Healthcare Industry News:  osteoporosis 

Biopharmaceuticals Generics Regulatory

 News Release - May 14, 2008

Simcere Pharmaceutical Group Announces SFDA Approval of First-to-Market Generic Biapenem Injection Anxin

NANJING, China, May 14 (Healthcare Sales & Marketing Network) -- Simcere Pharmaceutical Group (NYSE: SCR ), a leading manufacturer and supplier of branded generic pharmaceuticals and manufacturer of the patented anti-cancer biotech product Endu in China, today announced that it has received approval from the Chinese State Food and Drug Administration (SFDA) 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, 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."

About Simcere Pharmaceutical Group

Simcere Pharmaceutical Group (NYSE: SCR , Simcere ) is a leading manufacturer and supplier of branded generic pharmaceuticals and manufacturer of the patented anti-cancer biotech product Endu in the rapidly growing China market. In recent years, Simcere has focused its strategy on the development of first-to-market generic and innovative pharmaceuticals, and has introduced a first-to-market generic stroke management medication under the brand name Bicun and an innovative anti-cancer medication under the brand name Endu. Simcere currently manufactures and sells more than 50 pharmaceutical products including antibiotics, anti-cancer medication and stroke management medication and is the exclusive distributor of three additional pharmaceuticals that are marketed under its brand names. Simcere concentrates its research and development efforts on the treatment of diseases with high incidence and/or mortality rates and for which there is a clear demand for more effective pharmacotherapy such as cancer, strokes, osteoporosis and infectious diseases and currently has more than 12 pipeline products. For more information about Simcere Pharmaceutical Group, please visit http://www.simcere.com .


Source: Simcere Pharmaceutical Group

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