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]

Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) has seen a stock increase of over 4%, currently trading at 12.54 HKD, with a transaction volume of 43.1641 million HKD, 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 therapeutic biological products, targeting 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 approved anti-HER2 drugs for this indication [1] Group 2: Clinical Research Progress - Multiple key Phase III clinical studies for KN026 in gastric and breast cancer indications are currently progressing smoothly, with the potential to benefit more patients [1]

Core Viewpoint - 康宁杰瑞制药-B's new drug application for KN026 has been accepted by the National Medical Products Administration of China, leading to a nearly 6% increase in stock price [1][2] Group 1: Company Developments - 康宁杰瑞制药-B's collaboration with Shanghai Jinmant Biotech, a subsidiary of CSPC Pharmaceutical Group, focuses on developing KN026 for HER2-positive gastric cancer patients who have failed at least one systemic treatment [1] - The new drug application is based on a pivotal Phase II/III clinical trial that demonstrated significant clinical efficacy compared to existing standard treatments, improving progression-free survival (PFS) and overall survival (OS) [2] - KN026 has received breakthrough therapy designation from the National Medical Products Administration and has been granted priority review status [2] Group 2: Clinical Trial Results - The Phase II clinical trial results showed an objective response rate of 40.0% for KN026 in combination with chemotherapy, with a median PFS of 8.6 months as assessed by an independent review committee [2] - KN026 is the first bispecific antibody drug in China to achieve positive results in second-line treatment for HER2-positive gastric cancer, where no anti-HER2 drugs have been approved for this indication [2]