World's First CLDN18.2 ADC for Regulatory Review: Innovent Biologics Announces IBI343 (arcotatug tavatecan) Met Primary Endpoint in International Phase 3 Study in Advanced Refractory Gastric Cancer and NDA Accepted by China NMPA

World's First CLDN18.2 ADC for Regulatory Review: Innovent Biologics Announces IBI343 (arcotatug tavatecan) Met Primary Endpoint in International Phase 3 Study in Advanced Refractory Gastric Cancer and NDA Accepted by China NMPA

PR Newswire

SAN FRANCISCO and SUZHOU, China, June 4, 2026

SAN FRANCISCO and SUZHOU, China, June 4, 2026 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces that the international multi-center Phase 3 clinical study (G-HOPE-001, NCT06238843) of arcotatug tavatecan (IBI343; Takeda R&D code: TAK-921, an innovative TOPO1i CLDN18.2 ADC) has completed the per-protocol first interim analysis and reached the primary endpoint. Arcotatug tavatecan demonstrated excellent efficacy and a tolerable safety profile in the treatment of advanced gastric cancer. Based on the positive clinical results, Innovent has submitted the new drug application (NDA) for arcotatug tavatecan to the National Medical Products Administration (NMPA) of China, for the treatment of previously treated locally advanced unresectable or metastatic CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma (G/GEJA) who have received at least two prior systemic therapies. This application has been accepted with priority review.