刚刚，利好来了！

Core Viewpoint - The article highlights the introduction of a new regulatory framework for biomedical new technology clinical research and application in China, which is expected to significantly benefit the innovative drug industry and enhance its growth prospects [2][4][10]. Regulatory Framework - The newly published "Regulations on the Management of Clinical Research and Clinical Translation Application of Biomedical New Technologies" aims to standardize clinical research and application, promote scientific and technological progress, ensure medical quality and safety, and protect human dignity and health [3][4]. - The regulations consist of 7 chapters and 58 articles, emphasizing a people-centered approach, innovation-driven development, and a balance between development and safety [5]. Clinical Research and Application - Clinical research on biomedical new technologies must be proven safe and effective through non-clinical studies and undergo academic and ethical reviews before proceeding [5]. - The regulations require that clinical research be filed with the National Health Commission, which will evaluate the research and can halt it if risks are identified [5][6]. - Approved biomedical new technologies can be applied clinically, with clear approval processes and timelines established [6]. Industry Growth and Opportunities - The innovative drug sector is experiencing positive momentum due to favorable domestic policies, overseas licensing, and robust performance growth [11]. - By mid-2025, China's overseas licensing in the pharmaceutical sector is expected to exceed $66.8 billion, with 31% of innovative drugs introduced by international pharmaceutical companies originating from China [2][9]. - The global share of China's first-in-class (FIC) drug pipeline is currently 24%, ranking second globally, indicating a significant increase in innovation influence [9]. Supportive Policies - In July, the National Medical Insurance Administration and the National Health Commission issued measures to support the high-quality development of innovative drugs, addressing key issues in drug development, access, and payment [10]. - The measures include enhancing research support, facilitating entry into insurance directories, and improving multi-payment capabilities, which are crucial for the sustainability of innovative drug development [10][11].