我国创新药上半年对外授权近660亿美元

Core Insights - The National Medical Products Administration (NMPA) of China has approved 56 innovative drugs in 2025, including 18 biopharmaceuticals, marking a significant advancement in the field of biomedicine [1][2] - Biopharmaceuticals are at the forefront of the contemporary biomedicine technology revolution, providing new treatment possibilities for major and rare diseases [1] - The average review time for clinical trials of innovative drugs has significantly decreased, from 175 working days in 2017 to 50 working days in 2024, and the review time for drug listing applications has reduced from 420 working days to 235 working days in the same period [1] Summary by Categories Innovative Drug Approvals - In 2025, 56 innovative drugs have been approved in China, with 18 being biopharmaceuticals, including the first stem cell therapy product and the first gene therapy product for hemophilia [1] - In 2024, 48 innovative drugs were approved, with biopharmaceuticals accounting for 22 of them, representing 45.8% of the total [1] Clinical Trial and Review Efficiency - The NMPA has accelerated the approval process for urgently needed and innovative products, significantly reducing the average review time for clinical trials and drug applications [1] Research and Development Landscape - China has 2,400 advanced therapy drugs in the research pipeline, indicating a substantial increase in R&D activity [2] - China has been elected as a member of the International Council for Harmonisation (ICH) three times, implementing 71 ICH guidelines, which enhances the synchronization of drug development and approval processes [2] - The total amount of innovative drug licensing transactions from China in the first half of 2025 reached nearly $66 billion, surpassing the total of $51.9 billion for the entire year of 2024 [2]