Drug intelligence / Profile preview

XJ-MK-002

Development stage
Phase 1
Lead developer
HemaCell Biotechnology
Modality
Stem Cell Therapies → Cell Therapies
Administration
Intravenous
01

Overview

XJ-MK-002 is an investigational allogeneic cell therapy consisting of a suspension of megakaryocytes derived from human umbilical cord blood. The drug is developed using a proprietary platform for the ex vivo expansion and directed differentiation of megakaryocyte precursors. Upon intravenous infusion into the patient, these megakaryocytes undergo terminal differentiation and fragmentation into functional platelets within the circulatory system, a biological process driven by physiological regulation and hemodynamic shear stress. This mechanism is intended to rapidly elevate platelet levels in patients suffering from severe thrombocytopenia without the traditional reliance on donor platelet transfusions. XJ-MK-002 has received Orphan Drug Designation (ODD) from the US FDA for the treatment of Bernard-Soulier Syndrome (BSS) and is currently being evaluated in clinical trials for cancer therapy-induced thrombocytopenia.

Other names
Umbilical Cord Blood Megakaryocyte InjectionAllogeneic Megakaryocyte InjectionMegakaryocyte Injection

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