SINOVAC Begins Phase I Trials of Bivalent Enterovirus Vaccine

2023-09-21

Vaccine is First to Target Both EV71 and CA16 Viruses, Boosting HFMD Prevention

September 21, 2023, Beijing, China – Sinovac Biotech Ltd. ("SINOVAC" or the "Company") (NASDAQ: SVA), a leading provider of biopharmaceutical products in China, today announced that the Company has initiated Phase I clinical trials of its bivalent enterovirus inactivated vaccine, which aims to protect against hand, foot and mouth disease (HFMD) caused by Enterovirus 71 (EV71) and Coxsackievirus 16 (CA16).

The clinical trials mark the first for this type of vaccine in China, which was approved in July 2023. The Phase I studies, held in Yunnan Province, have two parts: an open-label group involving 36 adults aged 18 to 59 years and 36 children aged 6 to 12 years; and a randomized, double-blinded, positive-control group of 72 children aged 6 to 71 months, to evaluate the safety and immunogenicity of this vaccine.

A lack of specific antiviral drugs makes vaccination one of the most effective weapons in the prevention of HFMD, a common childhood infection that can lead to serious complications. SINOVAC's inactivated EV71 vaccine, Inlive^®, which boasts a protective efficacy of 94.6% against EV71-associated diseases¹, was approved in China at the end of 2015. Since then, the HFMD cases from EV71 infections have dropped significantly in China, reducing the risk of severe illness and death.

Recognizing its efficacy, Indonesia also approved Inlive^® for market use in children aged 6 months to 3 years in November 2022.

However, the diverse nature of enteroviruses and limited cross-immunity means HFMD caused by CA16 remains challenging. As a result, there is a medical need for a multivalent vaccine that can provide more comprehensive protection against the disease.

Reference:

[1] Fengcai Zhu, Wenbo Xu, Jielai Xia, et al. Efficacy, safety, and immunogenicity of an enterovirus 71 vaccine in China [J]. N Engl J Med, 2014 Feb 27;370(9):818-28.

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.