7 May 2024 - Innovent Biologics announced that the Center for Drug Evaluation of China's National Medical Products Administration has granted breakthrough therapy designation for IBI343 as monotherapy for the treatment of claudin18.2 positive advanced gastric/gastro-oesophageal junction adenocarcinoma patients who have progressed after at least 2 lines of prior systematic treatments.
The breakthrough therapy designation for IBI343 was based on the data from an on-going Phase 1 study, in which favourable safety and tolerability and promising anti-tumour activity of IBI343 monotherapy in advanced gastric cancer patients were observed.