In June 2025, China’s Center for Drug Evaluation (“CDE”), which is one of the specialized product centers affiliated with China’s chief drug regulator, the National Medical Products Administration (“NMPA”), released a report titled “Annual Report on the Progress of Clinical Trials for New Drug Registration in China (2024).” The report presents data on clinical trials in China in the past year, including the number of trials for different types of products (small molecule drugs, biologics, and traditional Chinese medicinal products), different disease areas, and different phases of trials. The report also analyzes the geographical distribution, implementation status, and quality control of clinical trials in China. According to CDE, the release of the report is to “showcase the current status of clinical trials for new drug registration in China, further enhance the transparency of clinical trials, and provide scientific reference for new drug research and development and review and approval.”
Below we highlight several key takeaways from the report.
First, the number of clinical trials registered in China continue to increase. In 2024, 4,900 clinical trials were registered in China, a 13.9% increase from 2023. Of those, 2,539 (51.8%) clinical trials were for innovative drugs, an increase of 9.3% from 2023. This is consistent with other reports that China is becoming one of the most popular sites for clinical trials in the world.[1]
Second, clinical trials for new-to-the-world product candidates make up the majority of clinical trials for innovative drugs registered in 2024. Of the 2,539 clinical trials on innovative drugs, 1,735 (68.3%) were for category 1 applications, i.e., applications for small molecule drugs or biologics that have not been approved anywhere in the world. In addition, of the 2,539 innovative drug trials registered in China in 2024, 337 (13.3%) of them were multi-regional clinical trials.
Third, oncology is the top disease area of innovative drug trials registered in China in 2024. Of the 1413 clinical trials for innovative small molecule drugs, 349 (24.7%) were on oncology drugs. Similarly, of the 1029 clinical studies for innovative biologics, 444 (43.1%) were for oncology medicines.
Fourth, there is a significant increase in the number of cell and gene therapy clinical trials. In 2024, 115 clinical trials for cell and gene therapy drugs were registered, an increase of 42.0% compared to 2023.
Finally, CDE has not ordered the pause or termination of any clinical trial in 2024. All pauses or terminations of clinical trials in 2024 were voluntary.
[1] See, e.g., World Health Organization, Number of clinical trials by year, country, WHO region and income group (1999-2024), https://www.who.int/observatories/global-observatory-on-health-research-and-development/monitoring/number-of-clinical-trials-by-year-country-who-region-and-income-group.
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Contributors for the China & APAC Food, Drug, Device, and Cosmetics blog:
John Balzano, Julia Post, Muyun Hu, Kaixin Fan, and Kexin Yang.