SFDA approves production license for Sinovac's H1N1 vaccine

Sep 4 2009

Sinovac Biotech Ltd. (NYSE: SVA), a leading provider of biopharmaceutical products in China, announced today that the State Food and Drug Administration (SFDA) has approved the registration application for PANFLU.1, Sinovac's H1N1 vaccine, and has issued Sinovac a production license for this vaccine.

Following top-line results which showed that PANFLU.1, Sinovac's H1N1 vaccine, has a good safety and immunogenicity profile, the Company announced the findings of an experts' evaluation conference organized by the SFDA on August 30 and 31. The experts unanimously agreed that Sinovac's H1N1 vaccine is suitable for all people from three to 60 years old on a single shot vaccination schedule.

Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "The approval of PANFLU.1, Sinovac's H1N1 vaccine, is a significant milestone in the campaign for the prevention and control of the H1N1 virus. With the support of the Ministry of Health, State SFDA, Chinese Center for Disease Control and Prevention (China CDC), Sinovac was able to successfully and rapidly complete the clinical trials and registration process for the H1N1 vaccine. By leveraging our expertise in R&D, production and commercialization of human vaccines, we continue to execute our mission to provide top-quality vaccines to eliminate human diseases."