The official approval marks a significant milestone in the growth of Sinovac’s inactivated vaccines portfolio and comes as the company is nearing completion of its new production line in Beijing.
The split flu vaccine, which is safe for use in children as well as the elderly, is the third Sinovac vaccine for which the SFDA has granted a new drug certificate. The first two Sinovac products, Healive, a hepatitis A vaccine, and Bilive, a combined vaccine for hepatitis A and B, have helped establish the company as an emerging leader in the Chinese biotechnology sector.
The company first undertook split flu vaccine R&D in 2001, completed clinical trials in early 2004 and filed its new drug application with the SFDA in June 2004. Sales approval of Sinovac’s flu vaccine is expected upon completion and GMP certification of the flu vaccine production line.
The company also intends to build another, much larger flu vaccine production facility if it can obtain the necessary financing.