A recombinant human erythropoietin(EPO) fused to hyFc
CKD induced Anemia(Dialysis and nondialysis)
Clinical Development (Phase 3)
Safety and tolerability were evaluated from phase 1 clinical trial in healthy volunteers, and phase 2 clinical trial in anemia patients with CKD have been completed and is currently in phase 3 trial with patients in 7 countries in Asia and Oceania.
GX-E4 is a Long-acting Erythropoiesis simulating agent. Differing from marketed glycosylation or PEGylation products, it uses the hyFc fusion protein technology to maximize half-life of the efficacy. It is intended for the treatment and for maintenance of anemia induced by chronic kidney disease (CKD) with or without dialysis.
It has non-cytolytic properties because it uses a sequence that does not have the ability to induce cytotoxicity among the sites of IgG4 and IgD that exist in vivo.
GX-E4 promotes erythropoiesis by interacting with erythropoietin receptors on the red blood cell (RBC) surface, resulting in the proliferation and terminal differentiation of erythroid progenitor cells.
Presentation at 2017 ASN Poster, Presentation at The Korean Society of Nephrology in 2018