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Recombinant human albumin–G-CSF fusion protein (also known as FY01 or M-GCSF) is a long-acting granulocyte colony-stimulating factor (G-CSF) analogue developed by Sino-Fugen Biotechnology and its partners. The molecule is a recombinant fusion protein consisting of human G-CSF covalently linked to recombinant human serum albumin (HSA). This design leverages the long circulatory half-life of albumin to extend the duration of action of G-CSF, thereby reducing the frequency of administration required to manage neutropenia compared to short-acting filgrastim. FY01 acts as an agonist at the G-CSF receptor (G-CSFR), stimulating the survival, proliferation, and differentiation of neutrophil lineage cells in the bone marrow. It is currently being evaluated in clinical trials for the prevention of chemotherapy-induced neutropenia (CIN) in patients with solid tumors, including breast cancer.
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