AIM's 13-valent Conjugate Pneumonia Vaccine Obtains Production approval, and the Blockbuster Single-Item Market Registration is Formally Accepted

2024-11-15 Source:Securities Market Weekly

On November 15th, the Center for Drug Evaluation, NMPA showed that the market registration of AIM Vaccine's developed 13-valent conjugate pneumonia vaccine was formally accepted.


It is reported that AIM's 13-valent conjugate pneumonia vaccine adopts a single-carrier tetanus toxoid carrier technology route, which has higher yield compared to the diphtheria toxin carrier variant (CRM197) in the single-carrier protein route, and fewer production capacity factors compared to the dual-carrier route, possessing multiple competitive advantages.


In addition, according to announcements previously released by AIM, the company's 13-valent conjugate pneumonia vaccine is mainly used for infants and children aged 6 weeks to 5 years to prevent invasive diseases caused by the 13 serotypes of pneumonia included in the vaccine (including bacteremic pneumonia, meningitis, sepsis, and bacteremia). The vaccine has good immunogenicity and safety, achieving the preset clinical goals. Furthermore, its wholly-owned subsidiary, AIM Persistence Biopharmaceutical Co., Ltd., has obtained the corresponding drug production license to produce this product.


In addition to this vaccine, in the series of pneumonia vaccine products, the company has also developed a series of iterative and upgraded vaccines, including: the 23-valent pneumonia polysaccharide vaccine has completed the Phase III clinical trial site work and is about to undergo unblinding statistical analysis; the iterative 20-valent conjugate pneumonia vaccine has submitted a clinical trial pre-application, and the globally synchronized first research of the 24-valent pneumonia conjugate vaccine has completed pre-clinical research work.


Pneumonia is an inflammatory lung disease, usually caused by bacterial, viral, fungal, or other microbial infections, with bacterial pneumonia accounting for 80% of pneumonia infections in the human body, among which Streptococcus pneumoniae is an important pathogen. As early as 2008, the WHO had classified pneumococcal disease as a disease that requires "extremely high priority" for prevention using vaccines.


According to Pfizer's 2023 annual report, Pfizer's conjugate pneumonia vaccine had global sales of about $6.44 billion in 2023. In addition, the penetration rate of the 13-valent conjugate pneumonia vaccine in the approved age group in China is estimated to be 25.9%, while the corresponding age group in the United States has a penetration rate of over 80%, indicating a huge upward space in the Chinese market. The domestic sales of this product in 2022 were about 9.5 billion yuan, and according to China Insights Consultancy (CIC)'s forecast, the market size is expected to reach 35 billion yuan by 2030.