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“十四五”创新药“成绩单”:210个获批,多项指标均位居世界前列
Yang Shi Wang· 2025-09-17 03:15
Group 1 - The core point of the article highlights that from January to July this year, the National Medical Products Administration (NMPA) has approved 50 innovative drugs, surpassing the total of 48 approved in the entire previous year, indicating a strong growth trend in drug approvals [1][5] - During the "14th Five-Year Plan" period, the NMPA has approved a total of 210 innovative drugs, maintaining an accelerated growth trajectory [1] - China ranks among the top globally in terms of the number of innovative drug pipelines and clinical trial projects, reflecting a robust momentum in pharmaceutical innovation [1][7] Group 2 - Among the 50 newly approved drugs this year, several high-profile products have gained significant public attention, including the country's first stem cell therapy drug and treatments for rare diseases [3] - The NMPA's Director of Drug Registration Management, Yang Ting, noted that many of the approved drugs target major diseases such as cancer, metabolic disorders, and immune diseases, including the first gene therapy product for Hemophilia B [5] - The shift in drug development focus from similar and improved drugs to original innovations is attributed to the NMPA's policies aimed at clinical value, with China currently holding about one-quarter of the global innovative drug development pipeline [7]
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].