China’s NMPA approves Astellas’ Vyloy

China’s National Medical Products Administration (NMPA) has approved Astellas Pharma’s (TYO: 4503) Vyloy (zolbetuximab), in combination with fluoropyrimidine- and platinum-containing chemotherapy.

The Japanese pharma major said the drug is authorized for the first-line treatment of patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive.

Zolbetuximab is the first NMPA-approved monoclonal antibody to target gastric tumor cells that express the biomarker CLDN18.2, offering a highly targeted approach to cancer treatment.