亚盛医药-B(06855)布局新一代BTK降解剂，APG-3288 IND申请获美国FDA许可

Core Viewpoint - Ascentage Pharma-B (06855) has received FDA approval for its new drug application (IND) for APG-3288, a next-generation BTK-targeted protein degrader, marking a significant advancement in the company's clinical research for treating relapsed/refractory B-cell malignancies [1][3]. Group 1: Clinical Research and Drug Development - The clinical study for APG-3288 is a global, multi-center, open-label Phase I trial aimed at evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy in patients with relapsed/refractory hematologic malignancies [3]. - BTK is a key kinase in the B-cell receptor (BCR) signaling pathway, and its abnormal activation is closely associated with various B-cell malignancies, including multiple types of lymphomas and chronic lymphocytic leukemia (CLL) [3][4]. - The global BTK market has grown into a nearly $30 billion space, reflecting the increasing demand for effective treatments in this area [4]. Group 2: Mechanism and Advantages of APG-3288 - APG-3288 is designed to degrade rather than inhibit BTK, providing a novel solution to overcome resistance issues associated with traditional BTK inhibitors [5][6]. - Preclinical studies indicate that APG-3288 demonstrates superior BTK degradation capability, higher selectivity, and better pharmacokinetic characteristics compared to other investigational BTK degraders [6]. Group 3: Combination Therapy Potential - APG-3288 has significant potential for combination therapy with Ascentage Pharma's approved BCL-2 inhibitor, which could lead to new treatment pathways for CLL [6][7]. - The combination of BTK inhibitors and BCL-2 inhibitors is expected to create a synergistic effect, enhancing treatment efficacy by targeting different mechanisms involved in tumor cell survival [7][8]. - Ascentage Pharma's BCL-2 inhibitor has shown promising clinical data, supporting its potential for use in combination therapies, particularly in patients with limited treatment options [7][8]. Group 4: Strategic Importance and Future Directions - The approval of APG-3288's IND is a major milestone for Ascentage Pharma, reflecting its commitment to advancing treatment options in hematologic malignancies [8]. - The company plans to accelerate the global clinical development of APG-3288 and explore its therapeutic potential in other BTK-related diseases, aiming to benefit a larger patient population [8].