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

2024-04-12

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 global biopharmaceutical company, with a mission of "supply vaccines to eliminate human diseases", the company specializes in the research, development, manufacturing and commercialization of vaccines and related biological products that protect against human infectious diseases.

The company's diversified portfolio includes vaccines for influenza, viral hepatitis, varicella, Hand-Foot-Mouth disease (HFMD), poliomyelitis, pneumococcal disease, etc., of which 3 vaccines have been prequalified by WHO, including inactivated hepatitis A vaccine Healive®, Sabin-strain inactivated polio vaccine (sIPV), and varicella vaccine.

SINOVAC has a leading edge in developing vaccines to combat infectious disease outbreaks and was among the first to initiate R&D during major public health emergencies, including SARS, H5N1, H1N1, and COVID-19. The company developed the world's first inactivated SARS vaccine (Phase I completed), China's first H5N1 influenza vaccine (Panflu®), the world's first H1N1 influenza vaccine (Panflu.1®), and CoronaVac®, the most widely used inactivated COVID-19 vaccine globally.

Beyond its marketed portfolio, the company is advancing a robust pipeline that includes combination vaccines,recombinant protein vaccines and next-generation platforms such as mRNA technologies and antibodies.

With a long-standing commitment to innovation and global health, SINOVAC is expanding its global footprint by strengthening partnerships with research institutions, international organizations, and local partners. Through broader market presence, technological cooperation, and localized production, the company aims to accelerate vaccine development and supply, enhance regional access to high-quality products, and better address unmet medical needs while improving preparedness for future pandemics.

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