Alphamab Oncology's KN026 NDA accepted for gastric cancer treatment

Alphamab Oncology has announced that its New Drug Application (NDA) for KN026 (anbenitabab injection), in combination with chemotherapy, has been accepted by China's National Medical Products Administration (NMPA). The application targets the treatment of HER2-positive locally advanced, recurrent, or metastatic gastric or gastroesophageal junction cancer patients who have failed at least one prior systemic therapy, including trastuzumab.

The NDA is primarily supported by a pivotal phase II/III clinical trial, with interim analysis showing that KN026, when combined with chemotherapy, significantly improved progression-free survival (PFS) and overall survival (OS) compared to the current standard of care. The treatment also demonstrated a favorable safety profile with low cardiotoxicity and low immunogenicity.

KN026, co-developed with Shanghai JMT-Bio Technology Co., Ltd., received breakthrough therapy designation from the Center for Drug Evaluation on November 4, 2023, and was granted priority review status on August 28, 2025. It is the first anti-HER2 bispecific antibody in the PRC to achieve positive results in the second-line treatment of gastric cancer, with a median PFS of 8.6 months and an objective response rate of 40.0% in a phase II trial.