Novel next-generation Bruton tyrosine kinase (BTK)-targeted protein degrader APG-3288 has received investigational new drug (IND) clearance from the U.S. FDA, marking another major expansion to the company’s global innovative pipeline.Ascentage Pharma will conduct a global Phase I study evaluating APG-3288 in patients with relapsed/refractory B-cell malignancies. ROCKVILLE, Md. and SUZHOU, China, Jan. 06, 2026 (GLOBE NEWSWIRE) -- Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855), a global, com ...

ROCKVILLE, Md. and SUZHOU, China, Dec. 17, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855) (“Ascentage Pharma” or the “Company”), a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer, announced today that the Company’s management plans to present at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco, CA. T ...

Core Viewpoint - Ascentage Pharma presented four-year follow-up data for Olverembatinib, demonstrating its long-term efficacy and safety in treating TKI-resistant/intolerant chronic-phase chronic myeloid leukemia (CML-CP) at the 67th ASH Annual Meeting [1][2][3] Group 1: Efficacy Results - Olverembatinib showed a median event-free survival (EFS) of 21.2 months compared to 2.9 months for the best available therapy (BAT) in patients with TKI-resistant/intolerant CML-CP [3][12] - For patients without the T315I mutation, Olverembatinib achieved an EFS of 11.9 months versus 3.1 months for BAT [3][12] - The complete hematologic response (CHR) rates were 85% for Olverembatinib compared to 35% for BAT, while complete cytogenetic response (CCyR) rates were 38% versus 19% [12] Group 2: Safety Profile - The safety profile of Olverembatinib was favorable, with a vascular occlusion incidence of 7% among patients [3][11] - No new safety signals were reported, and the study included patients with and without the T315I mutation [11] Group 3: Regulatory and Commercialization Status - Olverembatinib is the first third-generation BCR-ABL1 inhibitor approved in China for specific CML indications, and it is included in the China National Reimbursement Drug List (NRDL) [4][15] - Ascentage Pharma is conducting three global registrational Phase III studies for Olverembatinib in various indications, including newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) and gastrointestinal stromal tumors (GIST) [4][15] Group 4: Clinical Significance - The data presented at ASH 2025 reinforces Olverembatinib's role in clinical practice for long-term treatment of CML-CP, providing confidence to physicians and patients [5][11] - The study's findings highlight the need for effective treatment options for patients resistant to or intolerant of first- and second-generation TKIs [8][12]

Core Viewpoint - Ascentage Pharma has presented promising updated data on Olverembatinib, a novel drug for second-line treatment of chronic myeloid leukemia (CML) at the 67th American Society of Hematology (ASH) Annual Meeting, indicating its potential as a safe and effective treatment option for patients resistant to prior therapies [1][3][5]. Group 1: Efficacy and Safety Data - Olverembatinib demonstrated a complete cytogenetic response (CCyR) rate of 71.8% and a major molecular response (MMR) rate of 43.6% in patients with CML resistant/intolerant to one prior line of tyrosine kinase inhibitors (TKIs) without the T315I mutation [3][12]. - In patients who failed first-line treatment with second-generation TKIs, the CCyR rate was 76.7% and the MMR rate was 43.3% [3][12]. - The safety profile of Olverembatinib was consistent with previous reports, with no new safety signals identified [3][10]. Group 2: Clinical Study Details - The study was an open-label, single-arm, multicenter clinical trial evaluating Olverembatinib at 40 mg every other day in Chinese patients with CP-CML resistant/intolerant to one prior line of TKIs [8]. - As of July 24, 2025, 47 patients were enrolled, with 39 patients receiving at least one efficacy evaluation [8][12]. - The median treatment duration was 16.0 cycles, with 89.4% of patients experiencing treatment-related adverse events [10]. Group 3: Regulatory and Commercialization Aspects - Olverembatinib is the first third-generation BCR-ABL inhibitor approved in China, currently commercialized in partnership with Innovent Biologics [4][14]. - The drug is approved for adult patients with TKI-resistant CML-CP or accelerated-phase CML harboring the T315I mutation, and is included in the China National Reimbursement Drug List [4][14]. - Ascentage Pharma is conducting three global registrational Phase III studies for Olverembatinib in multiple indications, including CML-CP and newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia [4][14].

Core Insights - Ascentage Pharma presented promising data from the Phase III POLARIS-1 study of Olverembatinib for treating newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph ALL) at the ASH Annual Meeting [1][2][3] Group 1: Study Results - The POLARIS-1 study demonstrated a minimal residual disease (MRD) negativity rate of 66.0% and an MRD-negative complete response (CR) rate of 64.2% after three induction cycles in patients treated with Olverembatinib combined with low-intensity chemotherapy [3][6][12] - High-risk IKZF1 patients showed a 90% molecular response rate, indicating the drug's effectiveness in challenging cases [6][14] - The combination therapy exhibited a favorable safety profile, with common grade ≥ 3 treatment-emergent adverse events including neutropenia (63.6%) and thrombocytopenia (56.4%) [11][12] Group 2: Drug Development and Commercialization - Olverembatinib is the first third-generation BCR-ABL inhibitor approved in China, currently commercialized in partnership with Innovent Biologics [4][15] - The drug is approved for adult patients with TKI-resistant chronic-phase chronic myeloid leukemia (CML-CP) and accelerated-phase CML (CML-AP) harboring the T315I mutation, with all indications covered by the China National Reimbursement Drug List (NRDL) [4][15] - Ascentage Pharma is conducting three global registrational Phase III studies for Olverembatinib across multiple indications, including Ph ALL and gastrointestinal stromal tumors [4][15] Group 3: Conference Highlights - The ASH Annual Meeting is a significant event for the hematology community, showcasing advancements in scientific research and investigational therapies [2] - Ascentage Pharma's innovative pipeline, including Olverembatinib, Lisaftoclax, and APG-5918, received notable attention at the conference, with multiple presentations highlighting their potential [2][5]

Core Insights - Ascentage Pharma presented promising results from a Phase Ib/II study of Lisaftoclax in combination with azacitidine for treating myeloid malignancies at the 67th ASH Annual Meeting, highlighting its potential to address unmet medical needs in this area [1][2][5] Company Overview - Ascentage Pharma Group International is a global biopharmaceutical company focused on developing novel therapies for cancer, with a strong pipeline that includes Lisaftoclax, Olverembatinib, and APG-5918 [12][14] Clinical Study Highlights - The study demonstrated a 31.8% overall response rate (ORR) in patients with venetoclax-resistant myeloid malignancies and an 80% ORR in newly diagnosed high-risk MDS/CMML [6][15] - The safety profile of Lisaftoclax was favorable, with no dose-limiting toxicities reported across all patient cohorts in the study [10][11] Drug Mechanism and Approval Status - Lisaftoclax is an orally administered Bcl-2 selective inhibitor that restores apoptosis in cancer cells and is already approved in China for CLL/SLL patients who have received prior systemic therapy [4][14] - The company is conducting four global registrational Phase III studies for Lisaftoclax in various indications, including CLL/SLL, AML, and MDS [4][16] Future Directions - Ascentage Pharma aims to accelerate clinical programs for Lisaftoclax to provide effective therapies for patients with myeloid malignancies, fulfilling its mission to address unmet clinical needs globally [5][11]

Core Viewpoint - Ascentage Pharma presented promising results from a Phase Ib/II study of Lisaftoclax in combination with azacitidine for treating myeloid malignancies at the 67th ASH Annual Meeting, highlighting its potential to address unmet medical needs in patients resistant to venetoclax [1][2][3]. Company Overview - Ascentage Pharma Group International is a global biopharmaceutical company focused on developing novel therapies for cancer, with a strong pipeline including Lisaftoclax, Olverembatinib, and APG-5918 [12][14]. Clinical Study Highlights - The study presented at ASH 2025 demonstrated a 31.8% overall response rate (ORR) in venetoclax-resistant patients and an 80% ORR in newly diagnosed high-risk MDS/CMML patients [6][15]. - The combination of Lisaftoclax and azacitidine showed a strong safety profile with no dose-limiting toxicities reported across all patient cohorts in the study involving 103 patients [10][15]. Drug Mechanism and Approval Status - Lisaftoclax is an orally administered Bcl-2 selective inhibitor that restores apoptosis in cancer cells and is currently approved in China for CLL/SLL patients who have received prior systemic therapy [4][14]. - The company is conducting four global registrational Phase III studies for Lisaftoclax across multiple indications, including CLL/SLL, AML, and MDS [4][16]. Expert Commentary - The Chief Medical Officer of Ascentage Pharma emphasized the therapeutic potential of Lisaftoclax for newly diagnosed or venetoclax-exposed patients, aiming to improve clinical management of myeloid malignancies [5].

Core Viewpoint - Ascentage Pharma presented promising results from a Phase II study of Lisaftoclax, a Bcl-2 selective inhibitor, for treating relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) at the ASH Annual Meeting, supporting its recent NDA approval in China [1][6][7] Company Overview - Ascentage Pharma Group International is a global biopharmaceutical company focused on developing novel therapies for unmet medical needs in cancer [16] - The company has a pipeline that includes inhibitors targeting key apoptotic pathway proteins and next-generation kinase inhibitors [16] Study Results - Lisaftoclax monotherapy showed a 62.5% objective response rate (ORR) in heavily pretreated BTK-refractory R/R CLL/SLL patients, with a median progression-free survival of 23.89 months [6][11] - Among 77 enrolled patients, 42.9% had chromosomal complex karyotype, 39% had del(17p)/TP53 mutation, and 53.2% had unmutated IGHV, indicating a high-risk patient population [3][13] - The study reported no tumor lysis syndrome (TLS) and a manageable safety profile, with frequent grade ≥3 treatment-related adverse events being hematologic toxicities [14][6] Clinical Significance - The results highlight Lisaftoclax's potential as a new treatment option for patients with high-risk CLL/SLL, addressing an urgent clinical need for effective therapies [5][7] - The study's findings suggest that even in ultra-high-risk patients, Lisaftoclax can achieve deep and durable responses, with 21.8% of patients achieving minimal residual disease (MRD) negativity in peripheral blood [11][15] Future Directions - Ascentage Pharma is conducting four global registrational Phase III studies for Lisaftoclax in various indications, including CLL/SLL, acute myeloid leukemia (AML), and myelodysplastic syndrome (MDS) [4][18] - The company aims to accelerate clinical programs to provide safe and effective therapies to patients globally [7]

Core Viewpoint - Ascentage Pharma Group International is set to provide an update on its innovative portfolio and pipeline during an investor webcast, focusing on key presentations at the upcoming 67th American Society of Hematology Annual Meeting [1]. Company Overview - Ascentage Pharma is a global, commercial stage, integrated biopharmaceutical company dedicated to discovering, developing, and commercializing novel therapies for unmet medical needs in cancer [4]. - The company has developed a rich pipeline of innovative drug products, including inhibitors targeting key apoptotic pathway proteins and next-generation kinase inhibitors [4]. Product Pipeline - The first approved product, Olverembatinib, is a third-generation BCR-ABL1 inhibitor for treating chronic myeloid leukemia (CML) with specific mutations and is included in the China National Reimbursement Drug List [5]. - The company is conducting a global registrational Phase III trial (POLARIS-2) for Olverembatinib in CML and additional trials for newly diagnosed Ph+ acute lymphoblastic leukemia (ALL) and SDH-deficient gastrointestinal stromal tumors (GIST) [5]. - The second approved product, Lisaftoclax, is a Bcl-2 inhibitor for various hematologic malignancies and is undergoing multiple global registrational Phase III trials [6]. Research and Development - Ascentage Pharma has established a portfolio of global intellectual property rights and formed partnerships with leading biotechnology and pharmaceutical companies, including Takeda, AstraZeneca, Merck, and Pfizer [7].

Core Viewpoint - Ascentage Pharma Group International is actively participating in investor conferences in December 2025, highlighting its ongoing commitment to engage with the investment community and showcase its advancements in biopharmaceuticals targeting unmet medical needs in cancer [1][7]. Company Overview - Ascentage Pharma is a global, commercial stage biopharmaceutical company focused on discovering, developing, and commercializing novel therapies for cancer [2]. - The company has developed a robust pipeline of innovative drug products, including inhibitors targeting key apoptotic pathway proteins and next-generation kinase inhibitors [2]. Product Approvals and Trials - The first approved product, Olverembatinib, is a third-generation BCR-ABL1 inhibitor for treating chronic myeloid leukemia (CML) with specific mutations, currently undergoing a global Phase III trial [3]. - The second approved product, Lisaftoclax, is a Bcl-2 inhibitor for hematologic malignancies, with multiple global Phase III trials underway, including studies in chronic lymphocytic leukemia and acute myeloid leukemia [4]. Research and Development Partnerships - Ascentage Pharma has established a portfolio of global intellectual property rights and formed partnerships with leading biotechnology and pharmaceutical companies, including Takeda, AstraZeneca, Merck, and Pfizer, as well as collaborations with prominent research institutions [5].