迪哲医药: 迪哲医药：自愿披露关于DZD8586获美国FDA快速通道认定的公告

Core Viewpoint - DZD8586, 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) patients who have undergone at least two lines of treatment, including BTK inhibitors and BCL-2 inhibitors [1][2]. Group 1: About DZD8586 - DZD8586 is a globally innovative dual-target inhibitor that simultaneously blocks BTK-dependent and independent BCR signaling pathways, addressing resistance mutations and demonstrating high selectivity for other members of the TEC family [2]. - Clinical research results indicate an objective response rate (ORR) of 84.2% for CLL/SLL patients previously treated with various therapies at a recommended phase III dose of 50 mg once daily, with a duration of response (DOR) rate of 83.3% expected over nine months [3]. Group 2: Impact on the Company - The Fast Track Designation is a regulatory pathway that accelerates drug development and review for serious diseases with unmet medical needs, allowing the company to benefit from various expedited drug development policies [3].