Innovent Biologics reported interim success for its Claudin18.2-targeted antibody-drug conjugate arcotatug tavatecan (IBI-343, TAK-921) in the international Phase 3 G-Hope-001 trial in advanced gastric cancer. Following the positive primary endpoint results, the company submitted its NDA to China’s National Medical Products Administration (NMPA), with priority review accepted. The submission supports a near-term regulatory push for CLDN18.2-positive, previously treated locally advanced unresectable or metastatic disease after at least two prior systemic therapies. The update also signals intensified competition around CLDN18.2 targeting modalities as multiple companies have advanced programs in the same patient segment. For biotech stakeholders, the key operational takeaway is that Innovent moved rapidly from interim Phase 3 results into regulatory filing, aiming to compress the path to potential launch and market uptake in China.