生物医学“基本法”出炉，中国细胞与基因治疗新时代开启！

Core Points - The newly announced "Regulations on the Management of Clinical Research and Clinical Translation of Biomedical New Technologies" aims to standardize clinical research and application of biomedical technologies, promoting medical innovation and ensuring quality and safety in healthcare [1][7] - The regulations mark a significant shift from a previously ambiguous regulatory environment to a clearer and more structured framework for advanced biomedical technologies such as gene editing and stem cell therapy [1][8] Policy Historical Development - The regulations have been in preparation for six years, with initial drafts and public consultations starting in 2019, leading to the final approval in September 2025 [2] Policy Content Comparison - The regulations provide a clear definition of biomedical new technologies, distinguishing them from traditional medical technologies, which helps clarify the regulatory landscape for companies [3][8] - The regulations establish a structured pathway from preclinical research to clinical application, ensuring that only technologies proven safe and effective can proceed to clinical trials [10][12] Clinical Research Requirements - The regulations require that clinical research can only commence after non-clinical studies have demonstrated the safety and efficacy of the technology [4][12] - Institutions conducting clinical research must be qualified, including being a tertiary hospital with appropriate ethical and academic oversight [12][13] Commercialization Pathway - The regulations outline a clear commercialization pathway for biomedical technologies, allowing for the collection of fees once the technology is approved for clinical application [11][12] - The regulations also emphasize the importance of ethical considerations and the protection of participants in clinical research [5][11] Industry Impact - The regulations are expected to enhance the development of the biomedical industry by providing a clear framework that encourages innovation while ensuring compliance with safety and ethical standards [8][16] - Companies like MOTE Therapeutics are positioned to benefit from this regulatory clarity, as their technologies align with the new definitions and pathways established by the regulations [16][17]