CanSino Biologics Inc. (hereinafter referred to as "CanSino Biologics") announced today that its independently developed 24 -valent pneumococcal polysaccharide conjugate vaccine ( CRM197/ tetanus toxoid, hereinafter referred to as "PCV24" ) has received the "Drug Clinical Trial Approval Notice" issued by the National Medical Products Administration, agreeing to conduct clinical trials for the product. This marks the continued expansion of CanSino Biologics' R&D pipeline in the field of pneumococcal conjugate vaccines, laying the foundation for further enriching its portfolio of high-valent pneumococcal vaccine products.

Pneumococcal disease is one of the most serious public health problems worldwide . ¹ World Health Organization (WHO) data shows that approximately 1.6 million people die globally each year from pneumococcal-related diseases, with infants and the elderly being the most affected groups . ² Streptococcus pneumoniae is a major pathogen causing serious diseases such as pneumonia, meningitis, and bacteremia in children, and is also a significant contributing factor to common diseases such as acute otitis media and sinusitis. Studies show that approximately 550,000 children under the age of 5 in China develop pneumonia caused by Streptococcus pneumoniae each year .³ Severe pneumococcal pneumonia accounts for as much as 93% of all severe pneumonia cases .⁴ Furthermore, with the widespread use of antibiotics, drug resistance in pneumococci is becoming increasingly prominent, further increasing the difficulty of disease control. Pneumococcal vaccination is widely recognized as the most economical and effective method for preventing pneumococcal disease . ⁵

Against this backdrop, CanSino Biologics continues to deepen its research and development of pneumococcal vaccines. On September 29, 2025, the company's independently developed 13-valent pneumococcal polysaccharide conjugate vaccine, Upexin® ( PCV13i ) , was officially launched. This product, developed over more than ten years, received approval from the National Medical Products Administration in June 2025, becoming China's first pneumococcal polysaccharide conjugate vaccine using a dual-vector technology of a non-toxic diphtheria toxin mutant (CRM197) and tetanus toxoid (TT). Through its dual-vector design, Upexin® effectively avoids the risk of adverse reactions that may result from excessive administration of a single vector, reduces immune interference when co-injected with other vaccines, and enhances immunogenicity , especially providing superior protection against the serotypes (19F, 19A, 7F, and 3) that pose the heaviest burden of pneumococcal disease in Chinese children .

Building upon its existing technological foundation, the company is further advancing the research and development of a high-valent pneumococcal conjugate vaccine. The PCV24 vaccine, which has now received clinical trial approval, covers the major circulating serotypes of pneumococcus. It utilizes a covalent binding method between polysaccharide antigens and protein carriers, along with dual-carrier technology, and is intended for vaccination in individuals aged 2 months (minimum 6 weeks) and older to prevent infectious diseases caused by 24 pneumococcal serotypes. The company has completed the development and confirmation of the production process for purified polysaccharides and polysaccharide-protein conjugate stock solutions for 24 serotypes, as well as the final product formulation.
The approval of PCV24 for clinical trials marks a further enrichment and improvement of CanSino Biologics' R&D pipeline in the field of pneumococcal conjugate vaccines. Moving forward, the company will continue to focus on unmet public health needs, advance innovative vaccine development, help improve the overall prevention and control of pneumococcal disease, and accelerate the dissemination of more innovative achievements to a wider population.

https://bydrug.pharmcube.com/news/detail/9e75ee9b89306cdf3a0738d977c87cb4