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

Update: Read our summary of the 2025 Annual Report on the Progress of 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.

Planning a Clinical Trial in China? Contact Cisema to develop a tailored clinical trial strategy, assess regulatory requirements, and navigate China’s clinical development pathways.

Clinical Trial Activity in China

A total of 4,900 clinical trials were registered in China in 2024, representing a 13.9% increase from 2023.

Of these:

• 2,539 trials (51.8%) were associated with new drug applications
• 2,361 trials (48.2%) were bioequivalence (BE) studies

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%

Clinical Trial Phases

Phase I trials accounted for the largest share of clinical trials in 2024, at 46.9%, followed by:

• Phase II: 22.6%
• Phase III: 17.2%

Phase II and Phase III activity both increased modestly compared with the previous year, indicating continued progression of drug candidates into later-stage clinical development.

Leading Therapeutic Areas and Emerging Trends

The CDE report identifies several therapeutic areas with particularly strong clinical development activity.

Oncology Remains the Leading Indication

Oncology continued to dominate Class 1 innovative drug trials, accounting for 39.0% of the total.

Biological products had a particularly strong presence in oncology, accounting for 50.1% of trials compared with 30.9% for chemical drugs.

Cell and Gene Therapy Trials Continue to Expand

Cell and gene therapy (CGT) trials increased by 42.0% in 2024, with 115 new trials registered.

These included:

• 62 cell therapy trials
• 38 gene therapy trials

CGT development remained concentrated in early-stage research, with 56.5% of trials in Phase I. Key indications included oncology, hematology, and neurological diseases.

Metabolic Diseases Gain Momentum

Clinical development for metabolic disorders also increased. Semaglutide injections were the most frequently studied compound in this area, with 29 trials registered across chemical and biological drug categories.

Clinical Trials for Special Populations

The report also highlights continued development of therapies for pediatric patients and people with rare diseases.

Pediatric Clinical Trials

A total of 114 pediatric-specific clinical trials were registered in 2024, accounting for 4.5% of new drug trials.

Phase III studies represented 43.9% of pediatric trials, reflecting substantial activity in later-stage development. Regulatory initiatives, including dedicated review pathways and technical guidance, have helped support clinical research for pediatric medicines.

Rare Disease Clinical Trials

China registered 121 rare disease clinical trials in 2024. Hematological, neurological, and oncology indications accounted for 63.6% of these studies.

During the same period, the NMPA approved 55 rare disease drugs, including:

• 20 approved through priority review
• 2 approved through conditional approval pathways

These figures demonstrate the continued regulatory focus on addressing unmet medical needs in rare diseases.

Clinical Trial Implementation and Timelines

The CDE report also provides benchmarks for the operational implementation of clinical trials.

Time to First Trial Registration

The average time between approval and first trial registration was:

• New drug trials: 67.4 days
• BE trials: 12.1 days

First Informed Consent Within Six Months

The proportion of trials in which the first informed consent was signed within six months was:

• All trials: 65.5%
• Trials initiated in the same year: 96.9%

These metrics provide useful reference points for sponsors planning clinical development timelines and trial implementation in China.

What the 2024 Data Mean for Drug Developers in China

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.

Need clarity on timelines, costs, or compliance for China market entry? Cisema supports pharmaceutical companies with regulatory consulting, clinical trial strategy, and drug registration services across the Chinese market. Contact Cisema today to discuss a tailored market-entry strategy.

Further Information

• Explore Cisema's services for pharmaceutical consulting in China.
• Learn about how Cisema supports Clinical Development in China and the broader Asia-Pacific.
• Read our summary of the 2025 Annual Report on the Progress of Clinical Trials for New Drug Registration in China.
• ‍CDE 2024 Report: Drug Registration and Regulatory Trends A comprehensive analysis of the CDE’s 2024 annual report, highlighting clinical trial application trends, innovative drug approvals, and regulatory priorities in China.‍
• New CDE Guidelines for Clinical Trials in China Overview of the latest technical guidelines for clinical trial design and pharmacology studies, shaping the regulatory framework for innovative therapies.

References

The full report is available via the CDE website.