ALPHAMAB-B: KN026 (Anrituzumab Injection) New Drug Application Accepted by the National Medical Products Administration

According to the Zhitong Finance APP, ALPHAMAB-B (09966) announced that the new drug application (NDA) for KN026 combined chemotherapy, developed in collaboration with the subsidiary of CSPC Pharmaceutical Group Limited (01093), Shanghai Jinmant Biotech Co., Ltd., for the treatment of patients with epidermal growth factor receptor 2 (HER2) positive (HER2+) locally advanced, recurrent, or metastatic gastric/gastroesophageal junction adenocarcinoma (GC/GEJ) who have failed at least one systemic treatment (which must include trastuzumab combined chemotherapy), has been accepted by the National Medical Products Administration (NMPA) of China. This NDA is primarily based on a key Phase II/III clinical trial, the interim analysis results of which showed that KN026 combined chemotherapy significantly improved clinical efficacy, extended patients' progression-free survival (PFS) and overall survival (OS) compared to existing standard treatments, with no new safety risks and a low incidence of cardiac toxicity and immunogenicity. Additionally, KN026 was granted breakthrough therapy designation by the NMPA's Drug Evaluation Center on November 4, 2023, and has been qualified for priority review and approval on August 28, 2025.

Currently, there are no approved anti-HER2 drugs for second-line treatment of HER2+ gastric cancer, making KN026 the first anti-HER2 bispecific antibody drug in China to achieve positive results in second-line treatment for gastric cancer. The results of the Phase II clinical trial for KN026 will be presented for the first time at the 2024 European Society for Medical Oncology (ESMO) annual meeting, showing an objective response rate of 40.0% for KN026 combined chemotherapy, with a median PFS of 8.6 months as assessed by an independent review committee