Ascentage Pharma Group International announced that its novel BTK-targeted protein degrader APG-3288 has received IND clearance from both the U.S. FDA and China CDE, enabling clinical studies in patients with relapsed/refractory hematologic malignancies. The drug uses PROTAC technology to degrade BTK rather than inhibit it, potentially overcoming resistance to existing BTK inhibitors. This milestone strengthens the company's pipeline in hematologic malignancies alongside its approved products Olverembatinib and Lisaftoclax.

Ascentage Pharma presented its global innovation strategy at the J.P. Morgan Healthcare Conference, highlighting progress with two commercialized hematology products (Olverembatinib and Lisaftoclax) and announcing FDA IND clearance for next-generation BTK degrader APG-3288. The company is advancing multiple Phase III registrational trials and expects significant milestones in 2026 across commercialization, clinical development, and early-stage programs.

Ascentage Pharma received FDA IND clearance for APG-3288, a novel BTK-targeted protein degrader using PROTAC technology, to treat relapsed/refractory B-cell malignancies. The drug is designed to degrade BTK proteins rather than inhibit them, potentially overcoming resistance to existing BTK inhibitors and representing a major pipeline expansion for the company.

Ascentage Pharma presented four-year follow-up data for Olverembatinib, demonstrating improved disease control and safety in treating chronic myeloid leukemia patients resistant to existing tyrosine kinase inhibitors.

Ascentage Pharma presented promising Phase III study results for Olverembatinib in treating Philadelphia chromosome-positive acute lymphoblastic leukemia, showing a 66% minimal residual disease negativity rate and favorable safety profile.

Ascentage Pharma presented updated clinical trial data for Olverembatinib, showing promising efficacy in treating chronic myeloid leukemia patients who failed previous treatments, with 76.7% complete cytogenetic response rate and deepening molecular responses over time.

Ascentage Pharma presented promising clinical results for Lisaftoclax, a Bcl-2 inhibitor, in treating myeloid malignancies. The study showed a 31.8% overall response rate in venetoclax-exposed patients and an 80% response rate in newly diagnosed high-risk MDS/CMML, with a strong safety profile.

Ascentage Pharma presented clinical trial results for Lisaftoclax, a Bcl-2 inhibitor, demonstrating a 62.5% objective response rate in heavily pretreated patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who had failed previous treatments.

Ascentage Pharma received FDA and EMA clearance to conduct a global Phase III study of olverembatinib for treating newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), with promising early data showing high minimal residual disease negativity rates.

Ascentage Pharma published promising Phase Ib clinical trial results for olverembatinib in treating succinate dehydrogenase (SDH) deficient gastrointestinal stromal tumors (GIST), demonstrating a novel mechanism of action by modulating lipid metabolism with a 23.1% objective response rate.

Ascentage Pharma will present clinical study results for lisaftoclax at the 67th ASH Annual Meeting, showcasing promising data for treating chronic lymphocytic leukemia and myeloid malignancies, with positive efficacy and manageable safety profiles.

Ascentage Pharma will present clinical data on olverembatinib at the 67th ASH Annual Meeting, showcasing results from multiple studies in leukemia treatments, including the first dataset from the global Phase III POLARIS-1 study.