Sinovac Biotech (Sinovac) has filed an application with China’s State Food and Drug Administration (SFDA) to commence a human clinical trial for its vaccine against human enterovirus 71 (EV 71), which causes hand, foot and mouth disease (HFMD). This is the first clinical trial application for HFMD vaccine submitted in China, claims the company.
The company initiated preclinical development in 2008. Sinovac is independently developing the EV 71 vaccine and will retain full commercialisation rights of the vaccine upon approval.
Reportedly, created by Sydney University, the animal model showed cross protection and demonstrated that the vaccine is effective in animals. In addition, Sinovac is preparing to file a patent application covering the EV 71 vaccine.
Weidong Yin, chairman, president and CEO of Sinovac, stated: “We are very pleased to submit the clinical trial application for the EV 71 vaccine to the SFDA. Our ability to submit the application ahead of the projected 2010 timeline is a validation of the R&D capabilities of the team developing this vaccine.
“A vaccine against EV 71 represents unmet medical need, given that there are not effective preventive therapeutic alternatives for this life threatening viral illness affecting infants and children. Based on current expectations, we anticipate that the EV 71 vaccine, subject to positive human clinical trial results and commercialisation, represents a flagship product opportunity for the company as well as an opportunity to improve the lives of children around the world.”