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To analyze the developmental status and core characteristics of new drug registration clinical trials in China, and to forecast future trends, thereby providing references for the research and development (R&D) layout of the pharmaceutical industry and the optimization of relevant policies.
Based on public data from the Annual Drug Evaluation Report and the Annual Report on the Progress of Clinical Trials for New Drug Registration in China published by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) from 2020 to 2024, a comprehensive analysis was conducted on the growth in the number of clinical trials, drug types, distribution of indications, implementation efficiency, and progress in key areas.
In 2024, the total number of registered clinical trials reached 4 900, a record high. The proportion of Phase Ⅱ and Phase Ⅲ trials increased steadily, indicating continuous optimization of R&D efficiency. Clinical trials for chemical drugs and biological products were concentrated in the anti-tumor field, while trials for traditional Chinese medicine focused primarily on respiratory and digestive system diseases. Trials in key areas such as cell and gene therapy, drugs for rare diseases, and pediatric medications showed significant growth.
New drug clinical trials in China are demonstrating trends towards greater efficiency, innovation, and internationalization. Future efforts should focus on policy guidance and technological innovation to further optimize resource allocation, overcome homogeneous competition, and promote the high-quality development of the pharmaceutical industry.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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