Sinovac Biotech Ltd. has initiated human clinical trials for its pandemic flu (H5N1) vaccine Panflu. The vaccine was administered to the first 6 volunteers at the Beijing Sino-Japan Friendship Hospital in Beijing, China.

Due to this vaccine's mature technology, China's State Food and Drug Administration (SFDA) earlier approved modification to fast-track the clinical trial process from 3 phases to only 2 stages. Stage I includes 120 healthy volunteers, ages 18 - 60 years and is expected to take nine-months. However, preliminary results should be available by the end of March, 2006, states a company release.

Sinovac partnered with Beijing Sino-Japan Friendship Hospital for the successful phase I SARS clinical trials in 2004. Protocols for clinical trials are strictly regulated and include compliance with SFDA's National Institute for the Control of Pharmaceutical and Biological Products (NICPBP), World Health Organisation (WHO) 'Guidelines on clinical evaluation of vaccines,' and other relevant regulations. The trials will be compliant with good clinical practices (GCP) procedures, including ethical guidelines.

Sinovac's deputy general manager, Zhang Jiansan stated, "We have established an excellent reputation at Sinovac and maintain disciplined, safe procedures during all of our R&D and production functions."

These trials will use Sinovac's proprietary pandemic vaccine, Panflu, which is an adjuvant, whole virion type. If clinical trials are successful, the company estimates production capacity may be as high as 20 million doses per year using its current manufacturing facilities.

Sinovac Biotech Ltd. develops, manufactures and commercialises vaccines for endemic and pandemic viruses such as hepatitis and influenza, and for fast emerging viruses such as SARS and avian influenza (bird flu).