Stem cells are characterized by their capacity for self-renewal and their potential for multi-directional differentiation, enabling them to develop into various functional tissues and organs under specific conditions. Their applications hold considerable promise, and the market for stem cell products is progressively expanding. Internationally, several stem cell products have received approval for market release; however, in China, the field remains largely undeveloped, presenting substantial opportunities for growth. Recent years have witnessed significant advancements in stem cell research, driven by improvements in national policies, regulatory frameworks, and ongoing technological innovations. This progress has resulted in notable breakthroughs in basic science, as well as substantial advancements in clinical trials and industrial applications. Compared to previous decades, stem cell therapies in China have experienced remarkable progress, with numerous companies advancing to the clinical research phase, indicating a robust overall development trajectory. Nonetheless, the considerable variability in the sources, types, and preparation processes of stem cell products contributes to the complexity of their therapeutic mechanisms and in vivo activities, which are more intricate than those of traditional pharmaceuticals. Consequently, stem cell therapies encounter several challenges in drug development, including issues related to safety, induction efficiency, the exploration of clinical translation processes, and elevated research and development costs, all of which may hinder the advancement of stem cell therapies. Nevertheless, numerous companies and research institutions are actively engaged in promoting progress within the stem cell domain. It is anticipated that, as the stem cell sector continues to evolve, these challenges will be addressed, ultimately serving as a crucial catalyst for meeting various unmet clinical needs and effecting transformative changes in human healthcare and other sectors.
Li et al. (2025) studied this question.