On May 27, 2026, the official website of the U.S. Food and Drug Administration (FDA) announced that ARM101 (Human Renal Progenitor Cell Injection), an hiPSC-derived nephron progenitor cell drug independently developed by Asia Regenerative Medicine Co., Ltd., has officially received Orphan Drug Designation (ODD). The designated indication is for the prevention of Delayed Graft Function (DGF) in kidney transplant recipients. This is the world's first cell therapy targeting DGF to receive FDA Orphan Drug Designation, filling an international gap in the recognition of cell therapy products for this indication.

Delayed Graft Function (DGF) is a common and severe complication following kidney transplantation. When DGF occurs, the transplanted kidney cannot immediately resume function, leading to prolonged hospitalization, significantly increased medical costs, and a marked impact on the long-term survival of the graft. Currently, aside from supportive treatments like dialysis, there are no effective drugs to prevent or treat DGF, representing a significant unmet clinical need.

ARM101 is developed using induced pluripotent stem cell (iPSC) technology, enabling the large-scale, highly stable, off-the-shelf production of nephron progenitor cells (NPCs). It is Huayuan Regenerative Medicine's first cell therapy product in the field of kidney disease treatment and the world's first iPSC-derived kidney cell therapy for DGF. Previously, on May 14, 2026, ARM101 received Clinical Trial Implied Approval from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) for its first indication: the prevention of DGF in kidney transplant recipients.

Efung Capital invested in Huayuan Regenerative Medicine in 2023. Looking ahead, Efung Capital will continue to leverage its deep capital resources and industrial ecosystem advantages in the biopharmaceutical sector to support Huayuan Regenerative Medicine in achieving breakthroughs in pipeline expansion, international registration, and commercialization of its iPSC-derived kidney cell therapy. Efung Capital remains committed to standing alongside the company in addressing the clinical challenges of kidney disease treatment, advancing China's homegrown cell therapies to benefit patients worldwide, and fulfilling its mission of "empowering hard technologies with the power of capital."