New drugs approved by the NMPA in 2024: Synthesis and clinical applications

IF 5.9 2区医学 Q1 CHEMISTRY, MEDICINAL European Journal of Medicinal Chemistry Pub Date : 2025-07-05 Epub Date: 2025-04-17 DOI:10.1016/j.ejmech.2025.117643

Xinxin Zhao , Lin Yuan , Zheng Gong , Mengqi Li , Ye Yuan , Jin Geng

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Abstract

In 2024, the National Medical Products Administration (NMPA) approved 46 Class 1 or 1.1 innovative drugs, including 7 imported drugs and 39 domestically developed drugs, marking a new record in China's pharmaceutical innovation. These approvals encompassed 23 chemical drugs, 20 biological products, and 3 traditional Chinese medicines or natural products, demonstrating continuous growth in innovative drug development. Compared to 16 approvals in 2020 and the surge in 2021, when approvals equaled the total of the previous four years, the trend of increased approvals has resumed since 2024. Therapeutically, oncology drugs remained the dominant category in 2024, comprising 50 % (23/46) of approvals. Gastrointestinal and metabolic drugs, accounting for 13.04 % (6/46), surpassed other categories to rank second, followed by neurological drugs (8.7 %, 4/46). Anti-infectives, miscellaneous drugs, and traditional Chinese medicines each contributed three approvals (7.5 % each). Regulatory advancements played a significant role, with 18 drugs (39.13 %) approved via priority reviews, emergency reviews, or conditional approvals. This group included 9 chemical drugs and 9 biological products, with notable breakthrough therapies such as taletrectinib, lutetium monoclonal antibodies, and donanemab receiving special recognition. The 2024 data reflect China's growing capabilities in drug innovation and its commitment to addressing critical medical needs through accelerated regulatory pathways.

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2024 年国家药品管理局批准的新药：综述与临床应用

2024年，国家药品监督管理局（NMPA）批准了46个1类或1.1类创新药物，其中7个是进口药物，39个是国产药物，这标志着中国药品创新的新纪录。这些获批的药物包括23种化学药物、20种生物制品和3种中药或天然药物，显示出创新药物开发的持续增长。与2020年的16个批准和2021年的激增（批准数量相当于前四年的总数）相比，自2024年以来，批准数量增加的趋势已经恢复。在治疗方面，肿瘤药物在2024年仍然是主导类别，占批准的50%（23/46）。胃肠道和代谢类药物占13.04%(6/46)，超过其他类药物排名第二，其次是神经类药物（8.7%,4/46）。抗感染药、杂类药和中药各获批3个，各占7.5%。监管方面的进步发挥了重要作用，18种药物（39.13%）通过优先审查、紧急审查或有条件批准获得批准。该组包括9种化学药物和9种生物制品，其中突破性疗法显著，如taletrectinib、lutetium单克隆抗体和donanemab受到特别认可。2024年的数据反映了中国在药物创新方面不断增强的能力，以及通过加速监管途径解决关键医疗需求的承诺。

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来源期刊

European Journal of Medicinal Chemistry 化学-医药化学

CiteScore

11.70

自引率

9.00%

发文量

863

审稿时长

29 days

期刊介绍： The European Journal of Medicinal Chemistry is a global journal that publishes studies on all aspects of medicinal chemistry. It provides a medium for publication of original papers and also welcomes critical review papers. A typical paper would report on the organic synthesis, characterization and pharmacological evaluation of compounds. Other topics of interest are drug design, QSAR, molecular modeling, drug-receptor interactions, molecular aspects of drug metabolism, prodrug synthesis and drug targeting. The journal expects manuscripts to present the rational for a study, provide insight into the design of compounds or understanding of mechanism, or clarify the targets.