AsianScientist (May 5, 2014) – Chinese vaccine manufacturer Sinovac Biotech Ltd. will receive a RMB60 million (US$9.6 million) government grant to construct a dedicated production facility for its enterovirus 71 (EV71) vaccine against hand, foot and mouth disease (HFMD).
Sinovac’s EV71 vaccine commercial production project was approved as one of the projects supported by the Dedicated Funds for Strategic New Emerging Industry Development. Sinovac will be required to complete the construction of its production facility in compliance with China’s new GMP guidelines with an annual capacity of 20 million doses of EV71 vaccine, and to commercialize the vaccine in China. The grant will be funded in several tranches, of which RMB20 million (US$3.2 million) will be provided within the year, and the remaining will be provided after the criteria are met.
Mr. Yin Weidong, Chairman, President and CEO of Sinovac, commented, “From 2007 to 2013, over nine million cases of HFMD were reported in China with approximately 2,700 reported fatalities. This epidemic situation represents a significant unmet medical need for the EV71 vaccine.
“The grant provides the confidence and encouragement that EV71 vaccine is urgently needed and has attracted the attention from the Chinese government. We look forward to working with the regulatory agencies to complete the vaccine registration process as soon as possible.”
In March 2013, Sinovac completed a Phase III clinical trial for its EV71 vaccine candidate and reported preliminary top-line data that showed approximately 95 percent efficacy rate for the vaccine against HFMD caused by EV71. Throughout the three phases of the clinical trials, the results demonstrated a good safety, immunogenicity and efficacy profile for Sinovac’s proprietary EV71 vaccine candidate.
In May 2013, Sinovac filed a new drug application (NDA) for its proprietary EV71 vaccine, which was accepted by the China Food and Drug Administration. The NDA is currently under review by Centers for Drug Evaluation.
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Source: Sinovac.
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