Group 1 - Corning Jereh Pharmaceutical-B (09966) announced that its new drug application for KN026, in collaboration with Shanghai Jinmant Biotech Co., Ltd., has been accepted by the National Medical Products Administration of China for treating HER2-positive locally advanced, recurrent, or metastatic gastric/gastroesophageal junction adenocarcinoma patients who have failed at least one systemic treatment including trastuzumab-based chemotherapy [1] - The new drug application is based on a pivotal phase II/III clinical trial, which showed that KN026 combined with chemotherapy significantly improved clinical efficacy compared to existing standard treatments, extending progression-free survival (PFS) and overall survival (OS) without new safety risks, low incidence of cardiac toxicity, and low immunogenicity [1] - KN026 received breakthrough therapy designation from the National Medical Products Administration on November 4, 2023, and was granted priority review qualification on August 28, 2025 [1] Group 2 - Currently, there are no approved anti-HER2 drugs for second-line treatment of HER2-positive gastric cancer, making KN026 the first anti-HER2 bispecific antibody drug in China to achieve positive results in this indication [2] - The phase II clinical trial results for KN026 will be presented at the 2024 European Society for Medical Oncology annual meeting, showing an objective response rate of 40.0% and a median PFS of 8.6 months as assessed by an independent review committee [2]
康宁杰瑞制药-B(09966)：KN026(安尼妥单抗注射液)新药上市申请获国家药监局受理