Drug intelligence / Profile preview

REGEND003

Development stage
Phase 1
Lead developer
Regend Therapeutics
Modality
Gene Therapies, Stem Cell Therapies → Cell Therapies
Administration
Parenteral (likely Intravenous Or Direct Injection Into The Kidney)[1]
01

Overview

REGEND003 is an autologous renal progenitor stem cell therapy developed by Regend Therapeutics for the treatment of diabetic nephropathy and other kidney diseases. The therapy utilizes a patient's own kidney progenitor cells, which are isolated, expanded, and then reintroduced to promote regeneration and repair of damaged renal tissue. The mechanism of action is based on cell replacement—restoring or replacing lost or dysfunctional kidney cells to improve organ function. This approach aims to address chronic kidney damage in conditions such as type 2 diabetes with established diabetic nephropathy and fibrosis. As of mid-2025, the product has completed preclinical development and IND approval in China, with plans for clinical trials targeting type 2 diabetic kidney disease[1][2][5].

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