Ascentage Pharma (ASNC) Receives China CDE IND Clearance for APG-3288 in R/R Hematologic Malignancies

The China Drug Administration's Center for Drug Evaluation (CDE) granted an Investigational New Drug (IND) clearance to Ascentage Pharma (ASNC) for APG-3288, a potential treatment for relapsed or refractory hematologic malignancies. This marks a key regulatory milestone enabling the company to initiate global clinical trials. APG-3288 is designed to target B-cell malignancies by inhibiting Bruton's tyrosine kinase, a critical signaling pathway in B-cell development. The IND approval follows preclinical studies indicating efficacy and safety in hematologic cancers, including non-Hodgkin's lymphoma and multiple myeloma.