Innovent Biologics’ IBI343 met primary endpoint in phase 3 Gastric cancer trial with NDA accepted by NMPA

CAR-T Digest - August 2020

Weekly Digest - June 2026

04 June 2026: Innovent Biologics’ IBI343 met primary endpoint in phase 3 Gastric cancer trial with NDA accepted by NMPA

Innovent Biologics has announced that IBI343, a CLDN18.2-targeted antibody-drug conjugate, successfully met its primary endpoint in the pivotal phase 3 G-HOPE-001 trial for advanced gastric cancer, marking a major milestone for the development of CLDN18.2-directed therapies
Based on the positive phase 3 results, Innovent has submitted NDA for IBI343 to China’s National Medical Products Administration, which has accepted the application and granted priority review for patients with previously treated locally advanced, unresectable, or metastatic CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma
The international multicenter phase 3 G-HOPE-001 study, conducted across China and Japan, evaluated IBI343 monotherapy against investigator’s choice therapy in patients who had received at least two prior systemic treatments, with progression-free survival and overall survival serving as the primary endpoints
IBI343 is a biomarker-guided CLDN18.2 ADC that utilizes a cleavable linker to selectively deliver a topoisomerase I inhibitor payload to tumor cells and incorporates an Fc-silencing design intended to reduce off-target toxicity while maintaining potent anti-tumor activity
Strategically, the NDA acceptance and priority review position IBI343 to potentially become the world’s first approved CLDN18.2-targeted ADC, strengthening Innovent’s leadership in gastrointestinal oncology and validating CLDN18.2 as a promising ADC target in gastric cancer while expanding the competitive landscape of precision oncology therapies