SINOVAC's Hepatitis A Vaccine Healive^® Approved in Kyrgyzstan

February 8, 2023, Beijing, China – Sinovac Biotech Ltd. ("SINOVAC" or the "Company") (NASDAQ: SVA), a leading provider of biopharmaceutical products in China, announced that its inactivated hepatitis A vaccine, Healive^® has been approved by the Ministry of Health of the Kyrgyz Republic, the company's first direct authorization of a vaccine for market use in Kyrgyzstan.

The approval adds a powerful tool to the nation's fight against hepatitis transmission and infection. Once named a focus country for viral hepatitis by the World Health Organization (WHO), Kyrgyzstan has since taken measures to prevent and control the infectious disease. Hepatitis B vaccine has been included in Kyrgyzstan's national vaccination schedule since 2000, but hepatitis A vaccine is only available in the private sector for self-purchase.

According to the Department of Disease Prevention and State Sanitary and Epidemiological Surveillance, the first three quarters of 2022 saw a notable rise in reported cases of acute viral hepatitis in Kyrgyzstan. From January to September, 1,501 acute viral hepatitis cases were registered, a 25% increase compared to the same period in 2021.

Out of those cases, 1,388 hepatitis A cases contributed to 92.5% of the total incidences during that time frame, representing a year-on-year increase of 29%. A more accessible supply of hepatitis A vaccines in Kyrgyzstan will ensure local communities are better protected and will build on the country’s success lowering transmission as the dominant cause of viral hepatitis cases.

Healive^®, a SINOVAC flagship product, is the first and only hepatitis A vaccine from China pre-qualified by the WHO. It offers sustained protection for at least 30 years after full-course immunization, based on statistical modeling¹.

The vaccine has been registered in 23 countries and organizations around the world, including Kyrgyzstan, and is currently authorized for administration in more than 30 countries and areas.

Healive^® and SINOVAC's varicella vaccine, another WHO prequalified vaccine, can be administered simultaneously to children 1 year of age, to enhance vaccination efficiency and save cost and time for parents and doctors. According to a recent study², delivering the doses together offers additional benefits by reducing pain and establishing earlier immunity. 

Reference:

1.Yu, YP, Chen, JT, Jiang, ZW, et al. Modeling the Long-term Antibody Response and Duration of Immune Protection Induced by an Inactivated, Preservative-free Hepatitis A Vaccine (Healive) in Children. BIOMED ENVIRON SCI. 2020; 33 (7): 484-492. doi: 10.3967/bes2020.065

2. Dapeng Sun, Dan Yu, Zhenhua Du, Ningning Jia, Xiaodong Liu, Jianwen Sun, Qing Xu, Zhuoqun Sun, Chunfang Luan, Jingjing Lv, Ping Xiong, Li Zhang, Xueyan Sha, Yongjun Gao, and Dianmin Kang. Immunogenicity and safety of a live attenuated varicella vaccine co-administered with inactive hepatitis A vaccine: A phase 4, single-center, randomized, controlled trial. HUMAN VACCINES & IMMUNOTHERAPEUTICS 2022; doi: 10.1080/21645515.2022.2161789

About SINOVAC

Sinovac Biotech Ltd., (SINOVAC) is a China-based biopharmaceutical company that focuses on the R&D, manufacturing, and commercialization of vaccines 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, and mumps.

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 was 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 new vaccine R&D, with more combination vaccine products in its pipeline, and constantly explores global market opportunities. SINOVAC plans to conduct more extensive and in-depth trade and cooperation with additional countries, and business and industry organizations.

For more information, please see the Company's website at www.sinovac.com.

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