Innovent Biologics submitted an NDA to China’s NMPA for its CLDN18.2-targeted ADC arcotatug tavatecan (IBI-343, TAK-921) after positive interim results in the international multicenter Phase 3 G-Hope-001 trial. Innovent’s application covers previously treated locally advanced unresectable or metastatic CLDN18.2-positive gastric and gastroesophageal junction adenocarcinoma. The submission was accepted with priority review. Innovent said the trial met its primary endpoint, and the ADC is positioned for use after at least two prior systemic therapies. In a competitive CLDN18.2 landscape, this filing adds another potential option and emphasizes the pace of ADC development in China’s regulatory pipeline for next-generation gastrointestinal oncology targets.