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FB825 is a first-in-class humanized monoclonal antibody targeting the CεmX domain of membrane-bound immunoglobulin E (mIgE) on B cells. By binding to this specific domain, FB825 induces the depletion of mIgE-positive B lymphocytes, thereby preventing the production of IgE antibodies that drive allergic inflammation. This mechanism of action is distinct from existing anti-IgE therapies like omalizumab, which target circulating free IgE. Developed by Oneness Biotech and licensed to LEO Pharma for global development (excluding China), FB825 is primarily being evaluated for the treatment of moderate-to-severe atopic dermatitis and allergic asthma. Clinical data have suggested that FB825 can provide sustained reduction in IgE levels and clinical improvement in patients with high baseline biomarkers of allergic disease.
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