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

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.