12 June 2024 - Innovent Biologics announced that the US FDA has granted fast track designation to its TOPO1i anti-CLDN18.2 ADC (IBI343) for the treatment of advanced unresectable or metastatic pancreatic ductal adenocarcinoma that has relapsed and/or is refractory to one prior line of therapy.
Previously, IBI343 has already received FDA approval of its IND application for the treatment of pancreatic ductal adenocarcinoma.