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]

机构：中信建投证券 研究员：贺菊颖/袁清慧 核心观点 在2025 年ASCO 大会上，公司核心产品Lisaftoclax 展示了在维奈克拉耐药后患者中的研究结果。在28 例既往接受维奈克拉治疗的患者中，22 例可评估疗效患者的ORR 为31.8%，其中22.8%的患者CR/Cri， 同时在15 例CMML 患者中，ORR 为80%。整体看，产品Lisaftoclax 在维奈克拉耐药后的肿瘤患者中展 现了优异疗效，产品基本面良好，安全性优异，看好药物后续临床进展以及国际化进展。 事件 2025 年6 月3 日，公司发布公告，核心产品Lisaftoclax 针对维奈克拉治疗失败患者的口头报告在ASCO 大会上展示。 简评 Lisaftoclax 疗效数据优异，产品竞争力强 在ASCO 大会上，公司公布核心产品Lisaftoclax 针对维奈克拉治疗失败患者的最新数据。截至2025 年4 月，在28 例既往维奈克拉耐药的复发/难治AML/混合表型急性白血病（MPAL）患者中，疗效可评估的 患者有22 例，总反应率（ORR）为31.8%（7/22），其中22.8%的患者CR/ CR 伴血细胞未完全恢复 （Cri）；4 ...

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]

机构：中金公司 研究员：张琎/刘雅馨/朱言音 APG-115 单药和联合特瑞普利单抗展现出良好的抗肿瘤活性。截至2025年2 月13 日，单药治疗组17 例 疗效可评估患者中，12 例晚期腺样囊性癌（ACC）患者的ORR为16.7%，联合治疗组6 例胆管癌 （BTC）患者的ORR为16.7%，DCR为100%；6 例晚期脂肪肉瘤（LPS）患者的ORR为16.7%，DCR为 66.7%；2 例恶性周围神经鞘瘤（MPNST）患者达到经确认的PR且PFS显著延长。 盈利预测与估值 公司近况 近日，公司在2025 年美国临床肿瘤学会（ASCO）年会上口头报告了Bcl-2抑制剂APG-2575 （lisaftoclax）联合阿扎胞苷针对髓系恶性肿瘤的Ib/II期研究数据i，并更新了MDM2-p53 抑制剂 APG- 115（alrizomadlin）治疗晚期腺样囊性癌（ACC）或其它实体瘤患者的II期临床研究数据ii。 评论 APG-2575 R/R AML数据亮眼，展现出克服维奈克拉耐药的潜力。在APG-2575 的全球多中心Ib/II期研 究中，截至2025 年4 月，在44 例疗效可评估复发难治急性髓系白血病 / ...

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 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]

消息面上，亚盛医药已在第61届美国临床肿瘤学会（ASCO）年会上，口头报告了在研Bcl-2抑制剂 APG-2575（lisaftoclax）联合去甲基化药物阿扎胞苷治疗治疗初治（TN）或既往接受过维奈克拉治疗的 髓系恶性肿瘤患者的Ib/II期临床研究最新数据。该研究最新进展再次验证了lisaftoclax在恶性髓系肿瘤治 疗中卓越疗效和卓越安全性二者兼备的特点。值得注意的是，该研究首次报告了lisaftoclax在既往维奈 克拉治疗失败的患者中也有很好的治疗反应，显示出lisaftoclax和国外同类产品的差异化和疗效优势潜 力。 亚盛医药-B(06855)涨超7%，盘中高见59.55港元创历史新高，截至发稿，涨7.13%，报59.35港元，成交 额2.11亿港元。 据悉，Lisaftoclax是亚盛医药自主研发的新型Bcl-2选择性抑制剂，其新药上市申请（NDA）已于2024年 11月获国家药监局药品审评中心（CDE）受理并纳入优先审评程序，用于治疗复发/难治性（R/R）慢性 淋巴细胞白血病/小淋巴细胞淋巴瘤（CLL/SLL），是全球第二个递交NDA的Bcl-2抑制剂和中国首个递 交NDA并进入优先审评的国 ...

近日，作为肿瘤领域规模盛大的年度学术盛会——2025年美国临床肿瘤学会(ASCO)年会正如火如荼进行中，受到国际学界广泛关注，而全球二级市场投资 者也在积极挖掘其中的投资机会。 智通财经APP观察到，早在5月23日，亚盛医药-B(06855)股价便高开高走，最高涨幅达到9.13%，股价最高触及53.20港元，创下自2021年8月以来的新纪录。 二级市场之所以反应积极，在于当天盘前，公司披露了其在今年ASCO年会上的数据信息。 1. 在6例疗效可评估的新诊断(ND)AML/混合表型急性白血病(MPAL)患者中，ORR为 83.3%, 其中33.3%的患者获 CR/CRi ，50%的患者获PR。在 44 例疗效可 评估R/R AML/MPAL 患者中，ORR为 43.2%，其中31.8% 的患者获CR/CRi ，4.5%的患者获PR，6.8% 的患者获MLFS。 2.在15例疗效可评估的 ND MDS/慢性粒单核细胞白血病(CMML)患者中，ORR为 80%，其中40%的患者获CR，40%的患者获骨髓CR(mCR)。22 例疗效可评 估的 R/R MDS/CMML 患者中，ORR为 50%，其中27.3%的患者获 ...

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]