Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) has seen a significant stock increase following the acceptance of its new drug application for KN026 by the National Medical Products Administration of China, aimed at treating HER2-positive gastric cancer patients who have failed previous treatments [1][2] Group 1: Company Developments - Corning Jereh Pharmaceutical-B's stock opened nearly 6% higher and is currently up 5.9%, trading at HKD 11.12 with a transaction volume of HKD 500,400 [1] - The new drug application for KN026, developed in collaboration with Shanghai Jinmant Biotech Co., a subsidiary of CSPC Pharmaceutical Group, targets patients with locally advanced, recurrent, or metastatic gastric/gastroesophageal junction adenocarcinoma who have undergone at least one systemic treatment [1] - The application is based on a pivotal Phase II/III clinical trial, which demonstrated significant clinical efficacy compared to existing standard treatments, extending both progression-free survival (PFS) and overall survival (OS) without new safety risks [1] Group 2: Clinical Trial Results - KN026 is the first bispecific antibody drug in China to achieve positive results in second-line treatment for HER2-positive gastric cancer [2] - The Phase II clinical trial results, to be presented at the 2024 European Society for Medical Oncology Congress, indicate 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高开近6% 安尼妥单抗注射液新药上市申请获国家药监局受理