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Sinovac Reports Positive Phase I Clinical Trial Results for EV71 Vaccine Candidate Against Hand, Foot & Mouth Disease(HFMD)
Date:5/25/2011

BEIJING, May 25, 2011 /PRNewswire-Asia/ -- Sinovac Biotech Ltd. (NASDAQ: SVA - News), a leading provider of biopharmaceutical products in China, announced today the unblinded results of its Phase I clinical trial for its proprietary inactivated vaccine against human enterovirus 71 (EV71), which causes Hand, Foot, and Mouth Disease (HFMD). The safety observation results for the EV71 vaccine for all three age groups (adult, children and infant groups) showed good safety and tolerance profiles and the preliminary immunogenicity study results showed the vaccines can induce good immune responses.

The phase II clinical trial is scheduled to be commenced within one or two months. The purpose for the Phase II study is to evaluate safety and tolerance of the EV71 vaccine candidates within the expanded population and the vaccine's capability to induce an antibody response to enterovirus 71 to further determine the vaccination dosage.

The data unblinding conference for the Phase I clinical data for EV71 vaccine was held on May 25, 2011, Beijing time.  The conference was supervised under the Data Safety and Monitoring Committee (DSMC) and attended by experts from the Ministry of Health (MOH), China State Food and Drug Administration (China SFDA) and China Centers for Disease Control and Prevention (China CDC).

Dr. Weidong Yin, Chairman and CEO, remarked, "We were pleased to achieve this significant milestone in the development of our proprietary novel EV71 vaccine.  HFMD represents a significant unmet medical need given that the global lack of an identifiable treatment or vaccine against this disease that results in pediatric fatalities.  We completed the Phase I clinical trial for all three population groups and reported positive safety and tolerance profiles, as well as good immune responses induced by the vaccine candidates. We are on track to commence the
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SOURCE Sinovac Biotech Ltd.
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