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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 SINOVAC, 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 global biopharmaceutical company headquartered in China. Guided by its mission to “Supply Vaccines to Eliminate Human Diseases,” the Company is dedicated to the research, development, manufacturing and supply of vaccines and related biological products, providing vaccine products and related solutions for disease prevention and control worldwide.
SINOVAC has a diversified vaccine portfolio across multiple disease areas, including influenza, viral hepatitis, varicella, hand, foot and mouth disease (HFMD), poliomyelitis, rabies, tetanus, and pneumococcal disease. Three of SINOVAC's vaccines have been prequalified by the World Health Organization: the inactivated hepatitis A vaccine Healive®, the Sabin-strain inactivated poliomyelitis vaccine (sIPV), and the live attenuated varicella vaccine.
SINOVAC has extensive experience in vaccine research, development and commercialization for emerging infectious diseases and public health emergencies. The Company initiated vaccine R&D in response to major public health threats, including SARS, H5N1, H1N1, and COVID-19, and developed the world's first inactivated SARS vaccine (with Phase I clinical trials completed), China's first inactivated pandemic influenza vaccine against H5N1 (Panflu®), the world's first H1N1 influenza vaccine (Panflu.1®), and CoronaVac®, the world's most widely used inactivated COVID-19 vaccine. Beyond its marketed portfolio, SINOVAC continues to advance its R&D pipeline, spanning combination vaccines, recombinant protein vaccines, mRNA technologies, antibody-based products, and other next-generation technologies and product platforms, while expanding its capabilities in disease prevention and biopharmaceuticals.
With a long-standing commitment to innovation and global health, SINOVAC continues to deepen collaboration with research institutions, international organizations, and local partners while expanding its global presence. Through technological collaboration, localized production, and industrial partnerships, the Company aims to improve access to high-quality vaccines across regions, better address local disease prevention and healthcare needs, and strengthen preparedness for future public health challenges.
For more information, please see the Company's website at www.sinovac.com.