March 20, 2025, Shanghai — Shanghai Reinovax Biologics Co., Ltd. and its wholly subsidiary Changchun Reinovax Biologics Co., Ltd. (collectively called "Reinovax") today announced the successful completion of the Phase II clinical trial for their 24-valent pneumococcal polysaccharide conjugate vaccine (PCV24). This trial was initiated on April 17, 2024, and conducted by the Jiangsu Provincial Center for Disease Control and Prevention (CDC) with the aim of assessing the safety and immunogenicity of PCV24 in adults aged 18 years and older after immunization. Results from the trial shows that the PCV24 vaccine has an excellent safety profile and robust immunogenicity after a single administration. The vaccine elicited strong immune responses against all 24 serotypes, meeting all predefined clinical objectives. The Phase II trial provides a strong scientific basis for advancing to a Phase III trial and underscores significant progress toward the industrialization development. The success of this trial further demonstrated the Reinovax's capability in developing high-valent pneumococcal conjugate vaccine.

The Phase II trial adopted a randomized, double-blind, parallel-controlled design, enrolling 992 healthy adult volunteers (100% recruitment and completion rate). Led by Jiangsu CDC along with the Xuzhou and Pizhou CDCs, the study evaluated the safety and immunogenicity on Day 30 post-vaccination.  

The PCV24 vaccine provides broad-spectrum protection against invasive diseases caused by 24 serotypes of Streptococcus pneumoniae. Compared to the marketed 13-valent pneumococcal polysaccharide conjugate vaccine (PCV13) and 23-valent pneumococcal polysaccharide vaccine (PPV23) in China, PCV24 provides expanded serotype coverage, superior immunogenicity, and durable immunological memory for effective protection against pneumococcal infection.  

Notably, Reinovax's PCV24 is the world's first 24-valent pneumococcal conjugate vaccine with non-toxic dual-carrier proteins. This innovative design with an intellectual property right enhances the safety profile and immunogenicity by mitigating the interference from carrier proteins, while maintaining a robust specific antibody response against all 24 type polysaccharides.

Pneumococcal infection remains a major global health burden, particularly among infants, the elderly and immunocompromised populations. According to the World Health Organization (WHO), pneumococcal diseases infect tens of millions of people annually, with significant morbidity and mortality. PCV24's development and commercialization will address critical gaps in serotype coverage and immunological efficacy with a significant impact on public health.  

Following the successful completion of the Phase II trial, Reinovax is expected to initiate a Phase III clinical trial toward the end of 2025 and looking for potential partners to expand in the overseas market.

About Reinovax  

Reinovax is a research-based and clinical-stage biotechnology company focusing on research and development of novel vaccines and protein biologics from the initial concept to the GMP manufacturing. The company has established an R & D center with core technology platforms in Zhangjiang, Shanghai, a GMP-like pilot production workshop in Lingang, Shanghai, and an EU/WHO GMP-compliant commercial manufacturing factory in Changchun, Jilin Province.