Abstract
Innovative therapy, as a new paradigm of medical intervention deviating from standard routine practice, prioritizes the best interests of patients, offering alternative therapeutic pathways where standard treatments fail. In China, their application is increasing alongside advancements in medical technology. However, innovative therapy poses various ethical challenges in clinical settings, including misconceptions of being viewed as research rather than therapy, benefit‐risk assessment complexities, conflicts of interest, and barriers to the development of effective regulatory strategies. This paper elucidates the concept of innovative therapy and critically examines these challenges within the Chinese clinical context, emphasizing patients’ best interests. It proposes establishing guidelines and a comprehensive, adaptable regulatory framework to address the unmet healthcare‐related needs of individual patients and mitigate risks. Engaging in these discussions provides some ethical insights from China on innovative therapy, serving as a reference for fostering the development and responsible utilization of innovative therapy.
