CanSinoBIO Advances Pneumococcal Disease Prevention Strategy with Initiation of Phase I/II Trial for PCV24

2026.05.25

Tianjin, China, May 25, 2026 — CanSino Biologics Inc. ("CanSinoBIO" or the "Company") today announced that its 24-valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197/Tetanus Toxoid) ("PCV24") has recently initiated Phase I/II clinical trials, with the first participant successfully enrolled. The milestone marks another important step forward in CanSinoBIO's development of higher-valency pneumococcal conjugate vaccines and further strengthens the Company's efforts to enhance comprehensive pneumococcal disease prevention.

Pneumococcal disease, caused by Streptococcus pneumoniae, remains a major global public health challenge¹. Epidemiological data show that more than 100 pneumococcal serotypes have been identified to date², all of which are potentially pathogenic. Pneumococcal disease is also a leading cause of morbidity and mortality among infants, young children, and older adults in China³. The World Health Organization has classified pneumococcal disease as a disease for which vaccination should be given the "highest priority."²

In recent years, evolving pneumococcal serotype distribution and the growing risk posed by serotypes not covered by existing vaccines have drawn increasing attention worldwide. As a result, the development of higher-valency pneumococcal conjugate vaccines has become an important focus of global vaccine innovation⁴.

In September 2025, CanSinoBIO officially launched iPneucia® (PCV13i), the Company's 13-valent Pneumococcal Polysaccharide Conjugate Vaccine. After more than a decade of research and development, the vaccine received approval from China's National Medical Products Administration in June 2025, becoming the first⁵ pneumococcal conjugate vaccine in China to adopt a dual-carrier technology utilizing both CRM197 and tetanus toxoid (TT).

The dual-carrier design helps reduce the risk of adverse reactions associated with excessive exposure to a single carrier protein and minimizes potential immune interference during co-administration with other vaccines, thereby further enhancing immunogenicity⁶. The vaccine also demonstrated targeted protective advantages⁷ against serotypes such as 19F, 19A, 7F, and 3, which contribute significantly to pneumococcal disease burden among Chinese children.

Building on this foundation, CanSinoBIO is further advancing the development of higher-valency pneumococcal conjugate vaccines. The investigational PCV24 received Clinical Trial Application approval in January 2026. Covering the major circulating pneumococcal serotypes, PCV24 adopts covalent conjugation between polysaccharide antigens and protein carriers while continuing to utilize the Company's dual-carrier technology platform. The vaccine is intended for individuals aged two months (minimum six weeks) and older to help prevent infectious diseases caused by 24 pneumococcal serotypes.

The ongoing Phase I/II study is a randomized, blinded, dose-escalation, positive-controlled clinical trial designed to evaluate the safety and immunogenicity of PCV24 in individuals aged two months (minimum six weeks) and above.

CanSinoBIO remains committed to addressing major infectious disease challenges through continued innovation in vaccine research and clinical development. The Company will continue advancing high-quality vaccine solutions to help expand disease prevention coverage and contribute to stronger public health protection worldwide.

References:

1.肺炎球菌性疾病免疫预防专家共识（2020版）

https://html.rhhz.net/zhlxbx/20201201.htm

2. 肺炎链球菌擅长“潜伏”，预防有招！,中国疾病预防控制中心传染病预防控制所

https://icdc.chinacdc.cn/zxxx/hydt/202412/t20241217_303327.html.

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

4.Fu J, Yi R, Jiang Y,et al. Serotype distribution and antimicrobial resistance of Streptococcus pneumoniae causing invasive diseases in China: a meta-analysis [J]. BMC Pediatr. 2019 Nov 11;19(1):424.

5."the first": CanSinoBIO is the first company to use CRM197 and TT carrier for the PCV13 vaccine currently, based on the available PCV13 vaccine or those submitted for market application.

6.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.

7."targeted protective advantages": According to current clinical data, the GMC level of iPneucia® is higher than that of the control group.

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