Core Viewpoint - The application for the new drug KN026 (Anituzumab Injection) developed by the company's subsidiary has been accepted by the National Medical Products Administration of China, targeting HER2-positive gastric cancer patients who have failed at least one systemic treatment [1][2]. Group 1 - The product is a bispecific antibody that targets two non-overlapping epitopes of HER2, leading to HER2 signal blockade [2]. - The objective response rate for the product in combination with chemotherapy is reported at 40.0%, with a median progression-free survival of 8.6 months and a median overall survival of 13.2 months based on the results of a Phase II clinical trial [2]. - The application is primarily based on a key Phase II/III clinical trial (KC-WISE), which shows significant clinical efficacy compared to current standard treatments, with no new safety risks identified [2]. Group 2 - Currently, there are no approved anti-HER2 drugs for second-line treatment of HER2-positive gastric cancer, making this product the first bispecific antibody to achieve positive results in this indication in China [2]. - The company is actively advancing multiple clinical trials for the product targeting different solid tumor indications, with gastric and breast cancer developments currently in critical Phase III clinical trial stages [2].
石药集团(01093.HK)：KN 026(安尼妥单抗注射液)的新药上市申请获国家药品监督管理局受理