Sinovac Biotech Ltd. (NASDAQ:SVA) (“Sinovac” or the “Company”), a leading provider of biopharmaceutical products in China, announced that the China National Medical Products Administration (NMPA) has granted a conditional marketing authorization (CMA) to Sinovac for CoronaVac, Sinovac’s COVID-19 vaccine in individuals aged 18 and above.
Sinovac began rolling submission to the NMPA since September 2020 and the NMPA carried out rolling reviews when the submission was made. As of February 4, 2021, the Company made more than 40 submissions to the NMPA. After obtaining the preliminary efficacy results, Sinovac formally filed for application of a conditional marketing authorization on February 3, 2021. The approval is based on the results of the two-month data of phase III clinical trials. The final results are not yet available, and the efficacy and safety results shall be further confirmed.
Mr. Yin Weidong, Chairman, President and CEO of Sinovac, said, “Being granted a conditional marketing authorization for CorornaVac is a significant milestone for Sinovac after commencing development at the beginning of 2020. We show our respect and appreciation to the volunteers for their contribution to this research and thank all experts, scientists and partners who participated in this international collaborative project. The COVID-19 pandemic continues around the world, and the fight is far from over. We look forward to providing safe and effective vaccines to as many individuals as possible to combat this epidemic by increasing the vaccination rate. It is our sincere hope that people’s lives and social and economic activities can return to normal as soon as possible, and that we can wear a smile without masks.”
CoronaVac is being used under emergency use approval (EUA) in Indonesia, Brazil, Turkey and Chile. Sinovac is also actively seeking regulatory approval of CoronaVac in other countries and regions around the world in an effort to maximize global accessibility and affordability of the COVID-19 vaccine and to ensure global prevention and mitigate spread.
Sinovac Biotech Ltd. is a China-based biopharmaceutical company that focuses on the research, development, manufacturing and commercialization of vaccines that protect against human infectious diseases. Sinovac’s product portfolio includes vaccines against enterovirus71 (EV71), hepatitis A and B, seasonal influenza, 23-Valent Pneumococcal Polysaccharide (“PPV”), H5N1 pandemic influenza (avian flu), H1N1 influenza (swine flu), varicella vaccine and mumps. Healive, the hepatitis A vaccine manufactured by the Company, has passed the assessment under WHO prequalification procedures in 2017. The EV71 vaccine, an innovative vaccine developed by Sinovac against hand foot and mouth disease caused by EV71, was commercialized in China in 2016. In 2009, Sinovac was the first company worldwide to receive approval for its H1N1 influenza vaccine, which it has supplied to the Chinese Government’s vaccination campaign and stockpiling program. The Company is also the only supplier of the H5N1 pandemic influenza vaccine to the government stockpiling program. The Company is developing a number of new products including COVID-19 vaccine, CoronaVac, a Sabin-strain inactivated polio vaccine and combined vaccines. Sinovac primarily sells its vaccines in China, while also exploring growth opportunities in international markets. The Company is seeking market authorization of its products in over 30 countries outside of China.