Core Viewpoint - Ascentage Pharma's novel Bcl-2 selective inhibitor, lisaftoclax (APG-2575), has received conditional approval from China's National Medical Products Administration (NMPA) for treating adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously undergone at least one systemic therapy, marking it as the first Bcl-2 inhibitor approved for this indication in China and the second globally [1][3][7] Company Overview - Ascentage Pharma is a global biopharmaceutical company focused on addressing unmet medical needs in cancer treatment, with a rich pipeline of innovative drug candidates, including inhibitors targeting key proteins in the apoptotic pathway [10][11] - The approval of lisaftoclax represents a significant milestone in the company's development efforts, following its first commercialized drug, olverembatinib [2][10] Product Details - Lisaftoclax is an orally administered small-molecule Bcl-2 selective inhibitor designed to restore normal apoptosis in cancer cells by blocking the antiapoptotic protein Bcl-2 [2][5] - The drug has demonstrated broad therapeutic potential in various hematologic malignancies and solid tumors, particularly in CLL/SLL, both as a monotherapy and in combination therapies [2][3] Clinical Study Insights - The approval was based on a pivotal Phase II study (APG2575CC201) that evaluated the efficacy and safety of lisaftoclax in patients with relapsed or refractory CLL/SLL, achieving a compelling overall response rate (ORR) that met the prespecified endpoint [3][4] - Lisaftoclax exhibited a favorable safety profile, with no occurrences of tumor-lysis syndrome (TLS) and manageable hematologic and non-hematologic toxicities [3][4] Market Context - CLL/SLL is a common hematologic malignancy, particularly affecting older populations, with over 100,000 new diagnoses globally each year [4] - In China, the incidence of CLL/SLL is rising, necessitating safer and more effective treatment options beyond the current primary therapies, such as BTK inhibitors, which have limitations including high relapse rates and associated toxicities [4][5][6] Future Development Plans - Ascentage Pharma is conducting four global registrational Phase III trials for lisaftoclax, including studies in combination with BTK inhibitors and in various hematologic malignancies [7][13] - The company aims to accelerate the global development of lisaftoclax to address unmet clinical needs and expand its therapeutic applications [7][13]

Core Viewpoint - Ascentage Pharma Group International has appointed Veet Misra, Ph.D., as Chief Financial Officer and Eric Huang as Senior Vice President of Global Corporate Development and Finance, aiming to accelerate its global growth strategy in the biopharmaceutical sector [1][2][3] Management Appointments - Dr. Veet Misra brings over 20 years of investment banking experience, particularly in the biopharmaceutical sector, and holds a Ph.D. in Molecular Biology and an MBA in Finance & Strategy [4][5] - Mr. Eric Huang has over 20 years of experience in the global pharmaceutical industry, previously serving as CFO for Greater China and Asia-Pacific at Beigene, and holds an MBA in Finance [5] Company Strategy and Growth - The company is entering a notable growth phase, with the new executives expected to enhance its global strategy and operational excellence [2][3] - Ascentage Pharma is focused on becoming a leading fully integrated global biopharmaceutical company, leveraging its dual listing on the Hong Kong Stock Exchange and Nasdaq [2][4] Product Pipeline - Ascentage Pharma has a robust pipeline of innovative drug candidates targeting cancers, including apoptosis-targeted therapies and next-generation kinase inhibitors [6][7] - The lead asset, olverembatinib, is a third-generation BCR-ABL1 inhibitor approved in China for specific types of chronic myeloid leukemia (CML) and is undergoing global Phase III trials [8] - Another key asset, lisaftoclax, is a Bcl-2 inhibitor for hematologic malignancies, with its NDA accepted for Priority Review in China and multiple global Phase III trials ongoing [9] Partnerships and Collaborations - The company has established partnerships with leading pharmaceutical firms such as Takeda, AstraZeneca, Merck, and Pfizer, enhancing its research and development capabilities [10]

Core Insights - Ascentage Pharma announced results from 13 studies of its key assets, including olverembatinib and APG-5918, at the 2025 European Hematology Association Annual Congress, highlighting their potential in treating unmet medical needs in cancers [1][2][3] Group 1: Olverembatinib - Olverembatinib, a third-generation tyrosine kinase inhibitor, showed significant clinical benefits in treating Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), with high complete remission (CR) and complete molecular response (CMR) rates [2] - In a study combining olverembatinib with blinatumomab, all patients achieved CR after one treatment cycle, with an overall survival (OS) rate of 100% and an event-free survival (EFS) rate of 91.6% at 18 months [6] - The combination of olverembatinib with the VP regimen resulted in a 100% overall response rate (ORR) and a 97.3% CR rate, indicating its effectiveness as a first-line therapy for adult patients with Ph+ ALL [11] Group 2: APG-5918 - APG-5918, an investigational EED inhibitor, demonstrated potent antitumor activity in preclinical studies for T-cell lymphoma, supporting its further clinical development [3][18] - The combination of APG-5918 with histone deacetylase inhibitor tucidinostat showed enhanced antitumor effects, indicating its potential as a therapeutic option [18] Group 3: Company Overview - Ascentage Pharma is focused on addressing unmet medical needs in cancers and has developed a pipeline of innovative drug candidates, including olverembatinib and APG-5918 [13] - The company is conducting global registrational Phase III trials for olverembatinib in various indications, including newly diagnosed Ph+ ALL and GIST patients [14]

Core Insights - Ascentage Pharma announced that 13 studies of its key assets will be presented at the 2025 European Hematology Association Annual Congress in Milan, Italy, from June 12-15, 2025 [1][2] Group 1: Company Overview - Ascentage Pharma is a global biopharmaceutical company focused on addressing unmet medical needs in cancers, with a rich pipeline of innovative drug candidates [9] - The lead asset, olverembatinib, is the first novel third-generation BCR-ABL1 inhibitor approved in China for specific types of chronic myeloid leukemia (CML) [10] - The second lead asset, lisaftoclax, is a novel Bcl-2 inhibitor for treating various hematologic malignancies, with an NDA accepted for priority review in China [11] Group 2: Research Presentations - The congress will feature an oral presentation on integrating genomic and transcriptomic insights for predicting responses in patients with chronic myeloid leukemia (CML) [3] - Multiple poster presentations will include studies on the combination of olverembatinib with other therapies for newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) [4][5] - Online publications will cover various studies, including the efficacy and safety of olverembatinib in relapsed and persistent minimal residual disease positive Ph+ ALL patients [6][8]

Core Insights - Ascentage Pharma announced that 13 studies of its key assets will be presented at the 2025 European Hematology Association Annual Congress in Milan, Italy, from June 12-15, 2025 [1][2] Company Overview - Ascentage Pharma is a global biopharmaceutical company focused on addressing unmet medical needs in cancers, with a pipeline that includes innovative drug candidates targeting key proteins in the apoptotic pathway and next-generation kinase inhibitors [8][9] Key Assets and Studies - The lead asset, olverembatinib, is a third-generation BCR-ABL1 inhibitor approved in China for treating patients with chronic myeloid leukemia (CML) and is currently undergoing global registrational Phase III trials for CML and newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) patients [9][10] - The second lead asset, lisaftoclax, is a novel Bcl-2 inhibitor for various hematologic malignancies, with an NDA accepted for priority review in China [10] - Studies to be presented include: - Oral presentation on integrating genomic and transcriptomic insights for predicting responses in patients with chronic myeloid leukemia (CML) [3] - Poster presentations on the combination of olverembatinib with other therapies for newly diagnosed Ph+ acute lymphoblastic leukemia [4][5] - Online publications covering various studies on olverembatinib's efficacy and safety in different patient populations [6] Event Significance - The EHA Annual Congress is the largest gathering of the hematology community in Europe, attracting over 10,000 attendees from more than 100 countries, showcasing cutting-edge research and clinical results [2]

Core Insights - Ascentage Pharma announced new clinical data for its drug candidates, lisaftoclax and alrizomadlin, which will be presented at the 2025 ASCO Annual Meeting, indicating their potential in treating various cancers [1][2] Group 1: Lisaftoclax - Lisaftoclax is a Bcl-2 inhibitor being evaluated in a Phase 1b/2 study in combination with azacitidine for treatment-naïve or prior venetoclax-exposed myeloid malignancies [2][5] - The study enrolled nearly 100 patients, showing that the combination was well tolerated with preliminary efficacy; the overall response rate (ORR) for treatment-naïve myelodysplastic syndromes (MDS) was 64% [6][8] - In patients with venetoclax-refractory acute myeloid leukemia (AML), the ORR was 17%, while for high-risk MDS, it was 50% [6][8] Group 2: Alrizomadlin - Alrizomadlin is an MDM2-p53 inhibitor showing initial clinical activity in advanced adenoid cystic carcinoma (ACC) and other solid tumors [9][10] - The monotherapy arm demonstrated an ORR of 22.2% in ACC patients, with a disease control rate (DCR) of 100% in MPNST patients [12] - In the combination arm with toripalimab, the ORR was 20% in biliary-tract cancer patients, and 16.7% in liposarcoma patients, with prolonged progression-free survival observed in some MPNST patients [13]

ROCKVILLE, Md. and SUZHOU, China, April 28, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma (NASDAQ: AAPG; HKEX: 6855), a global biopharmaceutical company engaged in discovering, developing, and commercializing therapies to address global unmet medical needs primarily for hematological malignancies, today announced that it has presented results from five preclinical studies during poster presentations at the 2025 American Association for Cancer Research (AACR) Annual Meeting, taking place April 25-30, 2025, in Ch ...