New Drug Approvals in China: An International Comparative Analysis, 2019-2023

Yilong Yan,1,* Xiangyu Guo,2,* Ziming Li,1 Weilin Shi,3 Min Long,4 Xiaolin Yue,5 Fanpu Kong,6 Zhigang Zhao1 1Department of Pharmacy, Beijing Tiantan Hospital, Capital Medical University, Beijing, People’s Republic of China; 2School of Pharmaceutical Sciences, Capital Medical University, Beijing, People’s Republic of China; 3Data Center, Kangzhou Pharmaceutical Big Data Development and Application Research Institute, Chongqing, People’s Republic of China; 4Data Center, Chongqing Kangzhou Big Data (Group) Co., Ltd, Chongqing, People’s Republic of China; 5Party Committee Office, Beijing Tiantan Hospital, Capital Medical University, Beijing, People’s Republic of China; 6School of Medicine, Tsinghua University, Beijing, People’s Republic of China*These authors contributed equally to this workCorrespondence: Fanpu Kong; Zhigang Zhao, Email [email protected]; [email protected]: 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.Methods: 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.Results: 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.Conclusion: 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.Keywords: new drug, special approval, therapeutic areas, targets, first-in-class