Drug intelligence / Profile preview

LY01011

Development stage
Phase 3
Lead developer
Boan Biotech
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Subcutaneous
01

Overview

LY01011 is a recombinant fully human monoclonal antibody that targets the receptor activator of nuclear factor kappa-B ligand (RANKL). It is developed as a biosimilar to denosumab (reference product Xgeva) and is intended for the prevention of skeletal-related events in patients with bone metastases from solid tumors, treatment of adults and skeletally mature adolescents with unresectable giant cell tumor of bone or where surgical resection would result in severe morbidity, and treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. Clinical studies have demonstrated pharmacokinetic, pharmacodynamic, efficacy, safety, and immunogenicity profiles equivalent to those of denosumab. The drug was developed by Shandong Boan Biotechnology Co., Ltd., a subsidiary of Luye Pharma Group[2][3][5][7].

Brand names
LY01011LY-01011LY 01011
Other names
Denosumab biosimilar LY01011Recombinant anti-RANKL human monoclonal antibody injection
02

Targets

RANKL (Receptor Activator for Nuclear Factor-kappa B Ligand)

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