News - Sinovac Biotech Ltd. Begins Pandemic Flu (H5N1) Vaccine Clinical Trials
(Sinovac) (AMEX: SVA - News) announced today it has initiated human clinical trials for its pandemic flu (H5N1) vaccine Panflu(TM). 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.
Sinovac CEO and Director, Mr. Weidong Yin commented, "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."
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 Organization (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, Mr. 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(TM), which is an al adjuvant, whole virion type. Sinovac has produced sufficient vaccines to complete human clinical trials. 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.
About Sinovac: Sinovac Biotech Ltd. is a world leader in the 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). The Company's objective is to provide Chinese
children with the best vaccines in the world, and let children in the world use vaccines made in China.
Additional information about Sinovac is available on the Company website, http://www.sinovac.com
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Sinovac Biotech Ltd. Begins Pandemic Flu (H5N1) Vaccine Clinical Trials