国产药在去年上市新药中占比超85％

Core Insights - China has achieved record highs in the number of approved innovative drugs and total external licensing transactions, with approximately 30% of global drug pipelines being in development in China [2][4] - The National Medical Products Administration (NMPA) aims to continue promoting innovative drugs with new mechanisms and targets, supported by institutional backing and improvements in the payment system for innovative drugs [2][6] Group 1: Innovative Drug Approvals - In 2025, China approved 76 innovative drugs, significantly surpassing the 48 approved in 2024, marking a historical high [2] - Among the approved drugs, domestic products accounted for over 85%, with 80.85% of chemical drugs and 91.30% of biological products being domestically developed [3][2] - The number of first-in-class innovative drugs approved in China reached 11, with 4 being independently developed in China [4] Group 2: External Licensing Transactions - The total amount for external licensing transactions of innovative drugs in China exceeded $130 billion in 2025, with over 150 transactions, doubling from the previous year [6] - This growth reflects international recognition of the value of Chinese innovative drugs and is supported by ongoing reforms in drug review and approval processes [6][8] Group 3: R&D Pipeline and Quality - China's R&D pipeline now accounts for about 30% of the global total, a significant increase from just 4% a decade ago [4] - The quality of domestic drug development has improved, with contributions to early clinical pipelines for next-generation therapies like ADCs and bispecific/trispecific antibodies nearing or exceeding 50% globally [4] Group 4: Policy and Market Dynamics - The NMPA plans to enhance support for urgently needed drugs and improve the regulatory framework for drug trials and market exclusivity [7][8] - The introduction of the commercial insurance innovative drug directory is expected to facilitate access to high-priced innovative drugs, potentially boosting market sales [9] - The Chinese innovative drug market is projected to grow significantly, with estimates suggesting a market size of approximately 740 billion RMB in 2025 and a compound annual growth rate of 24.1% from 2024 to 2030 [10]