China’s National Medical Products Administration approved Suzhou Alphamab’s HER2 bispecific antibody anbenitamab (KN-026) for adults with locally advanced or metastatic HER2-positive gastric and gastroesophageal junction adenocarcinoma who received at least one trastuzumab-containing regimen. The approval used priority review. Alphamab said the label is supported by phase III results showing anbenitamab plus chemotherapy reduced the risk of disease progression or death by 75%. The company also suggested the combination could become a new standard of care for previously treated patients. This approval adds to the rapid expansion of bispecific antibodies in China’s oncology pipeline, especially in HER2-driven gastrointestinal cancers.
Get the Daily Brief