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亚盛医药-B涨超7% 股价创历史新高 Lisaftoclax口头报告数据强劲

Core Viewpoint - Ascentage Pharma's stock surged over 7%, reaching a historic high of 59.55 HKD, following the presentation of promising clinical trial data for its Bcl-2 inhibitor, APG-2575 (lisaftoclax), at the 61st American Society of Clinical Oncology (ASCO) annual meeting [1] Group 1: Clinical Research and Development - The latest data from the Ib/II clinical study of APG-2575 combined with azacitidine for treating newly diagnosed or previously treated myeloid malignancies demonstrated both excellent efficacy and safety [1] - The study reported for the first time that lisaftoclax showed good therapeutic responses in patients who previously failed treatment with venetoclax, highlighting its differentiated efficacy and potential advantages over similar products [1] Group 2: Regulatory Progress - Lisaftoclax, a novel Bcl-2 selective inhibitor developed by Ascentage Pharma, has had its New Drug Application (NDA) accepted for priority review by the National Medical Products Administration (NMPA) in November 2024 for treating relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) [2] - It is the second Bcl-2 inhibitor globally to submit an NDA and the first domestically developed Bcl-2 inhibitor in China to enter priority review [2] - Currently, there are four global registration III clinical trials underway for Lisaftoclax, covering indications such as CLL/SLL, acute myeloid leukemia (AML), and myelodysplastic syndromes (MDS), with one trial being FDA-approved for global registration [2]