January 5, 2026, Tianjin— CanSino Biologics Inc.(CanSinoBIO) announced today that its 24-valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197/Tetanus Toxoid) (the “PCV24”) has received clinical trial approval from the National Medical Products Administration (NMPA). This progress represents a significant expansion of the CanSinoBIO's pneumococcal conjugate vaccine R&D pipeline and strengthens its high-valent pneumococcal vaccine portfolio.

Pneumococcal disease, caused by Streptococcus pneumoniae, remains a major global public health challenge¹. According to the World Health Organization (WHO), pneumococcal disease claims approximately 1.6 million lives annually, predominantly affecting infants and the elderly². Streptococcus pneumoniae is a leading cause of severe infections in children, including pneumonia, meningitis, and bacteremia, and also contributes to common diseases such as acute otitis media and sinusitis. In China, around 550,000 cases³ of pneumococcal pneumonia occur annually among children under five, with severe pneumococcal pneumonia accounting for 93% of all severe pneumonia cases⁴. Rising antibiotic resistance among pneumococcal strains further underscores the need for effective vaccination, which remains the most cost-effective and efficient preventive measure⁵.

In response to this public health need, CanSinoBIO has continuously advanced its pneumococcal vaccine research. On September 29, 2025, the company's 13-valent pneumococcal conjugate vaccine, iPneucia® (PCV13i), was officially launched. Following over a decade of research, PCV13i  became the first⁶ domestically approved pneumococcal conjugate vaccine in China using a dual-carrier system with CRM197 and tetanus toxoid (TT). The dual-carrier design reduces the risk of adverse reactions from single-carrier overexposure, minimizes immune interference with co-administered vaccines, and enhances overall immunogenicity⁷. It provides better protection against the four most burdensome serotypes in Chinese children: 19F, 19A, 7F, and 3⁸.

Building upon this technological foundation, CanSinoBIO has now advanced the development of high-valent pneumococcal vaccines. The Company's PCV24 covers the major prevalent pneumococcal serotypes currently in circulation. It adopts covalent conjugation method of polysaccharide antigens to protein carriers and a dual‑carrier technology. The vaccine is intended for vaccination in individuals aged 2 months (minimum 6 weeks) and above to prevent infectious diseases caused by 24 pneumococcal serotypes. This product has completed the production processes for the purified polysaccharides of the 24 serotypes and for the polysaccharide-protein conjugate drug substance, as well as the development and validation of the final product formulation.

The approval of PCV24 for clinical trials represents an important step in CanSinoBIO's pneumococcal conjugate vaccine pipeline. Looking ahead, the company will continue to focus on addressing unmet public health needs, advancing innovative vaccine research and development, contributing to the comprehensive prevention of pneumococcal disease, and accelerating the delivery of more innovative solutions to benefit broader populations.

References

1. Expert Consensus on Immunization against Pneumococcal Diseases (2020 Edition). https://html.rhhz.net/zhlxbx/20201201.html

2.WHO. Meeting of the Immunization strategic Advisory Group of Experts,  November2007一-conclusionsand recommendations [J]. weekly Epidemiology Record, 2008,83(1): 1-15.

3.The current situation, challenges and recommendations regarding the vaccination of pneumococcal conjugate vaccines | Innovation Lab for Vaccine Delivery Research | Duke Kunshan University

4.Lai X, Wahl B, Yu W, et al. National, regional, and provincial disease burden attributed to Streptococcus pneumoniae and Haemophilus influenzae type b in children in China: Modelled estimates for 2010-17 [J]. Lancet Reg Health West Pac. 2022 Mar 16;22:100430.

5.Streptococcus pneumoniae is good at "hibernation". There are ways to prevent it! . Institute of Infectious Disease Prevention and Control, Chinese Center for Disease Control and Prevention.

6."First": Among the currently available or submitted-for-approval PCV13 vaccines that can be found in the CDE database, CanSinoBIO is the first company to adopt a dual-vector process mainly using CRM197 and supplemented with TT.

7.Ladhani SN, Andrews NJ, Waight P, et al. Interchangeability of meningococcal group C conjugate vaccines with different carrier proteins in the United Kingdom infant immunisation schedule [J]. Vaccine 2015; 33:648-55.

8."Better Protection": Based on the current clinical data, the GMC level of iPneucia® is higher than that of the control group.

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