Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, announced this morning that it received approval from the China State Food and Drug Administration (SFDA) to commence clinical trials for its proprietary inactivated EV71 vaccine against Hand, Foot and Mouth Disease (HFMD). Sinovac must conduct each phase of the human clinical trials in accordance with SFDA requirements, conduct studies to assess safety and immunogenicity in the phase I and II clinical trials, and conduct efficacy study in the phase III clinical trial. The company filed the application to commence human clinical trials for its inactivated EV71 vaccine in December of last year.
Dr. Weidong Yin, Chairman, President & CEO, stated, “We are very pleased to advance our near term vaccine development pipeline with the approval from the SFDA to commence clinical trials for our internally developed EV 71 vaccine. Currently, there is no vaccine available worldwide for this disease. We had no precedent to go by during the development, so we had to start with the basic research on this vaccine. Moreover, our R&D people has successfully completed pre-clinical research and made significant breakthroughs during the development. We will move forward with our research and development of vaccines with the objective to supply high quality vaccine products to children worldwide as soon as possible and to contribute to the prevention and control of HFMD.”
The Company began preclinical research for its independently developed EV 71 vaccine approximately two years ago. The animal model, built by researchers at Sydney University, showed cross protection and demonstrated that the vaccine is effective in animals. Sinovac has already filed five patent applications covering the EV 71 vaccine.