文｜胡香赟 "REGEND001的目标是'再生'出健康的肺泡，提升患者肺功能。我们会提取患者自身相对健康部位的气道基底层干细胞，在体外扩增后用支气管镜再回输到 肺部。"张婷介绍道："目前的临床试验数据显示，与对照组相比，接受REGEND001治疗的患者在关键疗效终点上表现出统计学上的显著改善。除肺功能改 善、生活质量提升外，在肺部结构性损伤修复方面，REGEND001可为受试者者带来数百毫升的肺脏容积的提升。" 2026年，吉美瑞生将在国内同步启动REGEND001治疗COPD、IPF的3期临床，完成更大样本量的疗效确认，目前正与监管部门沟通方案；此外，基于 REGEND001优化工艺开发的Pulmovinci已被美国FDA授予IPF适应症的"孤儿药资格"。 编辑｜海若镜 36氪获悉，近日，再生医疗领域企业吉美瑞生（Regend Therapeutics Limited）已完成3.5亿人民币C轮融资。本轮融资新引入投资方包括禹泽资本、合肥高 投、洪泰基金、合肥产投、共青城富汇等7家公司及机构，老股东冷杉溪资本、天士力资本等5家投资方持续追加投资；募集资金将用于推进干细胞/前体细 胞(stem/progenit ...

Core Insights - The approval of REGEND003, a novel kidney stem cell therapy developed by Shanghai Jirui Medical Technology Co., a subsidiary of Jimei Life Sciences, marks a significant advancement in the treatment of diabetic kidney disease (DKD) in China [1][11] - This therapy utilizes a dual mechanism of "regeneration + repair" to potentially reverse kidney function decline, offering a new treatment pathway for over 120 million chronic kidney disease patients in China [3][7] Group 1: Product Development and Approval - REGEND003 has received approval from the National Medical Products Administration (NMPA) to enter clinical trials, specifically targeting DKD [1][2] - The therapy is based on the R-Clone® precursor cell amplification platform, which isolates and amplifies SOX9+ kidney precursor cells from patients' urine [3][10] - The clinical trial application for REGEND003 was accepted in March 2025, with approval for Phase I/II trials granted in May 2025, reflecting regulatory support for innovative therapies [10][11] Group 2: Clinical and Market Implications - REGEND003 aims to fill a treatment gap for the 30%-40% of chronic kidney disease patients who suffer from diabetic kidney disease, which is increasing at a rate of 10% annually [7][9] - The therapy's autologous cell infusion method avoids the risks associated with allogeneic transplants and may reduce long-term treatment costs [9][11] - If successful, REGEND003 could become the first approved kidney regeneration therapy in China, potentially transforming the treatment landscape for chronic kidney diseases [11][12] Group 3: Competitive Landscape and Future Outlook - REGEND003 is positioned against ProKidney's kidney repair product in the U.S., which is currently in Phase III trials, highlighting the competitive nature of the regenerative medicine market [10][11] - The company has established a comprehensive industrial chain with GMP pilot bases and super organ research centers in multiple cities, ensuring efficient technology transfer [10][11] - The approval of REGEND003 not only signifies a breakthrough for diabetic kidney disease patients but also underscores China's growing leadership in the field of cell therapy [12]