Ascentage Pharma Announces IND Clearance by the U.S. Food and Drug Administration for BTK Degrader APG-3288

Core Viewpoint - Ascentage Pharma has received IND clearance from the U.S. FDA for its next-generation BTK-targeted protein degrader, APG-3288, which will enter clinical studies for patients with relapsed/refractory B-cell malignancies, marking a significant expansion of the company's innovative pipeline [1][7]. Company Overview - Ascentage Pharma Group International is a global, commercial stage biopharmaceutical company focused on discovering, developing, and commercializing novel therapies for unmet medical needs in cancer [11]. - The company has developed a rich pipeline of innovative drug products, including inhibitors targeting key proteins in the apoptotic pathway and next-generation kinase inhibitors [11]. Product Development - APG-3288 is the first highly potent and selective BTK degrader developed using Ascentage Pharma's proprietary PROTAC technology, designed to induce proteasome-mediated degradation of the BTK target [4]. - The drug aims to overcome resistance associated with existing BTK inhibitors by blocking the BCR-BTK signaling axis at its source, providing a novel therapeutic strategy [4][6]. Clinical Study - A global, multicenter, open-label Phase I study will evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of APG-3288 in patients with relapsed/refractory hematologic malignancies [2][7]. - Preclinical studies have shown that APG-3288 demonstrates more potent BTK degradation and higher selectivity compared to other BTK degraders in development [5]. Strategic Importance - The FDA clearance for APG-3288 represents a major milestone for Ascentage Pharma, validating its innovative design capabilities and strategic pipeline expansion in the field of hematologic malignancies [6]. - The company plans to accelerate the global clinical development of APG-3288 and explore its combinatory potential with existing proprietary small-molecule agents [6].