Ascentage Pharma Receives Clearance from China’s CDE for New Drug – ExecEdge
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Ascentage Pharma Receives Clearance from China’s CDE for New Drug
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Ascentage Pharma Receives Clearance from China’s CDE for New Drug

By Exec Edge Editorial Staff

Ascentage Pharma said China’s Center for Drug Evaluation has cleared its investigational new drug application for APG-3288, a next-generation Bruton’s tyrosine kinase (BTK) protein degrader, paving the way for clinical testing in the country and advancing the company’s global development strategy.

The company plans to begin a Phase I study in patients with relapsed or refractory hematologic malignancies to assess safety, tolerability and early signs of efficacy.

BTK is a key driver in B-cell cancers such as lymphoma and chronic lymphocytic leukemia, where resistance to existing inhibitors remains a persistent challenge.

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