Diabetes still is one of the most pressing global health challenges in the 21st century, with its prevalence expected to rise to 12.96% worldwide by 2050. Historically, treatments like insulin and GLP-1 receptor agonists focused solely on controlling blood sugar, yet they didn't address the root cause: restoring the body's natural ability to regulate blood glucose. Type 1 diabetes destroys pancreatic beta cells through an autoimmune response, forcing patients to rely on external insulin for life, while type 2 diabetes involves both insulin resistance and progressive beta cell dysfunction. Today, stem cell-derived beta cells and mesenchymal stem cell therapies are pushing diabetes treatment towards a cure by replacing or regulating the existing cells. Vertex's zimislecel (VX-880) is one of the most advanced therapies in development. It's a fully differentiated allogeneic stem cell-derived product administered via the hepatic portal vein and requires long-term immunosuppression. In the FORWARD-101 study, which included Phase 1/2/3 trials presented at the 2025 American Diabetes Association meeting, 12 patients who received a single full dose infusion with at least one year of follow-up achieved HbA1c levels below 7% and maintained their blood sugar in the target range (70-180 mg/dL) more than 70% of the time. Ten patients (83%) achieved insulin independence. The findings were published in The New England Journal of Medicine. As a result, Vertex plans to submit a BLA in 2026. Sana Biotechnology employs HIP technology to genetically modify donor pancreatic islet cells, allowing them to evade the immune system's recognition and attack. Its UP421 product has demonstrated over a year of graft survival and function without any immunosuppression, becoming the first global proof-of-concept for islet cell transplantation in type 1 diabetes without the need for immune suppression. Building on this success, Sana is applying the same technology to its iPSC-derived SC451 candidate, with the goal of normalizing blood sugar and eliminating both insulin and immune suppression requirements. 鉴于上述结果，Vertex 计划于 2026 年提交上市申请。Sana Biotechnology 通过低免疫性（HIP）技术对供体胰岛细胞进行基因工程改造，使移植细胞能够逃避宿主免疫系统的识别和攻击。其候选产品 UP421 在无需任何免疫抑制的情况下，已实现超过一年的移植物存活与功能维持，成为「无需免疫抑制移植异体细胞治疗 1 型糖尿病」的全球首个概念验证。基于此，Sana 正将同一技术应用于 iPSC 来源的下一代候选产品 SC451，目标同样是实现血糖正常化，且无需胰岛素和免疫抑制。