China's Clinical Trial Registrations Surpass 5,000 for First Time in 2025, Doubling 2020 Figures
核心洞察
China registered 5,215 clinical drug trials in 2025, more than double the 2020 total and the first time annual registrations exceeded 5,000.
New drug trials accounted for 57.5% of all registrations (2,997 trials), representing an 18% year-on-year increase, while the remainder were bioequivalence studies.
The average time from regulatory approval to trial initiation was shortened by four months compared with the previous year, and 248 new drugs received market approval across 18 therapeutic areas.
China's annual clinical trial registrations surpassed 5,000 for the first time in 2025, reaching a total of 5,215, according to a report released Monday by the National Medical Products Administration (搜索) (NMPA). The figure represents more than double the number recorded in 2020, underscoring the rapid expansion of the country's pharmaceutical research and development ecosystem.
The report, published by the NMPA's Center for Drug Evaluation (搜索), provides a comprehensive snapshot of China's evolving clinical research landscape.
New Drug Trials Drive Growth
Of the more than 5,000 clinical trials registered last year, 57.5% were conducted for new drugs, totaling 2,997 trials and marking an 18% year-on-year increase. The remainder consisted of bioequivalence studies designed to evaluate whether generic drugs perform identically to their branded counterparts in the body.
The number of international multicenter clinical trials reached 410 in 2025, nearly double the 2020 level, reflecting China's deepening integration into global drug development programs. However, Chinese companies and institutions initiated or funded 93% of all registered trials, and approximately 92% were conducted within China, while the rest were part of global studies that included patient sites in the country.
Therapeutic Areas and Emerging Technologies
Clinical trials involving cell and gene therapies continued to rise significantly, with oncology remaining the dominant therapeutic area. Meanwhile, the number of trials for rare disease drugs, medical imaging and radiopharmaceuticals, as well as studies of new drugs in pediatric populations, remained relatively stable.
Trials were concentrated in Beijing and Shanghai, as well as in the provinces of Guangdong and Jiangsu, the report noted.
Regulatory Acceleration and Market Approvals
Chinese drug regulators have prioritized accelerating the entire clinical trial process to speed patient access to high-quality medicines. In 2025, the average time from regulatory approval to trial initiation for new drugs was shortened by four months compared with the previous year. Additionally, a record-high 74.2% of trials obtained informed consent from the first participant within six months of approval.
According to the NMPA, 248 new drugs were approved for market entry in 2025, spanning 18 therapeutic areas, including oncology, endocrinology and mental disorders.