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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 Beijing Sinovac Biological Products Co., Ltd., a subsidiary of 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 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.