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康宁杰瑞制药-B涨超4% 此前宣布KN026新药上市申请获国家药监局受理

Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) saw a stock increase of over 4%, currently trading at HKD 12.54 with a transaction volume of HKD 43.1641 million, following the acceptance of its new drug application for KN026 by the National Medical Products Administration (NMPA) [1] Group 1: Company Developments - The new drug application (NDA) for KN026, a monoclonal antibody injection developed in collaboration with Shanghai Jinmant Biotech Co., Ltd., has been accepted by NMPA [1] - KN026 is being submitted as a Class 1 new drug for treatment, specifically for HER2-positive locally advanced, recurrent, or metastatic gastric/gastroesophageal junction adenocarcinoma that has failed at least one systemic treatment including trastuzumab [1] - KN026 is the first HER2 bispecific antibody drug in China to achieve positive results in the second-line treatment of gastric cancer, addressing a gap in the market where no anti-HER2 drugs have been approved for this indication [1] Group 2: Clinical Research Progress - Multiple key Phase III clinical studies for KN026 targeting gastric and breast cancer indications are currently progressing smoothly, with the potential to benefit more patients [1]