Sinovac Gets Chinese Government Grant For HFMD Vaccine
Sinovac Biotech, a China-based vaccine company, announced that it has won a 60 million Renmibi grant from the Chinese government for the construction of its dedicated production facility for its Enterovirus 71 (EV71) vaccine against hand, foot, and mouth disease (HFMD).
The funding criteria for the grant requires the completion of a production facility in compliance with China’s new GMP guidelines with an annual capacity of 20 million doses of the EV71 vaccine. The company is also required to commercialize the vaccine in China.
Mr. Weidong Yin, Chairman, president and CEO of Sinovac, said, “From 2007 to 2013, over 9 million cases of HFMD have been reported in China. HFMD has claimed the lives of approximately 2,700. 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 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 the 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.”
The company completed the Phase III clinical trial for EV71 and announced preliminary top-line results that demonstrated about 95 percent efficacy rate for the vaccine against HFMD caused by enterovirus 71. Sinovac’s new drug application for its proprietary EV71 vaccine is currently under technological review by Centers for Drug Evaluation.
The grant was approved by China’s Ministry of Finance, National Development and Reform Commission, Ministry of Industry and Information Technology, and National Health and Family Planning Commission. 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 in China.