On September 11, the official website of the Clinical Trial Registration and Information Platform showed that Andao Pharmaceuticals registered a Phase III clinical trial for oral AND017 capsules in subjects with anemia due to dialysis-dependent chronic kidney disease (DD-CKD). Public information indicates this is the first Phase III trial initiated for this drug.

Screenshot source: Clinical Trial Registration and Information Platform

This is a multicenter, randomized, open-label, active-controlled, parallel-group Phase III clinical trial designed to evaluate the efficacy and safety of AND017 in treating anemia in subjects with dialysis-dependent end-stage kidney disease (ESKD). The primary endpoint is the mean hemoglobin (Hb) level during the main treatment period.

AND017 is a First-in-Class hemoglobin elevating agent (HbEA) independently developed by Andao Pharmaceuticals based on a Nobel Prize-winning mechanism of action. Through comprehensive in vitro and in vivo pharmacodynamic studies, Andao Pharmaceuticals has discovered further innovative mechanisms of action for AND017, supporting its development as a pan-anemia therapy. Currently, AND017 is being developed globally for multiple indications, including anemia in chronic kidney disease, beta-thalassemia, anemia in myelodysplastic syndromes, sickle cell disease, and tumor-related anemia.

Screenshot source: Insight Database

Results from two completed international multicenter Phase II clinical trials indicate that AND017 is the only anemia treatment for chronic kidney disease globally that supports weekly oral administration, possessing significant market potential.