The National Medical Products Administration (NMPA) released the 2025 Annual Report on the Progress of New Drug Registration Clinical Trials in China today, providing authoritative data on the country's drug clinical trials.

The report shows that the total number of clinical trials in China exceeded 5,000 for the first time, reaching a record high of 5,215 registrations, a 6.4% increase over 2024 and double the figure from 2020.

These trials include both new drug clinical trials and bioequivalence studies.

Yang Zhimin, Deputy Director of the Center for Drug Evaluation (CDE) of the NMPA, stated that among the 5,215 registered trials in 2025, new drug clinical trials accounted for 2,997 (57.5%), an 18% increase year-over-year, while bioequivalence trials accounted for 2,218 (42.5%).

To accelerate patient access to new therapies and secure a competitive edge in global R&D, China has expedited the entire clinical trial process.In 2025, 1,088 new drug trials signed the first informed consent form, with the average start-up time shortened by four months compared to 2024.

Wang Haixue, Director of the Clinical Trial Management Division at the CDE, noted that over 40% of applicants completed and submitted their registration within one month, and more than 70% signed the first informed consent form within six months.

Yang Zhimin added that 248 new drugs were approved for marketing through clinical trials in 2025, covering 18 therapeutic areas, including oncology, endocrine disorders, and mental health conditions.

The report also highlights that China conducted 410 international multi-regional clinical trials in 2025, accounting for 13.7% of the annual total.

Wang Haixue noted that this figure has doubled since 2020, involving clinical trial sites in over 70 countries and regions, with the United States, Japan, and Germany hosting the highest number.

China's clinical trial technical guidelines are now aligned with international standards, facilitating mutual recognition of clinical data and results globally.

Yang Zhimin commented that domestic innovative companies are transitioning from participants to leaders in global multi-regional clinical trials, becoming key players in international collaboration and significantly enhancing China's global influence and voice in drug development.

Category I innovative drugs, defined as those not yet marketed anywhere in the world, accounted for over 70% of new drug trials, reflecting China's growing momentum in new drug R&D.

In 2025, among the 2,997 new drug trials, Category I innovative drugs comprised 2,171 trials (72.4%), a 4.1% increase over 2024, with anti-tumor drugs accounting for 37.5% of these Category I trials.

Han Xiaohong, Director of the Clinical Pharmacology Research Center at Peking Union Medical College Hospital: In 2025, Peking Union Medical College Hospital newly initiated 273 drug clinical trials, covering 127 disease types, of which 210 were innovative drug trials, with innovative drugs accounting for 76.9%.

According to reporter interviews, Phase I clinical trials accounted for nearly 40% of all new drug clinical trials in 2025.

Li Haiyan, Director of the Drug Clinical Trial Institution at Peking University Third Hospital: In the past, our Phase I clinical trials were fast follow—we moved quickly with reference products already in place. Today, we aim for global innovation, for first-in-class, for 0-to-1 breakthroughs. At this stage, our overall Phase I research capabilities need to be rapidly enhanced.

Yang Zhimin, Deputy Director of the Center for Drug Evaluation at the National Medical Products Administration: Among the 2,997 new drug clinical trials, Phase I trials account for the largest share at 39%, with Category I innovative drugs comprising 42.7% of Phase I trials. This demonstrates the strong innovation momentum in China's pharmaceutical R&D industry.

Phase I Clinical Trials of Innovative Drugs Rank First Globally

According to reporter interviews, Phase I clinical trials are critically important in the development of innovative drugs. They are regarded as the "soul" of drug clinical trials and a hallmark of original innovation capability. In 2025, the number of Phase I clinical trials for innovative drugs in China ranked first globally.

Li Haiyan, Director of the Drug Clinical Trial Institution at Peking University Third Hospital: Phase I clinical trials are the first step from the laboratory to clinical application, and they can be regarded as the soul of clinical trials. In this phase, we are problem-oriented, and the most important thing is to focus on safety.

Li Ning, Chief Physician at the Drug Clinical Trial Center of the National Cancer Center: Phase I clinical trials are the most critical stage in the development of innovative drugs. They serve as the bridge from basic research to clinical application. In Phase I trials, we validate the drug's dosage and administration route, and they form the foundation for Phase II and III trials—an essential step that cannot be bypassed.

The National Medical Products Administration stated that Phase I clinical trials hold an extremely important position throughout the entire drug clinical trial process, particularly in the research and development of innovative drugs. The principal investigators of drug clinical trials must possess both clinical and research capabilities to ensure the safety of trial participants.

Yang Zhimin explained that Phase I clinical trials represent the transition of an innovative drug from animal-based safety evaluation results to human clinical trials across species. This requires investigators to have a thorough understanding of the drug, the disease, and various aspects of drug development, as well as adequate capabilities in participant protection. Therefore, Phase I clinical trials essentially serve as a marker of a country's or an institution's capacity in clinical trials and drug development.

Addressing Bottlenecks and Enhancing 0-to-1 Original Innovation Capability

It is understood that Phase I clinical trials represent 0-to-1 original innovation and are central to addressing the bottlenecks in clinical drug supply in China. Experts noted that statistical data show that China ranked first globally in the number of Phase I clinical trials in 2025.

Li Haiyan, Director of the Drug Clinical Trial Institution at Peking University Third Hospital: Phase I research is critical to our nation's 0-to-1 innovation. Enhancing our Phase I research capabilities is a key step in resolving the bottlenecks in 0-to-1 innovation. More of our Phase I data are now being accepted by regulatory authorities in various countries, which can help our nation's new drugs—especially global-first new drugs—reach the world stage.。

Li Ning, Chief Physician at the Drug Clinical Trial Center of the National Cancer Center: The number of Phase I clinical trials represents a country's capacity for original innovation. According to statistics, China's number of Phase I clinical trials in 2025 has surpassed that of the United States, ranking first in the world, covering many innovative targets, cell therapy, gene therapy, and a range of other novel drug modalities.

Anti-Tumor Drugs Lead, Weight-Loss Drug Clinical Trials See Significant Increase

The report shows that in 2025, anti-tumor drugs continued to account for the largest share of clinical trials. In addition, in the endocrinology field, weight-loss drug clinical trials increased notably.

Among the 1,668 chemical drug clinical trials registered in 2025, 382 were anti-tumor drugs; among the 1,209 biological product clinical trials, 554 were anti-tumor drugs, both ranking first in their respective categories.

Chen Ying, Deputy Director of the Second Clinical Division for Chemical Drugs at the Center for Drug Evaluation of the National Medical Products Administration: Among the 2,171 Category I innovative drug clinical trials, oncology drugs ranked first with 814 trials, accounting for 37.5%. Among these, Category I biological innovative drugs totaled 991 trials, of which 498 were oncology drugs, accounting for more than half.

The reporter noted that among the 1,668 chemical drug clinical trials, endocrine system drugs ranked first among the top ten drug categories, with a total of 22 trials involving 4 drug varieties.

Chen Ying stated that the endocrinology field, particularly weight-loss therapies, has emerged as a rapidly growing area of clinical demand in recent years. Clinical trials for related drugs are also aligned with treatment needs, reflecting a new trend in industrial development.

Ji Linong, Chief Physician of the Department of Endocrinology at Peking University People's Hospital: Surveys show that the proportion of overweight and obese adults in China is close to 50%. In our endocrinology outpatient clinics, the number of patients seeking weight loss is increasing significantly, now accounting for about one-third of our endocrinology outpatient volume, and this number continues to rise.

According to reporter interviews, not only has the number of weight-loss patients in endocrinology outpatient clinics across the country increased significantly, but some hospitals have also successively established weight-loss clinics, even making appointments difficult to obtain. In 2025, clinical trials for weight-loss endocrine drugs in China showed significant growth.

Ji Linong noted that in 2025 alone, Peking University People's Hospital led more than 20 registered clinical studies, a large portion of which involved novel weight-loss drugs developed by domestic pharmaceutical companies. Currently, six weight-loss drugs have been approved for marketing in China, compared to only three in the United States. As a result, Chinese clinicians now have access to a greater number of weight-loss medications than those available in Europe and the United States.

In addition, drug clinical trials in the fields of dermatology, otorhinolaryngology, circulatory system, and nervous system were also very active in China in 2025.

Li Haiyan, Director of the Drug Clinical Trial Institution at Peking University Third Hospital: In 2025, Peking University Third Hospital operated a total of 1,146 clinical trials. The top five departments were cardiovascular medicine, ophthalmology, neurology, respiratory medicine, and dermatology. The total number of clinical trials in these five departments accounted for approximately one-third of the hospital's overall total.

Chen Ying, Deputy Director of the Second Clinical Division for Chemical Drugs at the Center for Drug Evaluation of the National Medical Products Administration: For example, in the fields of respiratory diseases and anti-allergy, particularly chronic obstructive pulmonary disease (COPD), which has been listed as one of China's major chronic diseases, global drug development targeting new mechanisms and new targets has been quite active in recent years, with many products successfully launched in the past two years. In China, the number of registrations and applications for related clinical trials has been growing at a relatively rapid pace.

Cell and Gene Therapy Clinical Trials Increase by Nearly 30% Year-on-Year

Cell and gene therapy represent a cutting-edge field in global biotechnology. In 2025, clinical trials for such drugs in China increased by nearly 30% compared to the previous year.

Lu Shuang, Deputy Director of the Clinical Division for Biological Products at the Center for Drug Evaluation of the National Medical Products Administration: In 2025, there were 149 newly registered clinical trials for cell and gene therapy drugs, a year-on-year increase of 29.6%. Among these, cell therapy accounted for 97 trials, comprising over 65%, and gene therapy accounted for 52 trials, comprising over 34%.

The reporter noted that these technologies are primarily targeted at major difficult-to-treat diseases, including malignant tumors, neurological disorders, hematological diseases, and dermatological and otorhinolaryngological conditions, offering new solutions for patients.

Han Xiaohong, Director of the Clinical Pharmacology Research Center at Peking Union Medical College Hospital: Cell and gene therapy drugs represent advanced therapeutic products globally. In 2025, Peking Union Medical College Hospital conducted 29 clinical trials for cell and gene therapy drugs, primarily involving disease areas including ophthalmology, rheumatology and immunology, and hematological disorders.

Priority Given to Clinical R&D for Pediatric and Rare Disease Drugs

Pediatric and rare disease drugs have always been urgent areas of clinical need. In 2025, China's new drug clinical trials placed a strong focus on ensuring drug access for key special populations, including children and patients with rare diseases.

Chen Ying, Deputy Director of the Second Clinical Division for Chemical Drugs at the Center for Drug Evaluation of the National Medical Products Administration: In 2025, there were 235 clinical trials involving pediatric participants, of which 129 were biological products, accounting for more than half. These were primarily preventive vaccines, drugs for respiratory and allergic diseases, and drugs for hematological disorders. Among the 95 trials specifically designed for pediatric populations, 50 were biological products, accounting for 52.6%, of which preventive vaccines accounted for 48%.

In the rare disease field, 118 clinical trials were registered in 2025, consistent with the previous year, primarily covering hematological disorders, neurological diseases, and oncology.

Chen Ying noted that among the rare disease drug clinical trials in 2025, 68 trials (57.6%) were in the categories of hematological disorder drugs, neurological disease drugs, and anti-tumor drugs, with hematological disorder drugs ranking first with 26 trials, accounting for 22%.

Yang Zhimin, Deputy Director of the Center for Drug Evaluation at the National Medical Products Administration: Among these, rare hematological disorders include paroxysmal nocturnal hemoglobinuria and hemophilia, rare tumors include melanoma and glioblastoma, and rare neurological diseases include amyotrophic lateral sclerosis and myasthenia gravis. The rare disease clinical trials in 2025 are expected to address urgent clinical needs for more than 20 rare diseases.

Source: CCTV News Client