CDE Releases 2025 Annual Report on the Progress of Clinical Trials for New Drug Registration in China

On June 22, 2026, the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) published the "Annual Report on the Progress of Clinical Trials for New Drug Registration in China (2025)." Leveraging data from the national Drug Clinical Trial Registration and Information Disclosure Platform, the report offers a comprehensive look at the evolution of China’s clinical trial landscape.

It is important to note that this report tracks trial registrations, rather than final regulatory approvals or commercial launches. As such, it is best understood as a leading indicator of clinical development activity, R&D investment, and ecosystem capacity — not as a direct measure of near-term commercial success.

Ultimately, the findings reveal a maturing ecosystem characterized by faster trial execution, accelerating innovation, and intensifying competition. Crucially, that competition is now predominantly domestic: Chinese sponsors account for 93.0% of all registered trials. For International companies, this reframes China from a market to enter into a market to compete in from day one.

At a Glance

• Innovation accelerating: New drug clinical trials grew 18% in 2025, with Class 1 innovative drugs accounting for 72.4% of all new drug studies.
• Faster start-up: Average time from trial approval to first patient enrollment dropped to 6.8 months — an improvement of roughly four months compared to 2024.
• Intensifying competition: Oncology remains the dominant therapeutic area, where a dense early-stage pipeline is driving significant competition for patients, investigators, and market positioning.
• Growing global integration: International multicenter trials have nearly doubled since 2020, reaching 410 in 2025 and accounting for 13.7% of new drug clinical trials.
• Expanding capacity: An increasingly sophisticated network of trial sites allows for broader geographic distribution, moving beyond traditional hubs to facilitate more efficient patient recruitment.
• Domestic sponsors lead the market: Chinese sponsors account for 93.0% of all registered clinical trials, underscoring that the primary competitive pressure on international companies now comes from local players, not just market complexity.

China's Clinical Development Ecosystem Continues to Expand

Clinical trial activity reached a milestone in 2025, with 5,215 total registrations — a 6.4% year-over-year increase and the first time annual registrations exceeded 5,000.

More notably, the pace of innovation is outpacing general growth. New drug clinical trials surged 18.0% to 2,997 studies. Among these:

• Chemical drugs accounted for 1,668 trials
• Biologics accounted for 1,209 trials
• Traditional Chinese medicine for 120 trials

Class 1 drugs accounted for 2,171 new drug clinical trials, or 72.4% of the total. This supports the view that China’s clinical development environment is shifting toward higher levels of innovative R&D activity, particularly in chemical drugs and biologics.

Faster Trial Execution Improves Development Timelines

Operational efficiency saw significant gains in 2025. The average time from clinical trial approval to initial registration dropped to 65.5 days, while the timeline from new drug trial approval to the first informed consent form signed compressed to 6.8 months.

Remarkably, among new drug trials approved and initiated in the same year, 96.4% signed the first informed consent form within six months.

Time to First Patient Consent for New Drug Trials, 2025

Time to First Registration for New Drug Trials, 2025

While these improved timelines can accelerate evidence generation and facilitate the earlier integration of Chinese studies into global programs, success remains dependent on rigorous feasibility assessments, strategic site selection, and optimized project management.

China's Innovation Pipeline Remains Early Stage but Continues to Mature

The phase distribution of 2025 new drug clinical trials shows a pipeline that remains weighted toward early development:

• 1,168 Phase I trials (39.0%)
• 694 Phase II trials (23.2%)
• 631 Phase III trials (21.1%)
• 45 Phase IV trials (1.5%)

China's 2025 New Drug Popeline Remains Weighted Towards Early Development

The rise in Phase II studies, at the expense of Phase III, suggests a growing volume of assets advancing through proof-of-concept. This trend is even more pronounced for Class 1 innovative drugs:

• Phase I accounted for 42.7%
• Phase II made up 26.8%
• Phase III represented 15.4%

For international companies evaluating licensing, collaboration, or acquisition opportunities, this expansion provides a deep, albeit complex, pool of assets requiring thorough scientific and commercial due diligence.

Oncology Continues to Dominate

Oncology remained the dominant therapeutic area in China’s innovative drug pipeline. The report states that oncology accounted for 37.5% of Class 1 innovative drug clinical trials.

In this crowded field, clinical differentiation is now as critical as development speed. Sponsors must prioritize early assessments of biomarker strategies, investigator capacity, and patient recruitment dynamics.

Outside of oncology, the pipeline is increasingly diversified, showing strong activity in:

• Endocrine disorders
• Dermatology and sensory organ diseases
• Cardiovascular disease
• Neurology
• Vaccines
• Respiratory and allergic diseases

Cell and Gene Therapy Continues Rapid Growth

CGT trials grew nearly 30% in 2025, reaching 149 registrations. The field remains early-stage, with 55.0% of studies in Phase I and only four reaching Phase III. This rapid expansion highlights a growing appetite for advanced therapies, though sponsors must remain prepared for heightened regulatory scrutiny regarding manufacturing, product characterization, and safety monitoring.

International Development Expands Within a Rapidly Growing Market

International multicenter clinical trials (IMCTs) reached 410 studies in 2025, comprising 13.7% of all new drug trials — nearly double the count from 2020. Even against a market till overwhelmingly led by  domestic sponsors, this steady rise in IMCTs confirms that China is increasingly viewed as an essential node in global clinical development.

Geographically, while Beijing and Shanghai remain the primary hubs, nine provincial-level regions reported over 2,000 clinical participation instances. This geographic expansion offers sponsors increased flexibility to leverage scientific leadership at top-tier centers while utilizing regional sites to accelerate patient recruitment.

Strategic Takeaways

The 2025 CDE data underscores a fundamental shift in China’s clinical landscape. To remain competitive, companies should prioritize the following:

Integrate China Early

As the regulatory and operational environment continues to mature, China should no longer be treated as an afterthought. Incorporating local regulatory requirements, clinical practice nuances, and patient recruitment strategies into early protocol design is now essential for seamless global development.

Prioritize Differentiation

The rapid acceleration of innovation—particularly in biologics, oncology, and advanced therapies—is crowding the pipeline. In this environment, development speed alone is insufficient; sponsors must prioritize clinical differentiation and conduct rigorous competitive intelligence to ensure market viability.

De-Risk Through Due Diligence

With intensifying competition for investigators and patients, portfolio planning must move beyond high-level feasibility. Success now requires a granular assessment of investigator capacity, site saturation, and real-world recruitment dynamics in specific therapeutic areas.

Leverage Global Connectivity

The near-doubling of International Multicenter Trials (IMCTs) since 2020 confirms that China is a critical node in global drug development. Sponsors should align their global and local evidence-generation strategies to capitalize on this increased integration.

Final Thoughts

The 2025 CDE report confirms that China’s clinical ecosystem is growing in size, speed, and sophistication. The defining trend is not just the volume of activity, but China’s transition into an integral node in the global drug development network. To capitalize on this, pharmaceutical firms should shift to a mindset that proactively integrates China into global portfolio strategy.

Navigating this shift requires more than just a local presence; it demands deep expertise in aligning complex regulatory, clinical, and market access pathways. Cisema serves as a strategic partner in this process, providing integrated support across regulatory affairs, clinical development, and market access to help pharmaceutical companies synchronize their China development programs with their global objectives.

To discuss how these trends impact your development strategy, contact Cisema today.

Further Information

• Explore Cisema’s services for pharmaceutical consulting

References

• CDE issued the 2025 Annual Report on Clinical Trials for New Drug Registration in China