Olverembatinib

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Ascentage Pharma to Participate in Three Upcoming Investor Conferences in October 2025
Globenewswire· 2025-10-07 12:00
Core Viewpoint - Ascentage Pharma Group International is actively participating in several investor conferences in October 2025, highlighting its ongoing commitment to engage with investors and stakeholders in the biopharmaceutical sector [1][7]. Company Overview - Ascentage Pharma is a global, commercial stage, integrated biopharmaceutical company focused on discovering, developing, and commercializing novel therapies for unmet medical needs in cancer [2][5]. - 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 chronic myelogenous leukemia (CML) patients 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, with multiple global registrational Phase III trials currently underway [4]. Research and Development - Ascentage Pharma has established a strong R&D capability and has built a portfolio of global intellectual property rights [5]. - 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 [5].
Ascentage Pharma to Participate in Three Upcoming Investor Conferences in September 2025
Globenewswire· 2025-08-25 12:00
Core Viewpoint - Ascentage Pharma Group International is actively participating in investor conferences in September 2025 to discuss its advancements in biopharmaceuticals, particularly in cancer therapies [1][8]. Company Overview - Ascentage Pharma is a global, commercial stage, integrated biopharmaceutical company focused on discovering, developing, and commercializing novel therapies for unmet medical needs in cancer [3][4]. - 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][4]. Product Pipeline - The first approved product, Olverembatinib, is a third-generation BCR-ABL1 inhibitor for treating chronic myeloid leukemia (CML) with T315I mutations and is included in China's National Reimbursement Drug List [4]. - Olverembatinib is currently undergoing registrational Phase III trials, including POLARIS-2 for CML and POLARIS-1 and POLARIS-3 for other specific patient groups [4]. - The second approved product, Lisaftoclax, is a Bcl-2 inhibitor for various hematologic malignancies and has been approved for chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients who have received prior systemic therapy [5]. - Lisaftoclax is involved in four global registrational Phase III trials, including studies in combination with BTK inhibitors and for newly diagnosed patients [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].
Ascentage Pharma Reports 2025 Interim Unaudited Six Months Financial Results and Business Updates
Globenewswire· 2025-08-20 23:57
Core Insights - Ascentage Pharma reported strong business momentum in the first half of 2025, with a 93% year-over-year growth in Olverembatinib sales to $30.3 million, driven by expanded NRDL coverage in China [2][6][7] - The approval of Lisaftoclax in July 2025 marks a significant milestone as the first Bcl-2 inhibitor approved for CLL/SLL treatment in China, with commercial sales commencing shortly after [2][13] - The company has a robust pipeline with nine registrational clinical trials ongoing, including three cleared by the FDA, demonstrating its commitment to innovative cancer therapies [2][3] Financial Performance - Total revenue for the six months ended June 30, 2025, was $32.6 million, a decrease of 71.6% compared to $113.4 million in the same period of 2024, primarily due to the absence of intellectual property revenue recorded in 2024 [12] - Product sales of Olverembatinib increased by 92.5% on a constant currency basis, contributing significantly to the overall revenue [12] - The company reported a loss of $82.5 million for the first half of 2025, compared to a profit of $22.4 million in the same period of 2024, with a loss per share of $0.24 [19] Commercial and Clinical Developments - Olverembatinib is the first third-generation BCR-ABL1 TKI approved in China for CML treatment, with ongoing evaluations for additional indications [3][28] - Lisaftoclax is being evaluated in multiple registrational Phase III trials for various hematologic malignancies, including CLL/SLL and AML [9][29] - The company completed a financing round in July 2025, raising $190.1 million in net proceeds, enhancing its financial position to support commercialization and development efforts [2][21] Operational Metrics - The number of pharmacies and hospitals where Olverembatinib is available increased by 17% to 782, with a notable 47% increase in hospitals to 295 as of June 30, 2025 [7] - Selling and distribution expenses rose by 53.7% to $19.2 million, reflecting increased commercialization efforts for Olverembatinib and preparations for Lisaftoclax [14] - Research and development expenses increased by 19.0% to $73.8 million, driven by ongoing global clinical trials [15]
Thirteen Studies of Ascentage Pharma’s Assets Including Olverembatinib and Lisaftoclax Selected for Presentations at 2025 European Hematology Association Annual Congress
Globenewswire· 2025-06-09 23:30
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]
Ascentage Pharma To Present Data from Two Clinical Studies at 2025 ASCO Annual Meeting, Including Oral Presentation on Its Key Assets Lisaftoclax and Alrizomadlin
Globenewswire· 2025-04-23 23:00
Core Insights - Ascentage Pharma announced the selection of results from two clinical studies of its drug candidates, lisaftoclax (APG-2575) and alrizomadlin (APG-115), for presentation at the 2025 ASCO Annual Meeting [1][3] - The ASCO Annual Meeting is a significant event in the oncology field, attracting over 40,000 professionals globally [2] - The company aims to advance its clinical development and provide more treatment options for patients with hematological malignancies [3] Company Overview - Ascentage Pharma is a global biopharmaceutical company focused on therapies for unmet medical needs, particularly in hematological malignancies [1][7] - The company has been listed on the Hong Kong Stock Exchange since October 2019 and on the Nasdaq since January 2025 [8] - Ascentage Pharma has a diverse pipeline of innovative drug candidates targeting key proteins in the apoptotic pathway and next-generation TKIs [9] Clinical Studies - A Phase 1b/2 study of lisaftoclax combined with azacitidine in patients with treatment-naïve or prior venetoclax-exposed myeloid malignancies will be presented [4] - A Phase 2 study of alrizomadlin with or without toripalimab in patients with advanced adenoid cystic carcinoma or other solid tumors will also be presented [5] Regulatory Status - Lisaftoclax and alrizomadlin are investigational drugs and are not yet approved in the U.S. [6] - Olverembatinib, another key asset, is approved in China and included in the National Reimbursement Drug List [10] - The company has received multiple Orphan Drug Designations from the US FDA and the European Medicines Agency for its investigational drug candidates [11] Partnerships and Collaborations - Ascentage Pharma has established partnerships with leading biotechnology and pharmaceutical companies, including Takeda, Merck, and Pfizer, as well as research institutions like Mayo Clinic and Dana-Farber Cancer Institute [11]