Ascentage Pharma Group International. (AAPG,6855.HK),a clinical-stage biotechnology company announced that its lead Bruton's tyrosine kinase or BTK targeted protein degrader, APG-3288, has received investigational new drug or IND application clearance from the China Centre for Drug Evaluation CDE.
This will enable Ascentage to enter a clinical study for APG-3288 in patients with relapsed/refractory hematologic malignancies.
This IND approval of APG-3288 by CDE follows shortly after the IND clearance by the U.S. Food and Drug Administration (FDA) in January 2026.
APG-3288 is a selective BTK degrader developed utilizing Ascentage Pharma's proprietary proteolysis-targeting chimera (PROTAC) technology platform.
BTK is a key kinase in the B-cell receptor (BCR) signaling pathway and plays a central role in the activation, proliferation, and survival of B-cells. Aberrant BTK activation is closely associated with the initiation and progression of multiple B-cell malignancies such as B-cell lymphoma,chronic lymphocytic leukemia and and Waldenström's macroglobulinemia.
In preclinical studies, compared to other BTK degraders in development, APG-3288 demonstrated potent BTK degradation, higher selectivity, and more favorable PK properties.
Ascentage will conduct a multicenter, open-label Phase I study to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of APG-3288 in patients with relapsed/refractory hematologic malignancies.
This IND clearance for APG-3288 in China may further strengthen Ascentage's pipeline and can be a foundation for potential combinations with other key assets within the pipeline.
"We will expeditiously advance this global clinical development program for APG-3288 and actively explore its combinatory potential in efforts to bring this innovative therapeutic to patients in China and around the world as soon as possible," said Yifan Zhai, M.D., PhD, Chief Medical Officer of Ascentage Pharma.
Ascentage 's portfolio of hematologic malignancies includes Olverembatinib for patients with Chronic myeloid leukemia (CML) in chronic phase and Lisaftoclax for adult patients with chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL) who have previously received at least one systemic therapy, including BTK inhibitors, which have already been approved in China.
The firm is currently conducting an FDA-cleared, global registrational Phase III trial, or POLARIS-2, of Olverembatinib for CML, as well as global registrational Phase III trials for patients with newly diagnosed Positive Acute Lymphoblastic Leukaemia ( Ph+ ALL) and succinate dehydrogenase (SDH) deficient Gastrointestinal Stromal Tumour (GIST) patients.
Also for Lisaftoclax, Ascentage is currently conducting four registrational Phase III trials for CLL/SLL combined with BTK inhibitors, newly diagnosed CLL/SLL, acute myeloid leukaemia (AML) and higher-risk myelodysplastic syndrome (HR MDS).
AAPG has traded between $17.09 and $48.45 in the last 1 year. The stock closed Thursday's trade at $24.19, up 0.17%.
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