31 July 2023 - Astellas Pharma today announced that the Center for Drug Evaluation of the China National Medical Products Administration has accepted the biologics license application for zolbetuximab, a first in class investigational Claudin 18.2 (CLDN18.2) targeted monoclonal antibody, for first-line treatment of patients with locally advanced unresectable or metastatic HER2 negative gastric or gastro-oesophageal junction adenocarcinoma whose tumours are CLDN18.2 positive. 

If approved, zolbetuximab would be the first CLDN18.2-targeted therapy available in China for these patients.

Read Astellas press release