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Simcere Pharmaceutical Group (NYSE: SCR) will seek approval from the SFDA to manufacture and sell products containing the flu drug zanamivir. Zanamivir was developed by GlaxoSmithKline (NYSE: GSK), which sells it under the brand name Relenza. Simcere has held a license to produce zanamivir since 2006, the only mainland China biopharma to hold such a license. Zanamivir is one of only two flu drugs that seem to be effective against the H1N1 strain of influenza.

Simcere said it has already begun preparation of raw materials and manufacturing facilities for zanamivir. It did not supply a projected timeline.

Zanamivir, a neuraminidase inhibitor, is an inhaled drug that is marketed with its own inhaler. It is given to people (over the age of 7) who have had contact with flu patients or during flu outbreaks to restrict spread of the disease. It is also administered to patients who have exhibited flu symptoms for less than two days to reduce the effects of flu. The dosing regimen calls for twice daily treatments over five days.

Simcere has built its business around first-to-market branded generic pharmaceuticals. In addition, the company sells the innovative cancer drug Endu and the first-to-market medication Sinofuan, also a cancer drug.

Disclosure: none.

Source: Simcere Pharma Set to Produce Flu Drug in China