In February 2025, U. S. Food and Drug Administration approved the first human xenotransplantation clinical trial, signaling that xenotransplantation will move from preclinical research and subclinical trials to clinical trials. China has formulated guidelines for clinical trials on xenotransplantation and expert consensus on subclinical trails, at the end of April 2026, the " Guidelines for the Clinical Research Filing of New Xenotransplantation Technologies (First Edition)" were released. Xenotransplantation clinical trials need to consider the requirements of data from preclinical researches (non-human primate survival time and subclinical trials), clinical trial design, defense of the selection of inclusion and exclusion criteria, informed consent, psychosocial assessment and support, and long-term monitoring of xenotransplantation participants. In order to ensure the quality of ethics review of xenotransplantation clinical trials, it is necessary to include the strengthening of ethics committees for reviewing xenotransplantation clinical trials, the training of ethics committees′ members and secretaries, the clarification of the key points of ethics review, and the rigorous assessment of risk-benefit ratios. These specific requirements for xenotransplantation clinical trials and their ethics review will help safeguard the safety and rights of xenotransplantation participants and escort the healthy and rapid development of their clinical trials.