Core Viewpoint - Ascentage Pharma has received regulatory clearance from the US FDA and EMA to conduct a global Phase III study of olverembatinib for treating newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), marking a significant advancement in its clinical development efforts [1][3]. Company Overview - Ascentage Pharma Group International is a global biopharmaceutical company focused on developing novel therapies for unmet medical needs in cancer, with a strong pipeline that includes third-generation kinase inhibitors and Bcl-2 inhibitors [6][7]. Clinical Development - The POLARIS-1 trial is a global, multicenter, randomized controlled Phase III study aimed at evaluating the efficacy and safety of olverembatinib in combination with chemotherapy for newly diagnosed Ph+ ALL patients [2][3]. - The trial is designed to accelerate the registration process for olverembatinib, particularly in the US and European markets, with simultaneous patient enrollment across multiple countries [1][2]. Efficacy and Safety Data - Preliminary data from the POLARIS-1 study indicates that approximately 65% of treatment-naïve Ph+ ALL patients achieved minimal residual disease (MRD) negativity and molecular MRD-negative complete response (CR) after three treatment cycles, significantly outperforming other drugs in the same class [3]. - The combination therapy demonstrated a favorable safety profile, with a low incidence of manageable adverse events [3]. Market Context - Ph+ ALL accounts for 20%-30% of all adult acute lymphoblastic leukemia cases and is associated with high relapse rates and poor prognosis, particularly in elderly patients [3]. - Prior to the introduction of tyrosine kinase inhibitors (TKIs), the five-year overall survival rate for Ph+ ALL was less than 20%, highlighting the need for improved treatment options [3]. Strategic Partnerships - Ascentage Pharma has signed an exclusive option agreement with Takeda for olverembatinib, which could lead to Takeda licensing global rights for the drug outside of certain regions, enhancing its commercial potential [4].

Core Insights - Ascentage Pharma has received FDA and EMA clearance for a global Phase III study of olverembatinib in combination with chemotherapy for newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) patients [1][2] - The POLARIS-1 trial aims to accelerate the registration process of olverembatinib in the US and European markets [1] - Initial data from the POLARIS-1 study indicates a 65% minimal residual disease (MRD) negativity rate and molecular MRD-negative complete response (CR) rate after three treatment cycles, showing improved efficacy compared to existing therapies [3] Company Overview - Ascentage Pharma is a global biopharmaceutical company focused on developing novel therapies for unmet medical needs in cancer [6] - The company has a diverse pipeline, including olverembatinib, a third-generation BCR-ABL inhibitor, and lisaftoclax, a Bcl-2 inhibitor [7][8] - Olverembatinib has been approved in China for multiple indications in drug-resistant chronic myeloid leukemia (CML) and is included in the National Reimbursement Drug List (NRDL) [7] Clinical Development - The POLARIS-1 study is a multicenter, randomized controlled trial designed to evaluate the safety and efficacy of olverembatinib in Ph+ ALL patients [2] - The study has also been initiated in China following clearance from the China Center for Drug Evaluation (CDE) [2] - Olverembatinib has received Breakthrough Therapy Designation from the China CDE, highlighting its potential in treating Ph+ ALL [3][4] Strategic Partnerships - Ascentage Pharma has signed an exclusive option agreement with Takeda for olverembatinib, which could lead to Takeda licensing global rights outside of certain regions [4] - The company collaborates with various leading biotechnology and pharmaceutical firms, enhancing its research and development capabilities [9]

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 Insights - Ascentage Pharma announced promising results from a Phase Ib study of olverembatinib for treating succinate dehydrogenase (SDH) deficient gastrointestinal stromal tumors (GIST), marking it as the largest prospective clinical trial for this rare tumor subtype to date [2][4][9] Company Overview - Ascentage Pharma Group International is a global biopharmaceutical company focused on developing novel therapies for unmet medical needs in cancer [12] - The company has a diverse pipeline, including olverembatinib, a third-generation BCR::ABL1 inhibitor approved in China for specific types of chronic myeloid leukemia [13] Clinical Study Details - The Phase Ib study (NCT03594422) involved 66 patients, including 26 with SDH-deficient GIST, showing an objective response rate (ORR) of 23.1% and a clinical benefit rate (CBR) of 84.6% [4][5] - The median progression-free survival (mPFS) for patients with SDH-deficient GIST was reported at 25.7 months [4][9] Mechanism of Action - Olverembatinib was found to modulate lipid metabolism, inhibiting CD36 expression, which is linked to the uptake of exogenous lipids in tumor cells [6][7] - The study established a novel connection between SDH deficiency and lipid metabolism dysregulation, highlighting the drug's unique mechanism compared to traditional therapies [6][7] Future Directions - Ascentage Pharma plans to continue clinical development for olverembatinib, with ongoing studies to validate its efficacy and safety in SDH-deficient GIST patients [9][10] - The drug has received Breakthrough Therapy Designation from China's National Medical Products Administration for this indication [10]

Core Insights - Ascentage Pharma announced promising results from a Phase Ib study of olverembatinib for treating SDH-deficient GIST, published in a high-impact journal [2][4][3] - The study is the largest prospective clinical trial to date for this rare tumor subtype, demonstrating significant clinical benefits and a novel mechanism of action [4][7][8] Company Overview - Ascentage Pharma is a global biopharmaceutical company focused on developing therapies for unmet medical needs in cancer [12] - The company has a diverse pipeline, including olverembatinib, which is a third-generation BCR::ABL1 inhibitor approved in China for specific indications [13][12] Clinical Study Details - The Phase Ib study involved 66 patients, including 26 with SDH-deficient GIST, showing an objective response rate (ORR) of 23.1% and a clinical benefit rate (CBR) of 84.6% [4][5] - The median progression-free survival (mPFS) for patients with SDH-deficient GIST was reported at 25.7 months [4][5] Mechanism of Action - Olverembatinib modulates lipid metabolism, inhibiting CD36 expression, which is linked to enhanced uptake of exogenous lipids in SDH-deficient tumors [6][7] - The study established a direct link between SDH deficiency and dysregulated lipid metabolism, providing a new therapeutic target for SDH-deficient GIST [7][6] Future Directions - Ascentage Pharma plans to continue clinical development of olverembatinib, with ongoing studies to validate its efficacy and safety in SDH-deficient GIST [9][10] - The drug has received Breakthrough Therapy Designation in China for this indication, indicating its potential as a new treatment option [10][11]

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].

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 [1][7]. Company Overview - Ascentage Pharma is a global, commercial stage biopharmaceutical company focused on discovering, developing, and commercializing novel therapies for unmet medical needs in 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 Portfolio - 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 [3]. - The second approved product, Lisaftoclax, is a Bcl-2 inhibitor for various hematologic malignancies, currently being commercialized in China after receiving NMPA approval for chronic lymphocytic leukemia/small lymphocytic lymphoma [4]. - Ascentage Pharma is conducting multiple global registrational Phase III trials for both Olverembatinib and Lisaftoclax, indicating a strong focus on expanding its clinical footprint [3][4]. Research and Development - The company has established a portfolio of global intellectual property rights and formed partnerships with leading biotechnology and pharmaceutical companies, enhancing its research capabilities [5]. - Collaborations include relationships with prominent research institutions, which support the company's innovative drug development efforts [5].

Core Insights - Ascentage Pharma Group International announced that results from two clinical studies of its drug, lisaftoclax, have been selected for presentations at the 67th American Society of Hematology (ASH) Annual Meeting, marking the fourth consecutive year for such recognition [1][2] - The company is focused on addressing unmet medical needs in cancer through the development of novel therapies, with multiple investigational drug candidates being presented at the ASH Annual Meeting [1][4] Company Overview - Ascentage Pharma is a global, commercial stage biopharmaceutical company engaged in the discovery, development, and commercialization of differentiated therapies for cancer [16] - The company has a robust pipeline that includes inhibitors targeting key proteins in the apoptotic pathway and next-generation kinase inhibitors [16][19] Drug Development and Clinical Trials - Lisaftoclax, an orally available Bcl-2 inhibitor, has shown efficacy in treating hematologic malignancies and is currently being commercialized in China for CLL/SLL patients who have received prior systemic therapy [2][18] - The company is conducting four global registrational Phase III studies for lisaftoclax, including trials in combination with BTK inhibitors and studies targeting newly diagnosed patients [18] ASH Annual Meeting Presentations - At the ASH Annual Meeting, Ascentage Pharma will present an oral report on a Phase II study of lisaftoclax monotherapy for relapsed/refractory CLL/SLL, and a poster on its combination with azacitidine in newly diagnosed or prior venetoclax-exposed myeloid malignancies [2][12] - The presentations will highlight the clinical efficacy and safety profiles of the drug candidates, reinforcing the company's commitment to innovation in cancer treatment [4][11] Efficacy and Safety Results - In a pivotal Phase II study of lisaftoclax, the objective response rate (ORR) was 62.5% among 72 evaluable patients with R/R CLL/SLL, with a median progression-free survival of 23.89 months [9][11] - The safety profile of lisaftoclax was manageable, with frequent grade ≥3 treatment-related adverse events primarily being hematologic toxicities [10][11] Future Directions - Ascentage Pharma aims to accelerate its clinical development programs to provide more treatment options for patients, with ongoing evaluations of its drug candidates in various hematologic malignancies [4][15]

Core Insights - Ascentage Pharma Group International has announced that results from two clinical studies of its drug, lisaftoclax (APG-2575), will be presented at the 67th American Society of Hematology (ASH) Annual Meeting, marking the fourth consecutive year for such presentations [1][2][4] Clinical Study Results - Lisaftoclax is an orally available Bcl-2 inhibitor showing efficacy in hematologic malignancies and solid tumors, currently approved in China for treating adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have received prior systemic therapy [2][18] - At ASH 2025, an oral report will present results from a registrational Phase II study of lisaftoclax monotherapy in patients with relapsed/refractory CLL/SLL, while a poster will feature data on its combination with azacitidine in newly diagnosed or prior venetoclax-exposed myeloid malignancies [2][11] Efficacy and Safety Data - In the Phase II study, among 72 evaluable patients with R/R CLL/SLL, the objective response rate (ORR) was 62.5%, with a median progression-free survival (mPFS) of 23.89 months [8][10] - The treatment demonstrated a manageable safety profile, with frequent grade ≥3 treatment-related adverse events primarily being hematologic toxicities, and no treatment-related deaths reported [9][10] Additional Presentations - The ASH Annual Meeting will also feature presentations on other investigational drug candidates from Ascentage Pharma, including olverembatinib and APG-5918, showcasing the company's robust capabilities in clinical development [4][5][19]

Core Insights - Ascentage Pharma's novel drug, olverembatinib, has been selected for presentations at the 67th American Society of Hematology (ASH) Annual Meeting, marking the eighth consecutive year for this recognition, highlighting its significance in the hematology community [1][4] - The company will present data from multiple clinical studies, including the global Phase III study (POLARIS-1) of olverembatinib combined with low-intensity chemotherapy for newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL) [2][6] - Ascentage Pharma is actively advancing its clinical development programs to provide more treatment options for patients [4][18] 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 [19] - The company has a robust pipeline that includes olverembatinib, the first third-generation BCR-ABL inhibitor approved in China, and other investigational drug candidates like lisaftoclax and APG-5918 [20][22] Clinical Study Highlights - The POLARIS-1 study aims to evaluate the efficacy and safety of olverembatinib combined with low-intensity chemotherapy in patients with newly diagnosed Philadelphia chromosome-positive ALL, with a primary endpoint of minimal residual disease negativity rate [7][9] - In the study, olverembatinib demonstrated a 64.2% MRD-negative complete response rate by the end of induction therapy, indicating its potential effectiveness [9] - Safety results showed that olverembatinib combined with chemotherapy was well tolerated, with common grade ≥3 treatment-emergent adverse events including neutropenia (63.6%) and thrombocytopenia (56.4%) [8] Additional Clinical Findings - In a registrational Phase II trial, olverembatinib showed a significant therapeutic advantage over the best available therapy in patients with TKI-resistant chronic-phase chronic myeloid leukemia (CML-CP), with a median event-free survival of 21.22 months compared to 2.86 months for the control group [14] - The study also reported high complete hematologic response rates (85% for olverembatinib vs. 34.8% for BAT) and complete cytogenetic response rates (37.5% vs. 18.9%) [14] Future Directions - Ascentage Pharma is conducting global registrational Phase III trials for olverembatinib in various indications, including newly diagnosed Ph+ ALL and SDH-deficient gastrointestinal stromal tumors (GIST) [20] - The company aims to continue accelerating its clinical development programs to expand treatment options for patients [4][18]