Beyond trial volume: What China’s clinical trial data signal for global development planning

Insights from the CDE’s 2025 annual report on clinical trial activity, multi-regional clinical trial participation and lifecycle-based evidence planning.

China’s Center for Drug Evaluation (CDE) recently released its Annual Report on the Progress of Clinical Trials for New Drug Registration in China (2025), providing a detailed view of one of the world’s most active clinical research environments. According to the report, the total number of registered drug clinical trials in China exceeded 5,000 for the first time in 2025, reaching 5,215 studies, an increase of 6.4% compared with 2024. Among these, 2,997 were new drug clinical trials, accounting for 57.5% of the total and representing an 18% year-over-year increase.

Beyond the overall increase in trial volume, the report highlights several signals that are highly relevant for sponsors planning multi-market development:

• Continued growth in innovative drug trials
• Improved trial registration and start-up efficiency
• Increasing participation in international multicenter trials
• Greater operational complexity across sites, regions and stakeholders

Taken together, these developments suggest that China is evolving from a high-volume clinical trial location into an increasingly important contributor to globally coordinated evidence generation. For sponsors, the strategic question is no longer simply how quickly studies can be conducted in China, but how China-generated evidence can support regulatory decision-making and product development across multiple markets.

China’s clinical development landscape is becoming more innovation-oriented

The 2025 CDE report reinforces the continued maturation of China’s clinical research environment. Among the 2,997 new drug clinical trials registered, 2,171 trials involved Class 1 drugs, accounting for 72.4% of all new drug clinical trials. This proportion underscores that innovation—not volume alone—is increasingly driving clinical development activity in China.

Oncology remained a major driver, with antineoplastic therapies representing 37.5% of Class 1 innovative drug trials. Activity also continued across other specialized and high-demand therapeutic areas, such as neuroscience, metabolic and endocrine, reflecting a broader and more diversified development landscape.

Advanced modalities are gaining momentum as well. In 2025, 149 clinical trials of cell and gene therapy drugs were registered, representing a 29.6% increase compared with 2024. Trials in pediatric populations, rare diseases, medical imaging and radiopharmaceuticals remained relatively stable, indicating a broader clinical development landscape that includes both high-growth innovation areas and specialized patient populations.

Taken together, the data points to a clinical research environment that is becoming more active, more diversified and more innovation oriented. China is increasingly a market where advanced modalities, specialized indications and global development considerations intersect.

As more innovative assets originate in China, and as more multinational programs incorporate China into global development strategies, clinical trial design can no longer be viewed only through a local or operational lens. Sponsors need to consider how China-generated evidence will contribute to the broader evidence package across regions, indications and lifecycle stages, ensuring that local execution is aligned with global development objectives.

Faster start-up timelines are reshaping development planning

The CDE report also points to continued improvement in trial registration and start-up efficiency. Among new drug trials in China for which the first subject informed consent form was signed in 2025, the average initiation time fell to 6.8 months, four months shorter than in 2024. Nearly three quarters of trials had the first informed consent signed within six months.

As development timelines compress and trial activation gains efficiency, clinical operations are becoming more closely linked to evidence-generation planning. Sponsors need to consider not only how quickly a study can be initiated, but also how the study will support the overall development program, how its data will be interpreted across regions, and how operational execution will affect regulatory readiness.

This is particularly important for programs that span multiple countries or are intended to support submissions in more than one market. Efficient execution must be matched by scientific alignment, data consistency and regional relevance. In this sense, clinical development efficiency is becoming part of a broader integrated development capability.

Multi-regional clinical trial growth highlights the need for earlier regional evidence planning

China’s participation in international multicenter development also continues to expand. In 2025, 410 new drug clinical trials registered in China were international multicenter trials, accounting for 13.7% of the total and involving more than 70 countries and regions outside China. Compared with 2020, the number of international multicenter trials nearly doubled.

This growth reflects a broader shift in China’s role in global development. China is no longer only a location for clinical trial execution; it is increasingly part of global evidence strategy.

For China-involved multi-regional clinical trials (MRCTs), sponsors should assess early whether global protocol assumptions fit Chinese patients, clinical practice, standards of care and regulatory expectations. Key design questions include whether the enrolled population is regionally representative, whether endpoints and comparators reflect local clinical practice, and whether the statistical plan can support interpretation of regional consistency.

This direction aligns with ICH E17 principles, which call for prospective consideration of regional factors in the design, conduct and interpretation of MRCTs. In practice, this means China-related development decisions should be considered early, rather than addressed as late-stage regional adaptations.

Regulatory expectations are reinforcing integrated evidence planning

Recent regulatory developments point in the same direction. ICH E17 emphasizes early planning for regional factors in MRCTs, while recent CDE guidance on MRCT-based benefit–risk assessment and clinical evaluation encourage sponsors to design trials within an overall global development strategy.

The practical message is that clinical trials should not be planned as isolated studies. Each trial should have a clear role in the broader evidence package, including how its data will support benefit–risk assessment in target markets.

Together with ICH E6(R3)’s emphasis on quality by design and risk-proportionate quality management, these expectations point to earlier integration of scientific, regulatory and operational planning. Decisions on protocol design, endpoint selection, regional enrollment, statistical planning and operational execution are becoming increasingly interconnected.

Integrated global development is becoming a strategic capability

As clinical development becomes more global, complex and data-driven, whether an asset originates in China, North America, Europe or elsewhere, the central challenge has shifted from executing individual clinical trials efficiently to designing integrated development programs that can generate evidence acceptable across markets.

Key capabilities and considerations include:

• Global regulatory and evidence strategy
• MRCT design and regional data interpretation
• Data quality, governance and traceability
• Coordinated clinical, laboratory, biomarker and operational execution
• Early alignment across clinical, CMC, supply chain and commercialization planning

Integrated development also requires earlier cross-functional alignment. Clinical decisions can influence biomarker strategy, laboratory operations, drug supply and statistical planning. Regulatory strategy can affect regional enrollment assumptions, comparator selection and the timing of agency engagement. CMC and supply chain readiness can determine whether global development timelines are achievable.

In this environment, integrated global development is becoming an organizational capability, not just a project management discipline.

China’s evolving role in global development

As stated earlier, China is becoming not merely a clinical trial location, but also a source of innovation and a coordinated contributor to global evidence generation. A movement that will continue to grow as more China-originated assets enter the global development pathways.

For China-originated innovative drugs, globalization requires more than conducting overseas trials. It requires early alignment across the target product profile, regional regulatory expectations, development sequences, MRCT strategy, evidence standards, CMC readiness, supply chain capabilities and commercialization pathways.

For multinational sponsors, China’s evolving clinical development environment creates new opportunities to incorporate China more strategically into global development programs. The opportunity is to treat China-related evidence not as a separate regional requirement, but as part of a coordinated global evidence strategy.

Scaling Chinese innovation for global value

Thermo Fisher Scientific and PharmCube explore these issues further in the blue paper Reshaping Global Value: Winning Strategies and Practices for Chinese Innovative Drug Globalization.

The blue paper explores how Chinese biopharmaceutical companies are moving from rapid clinical execution to integrated global development, and what capabilities are needed to translate innovation into sustainable global value.

Key topics include:

• The evolution of China’s innovation ecosystem
• Synchronized global development and MRCT planning
• Global regulatory and evidence-generation requirements
• Cross-border development partnerships
• Integrated clinical, CMC, supply chain and operational capabilities

Strategies for Chinese innovative drugs to win in the global market

Explore strategies for Chinese innovative drug globalization, from clinical and regulatory planning to global partnerships.

Get the full report

Looking ahead

China’s 2025 clinical trial data show more than continued growth in trial volume. They point to a broader shift toward integrated, cross-regional and lifecycle-based development planning.

For sponsors, the priority is to ensure that China-related evidence is planned early, generated with quality and interpreted within the broader global development strategy. As China’s role in clinical innovation continues to expand, integrated evidence planning will become increasingly important for regulatory readiness and long-term development success.

References:

1. Center for Drug Evaluation, National Medical Products Administration. Annual Report on the Progress of Clinical Trials for New Drug Registration in China (2025). June 2026.
2. Center for Drug Evaluation, National Medical Products Administration. Guideline on Clinical Evaluation for Clinical Trial Applications. April 2026.
3. Center for Drug Evaluation, National Medical Products Administration. Guideline on Benefit–Risk Assessment Based on Multi-Regional Clinical Trial Data in Global Simultaneous Drug Development (Trial Version). February 2026.
4. International Council for Harmonisation. E6(R3): Guideline for Good Clinical Practice. 2025.
5. International Council for Harmonisation. E17: General Principles for Planning and Design of Multi-Regional Clinical Trials.
6. Thermo Fisher Scientific and PharmCube. Reshaping Global Value: Winning Strategies and Practices for Chinese Innovative Drug Globalization. 2026.