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SINOVAC Initiated a Phase Ⅲ Clinical Trial on Bivalent Vaccine Against Hand Foot and Mouth Disease (HFMD)
The first phase III clinical trial on a multivalent HFMD vaccine in the world
December 16, 2024, Beijing, China – Sinovac Biotech Ltd. ("SINOVAC" or the "Company") (NASDAQ: SVA), a leading provider of biopharmaceutical products in China, today kicked off the enrollment for a Phase Ⅲ clinical trial on a vaccine candidate to prevent HFMD caused by both Enterovirus 71 (EV71) and Coxsackievirus 16 (CA16). Notably, no multivalent vaccines against HFMD have yet been approved for marketing worldwide.
The Phase III clinical trial is designed to be a multicenter, randomized, double-blind, controlled trial to evaluate the efficacy, safety and immunogenicity of this vaccine candidate in infants and young children aged 6 to 71 months.
SINOVAC has initiated a phase I/II clinical trial on its bivalent vaccine in China since September 2023. The results from Phase I/II clinical trial demonstrated that the vaccine candidate has favorable safety and immunogenicity.
HFMD can be caused by several enteroviruses, which often exhibit low cross-immunogenicity, leading to insufficient protection. HFMD mainly affects children under 5 years old, accounting for at least 90% of the total HFMD patients. To enhance protection for children, SINOVAC is committed to researching and developing multivalent vaccines that address protections against a broader range of dominant virus types. Based on these efforts, the Company has also developed the world's first tetravalent enterovirus inactivated vaccine which has recently been approved for clinical trials this December. This vaccine is aimed at preventing HFMD caused by EV71, CA16, CA10 and CA6.
Dedicated to providing comprehensive protection for children, SINOVAC will collaborate with partners to advance clinical research on both bivalent and tetravalent enterovirus inactivated vaccines, with the goal of making these vaccines available in the market as soon as possible.
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.