
China’s National Medical Products Administration (NMPA) has recently accepted the New Drug Application (NDA) of Alphamab Oncology’s (HK: 9966) nKN026 (anbenitamab).
If approved, KN026 is expected to become the first bispecific monoclonal antibody (MAb) targeting HER2-positive gastric or gastroesophageal (GEJ) carcinoma and evolve as a potential treatment option in the gastric cancer landscape in China, says pharma analytics company GlobalData.
KN026’s bispecific receptor blockade mechanism enables simultaneous binding to two HER2 epitopes, effectively blocking the HER2 signals. The NDA submission is supported by results from the Phase II/III KN026-001 trial. KN026, combined with chemotherapy for adult patients with HER2-positive locally advanced, recurrent, or metastatic gastric or GEJ adenocarcinoma who have failed at least one prior systemic therapy containing trastuzumab, demonstrated an improved progression-free survival (PFS) and overall survival (OS) compared to standard-of-care with no new safety concerns in the trail.
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