NEWS
13-VALENT PNEUMONIA CONJUGATE VACCINE: PHASE III CLINICAL TRIALS COMPLETED, PRODUCTION LICENSE OBTAINEDAND APPLICATION FOR DRUG MARKETING REGISTRATION DULY SUBMITTED
The application for drug marketing registration of the Group’s independently developed 13-valent pneumonia conjugate vaccine has been submitted to the National Medical Products Administration on October 31, 2024.
According to the results of the Phase III clinical trials that has completed unblinding, the Group’s 13-valent pneumonia conjugate vaccine has good immunogenicity and safety and has met the pre-defined clinical objectives. In addition, AIM Persistence Biopharmaceutical Co., Ltd., a wholly-owned subsidiary of the Group, has obtained the requisite drug production license for manufacturing the product.
According to the classification of the World Health Organization, pneumococcal disease is one of the diseases with very high priority use of vaccines for prevention. The 13-valent pneumonia conjugate vaccine is mainly used in infants and children aged 6 weeks to 5 years old to prevent invasive diseases caused by 13 pneumonia serotypes (including bacteremia pneumonia, meningitis, septicemia and bacteremia) included in the vaccine. According to Pfizer’s 2023 annual report, Pfizer’s global sales of the pneumonia conjugate vaccine in the year of 2023 was approximately USD6,440 million. In addition, the estimated penetration rate of the 13-valent pneumonia conjugate vaccine in the approved age group in China is 25.9%, while the penetration rate in the corresponding age group in the United States exceeds 80%, indicating that there is still significant room for growth in the Chinese market. Domestic sales of the product in 2022 was approximately RMB9,500 million. According to the forecast of China Insights Industry Consultancy Limited, it is expected that the market size of the product will reach RMB35,000 million in 2030.
Prior to the outbreak of the COVID-19 pandemic, the product had been the world’s top-selling vaccine for ten consecutive years. Based on the estimation of authoritative organizations, the global underserved demand for the 13-valent pneumonia conjugate vaccines is as high as 180 million doses. However, currently, only three companies have been approved to supply them globally. The Group will become an important supplier in the market after the launch of this product, which will significantly enhance the Company’s performance.
According to the results of the Phase III clinical trials that has completed unblinding, the Group’s 13-valent pneumonia conjugate vaccine has good immunogenicity and safety and has met the pre-defined clinical objectives. In addition, AIM Persistence Biopharmaceutical Co., Ltd., a wholly-owned subsidiary of the Group, has obtained the requisite drug production license for manufacturing the product.
According to the classification of the World Health Organization, pneumococcal disease is one of the diseases with very high priority use of vaccines for prevention. The 13-valent pneumonia conjugate vaccine is mainly used in infants and children aged 6 weeks to 5 years old to prevent invasive diseases caused by 13 pneumonia serotypes (including bacteremia pneumonia, meningitis, septicemia and bacteremia) included in the vaccine. According to Pfizer’s 2023 annual report, Pfizer’s global sales of the pneumonia conjugate vaccine in the year of 2023 was approximately USD6,440 million. In addition, the estimated penetration rate of the 13-valent pneumonia conjugate vaccine in the approved age group in China is 25.9%, while the penetration rate in the corresponding age group in the United States exceeds 80%, indicating that there is still significant room for growth in the Chinese market. Domestic sales of the product in 2022 was approximately RMB9,500 million. According to the forecast of China Insights Industry Consultancy Limited, it is expected that the market size of the product will reach RMB35,000 million in 2030.
Prior to the outbreak of the COVID-19 pandemic, the product had been the world’s top-selling vaccine for ten consecutive years. Based on the estimation of authoritative organizations, the global underserved demand for the 13-valent pneumonia conjugate vaccines is as high as 180 million doses. However, currently, only three companies have been approved to supply them globally. The Group will become an important supplier in the market after the launch of this product, which will significantly enhance the Company’s performance.
