Abstract
INTRODUCTION.
The policy of friendly states aimed at achieving and maintaining the state sovereignty regarding drug safety is essential when forming Russian strategy of pharmaceutical development. Considering rapid advancement of biomedical technologies and the growing role of national regulatory frameworks, China’s experience in developing and launching innovative medicinal products to the local market is of interest.
AIM.
This study aimed to analyze the list of Class 1 medicinal products classified by National Medical Products Administration of China (NMPA) and developed by Chinese companies to treat serious and life-threatening conditions and registered in China in 2024, focusing on their potential first-in-class status, degree of innovation, key technological solutions, and potential clinical significance.
MATERIALS AND METHODS.
Medicinal products developed in China within the breakthrough therapy program and registered in 2024 according to NMPA data were assessed. The analysis included the 2024 NMPA report.
RESULTS.
Nine medicinal products first approved in China and developed by Chinese companies were identified that were registered as Class 1 medicinal products aimed at treating serious or life-threatening conditions. These included targeted therapies, immunotherapies, antibody–drug conjugates, and CAR-T cell therapies developed by Chinese manufacturers. For each product, the mechanism of action, process cha racteristics, availability of similar foreign preparations, and clinical evidence from approval trials were examined. One medicinal product (ivonescimab) may be classified as first-in-class, whereas the remaining products were categorized as next-in-class. For several products (ivonescimab, taletrectinib, and ciltacabtagene autoleucel), post-registration data indicated a potential best-in-class profile. The analysis highlights that the key process strategies were primarily aimed at enhancing target selectivity, overcoming resistance mechanisms, optimizing pharmacokinetic properties, and improving safety profiles.
CONCLUSIONS.
The findings demonstrate the emerging mature and structured model for the accelerated development of innovative medicinal products in China, characterized by a high potential for clinical impact. The obtained results may be of interest to Russian developers considering the current national programs aimed at achieving technological sovereignty in pharmaceutical development.