BEIJING -- 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.