NANJING, China, May 14 /Xinhua-PRNewswire/ -- 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
For investor and media inquiries, please contact:
In Mainland China:
Chief Financial Officer
Tel: +86-25-8556-6666 x8818
In Hong Kong:
In the United States:
Brunswick Group LLC
|SOURCE Simcere Pharmaceutical Group|
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