Before stem cells become drugs, preclinical, clinical, and production process research needs to be conducted. The launch of the first stem cell therapy drug means that China has gradually improved in this regard, and the regulatory system has also been established. "On January 4th, Wang Xiaoning, deputy leader of the National Stem Cell Major Research and Development Special Expert Group and former director of the Geriatric Medicine Research Institute of the General Hospital of the People's Liberation Army, told Science and Technology Daily reporters that previously, whether stem cell therapy technology (non blood field) should be approved as a drug or registered as a medical technology has always been a hot topic in the industry. This listing means that the road to drug approval has been completed. On January 2nd, the National Medical Products Administration (NMPA) approved the first stem cell therapy drug in China, Amimatosa Injection, through a priority review and approval process, with conditions attached. It is used to treat acute graft-versus-host disease with hormone therapy failure mainly affecting the digestive tract in patients over 14 years old. It is necessary to better grasp the "uncertainty" of stem cells due to their pluripotency. Stem cells have always been considered to have the ability to repair and replace damaged cells and tissues in the body. Unlike drugs, stem cells are 'alive' Wang Xiaoning stated that due to its "active" nature, a series of indicator systems applicable to drugs need to be reconstructed. The approval of drugs requires a complete set of evaluation data such as toxicology evaluation and efficacy evaluation, and how to conduct toxicology evaluation, safety evaluation, and pharmacological evaluation on stem cells is a scientific problem that needs to be overcome after the development of stem cell therapy Wang Xiaoning explained that the clinical dosage and usage of chemical drugs and macromolecular drugs are based on their half-life in the human body. Cell drugs, including stem cell drugs, not only do not decay but may also proliferate after entering the human body. The growth decline curve within each individual is difficult to generalize, which is the biggest challenge in the application of cell drugs. Wang Xiaoning metaphorically compares stem cell therapy to the patient's body environment as the relationship between "seeds" and "soil". Stem cells themselves have heterogeneity, and their effectiveness in different individuals is difficult to grasp Wang Xiaoning said that "seeds" are good, but if the transferred body environment is not suitable for their effectiveness, it may also be difficult to produce therapeutic effects. In response to a series of new issues, relevant national departments have conducted a series of studies and transformed them into research and development guidelines and targeted guiding principles to help enterprises improve the quality and efficiency of research and development. For example, the "Technical Guidelines for Clinical Trials of Mesenchymal Stem Cell Prevention and Treatment of graft-versus-host Disease" released by the Drug Evaluation Center on January 12, 2024, have become important components in promoting the scientific, legal, and modern regulation of drugs in China. In depth research on stem cell biology characterization should be carried out. "From the name alone, it is easy to misunderstand 'universal stem cells' and think that they can treat any disease. In fact, universal stem cells refer to stem cell donors that are not limited and can be provided to different recipient patients for use." Wang Xiaoning reminds the public to understand the heterogeneity of stem cells. It is worth mentioning that predicting the effectiveness of cell therapy is still one of the issues that constrain the development of the cell therapy industry. Stem cell therapy is a major category of cell therapy, and other cell therapy products that have already been launched, such as CAR-T cell therapy, also face the problem of 'individualized' efficacy Wang Xiaoning said that precisely because of this, international pharmaceutical companies often adopt the method of no charge for ineffective services or halving the fees. The root cause of this problem is that basic research has not yet fully elucidated the mechanism of action of cell therapy In Wang Xiaoning's opinion, the indications for which chemical drugs are effective can be judged based on molecular groups, and for stem cell drugs, they should also be predicted based on the refined cellular characteristics of stem cells. Wang Xiaoning suggested that the current single-cell omics technology has already developed, and in-depth research on stem cell biology characterization should be carried out to find the corresponding relationship between stem cell markers and therapeutic effectiveness. "For example, answer the questions about which specific markers of stem cell subsets are effective for the treatment of autoimmune diseases, and which subsets are effective for diabetes." Wang Xiaoning said. In addition, China is also continuously exploring the "dual track" management model for stem cells, which means that while incorporating stem cell products into drug management, stem cell clinical research is also treated as medical technology for management. For example, the "Hainan Free Trade Port Boao Lecheng International Medical Tourism Pilot Zone Biomedical New Technology Promotion Regulations" issued by Hainan will be implemented from February this year, encouraging clinical research, transformation and application of biomedical new technologies such as cell therapy, gene therapy, and tissue engineering in the pilot zone, and also responding to the demand for the transformation from disease centered to health centered.