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 global biopharmaceutical company headquartered in China. Guided by its mission to “Supply Vaccines to Eliminate Human Diseases,” the Company is dedicated to the research, development, manufacturing and supply of vaccines and related biological products, providing vaccine products and related solutions for disease prevention and control worldwide.
SINOVAC has a diversified vaccine portfolio across multiple disease areas, including influenza, viral hepatitis, varicella, hand, foot and mouth disease (HFMD), poliomyelitis, rabies, tetanus, and pneumococcal disease. Three of SINOVAC's vaccines have been prequalified by the World Health Organization: the inactivated hepatitis A vaccine Healive®, the Sabin-strain inactivated poliomyelitis vaccine (sIPV), and the live attenuated varicella vaccine.
SINOVAC has extensive experience in vaccine research, development and commercialization for emerging infectious diseases and public health emergencies. The Company initiated vaccine R&D in response to major public health threats, including SARS, H5N1, H1N1, and COVID-19, and developed the world's first inactivated SARS vaccine (with Phase I clinical trials completed), China's first inactivated pandemic influenza vaccine against H5N1 (Panflu®), the world's first H1N1 influenza vaccine (Panflu.1®), and CoronaVac®, the world's most widely used inactivated COVID-19 vaccine. Beyond its marketed portfolio, SINOVAC continues to advance its R&D pipeline, spanning combination vaccines, recombinant protein vaccines, mRNA technologies, antibody-based products, and other next-generation technologies and product platforms, while expanding its capabilities in disease prevention and biopharmaceuticals.
With a long-standing commitment to innovation and global health, SINOVAC continues to deepen collaboration with research institutions, international organizations, and local partners while expanding its global presence. Through technological collaboration, localized production, and industrial partnerships, the Company aims to improve access to high-quality vaccines across regions, better address local disease prevention and healthcare needs, and strengthen preparedness for future public health challenges.
For more information, please see the Company's website at www.sinovac.com.
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