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

BEIJING--(BUSINESS WIRE)-- 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 biopharmaceutical company that focuses on the R&D, manufacturing, and commercialization of biomedical products that protect against human infectious diseases.

SINOVAC’s product portfolio includes vaccines against COVID-19, enterovirus 71 (EV71) infected hand-foot-mouth disease (HFMD), hepatitis A, varicella, influenza, poliomyelitis, pneumococcal disease, mumps, etc.

The COVID-19 vaccine, CoronaVac^®, has been approved for use in more than 60 countries and regions worldwide. The hepatitis A vaccine, Healive^®, passed WHO prequalification requirements in 2017. The EV71 vaccine, Inlive^®, is an innovative vaccine under “Category 1 Preventative Biological Products” and commercialized in China in 2016. In 2022, SINOVAC’s Sabin-strain inactivated polio vaccine (sIPV) and varicella vaccine were prequalified by the WHO.

SINOVAC was the first company to be granted approval for its H1N1 influenza vaccine Panflu.1^®, which has supplied the Chinese government's vaccination campaign and stockpiling program. The Company is also the only supplier of the H5N1 pandemic influenza vaccine, Panflu^®, to the Chinese government stockpiling program.

SINOVAC continually dedicates itself to pipeline development including but not limited to new technology, new vaccines as well as other biomedical products. We will constantly explore global opportunities of strategic expansion.

For more information, please visit the Company’s website at www.sinovac.com.

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Sinovac Biotech Ltd.

Helen Yang

Tel: +86-10-8279 9720

Email: ir@sinovac.com

Source: Sinovac Biotech Ltd.