SHANGHAI - Nanjing-based Simcere announced during the Chinese New Year celebration that the company received approval from China's State FDA to manufacture and market a generic version of GlaxoSmithKline's antiviral Relenza (zanamivir).

"All the preparation work, including the production line and active pharmaceutical ingredients have been ready to manufacture zanamivir," Yin Xiaojin, Simcere's senior VP of R&D told PharmAsia News.

"It is hard to predict sales because it depends on the prevalence of H1N1," Yin said, adding that sales would come mostly from the government if it sees the need for back-up medicines in the event of another flu outbreak.

The company will manufacture and market zanamivir through its subsidiary, Nanjing Simcere Dongyuan Pharmaceutical.

GSK licensed Simcere to market Relenza in China and 50 of the least-developed countries in 2006.

Simcere is the only company that has such a license in China and the license includes Hong Kong and Macao as well, according to Yin.

Although the company has not yet set the price for zanamivir, it will "definitely be lower than GSK's Relenza," Yin said.

Global sales for GSK's Relenza jumped to £700 million in 2009 from £60 million in 2008, which were largely boosted by the government purchases to prepare for the outbreak of A/H1N1, according to the VP. Last May, GSK received import drug approval from SFDA for Relenza.

"Until now, I don't see large sales in China from GSK's Relenza," Yin said.

Simcere filed the applications and was granted fast-track approval status last year. It took six months to get approval from SFDA, according to Yin.

"Under the fast-track approval process, we don't need to conduct clinical trials in China because Relenza has been approved in China and the efficacy and safety of zanamivir have already been demonstrated," Yin noted. "All we need to do is to demonstrate that our zanamivir is as safe and efficacious as Relenza."

SFDA does require postmarket safety studies once the drug is launched, he said.

The only other drug to fight the H1N1 virus, Roche's Tamiflu is also licensed to two local companies in China, Shanghai Pharmaceutical Group and Guangdong-based HEC Group (Also see "China Localizes Manufacturing Relenza, Tamiflu; Drugs Pending Marketing, Manufacturing Approval" - Scrip, 7 May, 2009.).

During the Chinese New Year from Feb. 8 to Feb.21, China's Ministry Of Health reported 321 cases and three deaths from the A/H1N1 virus. As of Feb. 23, 78.77 million people in China have been vaccinated.

The World Health Organization is now facing accusations that it overreacted to the threat of the A/H1N1 influenza outbreak (Also see "Did The World Health Organization Overreact To The Threat Of A/H1N1?" - Scrip, 4 February, 2010.).

-Dai Jialing (j.dai@elsevier.com)

China State FDA Grants Simcere Record Fast-track Approval To Market Generic Relenza

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