On January 23rd, Maxvax announced the successful enrollment and vaccination of all subjects in the Phase II clinical trial for its recombinant respiratory syncytial virus (RSV) vaccine (CHO cell) at the Disease Control and Prevention Center in Liangyuan District, Shangqiu City, Henan Province. This marks the first domestic RSV vaccine to enter Phase II clinical trials in China.

The Phase II clinical trial is a single-center, randomized, double-blind, controlled study designed to evaluate the safety and immunogenicity of two doses of the vaccine candidate in the target population, as well as to provide supportive data for selecting the Phase III dose. The clinical trial began on November 13, 2024, with safety assessments completed for both doses across two age groups. Blinded safety data collected 30 days post-inoculation confirmed that the vaccine was as safe as expected, supporting the continuation of the Phase II clinical trial. In just three months, Maxvax’s RSV vaccine research has progressed from the initiation of Phase I to the enrollment in Phase II, showcasing the “speed of Maxvax.” Moving forward, Maxvax will focus on preparing for the Phase III clinical trial, which is expected to begin in 2025. This trial will evaluate the safety and efficacy of this vaccine candidate.

Dr. Dexiang Chen, founder and CEO of Maxvax, said, “We would like to sincerely thank all the participants, investigators, and partners who contributed to this clinical trial. Their unwavering support and hard work have been crucial in helping us reach this important milestone. We remain committed to our scientific, rigorous, and pragmatic approach as we continue to advance the clinical trial of the RSV vaccine and work towards bringing the product to market as soon as possible. Our goal is to provide a safe and effective solution for global RSV prevention and control at the earliest opportunity.”

About Maxvax

Maxvax is a global biopharmaceutical company dedicated to the research, development, production, and commercialization of innovative vaccines and novel adjuvants. Guided by the values of “Integrity, Innovation, Collaboration, and Global Service,” the company’s vision is to “address global public health challenges and provide solutions for the prevention and control of major diseases and infectious diseases.” Focusing on the development of innovative human and veterinary (including pet) vaccines, Maxvax leverages world-leading novel adjuvants, recombinant protein platforms, and immunoassay technologies. The company has built a robust pipeline of groundbreaking vaccines targeting infectious and allergic diseases, as well as oncology, with three of these vaccine candidates already advancing into clinical trials.