ROCKVILLE, Md. and SUZHOU, China, Feb. 23, 2026 (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 is scheduled to participate in three upcoming investor conferences. Oppenheimer 36th Annual H ...

Core Viewpoint - Ascentage Pharma Group International is actively participating in the Guggenheim Emerging Outlook: Biotech Summit 2026, highlighting its commitment to addressing unmet medical needs in cancer through innovative therapies [1][2]. Company Overview - Ascentage Pharma is a global, commercial stage, integrated biopharmaceutical company focused on the discovery, development, and commercialization of novel therapies for cancer [3]. - The company has developed a rich pipeline of innovative drug products, including inhibitors targeting key proteins in the apoptotic pathway and next-generation kinase inhibitors [3]. Key Products - The lead asset, Olverembatinib, is the first third-generation BCR-ABL1 inhibitor approved in China for treating chronic myeloid leukemia (CML) with T315I mutations and is included in the China National Reimbursement Drug List [4]. - Olverembatinib is currently undergoing a global registrational Phase III trial (POLARIS-2) for CML and additional trials for newly diagnosed Ph+ acute lymphoblastic leukemia (ALL) and SDH-deficient gastrointestinal stromal tumors (GIST) [4]. - The second approved product, Lisaftoclax, is a novel Bcl-2 inhibitor for hematologic malignancies, currently being commercialized in China for chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) [5]. - Lisaftoclax is involved in four global registrational Phase III trials, including studies in combination with BTK inhibitors and in newly diagnosed patients with various hematologic conditions [5]. Research and Development - Ascentage Pharma has established a robust R&D capability and holds a portfolio of global intellectual property rights [6]. - The company has formed partnerships with leading biotechnology and pharmaceutical companies, including Takeda, AstraZeneca, Merck, and Pfizer, as well as collaborations with prominent research institutions [6].

Core Viewpoint - Ascentage Pharma has received investigational new drug (IND) application clearance for its novel BTK-targeted protein degrader, APG-3288, from the China Center for Drug Evaluation (CDE), following similar clearance from the U.S. FDA, marking a significant milestone in its clinical development for patients with relapsed/refractory hematologic malignancies [1][6]. Group 1: Drug Development and Clinical Trials - APG-3288 is set to enter a multicenter, open-label Phase I study to evaluate its safety, tolerability, pharmacokinetic profile, and preliminary efficacy in patients with relapsed/refractory hematologic malignancies [2]. - The IND clearance for APG-3288 enhances Ascentage Pharma's pipeline in hematologic malignancies, complementing existing products like Olverembatinib and Lisaftoclax, which have already been approved in China [5]. Group 2: Mechanism of Action and Innovation - APG-3288 utilizes Ascentage Pharma's proprietary PROTAC technology to induce the degradation of BTK, overcoming resistance associated with conventional BTK inhibitors by blocking the BCR-BTK signaling axis at its source [4]. - The drug is designed to provide a novel therapeutic strategy by inducing rapid and sustained degradation of both wild-type BTK and multiple BTK mutants, addressing the urgent clinical need for new treatment options in B-cell malignancies [3][4]. Group 3: Company Background and Strategy - Ascentage Pharma is a global biopharmaceutical company focused on developing innovative therapies for cancer, with a strong presence in hematologic malignancies and a diverse pipeline of drug candidates [8]. - The company has established partnerships with leading biotechnology and pharmaceutical firms, enhancing its research and development capabilities and expanding its global reach [11].

Core Viewpoint - Ascentage Pharma has received investigational new drug (IND) application clearance for its novel BTK-targeted protein degrader, APG-3288, from both the U.S. FDA and the China CDE, marking a significant milestone in its clinical development for treating relapsed/refractory hematologic malignancies [1][6]. Group 1: Drug Development and Clinical Trials - APG-3288 is set to enter a multicenter, open-label Phase I study to evaluate its safety, tolerability, pharmacokinetic profile, and preliminary efficacy in patients with relapsed/refractory hematologic malignancies [2]. - The IND clearance from the China CDE follows the earlier approval from the U.S. FDA, indicating strong global development capabilities in targeted protein degradation [1][6]. Group 2: Mechanism of Action and Clinical Need - APG-3288 is a highly potent and selective BTK degrader developed using Ascentage Pharma's proprietary PROTAC technology, designed to induce degradation of both wild-type BTK and multiple BTK mutants associated with resistance to existing BTK inhibitors [4]. - There is a significant clinical need for new drugs with novel mechanisms of action due to the limitations of current BTK inhibitors, which often face issues of acquired resistance [3][4]. Group 3: Company Background and Pipeline - Ascentage Pharma has established a strong presence in the field of hematologic malignancies, with a portfolio that includes approved products like Olverembatinib and Lisaftoclax, enhancing its pipeline in this area [5][9]. - The company is focused on developing innovative therapies to address unmet medical needs in cancer, leveraging its robust R&D capabilities and global partnerships with leading biotechnology and pharmaceutical companies [8][11].

Core Insights - Ascentage Pharma Group International presented its achievements in 2025 and outlined its global innovation strategy for 2026 at the J.P. Morgan Healthcare Conference [1][2] Company Overview - Ascentage Pharma is a global, commercial stage biopharmaceutical company focused on developing novel therapies for unmet medical needs in cancer [9] - The company has a diverse pipeline that includes inhibitors targeting key proteins in the apoptotic pathway and next-generation kinase inhibitors [9] Milestone Achievements - In 2025, Ascentage Pharma accelerated its global expansion, advancing product commercialization, clinical development, and pipeline innovation [2] - The company has established a strong foundation for sustained growth through its innovative engine in hematologic malignancies and solid tumors [2] Product Development - The two core products, Olverembatinib (a third-generation BCR-ABL inhibitor) and Lisaftoclax (a Bcl-2 inhibitor), are key growth drivers for 2026 [3] - Both products have shown significant progress in 2025 and are expected to generate a "dual-engine" effect for future growth [3] Clinical Studies and Innovations - Ascentage Pharma has made advancements in multiple clinical studies for its key drug candidates, presenting data at international academic congresses [4] - The company received IND clearance from the U.S. FDA for APG-3288, a novel BTK degrader, marking a significant step in targeted degradation [4][5] Pipeline Progress - The company is advancing several key clinical programs, including APG-5918 (EED inhibitor) and APG-2449 (FAK/ALK/ROS1 inhibitor), which are in various stages of clinical trials [6][7] - Multiple global registrational Phase III trials are progressing rapidly for its key products [5] Future Outlook - Potential milestones for 2026 include ongoing investigations of Olverembatinib, Lisaftoclax, and other pipeline candidates, which have not yet received FDA approval [8] - The company aims to continue its growth in commercial sales and expand patient accessibility across hospitals in China [12]

Core Viewpoint - Ascentage Pharma has received IND clearance from the U.S. FDA for its next-generation BTK-targeted protein degrader, APG-3288, which will enter clinical studies for patients with relapsed/refractory B-cell malignancies, marking a significant expansion of the company's innovative pipeline [1][7]. Company Overview - Ascentage Pharma Group International is a global, commercial stage biopharmaceutical company focused on discovering, developing, and commercializing novel therapies for unmet medical needs in cancer [11]. - The company has developed a rich pipeline of innovative drug products, including inhibitors targeting key proteins in the apoptotic pathway and next-generation kinase inhibitors [11]. Product Development - APG-3288 is the first highly potent and selective BTK degrader developed using Ascentage Pharma's proprietary PROTAC technology, designed to induce proteasome-mediated degradation of the BTK target [4]. - The drug aims to overcome resistance associated with existing BTK inhibitors by blocking the BCR-BTK signaling axis at its source, providing a novel therapeutic strategy [4][6]. Clinical Study - A global, multicenter, open-label Phase I study will evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of APG-3288 in patients with relapsed/refractory hematologic malignancies [2][7]. - Preclinical studies have shown that APG-3288 demonstrates more potent BTK degradation and higher selectivity compared to other BTK degraders in development [5]. Strategic Importance - The FDA clearance for APG-3288 represents a major milestone for Ascentage Pharma, validating its innovative design capabilities and strategic pipeline expansion in the field of hematologic malignancies [6]. - The company plans to accelerate the global clinical development of APG-3288 and explore its combinatory potential with existing proprietary small-molecule agents [6].

Core Insights - Ascentage Pharma Group International is a global, commercial stage biopharmaceutical company focused on developing novel therapies for cancer treatment [2][3] Company Overview - Ascentage Pharma has a rich pipeline of innovative drug products targeting key apoptotic pathway proteins and next-generation kinase inhibitors [2] - The company has established global partnerships with leading biotechnology and pharmaceutical firms, including Takeda, AstraZeneca, Merck, and Pfizer [5] Product Portfolio - The first approved product, Olverembatinib, is a third-generation BCR-ABL1 inhibitor for chronic myeloid leukemia (CML) patients with T315I mutations, covered by the China National Reimbursement Drug List [3] - The second approved product, Lisaftoclax, is a Bcl-2 inhibitor for hematologic malignancies, currently undergoing multiple global registrational Phase III trials [4] Upcoming Events - Company management plans to present at the 44th Annual J.P. Morgan Healthcare Conference on January 14, 2026 [1]

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]