Anbenitamab: First Approval

Anbenitamab (Ennituo^®), a bispecific IgG monoclonal antibody targeting human epidermal growth factor receptor 2 (HER2), is being developed by Alphamab Oncology for the treatment of various solid tumours (including gastric cancer and breast cancer). Anbenitamab received its first approval in China on 27 May 2026. Anbenitamab, in combination with chemotherapy, is approved for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have previously received at least one trastuzumab-containing therapy. This article summarizes the milestones in the development of anbenitamab leading to this first approval for gastric or GEJ cancer.