2025年我国批准创新药76个 对外授权超千亿美元

Group 1 - In 2025, China approved a record 76 innovative drugs, a significant increase of 58.3% from 48 in 2024, marking a historical high [1][2] - The approved innovative drugs included 47 chemical drugs, 23 biological products, and 6 traditional Chinese medicines, with domestic innovative drugs accounting for 80.85% of chemical drugs and 91.30% of biological products [1] - The total value of innovative drug licensing transactions reached $135.655 billion, with 157 deals, surpassing the previous year's $51.9 billion and 94 deals [2] Group 2 - Despite the achievements, there is a recognition of the shortfall in "head innovation," with only 11 of the approved drugs being first-in-class, and only 4 developed domestically [3] - The concentration of R&D projects on a few mature targets in China is high, with 41% of projects focused on the top 20 targets, compared to 28% in the U.S., leading to resource wastage and reduced innovation efficiency [3] - To transition from "follow-on innovation" to "leading innovation," there is a need for deeper integration of basic research and drug discovery, encouraging original innovation, and optimizing the R&D landscape through policy guidance [3] Group 3 - The National Medical Products Administration plans to focus more review resources on urgently needed clinical products, especially those with new mechanisms and targets, to accelerate the approval of critical drugs [4] - Support will be increased through pathways such as breakthrough therapy designation, conditional approval, priority review, and special approval to enhance the protection of innovation [4]