Ascentage Pharma Receives IND Clearance for BTK Degrader APG-3288 in China

Ascentage Pharma has received IND clearance from China's CDE and FDA for its BTK-targeted protein degrader, APG-3288, to treat relapsed/refractory hematologic malignancies. The multicenter Phase I study will evaluate safety, tolerability, PK profile, and preliminary efficacy of the drug. APG-3288 is a novel candidate using the company's proprietary PROTAC technology, which induces rapid, potent, and sustained degradation of BTK targets, including resistant mutants. The drug is designed to block the BCR-BTK signaling axis, providing a novel therapeutic strategy for BTK-targeted treatment.