Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for IBI343, a potentially best-in-class TOPO1i anti-CLDN18.2 ADC, as monotherapy for the treatment of CLDN18.2-positive advanced pancreatic ductal adenocarcinoma (PDAC) patients who have progressed after at least one line of prior systematic treatment.

The BTD for IBI343 was granted based on data from an ongoing Phase 1 study conducted in China, Australia and the U.S. (NCT05458219), which demonstrated favorable safety and tolerability, as well as promising antitumor activity of IBI343 monotherapy in advanced PDAC patients. Data from the study's dose-expansion cohort were presented orally at the 2024 ESMO Asia Congress:  

• A total of 43 patients with CLDN18.2-positive advanced PDAC (≥60% tumor cells with membranous staining intensity ≥1+ by IHC) received IBI343 6 mg/kg Q3W monotherapy. All participants had previously received at least one line of prior therapy, and 60.5% had received two or more lines of anticancer treatment.
• The confirmed overall objective response rate (ORR) was 23.3%, and progression-free survival (PFS) events occurred in 26 patients, with a median progression-free survival (mPFS) of 5.3 months (4.1-7.4) as of the data cutoff date. (link) 

Previously, in May 2024, the CDE has granted IBI343 its first BTD for monotherapy in the treatment of CLDN18.2-positive advanced gastric/gastro-esophageal junction adenocarcinoma (GC) patients who have progressed after at least two lines of prior systematic treatments. In addition, in June 2024, IBI343 was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of advanced, unresectable or metastatic PDAC that has relapsed and/or is refractory to one prior line of therapy. The first patient in the U.S. Phase 1 study of IBI343 was successfully dosed in December 2024.