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Sinovac Reports Positive Preliminary Phase II Clinical Trial Results for EV71 Vaccine Against Hand, Foot and Mouth Disease
Date:11/9/2011

rmining the phase III clinical trial proposal, selecting the clinical sites and preparing for the vaccines to be used in phase III clinical trial. We anticipate commencing the phase III clinical trial in the coming months, and aim to complete it in one year."

In parallel to the clinical development, Sinovac's engineering team is working on setting up a dedicated manufacturing facility for its EV71 vaccine and aims to complete the construction and GMP Certification in 2013.

About EV71

Enterovirus 71, or EV71, causes Hand, Foot, and Mouth Disease (or HFMD). More than 90% of the reported cases occur in children under five years old. HFMD is a common and usually mild childhood disease.  Since 1997, the number of reported HFMD cases associated with severe neurological symptoms caused by EV71 and fatalities has increased significantly across the Asia-Pacific region. Outbreaks have been reported in Vietnam (2011) Malaysia (1997), Taiwan (1998, 2000 & 2001), mainland China (1998-2008), Australia (1999) and Singapore (2000). No specific treatment for this enterovirus infection and no vaccine are currently available.

HFMD represent a very serious problem in China, some other Asian countries and other areas in recent years given that no vaccine and specific treatment is currently available to protect against this disease. EV71 represents a significant health threat to children as a growing number of HFMD cases have been reported in parts of Asia, including mainland China, Vietnam, Hong Kong, Singapore, South Korea, and Taiwan. According to the Chinese Ministry of Health's data available for the period from January 1 to September 30, 2011, the disease caused 399 deaths in China and over 1.2 million HFMD infection cases during the nine-month period, as reported by health authorities. In 2010, there were over 1.7 million reported EV71 infectious cases with over 800 fatal cases. In August of 2011, over 32,000 HFMD infectious cases were
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SOURCE Sinovac Biotech Ltd.
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