Alphamab Oncology has announced that its new drug application (NDA) for KN026, an Anbenitamab injection, has been accepted by the National Medical Products Administration (NMPA) of China. This application pertains to the use of KN026 in combination with chemotherapy for the treatment of patients with HER2-positive locally advanced, recurrent, or metastatic gastric or gastroesophageal junction cancer who have failed at least one prior systemic therapy. The NDA is supported by a pivotal phase II/III clinical trial that demonstrated significant improvements in progression-free survival and overall survival compared to the current standard of care. The drug, co-developed with Shanghai JMT-Bio Technology Co., Ltd., a subsidiary of CSPC Pharmaceutical Group Limited, has been granted breakthrough therapy designation and priority review status by the NMPA. Currently, there are no approved anti-HER2 therapies for second-line treatment of HER2+ gastric cancer, making KN026 the first anti-HER2 bispecific antibody in this context.