Chinese biopharmaceutical company Innovent Biologics Inc (HKEX:01801) on Monday reported updated Phase 1 study results for IBI343, a novel anti-CLDN18.2 ADC, for the treatment of advanced pancreatic cancer, at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.

With extended follow-up and more mature data on progression-free survival (PFS) and overall survival (OS), IBI343 has demonstrated promising therapeutic efficacy in patients with CLDN18.2-positive advanced pancreatic cancer, Innovent Biologics said. The findings point to the potential of IBI343 in this challenging-to-treat malignancy.

As the data cutoff date, the confirmed overall objective response rate (cORR) at the 6mg/kg dose was 22.7% and the disease control rate (DCR) was 81.8%. Median progression-free survival (mPFS) was 5.4 months, and median overall survival (mOS) was 9.1 months.

IBI343 has been granted Breakthrough Therapy Designation (BTD) by China's National Medical Products Administration (NMPA). A Phase 1 clinical trial of IBI343 is also being conducted in the United States, where the drug candidate has received Fast Track Designation (FTD) from the US Food and Drug Administration (FDA).

IBI343 is a recombinant human anti-CLDN18.2 monoclonal antibody-drug conjugate (ADC) developed by Innovent Biologics. The therapeutic potential of IBI343 is currently being explored in tumour types such as gastric and pancreatic cancer.

The Phase 3 trial of IBI343 for advanced gastric / gastroesophageal junction adenocarcinoma is now recruiting patients.