China's Order 818: A New Commercialization Pathway Reshaping Cell and Gene Therapy.

China has emerged as a global leader in the development and clinical translation of cutting-edge biotechnologies, including cell therapies, gene editing, and regenerative medicine. This review provides an analysis of China's landmark regulatory framework, the Regulations on the Administration of Clinical Research and Clinical Translational Application of New Biomedical Technologies, and examines the 112 clinical research projects that have been filed in the first nine batches under this framework. We discuss the dual-track regulatory system distinguishing new biomedical technologies from conventional drugs and medical devices. The findings demonstrate that China's approach of "wide entry with strict exit" and "balancing innovation with safety" represents a transformative paradigm for governing frontier biomedical technologies, with significant implications for global health innovation.