SINOVAC’s EV71 vaccine Inlive® is approved for children aged from 6 to 71 months

BEIJING – June 12, 2021 – SINOVAC Biotech Ltd. (“SINOVAC” or the “Company”) (NASDAQ: SVA), a leading provider of biopharmaceutical products in China, today announced that Inlive®, an innovative, inactivated Enterovirus Type 71 (EV71) vaccine developed by SINOVAC was approved for use in children of 6 to 71 months on June 8, 2021. Prior to this, Inlive® was applicable for children of 6 months to 3-year-old. This approval allows SINOVAC to protect more children to prevent infection from enterovirus type 71. 

In December 2015, National Medical Products Administration (NMPA), the former China Food and Drug Administration (CFDA) approved Inlive® use for children from 6 months to 3-year-old. The safety and effectiveness of Inlive® have been widely tested after massive use the vaccine in China after licensure.

In collaboration with Yunnan Center for Disease Control and Prevention, and National Institute for Food and Drug Control, SINOVAC conducted a phase III clinical study to evaluate the safety and immunogenicity of Inlive® children aged from 36 to 71 months. The study had been completed in 2019 and the results showed that the seroconversion rate and the geometric mean titer level were significantly higher than the control group among children aged from 36 to 71 months after fully vaccinated with 2 doses of Inlive® with 1 month apart. The paper of this study was published in the Journal of the Pediatric Infectious Diseases Society.

In January 2020, SINOVAC applied for a market authorization of Inlive® to be used in an expanded age range to the NMPA. The NMPA accepted SINOVAC’s application on January 19, 2020 and officially approved on June 8, 2021.

SINOVAC also carried out several studies to understand the safety and immunogenicity in conditions of simultaneous inoculation with Hepatitis A vaccine or meningococcal vaccines. According to the results of these studies, inoculating together with Hep A vaccine or Meningococcal vaccines, Inlive® demonstrated to be as safe and well tolerated as its being used only. More results will be published as soon as the studies completed. At present, many provinces and cities in China have issued relevant documents to provide policy support for joint vaccination, so that protection of vaccination can reach out to more children.

SINOVA’s mission is to "supply vaccines to eliminate human diseases". We hope to reduce incidence of vaccine preventable diseases and protect more people through improving vaccination coverage. Inlive®’s approval to be used in an wider age range will help more children in decreasing HFMD incident. Joint vaccination could achieve further reduction of burden of parents and vaccination clinics, facilitate children immunization, and achieve good protection for children.

About SINOVAC

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 COVID-19, enterovirus71 (EV71), hepatitis A and B, seasonal influenza, 23-Valent pneumococcal polysaccharide (“PPV”), H5N1 pandemic influenza (avian flu), H1N1 influenza (swine flu), varicella and mumps. SINOVAC’s COVID-19 vaccine, CoronaVac®, has been granted emergency use approval or conditional marketing authorization by over 40 countries or regions worldwide. 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 several new products including 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. For more information please see the Company’s website at www.sinovac.com.

Contact

SINOVAC Biotech Ltd.

Helen Yang

Tel: +86-10-8279-9871 or

+86-10-5693-1897

Fax: +86-10-6296-6910

Email: ir@sinovac.com