6 billion yuan market in China, with 30 percent annual growth over the past three years. Simcere believes that the biapenem's approval will enhance the firm's long-term strategy of focusing on first-to-market anti-infection generic drugs. (Click here for more - Chinese Language)