SINOVAC Receives NMPA Approval for Serum-Free Rabies Vaccine for Human Use

BEIJING, China, August 6, 2026 — SINOVAC announced that its Serum-Free Rabies Vaccine for Human Use has received a Drug Registration Certificate from China's National Medical Products Administration (NMPA) (Approval No. S20260060).

Developed using a serum-free and animal component-free manufacturing process, the vaccine is approved for both the conventional five-dose regimen and the reduced four-dose regimen, becoming the first serum-free rabies vaccine approved in China for the WHO-recommended reduced four-dose schedule[1].

Rabies is an acute zoonotic viral disease with an almost 100% case fatality rate once clinical symptoms develop[2]. Timely post-exposure prophylaxis (PEP), including rabies vaccination, remains the most effective measure for preventing disease following exposure[2].

Phase III Study Demonstrated Strong Immunogenicity and Favorable Safety[3]

The approval was supported by a randomized, double-blind, active-controlled Phase III clinical trial evaluating SINOVAC's rabies vaccine using the reduced four-dose post-exposure schedule.

The study demonstrated that:

· Neutralizing antibody seroconversion rates reached 100% at both 14 days after the first dose and three months after completion of the vaccination schedule.

· At six months after completion of vaccination, the seroconversion rate remained above 97.5%, compared with 96.47% for the control vaccine.

· The incidence of adverse events was comparable to that of the control vaccine, and no vaccine-related serious adverse events were observed.

The study results were published in the journal Vaccine in July 2026.

Serum-Free Manufacturing Platform

SINOVAC's Serum-Free Rabies Vaccine for Human Use is manufactured using ATCC-certified serum-free, animal component-free Vero cells (Vero-SF-ACF) and the rPV-2061 virus strain, together with fixed-bed bioreactor perfusion technology.

The manufacturing process is designed to exclude serum, preservatives, antibiotics, gelatin, and dextran throughout production, reducing exposure to animal-derived and other exogenous components.

Flexible Vaccination Schedules

In addition to the conventional five-dose regimen (Days 0, 3, 7, 14, and 28), the vaccine is also approved for the abridged four-dose regimen (Days 0, 3, 7, and 14–28) recommended by the World Health Organization. The reduced schedule may help simplify post-exposure vaccination while maintaining protection.

Expanding SINOVAC's Trauma Combination Products

The approval further strengthens SINOVAC's portfolio for trauma-related disease prevention and treatment.

The company has established active and passive immunization products targeting both rabies and tetanus. Its Tetanus Vaccine, Adsorbed is commercially available, while Serum-Free Rabies Vaccine for Human Use expands the active immunization portfolio. In passive immunization, SINOVAC's Anti-Rabies Cocktail Monoclonal antibody was approved in China in 2024, and the company's investigational Anti-Tetanus Toxin Monoclonal Antibody (SNA02-48) Injection is currently in clinical trials.

SINOVAC is also advancing the global development of its rabies vaccine through international collaborations, including a Product Development Partnership (PDP) project with the Government of Brazil and multiple international clinical studies in Pakistan.

The company will continue to address unmet public health needs by advancing innovative vaccines and biologics for the prevention and treatment of trauma-related infectious diseases.

References

[1] World Health Organization. Rabies vaccines: WHO position paper – April 2018. Vaccine. 2018;36(37):5500–5503.

[2] National Disease Control and Prevention Administration; National Health Commission of the People's Republic of China. Rabies Post-Exposure Prophylaxis Guidelines (2023 Edition). International Journal of Epidemiology and Infectious Disease,2023,50(05)：301-303. DOI:10.3760/cma.j.cn331340-20230919-00048

[3] Jing Y, Chang X, Jin Z, Yang F, Cai Y, Chen K, Liu S, Huang L, Li J. Immunogenicity and safety of serum-free rabies vaccine for human use with simulated post-exposure schedules: A randomized, double-blind, active-controlled phase III clinical trial. Vaccine. 2026 Jul 15;88:128914. doi: 10.1016/j.vaccine.2026.128914.

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.