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我国新药好药呈现快速增长态势:这些患者迎来临床急需用药新选择
Yang Shi Wang·2025-07-23 09:14

Core Viewpoint - The National Medical Products Administration (NMPA) reported a significant increase in the approval of innovative drugs in China, with 43 new drugs approved in the first half of the year, representing a 59% year-on-year growth, nearing the total of 48 approved in the entire previous year [1][3][7]. Group 1: Drug Approval Statistics - In the first half of this year, 43 innovative drugs were approved, which is close to the total of 48 approved in the entire previous year [1][7]. - The approval of innovative drugs has increased by 59% compared to the same period last year, reflecting the effectiveness of the drug review and approval reform initiated in 2018 [3][5]. Group 2: Types of Approved Drugs - The newly approved drugs include significant treatments for major diseases such as cancer, metabolic disorders, and immune diseases, including China's first gene therapy product for hemophilia B [7][9]. - Notable products include a stem cell therapy drug, an anti-influenza drug, and treatments for rare diseases, providing new options for patients in urgent need [9][11]. Group 3: Policy and Reform Impact - The drug review and approval reform has accelerated the process from the research phase to market entry, particularly for urgently needed new drugs [3][5]. - The NMPA has prioritized the development and approval of drugs for rare diseases and pediatric medications through specific initiatives, aiming to approve 70 pediatric drugs and 21 rare disease drugs by 2025 [9][11]. Group 4: China's Position in Global Drug Development - China's pharmaceutical innovation is showing strong growth, transitioning from a "follower" to a "runner" and even "leader" in certain areas [11]. - Currently, China's innovative drug development pipeline accounts for approximately 25% of the global total, with around 3,000 clinical trials conducted annually, placing China among the top in the world [11].