迪哲医药(688192.SH)：DZD8586获美国FDA快速通道认定

Core Viewpoint - DZD8586, a dual-target inhibitor developed by the company, has received Fast Track Designation from the FDA for the treatment of relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) in patients who have previously undergone at least two lines of treatment, including BTK inhibitors and BCL-2 inhibitors [1] Group 1 - DZD8586 is a globally innovative LYN/BTK dual-target inhibitor that can block both BTK-dependent and independent BCR signaling pathways [1] - The drug demonstrates high selectivity against other members of the TEC family and can fully penetrate the blood-brain barrier [1] - The Fast Track Designation was granted based on the analysis of Phase I/II clinical study results for CLL/SLL patients who had previously received covalent or non-covalent BTK inhibitors and BTK degraders [1] Group 2 - The clinical study results for DZD8586 will be presented in oral reports at the 2025 American Society of Clinical Oncology (ASCO) and the 18th International Conference on Malignant Lymphoma (ICML), with further publication at the 2025 European Hematology Association (EHA) annual meeting [1]