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CG001 is a human-derived, antibody-like complement inhibitor engineered as a bivalent fusion protein comprising the extracellular domain of complement receptor of the immunoglobulin superfamily (CRIg) linked to regulatory domains of complement factor H (FH) and fused to a human IgG4 Fc region. CG001 binds complement component C3b on cell surfaces, simultaneously engaging distinct C3b sites via CRIg and FH, thereby blocking assembly and activity of C3/C5 convertases and effectively inhibiting all three complement pathways (classical, lectin, and alternative) at the level of C3 and C5. By accelerating decay of C3/C5 convertases and promoting factor I–mediated degradation of C3b, CG001 suppresses complement-mediated hemolysis and tissue injury, shows therapeutic effects in preclinical models of alternative-pathway–driven hemolysis and classical-pathway–induced mesangial proliferative glomerulonephritis, and exhibits antibody-like pharmacokinetics with no observable toxicity in rats and cynomolgus monkeys, positioning it as a potential systemic therapy for diverse complement-mediated diseases.[1][3][12]
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