Alphamab Oncology's KN026 NDA for HER2+ Gastric Cancer Accepted by China's NMPA, Achieving Breakthrough Therapy Designation and Priority Review Status

Reuters
2025.09.11 11:35
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Alphamab Oncology's new drug application (NDA) for KN026, an Anbenitamab injection for HER2-positive gastric cancer, has been accepted by China's NMPA. The NDA, supported by a pivotal clinical trial, aims to treat patients who have failed prior therapies. KN026 has received breakthrough therapy designation and priority review status, marking it as the first anti-HER2 bispecific antibody for second-line treatment in this context. Currently, there are no approved anti-HER2 therapies for this indication.