Innovent Biologics disclosed that its Claudin18.2 antibody-drug conjugate arcotatug tavatecan (IBI-343, TAK-921) met a primary endpoint in an international Phase 3 study (G-Hope-001) for advanced gastric cancer. Following interim results, Innovent submitted a New Drug Application to China’s NMPA and the agency accepted it for priority review. The trial enrolled previously treated patients with CLDN18.2-positive locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma who had received at least two prior systemic therapies. Innovent said the PFS readout favored the ADC arm, while keeping the detailed numbers and safety metrics for upcoming academic disclosure. The filing deepens competition in the CLDN18.2 space, where multiple modalities—antibodies, bispecifics, and ADCs—are moving through late-stage development. It also strengthens Innovent’s position as it leverages Takeda’s deal structure for ex-China rights and advances regulatory momentum in China first. If priority review timelines hold, the decision will set up the next phase of confirmatory scrutiny around survival and toxicity profiles across broader patient segments.