医药导报2026，Vol.45Issue(4)：603-608,6.DOI:10.3870/j.issn.1004-0781.2026.04.007
2020-2025上半年中国创新药临床试验发展趋势分析
Analysis of Trends in China’s Innovative Drug Clinical Trials(2020-First Half of 2025)
摘要
Abstract
Objective To systematically analyze the trends and dynamic characteristics of clinical trials for innovative drugs in China from 2020 to the first half of 2025,and to provide data-informed insights for policy formulation and industry decision-making.Methods Data on innovative drug clinical trials initially disclosed from January 1,2020,to June 30,2025,were extracted from the PharmaGo database(Pharmcube).Estimates of China's disease burden for 2023 were obtained from the University of Washington’s Global Burden of Disease(GBD)database.The analysis covered multiple dimensions:trends in trial volume,drug type,trial phase,disease area distribution,alignment with disease burden,and geographical distribution of sponsors and major research institutions.Results The number of innovative drug clinical trials in China showed sustained growth.Over 80%of trials were sponsored by domestic entities,and more than half were in Phase I.Biological products and chemical drugs accounted for comparable proportions.Nearly 60%of trial projects focused on oncology,endocrine/metabolic diseases,and hematologic/immune disorders,which collectively represented less than 25%of the total disease burden.In contrast,cardiovascular and cerebrovascular diseases,comprising less than 5%of trials,accounted for over 26%of the disease burden.The geographical distribution of both sponsors and primary research institutions was highly concentrated,with the top five provinces responsible for more than 70%of trial projects.Conclusions China's innovative drug clinical trials continue to increase in number,dominated by domestically developed drugs and early-phase studies.A significant mismatch exists between R&D focus and disease burden,and trial resources are heavily concentrated in coastal regions.It is recommended that policymakers encourage more clinical value-driven drug development and promote regionally balanced allocation of trial resources.Enterprises,in turn,should consider optimizing their R&D pipelines based on disease burden,thereby fostering efficient and balanced growth of the innovative drug sector.关键词
创新药/临床试验/疾病负担/资源配置/地理分布Key words
Innovative drugs/Clinical trials/Disease burden/Resource allocation/Geographic distribution分类
医药卫生引用本文复制引用
黄佳欣,姚泽坤,李惟妙,史录文,陈敬..2020-2025上半年中国创新药临床试验发展趋势分析[J].医药导报,2026,45(4):603-608,6.基金项目
"癌症、心脑血管、呼吸和代谢性疾病防治研究"国家科技重大专项(2023ZD0509600) （2023ZD0509600）
首都高端智库研究项目(2025-ZK-01-02). （2025-ZK-01-02）
