Simcere Granted SFDA Approval for Generic Antibiotic

Simcere Pharmaceutical Group (NYSE: SCR) received SFDA approval for a first-to-market generic Biapenem injection, an antibiotic that it will market under the brand name Anxin. Biapenem is a member of the carbenicillin family, and it will compete in the marketplace against brand-name drugs such as Tienam from Merck (NYSE: MRK) and Mepem from Sumitomo Pharmaceuticals. Carbenicillins are used in patients who have developed resistance to other antibiotics.

The carbenicillin family of drugs has seen a 30% year-over-year growth rate in China over the last three years. As a first-to-market branded generic 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, provided they have not yet entered into clinical trial. Simcere puts the market for carbenicillin drugs at 1.6 billion RMB ($230 million) annually.

Simcere already markets two generic antibiotics: Zailin, an amoxicillin, and Anqi, an amoxicillin and clavulante potassium combination.

Simcere also has developed the innovative anti-cancer drug Endu and another first-to-market generic drug, Bicun, an edaravone injection that treats the after-effects of stoke.

Disclosure: none.

Comments

[mindthegap_ca]

Very good news