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SINOVAC's Hepatitis A and B Combined Vaccine Bilive® Is Relaunched in China
BEIJING, July 25, 2025 – Bilive®, the only hepatitis A and B combined vaccine approved in China, received a drug re-registration approval notice on July 21, 2025. Manufactured by Beijing Sinovac Biological Products Co., Ltd., the vaccine provides a consolidated immunization option against both hepatitis A and hepatitis B viruses as global health initiatives work toward the elimination of viral hepatitis as a public health threat by 2030.
Bilive® is manufactured by cultivating the TZ84 hepatitis A virus strain in 2BS human embryonic lung diploid cells. The viral harvest is purified, inactivated, and adsorbed onto an aluminum adjuvant before being combined with recombinant hepatitis B surface antigen (HBsAg) expressed in yeast.
The vaccine is available in two formulations:
Pediatric Formulation: For non-immune children and adolescents aged 1 to 15 years (inclusive)who are at risk of infection.
Adult Formulation: For non-immune adults and adolescents aged 16 and older (inclusive) who are at risk of infection.
Research data supports flexible clinical applications for Bilive®:
Booster Immunization: A single booster dose of Bilive® significantly elevates antibodylevels for both hepatitis A and B in individuals who have previouslycompleted their full primary vaccination series for both viruses. 1
Primary and Supplemental Response: For individuals without prior hepatitis Avaccination, a two-dose schedule of Bilive® effectively establishesimmunity against hepatitis A while simultaneously increasing hepatitis Bantibody titers. 2
References
Chen Y, Yao J, Liang X, et al. Evaluation of the boosterimmunization effect of combined hepatitis A and B vaccine in children. ChineseJournal of Preventive Medicine. 2012;13(4):256-259.
Wang Y, Chen W, Xu W, et al. Safety and immunogenicityof a combined hepatitis A and B vaccine administered on a 0- and 6-monthschedule in children. Chinese Journal of Preventive Medicine.2010;44(2):154-156.
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 (Panflu®), 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.