迪哲医药：在研产品DZD8586获美FDA快速通道认定，有望加快研发和上市进程

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) in patients who have undergone at least two lines of treatment, including BTK inhibitors and BCL-2 inhibitors [1][2] Group 1 - DZD8586 is a first-in-class dual-target inhibitor that simultaneously blocks both BTK-dependent and independent BCR signaling pathways, addressing two major resistance mechanisms in CLL/SLL [1] - The drug has shown a high objective response rate (ORR) of 84.2% in patients previously treated with various therapies, including BTK inhibitors and BCL-2 inhibitors, with a duration of response (DOR) rate of 83.3% expected at 9 months [2] - The Fast Track Designation allows for expedited drug development and review processes, facilitating quicker access to new therapies for serious diseases with unmet medical needs [2]