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LY01019 is a recombinant humanized monoclonal antibody targeting Claudin 18.2 (CLDN18.2), developed by Shandong Boan Biotechnology, a subsidiary of Luye Pharma. CLDN18.2 is a tight junction protein that is highly expressed in various solid tumors, including gastric, gastroesophageal junction, and pancreatic cancers, while its expression in normal tissues is strictly limited to the gastric mucosa. LY01019 exerts its anti-tumor effects by binding specifically to CLDN18.2 on the surface of tumor cells, thereby inducing antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). The drug is currently being evaluated in Phase 1 clinical trials for the treatment of advanced solid tumors, aiming to provide a targeted therapeutic option for patients with CLDN18.2-positive malignancies.
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