Astellas files for Japanese approval of zolbetuximab

A New Drug Application (NDA) was filed on June 9, 2023 with Japan's Ministry of Health, Labor and Welfare (MHLW) for zolbetuximab.

Developed by Japan’s Astellas Pharma (TYO: 4503), zolbetuximab is 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 gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2-positive. If approved, zolbetuximab would be the first CLDN18.2-targeted therapy available in Japan for these patients. Astellas’ shares edged up 1.1% to 2,260 yen on the news.

Originated at Ganymed Pharmaceuticals, zolbetuximab (IMAB362) came into Astellas’ hands in 2016, when it acquired the German company for $1.4 billion. The drug was discovered by Uğur Şahin and Özlem Türeci, who became known as the couple behind one of the world’s first Covid-19 vaccines, Comirnaty, even before they founded BioNTech (Nasdaq: BNYX).