Drug intelligence / Profile preview

Y003

Development stage
Phase 1
Lead developer
Shandong New Era Pharmaceutical
Modality
Fc-Fusion Proteins → Carrier/Scaffold Proteins → Recombinant Proteins and Enzymes
Administration
Subcutaneous
01

Overview

Y003 is a long-acting recombinant human thrombopoietin-human serum albumin (rhTPO-HSA) fusion protein developed by Shandong New Era Pharmaceutical, a subsidiary of Lunan Pharmaceutical Group. It is designed for the treatment of primary immune thrombocytopenia (ITP) and chemotherapy-induced thrombocytopenia (CIT). By fusing recombinant human thrombopoietin with human serum albumin, Y003 achieves a significantly prolonged half-life compared to first-generation rhTPO therapies, allowing for a reduced dosing frequency of once weekly or once every two weeks. The drug acts as an agonist of the thrombopoietin receptor (MPL), binding to the receptor on the surface of hematopoietic stem cells and megakaryocyte progenitor cells. This binding activates downstream signaling pathways, such as JAK2/STAT, which promote the survival, proliferation, and maturation of megakaryocytes, ultimately increasing the circulating platelet count. Y003 is currently in Phase III clinical development in China.

Other names
recombinant human thrombopoietin-human serum albumin fusion proteinrhTPO-HSA fusion protein
02

Targets

TPOR (Thrombopoietin receptor)

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