2025 年 08 月 27 日 亚盛医药-B(06855.HK) 奥雷巴替尼持续放量，Lisaftoclax 国 内获批成为新增量 事件：公司发布 2025 年中期业绩，报告期内公司实现营业收入 2.34 亿元，实现归母净利润-5.91 亿元。 奥雷巴替尼持续放量，多个临床快速推进中。销售放量方面， 2025 年上半年奥雷巴替尼在中国的销售收入增长 93%，从 2024 年 上半年的 1.13 亿元人民币增至 2.17 亿元人民币，放量趋势明显。 临床开发方面，治疗既往系统性治疗失败的琥珀酸脱氢酶（SDH） 缺陷型胃肠间质瘤（GIST）患者的注册 III 期临床 POLARIS-3 研 究、治疗伴有或不伴有 T315I 突变的经治 CML-CP 成年患者的注 册 III 期临床 POLARIS-2 研究、联合化疗对比伊马替尼联合化疗 治疗新诊断费城染色体阳性（Ph+）急性淋巴细胞白血病（ALL） 患者的注册 III 期临床 POLARIS-1 研究正顺利推进中，且公司正 计划争取 FDA 许可以开展一项针对新诊断 Ph+ ALL 患者的注册 III 期临床研究。 Bcl-2 抑制剂 Lisaftoclax ...

ROCKVILLE, Md. and SUZHOU, China, Aug. 25, 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 will participate in the following investor conferences in September 2025. The live webcast of ...

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]

Core Viewpoint - The company’s core product, Lisaftoclax, demonstrated excellent efficacy in patients who were resistant to venetoclax, with an overall response rate (ORR) of 31.8% in 22 evaluable patients and 80% in 15 CMML patients, indicating strong potential for future clinical and international development [1][2]. Event - On June 3, 2025, the company announced the presentation of oral data on Lisaftoclax for patients who failed venetoclax treatment at the ASCO conference [1]. Efficacy Summary - In a study of 28 patients previously treated with venetoclax, 22 evaluable patients showed an ORR of 31.8%, with 22.8% achieving complete response (CR) or complete response with incomplete blood count recovery (Cri). Additionally, in 15 evaluable CMML patients, the ORR was 80%, with 40% achieving CR [1]. - Among 22 evaluable R/R MDS/CMML patients, the ORR was 50%, with 27.3% achieving CR and 18.2% achieving marrow CR [1]. Future Outlook - The company anticipates accelerated global commercialization, with core products expected to enter the U.S. market between 2026 and 2027. The commercial launch of Venetoclax is expected to further increase in 2025 as its indications expand [2]. - The POLARIS-2 clinical trial for Venetoclax is expected to be completed in 2026, with an NDA submission planned for the same year, potentially leading to U.S. market entry [2]. - The GLORA clinical trial for APG-2575 is expected to complete in 2027, with subsequent NDA submission and potential U.S. market launch [2]. Revenue Forecast and Investment Suggestion - The company has established multiple product pipelines in hematological malignancies and solid tumors, with significant revenue growth expected from international product launches and upfront payments. Revenue projections for 2025-2027 are 588 million, 883 million, and 1.324 billion respectively, with year-on-year growth rates of -40%, 50%, and 50% [2].

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 Viewpoint - Ascentage Pharma's stock surged over 7%, reaching a historic high of 59.55 HKD, following the presentation of promising clinical trial data for its Bcl-2 inhibitor, APG-2575 (lisaftoclax), at the 61st American Society of Clinical Oncology (ASCO) annual meeting [1] Group 1: Clinical Research and Development - The latest data from the Ib/II clinical study of APG-2575 combined with azacitidine for treating newly diagnosed or previously treated myeloid malignancies demonstrated both excellent efficacy and safety [1] - The study reported for the first time that lisaftoclax showed good therapeutic responses in patients who previously failed treatment with venetoclax, highlighting its differentiated efficacy and potential advantages over similar products [1] Group 2: Regulatory Progress - Lisaftoclax, a novel Bcl-2 selective inhibitor developed by Ascentage Pharma, has had its New Drug Application (NDA) accepted for priority review by the National Medical Products Administration (NMPA) in November 2024 for treating relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) [2] - It is the second Bcl-2 inhibitor globally to submit an NDA and the first domestically developed Bcl-2 inhibitor in China to enter priority review [2] - Currently, there are four global registration III clinical trials underway for Lisaftoclax, covering indications such as CLL/SLL, acute myeloid leukemia (AML), and myelodysplastic syndromes (MDS), with one trial being FDA-approved for global registration [2]

Core Viewpoint - The 2025 American Society of Clinical Oncology (ASCO) Annual Meeting is a significant event in the oncology field, attracting global attention from both academia and investors, particularly regarding investment opportunities in innovative drugs like Lisaftoclax from Ascentage Pharma [1][3]. Group 1: Company Developments - Ascentage Pharma's stock price surged by 9.13% on May 23, reaching a peak of 53.20 HKD, marking the highest level since August 2021, following the announcement of data at the ASCO meeting [1]. - Lisaftoclax (APG-2575), a Bcl-2 inhibitor, is the second globally to submit a New Drug Application (NDA) and the first domestic Bcl-2 inhibitor in China to enter priority review, showcasing its potential in treating various hematological malignancies [3][12]. - The drug has been included in the 2025 CSCO Lymphoma Diagnosis and Treatment Guidelines, marking its first inclusion and recognition by a top academic institution in China [4]. Group 2: Clinical Research and Data - The latest clinical data presented at ASCO demonstrated that Lisaftoclax, in combination with Azacitidine, showed good tolerability and preliminary efficacy in treating newly diagnosed or previously treated acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) patients [5][7]. - In a study involving 103 patients, the overall response rate (ORR) for newly diagnosed AML patients was 83.3%, while the ORR for relapsed/refractory AML patients was 43.2% [6]. - Among 28 patients with relapsed/refractory AML who were previously treated with Venetoclax, the ORR was 31.8%, indicating Lisaftoclax's potential to overcome Venetoclax resistance [8][11]. Group 3: Market Potential - The global market for hematological malignancy treatments is projected to reach $40 billion by 2024, with a compound annual growth rate (CAGR) of 6% from 2024 to 2029, highlighting the significant unmet clinical needs in this area [10]. - Lisaftoclax is expected to achieve over $2 billion in sales potential, driven by its unique positioning and clinical data that suggest it could surpass the market performance of existing Bcl-2 inhibitors like Venetoclax [9][11].