Innovent Biologics received Breakthrough Therapy Designation (BTD) from the NMPA for IBI343 as a monotherapy for advanced pancreatic cancer

The BTD was granted based on favorable results from a Phase 1 study conducted in China, Australia, and the U.S., showing promising safety, tolerability, and antitumor activity

In the ongoing study, 43 patients with advanced PDAC received IBI343, showing a confirmed ORR of 23.3% and a mPFS of 5.3 months

In May 2024, IBI343 also received BTD for the treatment of CLDN18.2-positive advanced gastric/gastro-esophageal junction adenocarcinoma

Additionally, IBI343 received Fast Track Designation from the FDA in June 2024 for advanced, unresectable or metastatic PDAC, with the first U.S. Phase 1 study patient dosed in December 2024