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Sinovac Obtains Production License for H1N1 Vaccine

Thursday, September 17, 2009 General News
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BEIJING, Sept. 3 Sinovac Biotech Ltd. (NYSE: SVA), aleading provider of biopharmaceutical products in China, announced today thatthe State Food and Drug Administration (SFDA) has approved the registrationapplication for PANFLU.1, Sinovac's H1N1 vaccine, and has issued Sinovac aproduction license for this vaccine.
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Following top-line results which showed that PANFLU.1, Sinovac's H1N1vaccine, has a good safety and immunogenicity profile, the Company announcedthe findings of an experts' evaluation conference organized by the SFDA onAugust 30 and 31. The experts unanimously agreed that Sinovac's H1N1 vaccineis suitable for all people from three to 60 years old on a single shotvaccination schedule.
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Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "Theapproval of PANFLU.1, Sinovac's H1N1 vaccine, is a significant milestone inthe campaign for the prevention and control of the H1N1 virus. With thesupport of the Ministry of Health, State SFDA, Chinese Center for DiseaseControl and Prevention (China CDC), Sinovac was able to successfully andrapidly complete the clinical trials and registration process for the H1N1vaccine. By leveraging our expertise in R&D, production and commercializationof human vaccines, we continue to execute our mission to provide top-qualityvaccines to eliminate human diseases."

About Sinovac

Sinovac Biotech Ltd. is a China-based biopharmaceutical company thatfocuses on the research, development, manufacture and commercialization ofvaccines that protect against human infectious diseases. Sinovac's vaccineproducts include Healive(R) (hepatitis A), Bilive(R) (combined hepatitis A andB), and Anflu(R) (influenza). Panflu(TM), Sinovac's pandemic influenza vaccine(H5N1), has already been approved for government stockpiling. Sinovac isdeveloping vaccines for enterovirus 71, universal pandemic influenza, Japaneseencephalitis, and human rabies. Its wholly owned subsidiary, Tangshan Yian, isconducting field trials for independently developed inactivated animal rabiesvaccines.

Safe Harbor Statement

This announcement contains forward-looking statements. These statementsare made under the "safe harbor" provisions of the U.S. Private SecuritiesLitigation Reform Act of 1995. These forward-looking statements can beidentified by words or phrases such as "will," "expects," "anticipates,""future," "intends," "plans," "believes," "estimates" and similar statements.Among other things, the business outlook and quotations from management inthis press release contain forward-looking statements. Statements that are nothistorical facts, including statements about Sinovac's beliefs andexpectations, are forward-looking statements. Forward-looking statementsinvolve inherent risks and uncertainties. A number of important factors couldcause actual results to differ materially from those contained in anyforward-looking statement. Sinovac does not undertake any obligation to updateany forward-looking statement, except as required under applicable law.For more information, please contact: Sinovac Biotech Ltd.: Helen G. Yang Tel: +86-10-8289-0088 x9871 Fax: +86-10-6296-6910 Email: [email protected] Investors: Amy Glynn/Sara Pellegrino The Ruth Group Tel: +1-646-536-7023/7002 Email: [email protected] [email protected] Media: Janine McCargo The Ruth Group Tel: +1-646-536-7033 Email: [email protected]

SOURCE Sinovac Biotech Ltd.
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