SHANGHAI - Although China has not reported a case of swine flu, except for two suspected cases in Hong Kong, the government has taken actions to prevent the virus from entering China and to prepare for a potential outbreak, including quarantining people who arrived from Mexico suspected of exposure to swine flu.

Chinese companies were granted licensing rights for the only two drugs effective against swine flu, GlaxoSmithKline's Relenza (zanamivir) and Roche's Tamiflu (oseltamivir).

There are four influenza antiviral drugs approved for use in the U.S., including oseltamivir, zanamivir, amantadine and rimantadine, but according to the World Health Organization and U.S. Centers for Disease Control and Prevention, the swine flu virus is only sensitive to oseltamivir and zanamivir.

"In China, Relenza hasn't been registered or marketed," Xu Xiaofang, a GSK spokeswoman, told PharmAsia News.

According to Xu, GSK out-licensed Relenza to Nanjing-based Simcere in 2006. Simcere has the right to manufacture zanamivir for 50 of the least-developed countries and China.

Simcere recently received clinical trials approval from China's State FDA for zanamivir (PharmAsia News, Jan. 15, 2009.

"GSK stands ready to begin manufacture of a vaccine against the new H1N1 strain virus once the WHO refines the specific virus strain for swine flu," Xu said.

Roche reached similar deals with local companies in 2005 and 2006. "Roche has sub-licensed Tamiflu to Shanghai Pharmaceutical Group and Guangdong-based HEC Group for China's market," Cao Yong, a Roche spokesperson, told PharmAsia News. But Roche also sells its own oseltamivir in China, which is packaged in Roche's production facility in China, according to Cao.

Cao also noted that shikimic acid, a key component to produce Tamiflu, is sourced mostly from China. "The intermediate can be exacted from anise [which is a common plant in China]."

Cao also noted Roche is working closely with governments to fight the outbreak of influenza. "Globally, we are also working with the Chinese government [so that] if the government order comes out, we will contact our global supply chain to order Tamiflu."

Roche confirmed the WHO requested deployment of Tamiflu as a "rapid response stockpile" May 2. The stockpile includes both the 2 million treatment courses held by the WHO and the 3 million treatment course held by Roche.

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

China Localizes Manufacturing Relenza, Tamiflu; Drugs Pending Marketing, Manufacturing Approval

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