20-valent pneumococcal polysaccharide conjugate vaccine approved for clinical trials.

AIM VACCINE (06660) announced that the group has developed an optimized and upgraded version of the 20-valent pneumococcal conjugate vaccine based on the 13-valent pneumococcal conjugate vaccine. The vaccine has recently obtained the Drug Clinical Trial Approval Notice issued by the National Medical Products Administration, allowing clinical trials to be conducted. Pneumococcal diseases are a serious global public health issue and a major cause of illness and death in Chinese children and adults. The clinical treatment of pneumococcal diseases mainly relies on antibiotics, but the increasing antibiotic resistance of pneumococci is becoming a serious problem. Therefore, it is necessary and urgent to use pneumococcal vaccines to prevent pneumococcal diseases and reduce bacterial resistance. Pneumococci are the main pathogen causing serious diseases such as pneumonia, meningitis, and septicemia in children, as well as common causes of acute otitis media and sinusitis. According to the WHO, in 2008, there were approximately 8.8 million deaths of children under 5 years old globally, with around 476,000 deaths attributed to pneumococcal infections. The latest study published in 2018 showed that approximately 294,000 children under 5 years old died globally from pneumococcal infections, with developing countries and regions having higher incidence and mortality rates than developed countries and regions, and most deaths occurring in Africa and Asia. Pneumococci are also a significant cause of illness and death in infants, young children, and the elderly in China. The top 10 countries with the highest number of cases of pneumococcal diseases in children under 5 years old are all in Africa and Asia, accounting for 66% of the total global cases, with China ranking second at 12% of the total global cases. In WHO's classification of diseases preventable by vaccines, pneumococcal diseases are considered "highly prioritized" for vaccination. Using the advantages of polysaccharide conjugate vaccine technology platform, the group has developed a series of iterative pneumococcal vaccine products through continuous technological innovation. This includes an optimized and upgraded iteration of the 20-valent pneumococcal conjugate vaccine based on the 13-valent pneumococcal conjugate vaccine, with the addition of 7 serotypes for a total of 20 serotypes, covering the main prevalent serotypes of pneumococci, to prevent invasive diseases caused by these serotypes (such as pneumonia, meningitis, septicemia, etc.). The vaccine is intended for vaccination in individuals aged 2 months and older (minimum 6 weeks old) to prevent infectious diseases caused by the 20 serotypes covered by the product. Currently, only Pfizer's Prevenar 20 has been approved for marketing overseas, with no similar vaccine products approved for marketing domestically. The approval of the clinical trial for the 20-valent pneumococcal conjugate vaccine marks a further enrichment and improvement of the group's R&D pipeline in the field of pneumococcal vaccines. In the future, the group will continue to focus on unmet clinical needs in core disease areas, promote the development of innovative vaccines, further enhance the company's innovation, core competitiveness, and comprehensive strength, and provide more safe and effective vaccine products to support global disease prevention and control efforts.