China-based Innovent Biologics (HKEX: 01801) has submitted a New Drug Application (NDA) to China's National Medical Products Administration (NMPA) for IBI343 (arcotatug tavatecan), a CLDN18.2-targeted antibody-drug conjugate (ADC). The first potential indication for the molecule is as a third-line or later treatment for locally advanced unresectable or metastatic CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma (G/GEJA). The NMPA has accepted the application with priority review designation.
The proposed setting of third-line and beyond in CLDN18.2-positive G/GEJA represents a population in which treatment options remain limited and prognosis is poor. Innovent reported that the NDA is supported by positive interim results from a Phase III study and that priority review was granted, though no PDUFA-equivalent target action date has been disclosed. Under the Takeda Pharmaceuticals partnership announced in October 2025, Takeda holds exclusive rights to arcotatug tavatecan outside Greater China, where the asset carries the R&D designation TAK-921.
The submission is supported by data from the G-HOPE-001 study (NCT06238843), an international, multicenter, randomized, open-label Phase III trial conducted across sites in China and Japan. The study evaluated arcotatug tavatecan monotherapy against investigator-selected therapy in patients with CLDN18.2-positive locally advanced unresectable or metastatic G/GEJA who had received at least two prior systemic regimens. Co-primary endpoints were progression-free survival (PFS) and overall survival (OS). Innovent reported that the pre-specified first interim analysis met the primary PFS endpoint, with the company describing the efficacy as demonstrating an encouraging anti-tumor effect and a manageable safety profile, including a low incidence of gastrointestinal-related toxicity. Detailed data are expected to be presented at a future academic conference or published in a peer-reviewed journal.