Drug intelligence / Profile preview

BAT4406F

Development stage
Phase 3
Lead developer
Bio-Thera Solutions
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
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Overview

BAT4406F is a glycosylation-optimized, fully humanized anti-CD20 monoclonal antibody of the IgG1 subclass with enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) effect. Developed by Bio-Thera Solutions, BAT4406F is designed to deplete B cells more effectively than existing anti-CD20 antibodies such as rituximab, ocrelizumab, and ofatumumab. In preclinical and clinical studies, BAT4406F demonstrated potent B-cell depletion activity and favorable safety in patients with neuromyelitis optica spectrum disorders (NMOSD). The drug works by binding to the CD20 antigen on B lymphocytes, leading to their destruction primarily through ADCC. Clinical trials have shown that BAT4406F maintains low levels of B lymphocytes for an extended period post-administration and has a generally nonlinear pharmacokinetic profile with a mean elimination half-life ranging from 9.0–16.4 days[1][2][5].

02

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