ARM101: World’s First iPSC-Derived Kidney Cell Therapy Receives IND Approval for Clinical Use

May 14, 2026Center for Drug Evaluation, National Medical Products AdministrationOfficial website announcement,Guangzhou Huayue Nephrology Regenerative Medicine Technology Co., Ltd. (a wholly-owned subsidiary of AR)Declared“Human-Derived Renal Progenitor Cell Injection (ARM101)” First Indication Approved for Clinical Trials, for the prevention of delayed graft function in kidney transplant recipients, to promote postoperative recovery of the transplanted kidney and to maintain long-term renal function of the allograft in kidney transplant patients.

Public Information on the Official Website of the Center for Drug Evaluation, National Medical Products Administration, Regarding Human Renal Progenitor Cell Injection (ARM101)

ARM101PassInduced Pluripotent Stem Cell (iPSC) Technology, achieving scalable, highly stable, and off-the-shelf production of nephron progenitor cells (NPCs),It is AR Regenerative Medicine’s first cell therapy product in the field of kidney disease treatment, and also the world’s first iPSC-derived renal cell therapy in this field.The approval of the clinical trial implicit permission for this product demonstrates China's innovative capabilities in the research and development of iPSC-derived cell therapies and new drugs for kidney diseases. It adds a new variety to China's Class 1 advanced therapy medicinal products, opens up new pathways for the global treatment of kidney diseases, and enriches future therapeutic options for patients with renal conditions.

Following this indication, AR is advancing the clinical trial application for ARM101 in the treatment of acute and chronic kidney diseases, as well as hereditary kidney diseases.Leveraging Huayuan’s proprietary iPS cell gene editing and engineering platform, AR Regenerative Medicine has developed multiple generations of targeted therapies for various kidney diseases.

ARis a company dedicated toNovel Therapies for Kidney Disease and the Development of Implantable Bioartificial Organs, a high-tech enterprise dedicated to addressing clinical pain points in kidney disease and organ function decline, thereby extending patients' lives with high quality,Established an industry-leading R&D and production platform for kidney stem cell-based drugs and medical devicesThe company’s core business spans from intervening in and reversing early- to mid-stage chronic kidney disease (CKD) using stem cell therapies, to replacing organs in end-stage renal disease (ESRD) through tissue engineering approaches, establishing a comprehensive product pipeline. It is internationally leading in the field of differentiating stem cells into renal cells. The company has successfully built five unique core technology platforms: an engineered platform for independent R&D of pluripotent stem cell-derived therapeutics, a GMP manufacturing platform, a kidney organoid platform, and a nanomembrane and medical device synthesis platform. This achieves full-cycle coverage from research and development to clinical trial application.