The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) released its annual report on clinical trials in support of innovative drugs for the year 2024.
Key Figures
In 2024, the number of general drug clinical trial filings reached 4,900, marking a 13.9% increase compared to 2023 and setting a new record. Clinical trial filings for innovative drugs stood at 2,539, representing a 9.3% increase.
Breakdown by Drug Type
Clinical trials for chemical drugs accounted for 55.7% of filings, followed by biological products at 40.5%. A total of 1,735 trials were registered for Category 1 drugs, making up 68.3% of the total. Among these, chemical drugs accounted for 52.3%, and anti-tumor drugs accounted for 30.9%.
Growth in Specific Sectors
A total of 115 clinical trials for cell and gene therapy (CGT) products were filed in 2024, marking a 42.0% increase compared to 2023. Additionally, 23 clinical trials were registered in the fields of medical imaging and radiopharmaceuticals, the highest number in recent years. Clinical trials for rare diseases reached 121, while 114 trials focused on pediatric populations.
Efficiency Improvements
In 2024, the efficiency of clinical trial filing and implementation further accelerated. The average time required to complete initial clinical trial registration after approval (for IND trials) and after BE study filing was 67.4 days and 12.1 days, respectively. Among these, 39.1% of IND trials and 91.7% of BE studies achieved trial registration and submission within one month.-Fineline Info & Tech