1类创新药

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去年我国新药临床试验数量再创新高
第一财经· 2025-06-20 07:36
Core Viewpoint - The report from the National Medical Products Administration (NMPA) indicates a significant increase in new drug clinical trial registrations in China, highlighting a growing trend in the pharmaceutical industry towards innovative therapies, particularly in cell and gene therapy, as well as pediatric drug development [1][2]. Summary by Sections Clinical Trial Registration Growth - In 2024, the number of new drug clinical trial registrations reached a record high of 4,900, marking a 13.9% increase from the previous year [1][2]. - The efficiency of initiating clinical trials has improved, with over 60% of trials obtaining the first informed consent within six months, and 70.2% for biological products [1]. Regional Concentration of Trials - The report notes a concentration of clinical trials in specific regions, with six areas having over 2,000 participating units, an increase from three regions the previous year. Guangdong Province led with 2,892 participations [3]. Focus on Metabolic Drugs - The competition in the development of metabolic drugs is intensifying, driven by the rising prevalence of sub-health populations, diabetes, and obesity. In 2024, 86 clinical trials for the top 10 chemical drugs were registered, accounting for 6.1% of the total [4]. Pediatric Drug Development - The number of clinical trials targeting pediatric populations has been increasing, with a focus on respiratory diseases, allergies, and preventive vaccines. The NMPA has established a special group for pediatric drug review to address the shortage of medications for children [9][10]. Rare Disease Drug Trials - Clinical trials for rare disease medications are also on the rise, with a stable focus on blood system diseases, neurological disorders, and anti-tumor drugs. In 2024, trials for blood system disease drugs accounted for nearly 30% of the total rare disease clinical trials [10]. Advances in Cell and Gene Therapy - There has been a notable increase in clinical trials for cell and gene therapy products, with the NMPA moving towards a more open regulatory environment for advanced therapies. This includes the potential inclusion of CAR-T and tumor vaccines as advanced treatment drugs [11].