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.
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.
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."
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.
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SOURCE Sinovac Biotech Ltd.