Sinovac begins phase 1 clinical trials for pandemic flu vaccine Panflu

By E. Janene Geiss

Philadelphia, Dec. 21 - Sinovac Biotech Ltd. announced Wednesday that it has initiated human clinical trials for its pandemic flu (H5N1) vaccine Panflu.

The vaccine was administered to the first six volunteers at the Beijing Sino-Japan Friendship Hospital in Beijing, China, according to a company news release.

Due to this vaccine's mature technology, China's State Food and Drug Administration approved modification to "fast-track" the clinical trial process from three phases to only two stages.

Stage 1 includes 120 healthy volunteers, ages 18 to 60, and is expected to take nine months.

Company officials said preliminary results should be available by the end of March.

"This is a great day for us as we simultaneously advance China's National Pandemic Preparedness Plan and our corporate growth strategy. In addition to our successful R&D program, Sinovac has introduced two new vaccines into the market this year. Our national and international name recognition is expanding, and I expect tremendous revenue growth in 2006," Weidong Yin, Sinovac chief executive officer and director, said in the release.

Sinovac said it partnered with Beijing Sino-Japan Friendship Hospital for the successful phase 1 SARS clinical trials in 2004.

If clinical trials of Panflu are successful, the company said it estimates production capacity may be as high as 20 million doses per year using its current manufacturing facilities.

Sinovac is a Beijing, China, biotechnology company that specializes in research, development, manufacture and commercialization of vaccines for endemic and pandemic viruses such as hepatitis and influenza, and for fast-emerging viruses such as SARS and avian influenza (bird flu).

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