Core Insights - Corning Jereh Pharmaceutical-B (09966) has received acceptance for its new drug application for KN026, a combination chemotherapy treatment for HER2-positive gastric cancer patients who have failed at least one systemic therapy, from the National Medical Products Administration of China [1] - The application is based on a pivotal Phase II/III clinical trial that demonstrated significant clinical efficacy, prolonging progression-free survival (PFS) and overall survival (OS) compared to existing standard treatments, with a low incidence of cardiac toxicity and immunogenicity [1] - KN026 is the first bispecific antibody drug in China to achieve positive results in second-line treatment for HER2-positive gastric cancer, with an objective response rate of 40.0% and a median PFS of 8.6 months reported at the 2024 European Society for Medical Oncology annual meeting [2] Company Developments - The collaboration between Corning Jereh Pharmaceutical and Shanghai Jinmant Biotech, a subsidiary of CSPC Pharmaceutical Group (01093), is focused on the development of KN026 [1] - KN026 has been granted breakthrough therapy designation by the National Medical Products Administration and has received priority review status, indicating its potential significance in treating gastric cancer [1] Industry Context - Currently, there are no approved anti-HER2 drugs for second-line treatment of HER2-positive gastric cancer, highlighting the market opportunity for KN026 [2] - The positive clinical trial results for KN026 may pave the way for its adoption in clinical practice, addressing an unmet medical need in the treatment of gastric cancer [2]
康宁杰瑞制药-B：KN026(安尼妥单抗注射液)新药上市申请获国家药监局受理