On October 22, 2025, Maxvax Biotechnology Co., Ltd. (“Maxvax”) announced that its wholly owned subsidiary, Shanghai Maxvax Biotechnology Co., Ltd., has officially initiated the Phase III clinical trial for its Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell). The first group of participants has been successfully enrolled in Xianning, Hubei Province.

RSV: The “Invisible Threat” to Public Health

Respiratory Syncytial Virus (RSV) is a single-stranded RNA virus that can infect individuals of all ages. Older adults are particularly at risk due to declining immunity and underlying health conditions, which significantly increase the likelihood of severe RSV disease. Infection can lead to serious lower respiratory tract infections, cardiac complications, and worsening of chronic conditions such as COPD, asthma, and chronic heart failure, sometimes resulting in pneumonia, hospitalization, or even death.

Studies have shown that RSV and influenza are major causes of respiratory infection–related mortality in older populations. According to research conducted in Guiyang between 2016 and 2020, the mortality rate of RSV infection in patients over 60 years old was 5.8%, higher than that of influenza, and hospitalized elderly patients infected with RSV had a 5.4-fold higher risk of death than those not infected.

RSV is characterized by high infectivity and a high rate of severe illness. Natural infection does not provide lasting immunity, and reinfection is common, making RSV a serious global public health concern. At present, no specific antiviral treatment for RSV is available, and clinical management primarily relies on supportive care. Therefore, vaccination is recognized as the most effective preventive measure. Vaccination, therefore, has become the most promising and preferred strategy for the prevention and control of RSV disease. However, no RSV vaccine has yet been approved for marketing in China.

Recombinant RSV Vaccine (CHO Cell): Innovation Driving Progress

The recombinant RSV vaccine developed by Maxvax is the first domestically developed RSV recombinant protein vaccine to receive clinical trial approval from China’s Center for Drug Evaluation (CDE). The vaccine uses a recombinant protein technology platform, with RSV Pre-F protein as the antigen, combined with the company’s proprietary MA103 adjuvant system. It is designed to prevent both lower and upper respiratory tract diseases caused by RSV, reducing morbidity and mortality in high-risk populations.

Results from Phase I and Phase II clinical studies have demonstrated excellent safety, tolerability, and immunogenicity. The Phase III study will be conducted in accordance with international and national regulatory guidelines, using a multicenter, randomized, double-blind, placebo-controlled design. A total of 25,000 eligible participants will be recruited across multiple clinical sites in China to further evaluate the vaccine’s safety, immunogenicity, and protective efficacy, providing key data to support future marketing authorization.

Collaborative Innovation Accelerating Translation

As China’s first RSV vaccine based on a recombinant protein platform, this clinical trial represents a complex and pioneering effort in design and implementation. Maxvax continues to leverage its leading adjuvant and recombinant protein technology platforms to optimize manufacturing processes, enhance product quality, and ensure safety.

The company collaborates with research institutions and medical centers nationwide to establish rigorous clinical trial protocols and quality control systems, ensuring full oversight throughout the trial process. Maxvax has also engaged domestic and international experts to provide technical guidance and solve challenges in real time, while maintaining close communication with regulatory authorities to ensure compliance and efficient progress.

Through deep integration of industry, academia, clinical research, and regulatory collaboration, Maxvax aims to accelerate the translation of scientific innovation into real-world health solutions—bringing effective, high-quality vaccines to protect public health as soon as possible.

About Maxvax

Maxvax is a global biopharmaceutical company dedicated to the research, development, manufacturing, and commercialization of innovative vaccines and novel adjuvants. Guided by the values of Integrity, Innovation, Collaboration, and Global Service, Maxvax is committed to addressing global public health challenges and delivering solutions for major infectious and chronic diseases.

The company focuses on developing innovative vaccines for humans and animals (including companion animals), powered by cutting-edge adjuvant, recombinant protein, and immune evaluation platforms. Maxvax has established a robust vaccine pipeline targeting infectious, allergic, and oncological diseases, with three vaccine candidates currently in clinical development.