Sinovac Biotech Ltd., a China-based vaccine manufacturer, this week announced that it has received a RMB 60 million (USD 9.6 million) grant by China’s Ministry of Finance National Health and Family Planning Commission for construction of a dedicated production facility for Sinovac’s Enterovirus 71 (EV71) vaccine against hand foot and mouth disease (HFMD).
The funds are directed for completion of the 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 RMB 20 million will be provided within the year, and the remaining will be provided after the criteria are met.
Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, “From 2007 to 2013, over 9 million cases of HFMD have reported in China with approximately 2,700 reported fatalities. This epidemic situation represents a significant unmet medical need for the EV71 vaccine. With the government support for building out the dedicated production capacity, Sinovac is poised to provide the EV71 vaccine to help address this potentially fatal childhood disease for which no commercialized vaccine and no EV71 specific treatment exist. 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 the Phase III clinical trial for its EV71 vaccine candidate and reported preliminary top-line data that showed approximately 95% efficacy rate for the vaccine against HFMD caused by enterovirus 71 (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’s new drug application (NDA) for its proprietary EV71 vaccine has been filed and accepted by the China Food and Drug Administration.