Sinovac Biotech Ltd. announced that it has submitted a Clinical Trial Application with the China Food and Drug Administration (CFDA) to commence human clinical trials for its vaccine against Avian influenza A(H7N9) virus. The CTA was officially accepted by CFDA on January 29, 2014. Incidence rates for H7N9 continue to increase in China, with 153 H7N9 Human infectious cases reported in 2013, according to the World Health Organization (WHO).

In January 2014, 96 H7N9 cases were reported in China, including 20 fatalities. Sinovac commenced development of its proprietary H7N9 vaccine at the beginning of 2013, when the continuous H7N9 infectious cases were reported in China. The H7N9 vaccine was developed utilizing Sinovac's existing flu vaccine development and production platform that includes its seasonal influenza vaccine, its pandemic influenza vaccine against H5N1 and its pandemic A(H1N1) vaccine.

The company obtained the avian influenza A(H7N9) virus strain from the WHO in May 2013. The company has completed the pre-clinical research, and prepared different types of vaccine candidates for clinical testing. Once the CTA is approved, Sinovac is prepared to initiate the clinical trials in a timely manner.

Sinovac is the only company in China that is qualified to manufacture the vaccine against H5N1 avian flu following the regulatory approval in April 2008 and also was the first company globally to successfully develop and launch the H1N1 vaccine in September 2009.