EV71 Commercialization Preparation
Sinovac has completed construction of the dedicated EV71 vaccine manufacturing facility at its Changping site north of Beijing, China, and finished installing its equipment. The Company is currently conducting its internal qualification and validation of the manufacturing equipment and production processes at the production plant. According to the Chinese regulation, before submitting a GMP inspection application, a manufacturer shall complete clinical studies and submit the clinical study report to SFDA. Once the result of clinical study is confirmed by SFDA experts, SFDA will issue the production license, which is a pre-requisite for GMP inspection application. By obtaining GMP certificate, the real commercial production can be commenced. Our objective with doing human trials and preparing facilities in parallel is to shorten the time for entire regulatory approval process for the EV71 vaccine.
"The current HFMD epidemic situation is one of the most serious in the past five years, with a nearly 110% increase in reported cases between January 2012 and May 2012, and with almost twice the number of fatalities," said Dr. Weidong Yin, Chairman and CEO. "There are no specific treatments for EV71 and no effective prevention methods, and we are continually reminded of the importance of rapidly developing a high quality vaccine against EV71. By simultaneously conducting the EV71 vaccine Phase III trial, maintaining ongoing discussions with the SFDA, and preparing our dedicated production facility, we intend to address this unmet need by being well positioned to provide this vaccine to our children soon after the vaccine is approved. We are on track to complete Phase III of the trial before the middle of next year."
Sinovac Biotech Ltd. is a China-based biopharmaceutical company that focuses on the research, development, manufacturing and commercialization of vaccines that protect against human infectious diseases including hepatitis A and B, seasonal influenza, H5N1 pandemic influenza (avian flu) and H1N1 influenza (swine flu), as well as animal rabies vaccine for canines. In 2009, Sinovac was the first company worldwide to receive approval for its H1N1 influenza vaccine, Panflu.1, and has manufactured it for the Chinese Central Government, pursuant to the government-stockpiling program. The Company is also the only supplier of the H5N1 pandemic influenza vaccine to the government-stockpiling program. Sinovac is developing a number of new pipeline vaccines including vaccines for enterovirus 71 (against hand, foot and mouth disease), pneumococcal conjugate, pneumococcal polysaccharides, mumps and rubella. Sinovac sells its vaccines mainly in China and exports selected vaccines to Mongolia, Nepal, and the Philippines.