我国创新药对外授权首破千亿美元

Core Insights - In 2025, China approved a record 76 innovative drugs, significantly surpassing the 48 approved in 2024, marking a historical high [1] - The total value of innovative drug licensing transactions in 2025 exceeded $130 billion, with over 150 transactions, also a historical high [2] - The increase in innovative drug approvals and licensing reflects China's progress in drug evaluation reforms and the international recognition of the value of its innovative drugs [2] Summary by Sections Innovative Drug Approvals - In 2025, 76 innovative drugs were approved, including 47 chemical drugs, 23 biological products, and 6 traditional Chinese medicines [1] - Among the 47 chemical drugs, 38 were domestically developed, representing 80.85% of the total [1] - For the 23 biological products, 21 were domestically developed, accounting for 91.30% [1] - 11 first-in-class innovative drugs were approved, with 4 being independently developed in China [1] Licensing Transactions - The total licensing transaction amount for innovative drugs in 2025 was over $130 billion, nearly doubling from $51.9 billion in 2024 [2] - The number of licensing transactions increased to over 150, compared to 94 in 2024 [2] - China's pipeline of new drugs accounts for approximately 30% of the global total, ranking second worldwide [2] Future Initiatives - Starting in 2026, the National Medical Products Administration (NMPA) will implement more measures to accelerate the development of innovative drugs [3] - There will be a focus on prioritizing review resources for urgently needed clinical products, especially those with new mechanisms and targets [3] - The NMPA plans to enhance support through breakthrough therapy designations, conditional approvals, and priority reviews to expedite the market entry of critical drugs [3]