从“3个10”到“3个准入” 中国逐渐成为全球医药创新重要源头 我国首创新药管线占全球19%

Core Viewpoint - The article discusses the recent measures introduced by the National Healthcare Security Administration and the National Health Commission to support the high-quality development of innovative drugs in China, marking a significant shift from a generic drug powerhouse to an innovative drug leader since 2015 [1][2]. Group 1: Policy Measures and Support - The "Measures" introduced on July 1 aim to enhance the entire chain of support for innovative drug development, including research, payment, and access [1][2]. - Regions such as the Yangtze River Delta and the Pearl River Delta have allocated substantial financial resources to support drug innovation, providing concrete measures across various aspects of drug development [2][3]. Group 2: Current Landscape of Innovative Drugs - China currently has 1,775 first-in-class drug pipelines, accounting for 19% of the global total, and holds 14% of the global license-out transactions, with 30% of the total value [2]. - The article highlights the challenges faced in the drug development cycle, particularly the long timelines and high costs associated with innovative drug research [3]. Group 3: Clinical Institutions and Innovation - Clinical institutions play a crucial role in identifying unmet clinical needs, and there is a call for more involvement in source innovation to enhance the development of first-in-class drugs [4]. - The need for a unified data platform and an internationally recognized evaluation system is emphasized to facilitate clinical research and innovation [4]. Group 4: Real-World Data and Application - The "Guangdong-Hong Kong-Macao Drug and Device Pass" policy has enabled the introduction of innovative drugs and devices in pilot hospitals, benefiting over 6,000 patients and generating valuable real-world data [5]. - Real-world studies are essential for accelerating drug development and regulatory approval, as demonstrated by the successful completion of a study on a novel migraine treatment [5]. Group 5: Overcoming Barriers to Access - Efforts are being made to address the "last mile" challenges in getting innovative drugs into hospitals, including the establishment of a digital innovation laboratory to enhance data collection and evaluation [6]. - The article discusses the importance of risk assessment and safety evaluations for innovative drugs, particularly in oncology, to build confidence among healthcare providers [6]. - The overall goal is to create a win-win situation where patients have access to innovative treatments, funding is sustainable, and companies are motivated to innovate [6].