On December 30, 2025, the Hainan Boao Lecheng Medical and Drug Administration officially approved Ciming Boao International Hospital to carry out the translational application of the "Human Umbilical Cord Mesenchymal Stem Cell Therapy Technology for Type 2 Diabetes" project. The project precisely targets type 2 diabetes — a chronic disease with an enormous patient base — marking a historic leap for stem cell therapy from an exploratory therapy toward addressing major public health problems. This means that stem cell therapy is no longer merely a "luxury" for a small number of rare diseases but is poised to become an accessible therapy that can benefit hundreds of millions of diabetic patients, providing entirely new ideas for chronic disease management with enormous market prospects and social value.
According to the approval document, the cell preparation used in this translational project is supplied by Shenzhen Beike Biotechnology Co., Ltd. Preparation specifications: 1×107 cells/1 ml/vial, 2×107 cells/1 ml/vial, and 5×107 cells/2.5 ml/vial. Route of administration: intravenous infusion. Dosage: 1×106 cells/kg per dose, once a week for three consecutive doses.
Type 2 diabetes mellitus (T2DM) is a chronic metabolic disease caused jointly by insulin resistance and impaired pancreatic islet β-cell function, accounting for approximately 90% to 95% of all diabetic patients. Although conventional treatments (such as oral hypoglycemic agents and insulin injections) can keep blood glucose relatively stable in some patients, a substantial proportion of patients still cannot return to normal blood glucose levels, and existing means struggle to achieve a cure. There is therefore an urgent clinical need for new therapeutic strategies that can improve insulin resistance and repair islet function.
Studies show that human umbilical cord mesenchymal stem cells (UC-MSCs) feature low immunogenicity, abundant sources, and low tumorigenic risk, providing a sound foundation for therapy. Their potential mechanisms of action include repairing damaged pancreatic islet β-cells, improving the body's insulin resistance, and regulating glucose metabolism and inflammatory states through the secretion of bioactive substances such as exosomes[1]. The project, now approved, will provide a new option for patients with insufficient response to conventional treatment.
As the cell preparation provider for this approved project, Beike Biotech employs a fully automated, closed-system intelligent cell manufacturing line independently developed by the National Engineering Research Center for Key Common Technologies of the Cell Industry. Unlike conventional cell preparation, which is difficult to standardize at scale, this production line achieves large-scale production while ensuring that the quality of every dose of the cell product is highly uniform, safe, and controllable. On this foundation, Beike Biotech strictly controls quality from the source — its stem cell products undergo full quality testing by independent third-party CNAS-accredited institutions and are backed by a mature technology system and rigorous quality standards, providing a source-level guarantee for the safety and efficacy of this project.
Notably, this project has established a comprehensive patient rights protection mechanism: Beike Biotech has set up an online lookup system through which the public can verify the compliance of the preparation manufacturer and technology via the official online lookup system, ensuring the safety, efficacy, and uniqueness of the cell preparation and giving real meaning to "treatment with peace of mind".
Since comprehensively launching systematic research and new drug development on mesenchymal stem cells in 2009, Beike Biotech has accumulated over 16 years of process development, quality research, and stability data. The company has also developed a series of testing methods closely related to cell safety and efficacy, and has successfully developed industry-leading next-generation stem cell preparation technologies, filing and obtaining grants for multiple invention patents — demonstrating its sustained capacity for technological innovation.
As a national high-tech enterprise dedicated to the clinical translation of biotherapy technologies, Beike Biotech has consistently regarded the translation of innovative scientific and technological achievements as its core driving force. In the future, building on its end-to-end safety management system and deep R&D foundation, the company will continue to advance stem cell new drug applications in more indications such as autoimmune diseases, accelerate the translation and clinical application of frontier technology products, create innovative solutions with proprietary intellectual property, and make tireless efforts to improve human health.
References:
[1] Wang Zi'an, Dai Jianguo. Research progress of human umbilical cord mesenchymal stem cell-based therapy for type 2 diabetes [J]. Journal of Clinical Military Medicine, 2024, 52(07):758-761. DOI:10.16680/j.1671-3826.2024.07.27.
