Innovent Biologics has announced that its investigational CLDN18.2-targeted antibody-drug conjugate (ADC), IBI343, has been recommended for priority review by China's Centre for Drug Evaluation (CDE) for the treatment of advanced gastric or gastroesophageal junction adenocarcinoma. The candidate, which has also received breakthrough therapy designation (BTD) for this indication, is a first-in-class ADC comprising a CLDN18.2 antibody conjugated to a TopI inhibitor payload. It is designed to exert both direct and bystander killing effects on tumour cells.

IBI343 is also in Phase III development for pancreatic cancer. The priority review recommendation is supported by Phase I data showing a confirmed objective response rate (ORR) of 29% and a median progression-free survival (PFS) of 5.5 months in patients with high CLDN18.2-expressing gastric cancer. The drug has also received fast track designation in the US for pancreatic cancer.

PharmCube's NextBiopharm® database shows that Innovent acquired the drug in 2021 from Synaffix before transferring ex-China rights to Takeda in 2025. Click here to request a free trial for NextBiopharm®.