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Source document· January 7, 2026

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

View original at globenewswire.com
Ascentage Pharma Announces IND Clearance by the U.S. Food and Drug Administration for BTK Degrader APG-3288 Novel next-generation Bruton tyrosine kinase (BTK)-targeted protein degrader APG-3288 has received investigational new drug (IND) clearance from the U.S…
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  • APG-3288 is designed to act through degradation rather than inhibition, inducing rapid, potent, highly selective, and sustained degradation of both wild-type BTK and multiple BTK mutants associated with resistance to existing BTK inhibitors

    80% confidence

  • APG-3288 represents a strategic clinical stage candidate in the field of BTK-targeted therapies with high selectivity, potency, and consistent PK/PD profiles across multiple BTK-resistant models that validate differentiated design capabilities of PROTAC-based therapeutic candidates

    80% confidence

  • In preclinical studies, APG-3288 demonstrated more potent BTK degradation, higher selectivity, and more favorable PK properties compared to other BTK degraders in development

    80% confidence

  • Compared to existing conventional BTK inhibitors, Ascentage Pharma's BTK degraders developed with PROTAC technology can achieve complete degradation of target protein and are enabled by a molecular mechanism that can induce stronger efficacy

    80% confidence

  • The FDA clearance marks a major milestone for the development of APG-3288 and strategic pipeline expansion that underscores persistent innovation in the field of hematologic malignancies and lays a strong foundation for future exploration of combinatory potential between APG-3288 and existing proprietary small-molecule agents

    80% confidence
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Ascentage Pharma Announces IND Clearance by the U.S. Food and Drug Administration for BTK Degrader APG-3288 — Source | Via News | Via News