Sinovac Biotech Ltd., a China-based vaccine manufacturer, announced that it has received notification that a 60 million Renminbi government grant has been 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 for construction of the Company’s dedicated production facility for its Enterovirus 71 (EV71) vaccine against hand foot and mouth disease (HFMD).
Given the severity of HFMD epidemic levels in China and the government’s focus on developing the biotechnology industry, 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. The funding criteria as outlined in this grant are 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 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 3 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 (CFDA). Currently, the NDA is under the technological review by Centers for Drug Evaluation.
Date: April 24, 2014