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BA1301 is an **antibody-drug conjugate (ADC)** developed by Boan Biotech, a subsidiary of Luye Pharma Group, that targets the **Claudin 18.2** protein, a transmembrane protein significantly expressed in several gastrointestinal tumors, notably **gastric cancer, gastroesophageal junction adenocarcinoma, and pancreatic cancer**. BA1301 is constructed using a **site-specific conjugation technique**, coupling a monoclonal antibody specific for Claudin 18.2 with a cytotoxic small-molecule payload. The antibody directs the cytotoxic payload to Claudin 18.2-expressing tumor cells, providing high internalization and bystander killing activity, while maintaining a stable and low off-target release of the toxin. BA1301 has demonstrated **excellent anti-tumor efficacy** in preclinical models, including significant tumor growth inhibition and even elimination in gastric and pancreatic cancer xenografts. The ADC has shown a favorable safety and tolerability profile in animal studies, and is currently in Phase 1 clinical trials in China for the treatment of advanced solid tumors expressing Claudin 18.2. BA1301 has been granted Orphan Drug Designation by the U.S. FDA for gastric cancer (including gastroesophageal junction cancer) and pancreatic cancer[1][2][3][4][5][7].
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