BEIJING--(BUSINESS WIRE)--Nov. 22, 2005--Sinovac Biotech Ltd. (AMEX:SVA - News) announced the China State Food and Drug Administration (SFDA) approved commencement of human clinical trials for Sinovac's Pandemic Influenza (H5N1, bird flu) Vaccine ("prototype").
In response to the severe nature a potential pandemic based on the avian virus, the SFDA fast-tracked Sinovac's October 21st, 2005 application in one month. The SFDA's regulatory agency for drug and biological products validation, the National Institute for the Control of Pharmaceutical and Biological Products (NICPBP), closely monitored and tested Sinovac's vaccine throughout the preclinical phase. Sinovac plans to initiate clinical trials as soon as possible.
Due to this vaccine's uniqueness, the clinical trial process will be modified slightly, from three phases, to only two stages. Preclinical trial results demonstrated the Company's pandemic vaccine safely induces a high quality immune response in animals (i.e. immunogenicity). Scientists will use clinical trials to further examine safety and immunogenicity in humans, and to establish the ideal dosage and immunization schedule. Once initiated, it is expected to take about three months to complete preliminary testing for the first clinical stage.
The British National Institute for Biological Standards and Control (NIBSC) provided Sinovac with a reassortant virus strain. This highly infectious H5N1 strain is reassortanted with a human influenza virus strain through reverse genetic technology; which is used to imitate the potential pandemic strain. The NIBSC reported it conducted safety tests on mice, rats, and ferrets. The results showed the strain is safe and it should not have biosafety problems while conducting R&D and clinical trials.
On Nov 17 2005, China Premier Wen Jiabao, Deputy Premiers, Ms. Wu Yi and Mr. Hui Liangyu, and several Health Ministers visited the Sinovac headquarters in Beijing and the influenza vaccine facilities. Mr. Weidong Yin, CEO, explained the vaccine production process developed by Sinovac. Premier Wen was interested in every step of vaccine production and expressed concern about the vaccine development status, production method, and production capacity. Once he learned that the safety of the vaccine developed by Sinovac can be totally guaranteed, he was very excited and commented that the safety of the vaccine is an essential issue; "we can never treat it lightly."
Sinovac's successful development of a SARS vaccine in 2003 underlies the Company's confidence for successfully developing a pandemic influenza vaccine. Premier Wen Jiabao was fascinated by Sinovac employees' confidence. He commented, "You have made a breakthrough on human use bird flu vaccine; our country and people have great expectations for your success. I hope you can take the vaccine development as a national responsibility and give your dedication to our national public health."
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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Craig H. Bird
Source: Sinovac Biotech Ltd.