EN
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 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 (Paneflu®), 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.