WEDNESDAY, SEPTEMBER 28, 2016

Sinovac submits CTA for H7N9 flu vaccine trials in China

Sinovac Biotech, Ltd., a China-based biopharmaceutical company, announced on Wednesday that it submitted an application to commence human clinical trials for its H7N9 influenza vaccine.

Sinovac filed the clinical trial application with the China Food and Drug Administration to begin trials for its avian influenza vaccine. The CFDA officially accepted the application on Wednesday.

Sinovac began developing its proprietary H7N9 vaccine at the start of 2013 when the first infectious H7N9 cases were reported in China. The company used its existing flu vaccine development and production platform to develop the vaccine after obtaining the H7N9 influenza virus strain from the World Health Organization in May.

"In line with our corporate mission to supply vaccines to eliminate human diseases, Sinovac had established a quick responding mechanism to provide vaccines to deal with the influenza pandemic, which has successfully applied to the development on H5N1 vaccine and H1N1 vaccine in the previous years," Weidong Yin, the chairman, president and CEO of Sinovac, said. "This time, the H7N9 vaccine was developed with the existing flu vaccine technology and production platform."

According to the World Health Organization, there were 153 human H7N9 cases reported in 2013 in China. There were 96 additional human H7N9 cases reported in 2014, including 20 fatalities.

"The H7N9 vaccine will be produced in our existing flu facilities," Yin said. "We are well prepared to move forward with the clinical development to prove the safety and immunogenicity profile of the H7N9 vaccine candidates. We look forward to making our contributions to the prevention and control of avian influenza A(H7N9) virus."

After completing its preclinical research, Sinovac said it is prepared to initiate the clinical trials following approval from the CFDA.

Sinovac focuses on researching, developing and manufacturing vaccines that protect against human infectious diseases like seasonal influenza, hepatitis A and B and mumps.