Drug intelligence / Profile preview

9MW0311

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

Overview

9MW0311 is a biosimilar of denosumab (Prolia), developed by Mabwell and its subsidiary T-mab. It is a recombinant fully human anti-RANKL monoclonal antibody injection designed to treat osteoporosis and bone metastases. The drug works by binding to RANK ligand (RANKL), thereby preventing the activation of RANK on the surface of osteoclasts and their precursors. This inhibition reduces the formation, activation, and survival of osteoclasts—cells responsible for bone resorption—leading to decreased bone loss and reduced risk of fractures in patients with osteoporosis or cancer-related bone disease[1][2][3][6]. Clinical studies have demonstrated that 9MW0311 effectively increases bone mineral density (BMD) and decreases markers of bone resorption in postmenopausal women at high risk for fracture[5][7].

Brand names
MAILISHU
Other names
Denosumab biosimilarMAIWEIJIANMW-031MW031MW 031TK-006TK006TK 006
02

Targets

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

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