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CM313 is a humanized IgG1 monoclonal antibody that targets CD38, a glycoprotein highly expressed on plasma cells, NK cells, and other immune cells. By binding to CD38, CM313 induces cell death through multiple mechanisms including complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC), and antibody-dependent cellular phagocytosis (ADCP). It also inhibits the enzymatic activity of CD38. CM313 has demonstrated preclinical anti-tumor activity comparable to daratumumab and stronger CDC activity than isatuximab. Clinically, it is being developed for diseases with high unmet medical needs such as relapsed/refractory multiple myeloma, relapsed/refractory lymphoma (including Waldenstrom’s macroglobulinemia and marginal zone lymphoma), primary immune thrombocytopenia (ITP), and systemic lupus erythematosus. The drug has shown promising safety and efficacy in early-phase clinical trials for these indications[1][2][3][4][5].
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