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Sinovac Files Clinical Trial Application with SFDA for Vaccine Against Hand, Foot, and Mouth Disease
Date:12/28/2009

BEIJING, Dec. 28 /PRNewswire-Asia/ -- Sinovac Biotech Ltd. ( SVA), a leading provider of biopharmaceutical products in China, announced today that it has filed the application with China's State Food and Drug Administration (SFDA) to commence a human clinical trial for its vaccine against human enterovirus 71 (EV 71), which causes hand, foot, and mouth disease (HFMD). This is the first clinical trial application for HFMD vaccine submitted in China.

No vaccine or antiviral treatment is currently available for HFMD worldwide, though it has become a very serious problem in Asia in recent years. The disease is highly contagious and a growing number of HFMD cases have been reported in parts of Asia, including Mainland China, Hong Kong, Singapore, Korea, and Taiwan. According to China's Center for Disease Control (CDC) between January 1 and November 30 of this year, the disease has caused more than 400 deaths in China, where health authorities reported over 1.1 million HFMD infections, compared to about 200 reported H1N1 deaths. HFMD is common among infants and children, as most of the recently reported cases have occurred in children. Due to the severity of the disease epidemic, China authorities recognize the unmet medical need and are expected to support the launch of a HFMD vaccine as soon as possible. Therefore, Sinovac believes that fast track status for the reviewing process and approval may be granted.

As previously announced, the Company began preclinical development in 2008. Sinovac is independently developing the EV 71 vaccine and will retain full commercialization rights of the vaccine upon approval. Created by Sydney University, the animal model showed cross protection and demonstrated that the vaccine is effective in animals. In addition, Sinovac is preparing to file a patent application covering the EV 71 vaccine.

Weidong Yin, Chairman, President & CEO,
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SOURCE Sinovac Biotech Ltd.
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