CDE Releases 2024 Annual Report on Clinical Trials for New Drug Registration in China

On June 19, 2025, China’s Center for Drug Evaluation (CDE) released its annual report on clinical trial progress, drawing on data from 4,900 studies registered in 2024. The report highlights activity across therapeutic areas, emerging trends, and key regulatory milestones, offering a clear snapshot of how China’s drug development landscape continues to evolve.

Trial Activity and Composition

The total number of clinical trials registered in 2024 reached 4,900, reflecting a 13.9% increase compared to 2023. Of these, 2,539 trials were associated with new drug applications (51.8%), while 2,361 trials were bioequivalence (BE) studies (48.2%).

Drug Categories and Registration Classifications

Chemical drugs continued to dominate the trial landscape, accounting for 76.9% of all registrations. Biological products represented 21.1%, and traditional Chinese medicine (TCM) accounted for 2.0%.

Among new drug trials, Class 1 innovative drugs remained the leading registration category, comprising 68.3% of the total. Within this group:

Chemical drugs represented 52.3%
Therapeutic biologics accounted for 79.0%
Preventive biologics accounted for 46.3%

Trial Phases

Phase I trials made up the largest share at 46.9%, followed by Phase II (22.6%) and Phase III (17.2%). Both Phase II and III trials showed modest increases compared to the previous year, indicating gradual progression toward later-stage development.

Therapeutic Focus Areas

The report highlights several areas of concentrated activity:

Oncology remained the leading indication, accounting for 39.0% of Class 1 trials. Biologics were more heavily represented in this area than chemical drugs (50.1% vs. 30.9%).
Cell and Gene Therapy (CGT) trials increased by 42.0%, with 115 new trials registered. These included 62 cell therapy and 38 gene therapy products. Most trials were early phase (56.5% in Phase I), with indications focused on oncology, hematology, and neurology.
Metabolic disorders saw increased activity, with semaglutide injections emerging as the most frequently studied compound (29 trials across chemical and biologic categories).

Special Populations

Pediatric trials: 114 trials were specifically designed for pediatric populations, representing 4.5% of new drug trials. Phase III trials accounted for 43.9% of these. Regulatory measures, including dedicated review pathways and guidance documents, have supported this growth.
Rare disease trials: 121 trials were registered, with hematological, neurological, and oncological indications comprising 63.6%. The NMPA approved 55 rare disease drugs, including 20 via priority review and 2 with conditional approval.

Operational Timelines

The report also includes metrics on trial implementation:

Average time to first trial registration post-approval:
- New drug trials: 67.4 days
- BE trials: 12.1 days
First informed consent signed within 6 months:
- All trials: 65.5%
- Trails initiated in the same year: 96.9%

The 2024 data reflect continued expansion in China’s clinical trial infrastructure, with concentrated activity in oncology, CGT, and pediatric indications. While the report is descriptive in nature, it provides relevant benchmarks for sponsors and stakeholders evaluating trial feasibility, regulatory timelines, and therapeutic alignment in the Chinese market.

Further Information

Read the official announcement about the Annual Report on the Progress of Clinical Trials for New Drug Registration in China (2024) published by the Center for Drug Evaluation (CDE) here.

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The full report is available via the CDE website.