Key facts
- Innovent Biologics' NDA for IBI343 (arcotatug tavatecan) accepted by China's NMPA.
- IBI343 is the world's first CLDN18.2 ADC.
- The drug met its primary endpoint in an international Phase 3 study.
- The study focused on advanced refractory gastric cancer patients.
Innovent Biologics, Inc. announced on June 4, 2026, that its New Drug Application (NDA) for IBI343 (arcotatug tavatecan) has been accepted by China's National Medical Products Administration (NMPA). IBI343 is described as the world's first CLDN18.2 antibody-drug conjugate (ADC). The acceptance follows the drug meeting its primary endpoint in an international Phase 3 study involving patients with advanced refractory gastric cancer. Innovent Biologics is a biopharmaceutical company focused on oncology, cardiovascular, and metabolic diseases.