Anbenitamab (KN026) is an investigational anti-HER2 bispecific monoclonal antibody developed by Alphamab Oncology. It is being evaluated across HER2-positive breast and gastric/gastroesophageal cancers in multiple pivotal studies. The first NMPA NDA was accepted in September 2025 and remains under regulatory review.
- Drug Class
- Anti-HER2 bispecific monoclonal antibody
- Approval Status
-
Investigational; first NMPA NDA accepted in September 2025 and under review
- Mechanism of Action
- Simultaneously binds two non-overlapping HER2 epitopes, blocks HER2 signaling, enhances ADCC/CDC, and promotes HER2 receptor down-regulation
Indications
- \HER2-positive gastric/gastroesophageal junction cancer\
- \HER2-positive breast cancer (including neoadjuvant/adjuvant and first-line settings under study)\