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SINOVAC EV71 Vaccine Receives GMP Certification from Malaysia's NPRA
BEIJING, March 19, 2025 – The Enterovirus Type 71 (EV71) inactivated vaccine, Inlive®, manufactured by SINOVAC, has received a Good Manufacturing Practice (GMP) certificate from the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia. As Malaysia is a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), the certification indicates that Beijing SINOVAC’s manufacturing and quality management system meets PIC/S GMP requirements, creating opportunities for Inlive® to enter broader international markets.
PIC/S is the only international cooperative organization composed of GMP inspectorates and regulatory authorities. Its standards are widely recognized in pharmaceutical manufacturing inspections. Several SINOVAC vaccines have previously passed on-site GMP inspections by PIC/S member authorities, including those from Turkey, Argentina, and Ukraine. The Malaysian GMP certificate adds to this record of international GMP compliance.
Inlive® is an EV71 vaccine independently developed by SINOVAC and was the world’s first preventive biological product of its kind. The launch of Inlive® has played an important role in reducing the incidence of EV71-associated hand, foot and mouth disease among children in China, particularly in lowering disease-related mortality. It has also significantly reduced the economic burden on both the government and patients.
In 2024, SINOVAC shipped its first batch of EV71 vaccine to Indonesia marking the start of international supply for the product. Following the Malaysian GMP certification, SINOVAC will have the opportunity to provide more high-quality vaccines to international markets, including Southeast Asia, and support the prevention and control of hand, foot and mouth disease in more countries.
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.