China National Medical Products Administration Granted Approval to SINOVAC's 5-dose Inactivated Poliomyelitis Vaccine

Beijing, China – April 12, 2024 – Sinovac Biotech Ltd. ("SINOVAC" or the "Company") (NASDAQ: SVA), a leading provider of biopharmaceutical products in China, announced that its Poliomyelitis Vaccine (Vero Cell), Inactivated, Sabin Strains (Five-Dose) (2.5ml/vial) (hereinafter referred to as "msIPV") is authorized on 9th April 2024 by the China National Medical Products Administration (NMPA) for market use.

The same as SINOVAC’s single-dose Poliomyelitis Vaccine (Vero Cell), Inactivated, Sabin Strains (0.5 ml/vial) (sIPV), the msIPV is used to prevent poliomyelitis (polio) caused by wild poliovirus types 1, 2, and 3 and is suitable for immunization of infants and children aged 2 months old and above. Compared with sIPV, msIPV significantly reduces immunization costs. It is currently listed as an emergency needed vaccine in the World Health Organization (WHO) Polio Eradication Action Plan. The launch of SINOVAC's msIPV is expected to change the current situation of insufficient global vaccine supply and solve the lack of immunity caused by the inability to access the vaccine.

Poliomyelitis is a highly contagious disease that affects infants and young children under the age of 5. Since the World Health Assembly launched the Global Polio Eradication Initiative (GPEI) in 1988, the global polio incidence rate has declined and remarkable prevention and control results have been achieved.

Reaching the last mile of global polio eradication is critical by permanently interrupting all poliovirus transmission in endemic countries, stopping circulating vaccine-derived poliovirus (cVDPV) transmission, and preventing outbreaks in non-endemic countries. The use of inactivated polio vaccine is essential to achieving global eradication of polio.

In 2011, the WHO commissioned Intravacc of the Netherlands to develop Sabin Inactivated Poliovirus Vaccine and transfer technology to qualified manufacturers worldwide. SINOVAC is one of the six qualified manufacturers in the world and successfully obtained the technology transfer qualification. In April 2014, two parties formally signed a technology transfer contract, and SINOVAC began developing the sIPV vaccine.

SINOVAC's sIPV obtained the drug registration approval issued by the China NMPA on July 12, 2021, and passed WHO prequalification requirements (PQ) on June 2, 2022.

In the future, SINOVAC will continue to provide poliomyelitis vaccines for global immunization programs and support the fundamental principles of health rights, encompassing its availability, accessibility, acceptability, and quality.

About SINOVAC

Sinovac Biotech Ltd. (SINOVAC) is a China-based biopharmaceutical company that focuses on the R&D, manufacturing, and commercialization of vaccines that protect against human infectious diseases.

SINOVAC's product portfolio includes vaccines against COVID-19, enterovirus 71 (EV71) infected Hand-Foot-Mouth disease (HFMD), hepatitis A, varicella, influenza, poliomyelitis, pneumococcal disease, and mumps.

The COVID-19 vaccine, CoronaVac®, has been approved for use in more than 60 countries and regions worldwide. The hepatitis A vaccine, Healive®, passed WHO prequalification requirements in 2017. The EV71 vaccine, Inlive®, is an innovative vaccine under "Category 1 Preventative Biological Products" and was commercialized in China in 2016. In 2022, SINOVAC's Sabin-strain inactivated polio vaccine (sIPV) and varicella vaccine were prequalified by the WHO.

SINOVAC was the first company to be granted approval for its H1N1 influenza vaccine Panflu.1®, which has supplied the Chinese government's vaccination campaign and stockpiling program. The Company is also the only supplier of the H5N1 pandemic influenza vaccine, Panflu®, to the Chinese government stockpiling program.

SINOVAC continually dedicates itself to new vaccine R&D, with more combination vaccine products in its pipeline, and constantly explores global market opportunities. SINOVAC plans to conduct more extensive and in-depth trade and cooperation with additional countries, and business and industry organizations.

For more information, please see the Company’s website at www.sinovac.com.

Contact:

Sinovac Biotech Ltd. 

PR Team 

pr@sinovac.com