Yan Yilong, Guo Xiangyu, Li Ziming, Shi Weilin, Long Min, Yue Xiaolin, Kong Fanpu, Zhao Zhigang
Department of Pharmacy, Beijing Tiantan Hospital, Capital Medical University, Beijing, People's Republic of China.
School of Pharmaceutical Sciences, Capital Medical University, Beijing, People's Republic of China.
Drug Des Devel Ther. 2025 Apr 3;19:2629-2639. doi: 10.2147/DDDT.S514132. eCollection 2025.
Over the past five years, China's pharmaceutical industry has rapidly developed but still lags behind global leaders. This study aims to analyze and compare the trends in new drug approvals in China, the United States (US), the European Union (EU), and Japan from 2019 to 2023.
Data on new drug approvals were collected from the National Medical Products Administration (NMPA), Food and Drug Administration (FDA), European Medicines Agency (EMA), and Pharmaceuticals and Medical Devices Agency (PMDA), including information on the generic name, trade name, applicants, target, approval date, drug type, approved indications, therapeutic area, the highest R&D status in China, and special approval status. The approval time gaps between China and other regions were calculated.
From 2019 to 2023, China led with 256 new drug approvals, followed by the US (243 approvals), the EU (191 approvals), and Japan (187 approvals). Oncology, hematology, and infectiology were identified as the leading therapeutic areas globally and in China. Notably, PD-1 and EGFR inhibitors saw substantial approval, with 8 drugs each approved by the NMPA. China significantly reduced the approval timeline gap with the US and the EU since 2021, approving 15 first-in-class drugs during the study period.
Despite COVID-19 challenges, China has improved in both the quantity and speed of new drug approvals, narrowing timeline gaps with major markets and enhancing its global pharmaceutical presence.
在过去五年中，中国制药行业迅速发展，但仍落后于全球领先者。本研究旨在分析和比较2019年至2023年中国、美国、欧盟和日本新药批准的趋势。
从国家药品监督管理局（NMPA）、食品药品监督管理局（FDA）、欧洲药品管理局（EMA）和日本药品和医疗器械管理局（PMDA）收集新药批准数据，包括通用名、商品名、申请人、靶点、批准日期、药物类型、批准适应症、治疗领域、在中国的最高研发状态和特殊批准状态。计算中国与其他地区之间的批准时间差。
2019年至2023年，中国以256项新药批准领先，其次是美国（243项批准）、欧盟（191项批准）和日本（187项批准）。肿瘤学、血液学和传染病学被确定为全球和中国领先的治疗领域。值得注意的是，PD-1和EGFR抑制剂获得大量批准，国家药品监督管理局各批准了8种药物。自2021年以来，中国显著缩小了与美国和欧盟的批准时间差距，在研究期间批准了15种同类首创药物。
尽管面临新冠疫情挑战，中国在新药批准的数量和速度方面均有所改善，缩小了与主要市场的时间差距，并提升了其在全球制药领域的地位。
