Zolbetuximab for Injection Approved for Marketing by China NMPA
Recently, the Zolbetuximab for Injection (trade name: 威络益/VYLOY) of Astellas Pharma Europe B.V. is approved for marketing by China NMPA. Indications: This product is indicated for use in combination with fluorouracil and platinum-based chemotherapy regimens as first-line treatment for patients with CLDN18.2-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Zolbetuximab is a human-mouse chimeric IgG1 monoclonal antibody targeting claudin 18 splice variant 2 (CLDN18.2), which specifically binds to CLDN18.2 and induces antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). The marketing of this drug provides a new treatment option for relevant patients.