十年磨一剑，从肺再生到肾再生，这个新药证明了中国在细胞治疗领域的创新能力

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]