Blinatumomab

Ascentage Pharma (NASDAQ: AAPG; HKEX: 6855)  announced that results from 13 studies of its core assets, including the novel drug olverembatinib (HQP1351), and the investigational EED inhibitor APG-5918, have been reported at the 2025 European Hematology Association (EHA) Annual Congress.Notably, in multiple studies presented at this year’s EHA Annual Congress, the third-generation tyrosine kinase inhibitor (TKI) olverembatinib showed broad therapeutic potential and demonstrated particular clinical benefit in the treatment of Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). According to the results, olverembatinib demonstrated high complete remission (CR) and complete molecular response (CMR) rates, as well as favorable tolerability in the first-line treatment of newly diagnosed and relapsed/refractory Ph+ ALL, and specific subtypes of some hematologic malignancies (e.g., myeloid/lymphoid neoplasm with FGFR1 rearrangement). Furthermore, studies on various combinations of olverembatinib (with venetoclax plus azacitidine, the VP regimen, blinatumomab, or inotuzumab ozogamicin) have shown encouraging results that revealed olverembatinib’s potential in offering more treatment options and improved long-term prognoses to patients with Ph+ ALL.In addition, a preclinical study of the investigational EED inhibitor APG-5918, another key asset in Ascentage Pharma’s pipeline, was featured in a poster presentation at the Congress. These data showed the potent antitumor activity of APG-5918 in T-cell lymphoma and support further clinical development of the agent.Highlights of select abstracts presented at EHA 2025 are as follows (for detailed results from all 13 studies of the company's assets, please visit the official website of the EHA):Efficacy and Safety of Regimen with Olverembatinib and Blinatumomab for the Frontline Treatment of Ph-Positive or Ph-Like Acute Lymphoblastic LeukemiaAbstract#：PS1367Format：Poster PresentationPrincipal Authors：Prof. Hongsheng Zhou, Nanfang Hospital, Southern Medical University; Xiuli Xu, Nanfang Hospital, Southern Medical UniversityHighlights:This is a single-arm, single-center, prospective study that assessed the clinical experience with olverembatinib in combination with blinatumomab as a first-line treatment for patients with Ph+ or Ph-like ALL.Results from this study show that with a median follow-up duration of 17 months, all patients achieved CR following one cycle of treatment. At 18 months, the overall survival (OS) rate was 100% and the event-free survival (EFS) rate was 91.6%. The regimen was well tolerated and no patient experienced cardiovascular events. Notably, administration of olverembatinib and blinatumomab was not interrupted throughout the treatment course with no dose reduction required.These findings suggest that the combination of olverembatinib and blinatumomab offers promising clinical benefits and an optimal safety profile in patients with Ph+ or Ph-like ALL, thus representing a promising chemotherapy-free treatment option for patients with Ph+ ALL.Combination of Olverembatinib and VP Regimen as First-Line Therapy for Adult Patients with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: A Single-Arm, Multicentre, Phase 2 TrialAbstract#：PS1372Format: Poster PresentationPrincipal Authors：Prof. Jie Jin, The First Affiliated Hospital, Zhejiang University School of Medicine; Gaixiang Xu, The First Affiliated Hospital, Zhejiang University School of MedicineHighlights:This single-arm, multicenter Phase II study assessed the efficacy and safety of olverembatinib in combination with the VP (vindesine+prednisone) regimen (OVP) in the first-line treatment of adult patients with Ph+ ALL.Results from this study showed that in patients treated with the OVP induction therapy, the overall response rate (ORR) was 100%, the CR rate was 97.3%, and 89.2% (33/37) of patients achieved CMR within 3 treatment cycles. The 2-year OS and progression-free survival (PFS) rates were 96.3% and 96%, respectively.These findings suggest that the OVP regimen is effective in achieving a high CMR rate in the early treatment of patients with newly diagnosed Ph+ ALL, with surprisingly few toxic effects and good tolerability, thus representing a potential new treatment option in the first-line setting.Efficacy and Safety of the Third-Generation Tyrosine Kinase Inhibitor Olverembatinib in Combination with Inotuzumab Ozogamicin for the Treatment of Adult Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia Patients With Relapsed Disease or Persistent Minimal Residual Disease Bridging to Hematopoietic Stem Cell Transplantation: A Phase II StudyAbstract#：PS1387Format: Poster PresentationPrincipal Authors：Erlie Jiang, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College; Xiaoyu Zhang, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical CollegeHighlights:This is an open-label, single-center Phase II study that evaluated the efficacy and safety of olverembatinib in combination with inotuzumab ozogamicin (INO) in patients with Ph/BCR-ABL1+ ALL who had relapsed or persistent MRD after at least three rounds of chemotherapy.Results from this study show that after receiving the treatment, all patients achieved hematologic CR, 11 patients achieved CMR, with an overall CMR rate of 78.6% and an MRD-negativity rate of 100%. 64.3% (n=9) of patients successfully underwent bridged allogeneic hematopoietic stem cell transplantation (allo-HSCT). The 2-year OS and relapse-free survival (RFS) rates were 88.2 ± 15.2% and 62.9 ± 17.9%, respectively.These findings suggest that olverembatinib in combination with INO can achieve deep molecular responses and was well tolerated in patients with Ph+ ALL who had relapsed disease or persistent MRD-positivity.A Phase 2 Study of Olverembatinib for the Treatment of Myeloid/Lymphoid Neoplasms with FGFR1 RearrangementAbstract#：PF390Format: Poster PresentationPrincipal Authors：Prof. Suning Chen, The First Affiliated Hospital of Soochow University; Wenzhi Cai, The First Affiliated Hospital of Soochow UniversityHighlights:This is a Phase II study that evaluated the efficacy and safety of olverembatinib for the treatment of myeloid/lymphoid neoplasms with FGFR1 rearrangement (MLN-FGFR1).Results show that in the 13 patients who were analyzed for efficacy, 10 (76.9%) achieved CR/compete hematologic response (CHR), among whom 1 achieved complete cytogenetic response (CCyR, by a patient who received olverembatinib alone) and 1 patient achieved CMR at 2 months’ evaluation.In this study, olverembatinib showed a promising CR/CHR rate and favorable tolerability in MLN-FGFR1, potentially enabling allo-HSCT in greater numbers of eligible patients. These findings revealed an effective targeted therapy for MLN-FGFR1, a rare hematologic malignancy with a poor prognosis that currently lacks standard-of-care treatment.Embryonic Ectoderm Development (EED) Inhibitor APG-5918 Exhibits Potent Antitumor Activity and Synergizes with Histone Deacetylase Inhibitor Tucidinostat in Preclinical T-Cell Lymphoma (TCL) ModelsAbstract#：PS1993Format: Poster PresentationPrincipal Authors：Dr. Eric Liang, Ascentage Pharma Group Inc.Highlights:APG-5918 demonstrated potent inhibitory effects on the proliferation of TCL cell lines in vitro, showing superior activity compared to other EZH and EED inhibitors. Its combination with tucidinostat synergistically suppressed cell proliferation.APG-5918 induced dose-dependent apoptosis and cell cycle arrest in TCL cells.In a HuT102 cell line-derived xenograft (CDX) model, APG-5918 exhibited significant, dose-dependent antitumor activity, achieving complete tumor regression at 30 mg/kg with a 100% ORR. Its combination with tucidinostat synergistically enhanced antitumor activity.Mechanistically, APG-5918 modulated PRC2 complex and induced apoptosis and cell cycle arrest. Combination with tucidinostat further enhanced these effects.These findings provide strong rationale for the clinical development of APG-5918, both as a monotherapy and in combination with HDAC inhibitors, for TCL.*Olverembatinib and APG-5918 are investigational compounds and have not been approved by the US FDA.About Ascentage PharmaAscentage Pharma (NASDAQ: AAPG; HKEX: 6855) is a global biopharmaceutical company dedicated to addressing unmet medical needs in cancers. The company has built a rich pipeline of innovative drug candidates that includes inhibitors targeting key proteins in the apoptotic pathway, such as Bcl-2 and MDM2-p53 and next-generation kinase inhibitors.The lead asset, olverembatinib, is the first novel third-generation BCR-ABL1 inhibitor approved in China for the treatment of patients with CML in chronic phase (CML-CP) with T315I mutations, CML in accelerated phase (CML-AP) with T315I mutations, and CML-CP that is resistant or intolerant to first and second-generation TKIs. It is covered by the China National Reimbursement Drug List (NRDL). The Company is currently conducting an FDA-cleared, global registrational Phase III trial, or POLARIS-2, of olverembatinib for CML, as well as global registrational Phase III trials for patients with newly diagnosed Ph+ ALL and SDH-deficient GIST patients.The second lead asset, lisaftoclax, is a novel Bcl-2 inhibitor for the treatment of various hematologic malignancies. The NDA for the treatment of relapsed and/or refractory CLL and SLL was accepted with Priority Review designation by China’s National Medical Products Administration. The Company is currently conducting an FDA-cleared, global registrational Phase III trial, or GLORA, of lisaftoclax in combination with BTK inhibitors for patients with CLL/SLL previously treated with BTK inhibitors for more than 12 months with suboptimal response, as well as global registrational Phase III trials for patients with newly diagnosed CLL/SLL, AML, and MDS.Leveraging its robust R&D capabilities, Ascentage Pharma has built a portfolio of global intellectual property rights and entered into global partnerships and other relationships with numerous leading biotechnology and pharmaceutical companies, such as Takeda, AstraZeneca, Merck, Pfizer, and Innovent, in addition to research and development relationships with leading research institutions, such as Dana-Farber Cancer Institute, Mayo Clinic, National Cancer Institute and the University of Michigan. For more information, visit https://ascentage.com/Cautionary Note Regarding Forward-Looking StatementsThis press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, contained in this press release may be forward-looking statements, including statements that express Ascentage Pharma’s opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results of operations or financial condition. These forward-looking statements are subject to a number of risks and uncertainties as discussed in Ascentage Pharma’s filings with the SEC, including those set forth in the sections titled “Risk factors” and “Special note regarding forward-looking statements and industry data” in its Registration Statement on Form F-1, as amended, filed with the SEC on January 21, 2025, and the Form 20-F filed with the SEC on April 16, 2025, the sections headed “Forward-looking Statements” and “Risk Factors” in the prospectus of the Company for its Hong Kong initial public offering dated October 16, 2019, and other filings with the SEC and/or The Stock Exchange of Hong Kong Limited we made or make from time to time that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. The forward-looking statements contained in this presentation do not constitute profit forecast by the Company’s management.As a result of these factors, you should not rely on these forward-looking statements as predictions of future events. The forward-looking statements contained in this press release are based on Ascentage Pharma’s current expectations and beliefs concerning future developments and their potential effects and speak only as of the date of such statements. Ascentage Pharma does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.This press release is issued by Ascentage Pharma solely for the purpose of disclosing the company’s latest business developments and is not intended as advertising. The drug-related information contained herein is for reference only by healthcare professionals and does not constitute commercial promotion of any drug or recommendation of treatment options. For further disease or drug information, please consult a qualified healthcare professional.

亚盛医药（纳斯达克代码：AAPG；香港联交所代码：6855）宣布，涉及公司原创1类新药奥雷巴替尼（商品名：耐立克®）和EED抑制剂APG-5918等重磅品种的13项研究进展已在2025年欧洲血液学协会（EHA）年会上精彩亮相。特别值得关注的是，本次EHA年会上入选的多篇研究展示了奥雷巴替尼广泛的治疗潜力，尤其是该药物作为新型第三代TKI在费城染色体阳性（Ph+）急性淋巴细胞白血病（ALL）领域呈现出积极数据。无论是针对新诊断Ph+ ALL患者的一线治疗研究，还是针对复发或难治性患者以及特定亚型疾病（如FGFR1重排的髓系/淋巴系肿瘤）的研究，奥雷巴替尼均表现出较高的完全缓解（CR）率、完全分子学反应（CMR）率和良好的耐受性。与多种药物（如维奈克拉+阿扎胞苷、VP方案、贝林妥欧单抗、奥加伊妥珠单抗等）的联合治疗的多项积极数据提示，奥雷巴替尼有望为Ph+ ALL患者提供更多的治疗选择，并进一步改善患者的长期预后。此外，亚盛医药另一重要在研品种EED抑制剂APG-5918通过壁报形式展示了其一项最新临床前进展。数据显示该药物在T细胞淋巴瘤（TCL）临床前模型中的强劲抗肿瘤活性，有望为后续临床开发提供有力参考。在此次EHA年会上展示的精选研究核心要点如下（更多公司在研品种相关研究数据请查询EHA官网）：Efficacy and Safety of Regimen with Olverembatinib and Blinatumomab for the Frontline Treatment of Ph-Positive or Ph-Like Acute Lymphoblastic Leukemia奥雷巴替尼联合贝林妥欧单抗一线治疗Ph+或Ph样ALL的疗效和安全性摘要编号：PS1367展示形式：壁报展示主要作者：南方医科大学南方医院周红升教授，南方医科大学南方医院许秀丽核心要点：这是一项单臂、前瞻性、单中心研究，探索了奥雷巴替尼联合贝林妥欧单抗作为一线治疗方案用于 Ph+ 或 Ph样ALL患者的临床经验。结果显示，中位随访17个月后，所有患者在接受一个治疗周期后均达到CR，18个月时OS率为100%，无事件生存（EFS）率为91.6%。该方案耐受性良好，未观察到心血管不良事件，且在整个治疗过程中无需中断奥雷巴替尼和贝林妥欧单抗的给药，也无需减少剂量。该研究结果表明，奥雷巴替尼联合贝林妥欧单抗的无化疗方案在 Ph+或Ph样ALL患者中具有优异的疗效，且具有极佳的安全性，提示该方案是Ph+ ALL患者非常有前景的无化疗治疗选择。Combination of Olverembatinib and VP Regimen as First-Line Therapy for Adult Patients with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: A Single-Arm, Multicentre, Phase 2 Trial奥雷巴替尼联合VP方案一线治疗成人Ph+ ALL：一项单臂、多中心II期研究摘要编号：PS1372展示形式：壁报展示主要作者：浙江大学医学院附属第一医院金洁教授，浙江大学医学院附属第一医院许改香核心要点：这是一项单臂、多中心、II 期试验，评估了奥雷巴替尼联合VP（长春地辛和泼尼松）方案（OVP）一线治疗成人 Ph+ ALL患者的疗效和安全性。研究结果显示，OVP诱导治疗的总缓解率（ORR）为100%，其中CR率为97.3%，89.2%（33/37）的患者在3个周期内达到CMR。2年总生存（OS）率和无进展生存（PFS）率分别为96.3%和96%。该研究结果表明，OVP方案在新诊断Ph+ ALL患者中实现早期高CMR率，并呈现显著的低毒性反应且耐受性良好，有望成为一线治疗的新选择。Efficacy and Safety of the Third-Generation Tyrosine Kinase Inhibitor Olverembatinib in Combination with Inotuzumab Ozogamicin for the Treatment of Adult Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia Patients With Relapsed Disease or Persistent Minimal Residual Disease Bridging to Hematopoietic Stem Cell Transplantation: A Phase II Study奥雷巴替尼联合奥加伊妥珠单抗治疗复发或造血干细胞移植前持续MRD阳性成人Ph+ ALL的疗效与安全性：一项Ⅱ期研究摘要编号：PS1387展示形式：壁报展示主要作者：中国医学科学院北京协和医学院血液病医院姜尔烈教授，中国医学科学院北京协和医学院血液病医院张潇予核心要点：这是一项开放标签、单中心、II 期研究，探讨了奥雷巴替尼联合奥加伊妥珠单抗（INO）在治疗至少经过3次化疗后复发或持续MRD的成人Ph/BCR-ABL1+ ALL患者的疗效和安全性。治疗后，所有患者均达到血液CR，11 例患者达到CMR，总体CMR率为78.6%，MRD阴性率为100%。64.3%（9例）的患者成桥接allo-HSCT。2年总生存（OS）率和无复发生存（RFS）率分别为88.2±15.2%和62.9±17.9%。该研究结果表明，在复发或持续MRD阳性的Ph+ ALL患者中，奥雷巴替尼联合 INO的组合具有较深的分子学反应和良好的耐受性。A Phase 2 Study of Olverembatinib for the Treatment of Myeloid/Lymphoid Neoplasms with FGFR1 Rearrangement一项评估奥雷巴替尼用于治疗伴FGFR1重排的髓系/淋巴系肿瘤的II期研究摘要编号：PF390展示形式：壁报展示主要作者：苏州大学附属第一医院陈苏宁教授，苏州大学附属第一医院蔡文治核心要点：这是一项II期研究，评估了奥雷巴替尼在FGFR1重排的髓系/淋巴系肿瘤（MLN-FGFR1）治疗中的疗效和安全性。研究结果显示，13例患者接受了疗效分析，10例（76.9%）达到CR/CHR，其中在2个月评估时，1例达到CCyR（该患者仅接受奥雷巴替尼治疗），1例达到CMR。该研究表明，奥雷巴替尼在治疗MLN-FGFR1中显示出良好的CR/CHR 率和良好的耐受性，可能使更多符合条件的患者能够接受allo-HSCT。该研究为缺乏标准疗法且预后较差的罕见病提供了高效靶向治疗方案。Embryonic Ectoderm Development (EED) Inhibitor APG-5918 Exhibits Potent Antitumor Activity and Synergizes with Histone Deacetylase Inhibitor Tucidinostat in Preclinical T-Cell Lymphoma (TCL) Models胚胎外胚层发育蛋白（EED）抑制剂APG-5918在T细胞淋巴瘤（TCL）临床前模型中展现强效抗肿瘤活性，并与组蛋白去乙酰化酶抑制剂西达本胺协同增效摘要编号：PS1993展示形式：壁报展示主要作者：亚盛医药Eric Liang博士核心要点：APG-5918在体外实验中表现出强效的TCL细胞系增殖抑制活性，其活性优于其他EZH和EED类抑制剂。此外，APG-5918与西达本胺联用表现出显著的协同增殖抑制效应。APG-5918可诱导TCL细胞发生剂量依赖性的细胞凋亡和细胞周期阻滞。在HuT102细胞来源异种移植瘤（CDX）模型中，APG-5918展现出显著的、剂量依赖性的抗肿瘤活性，其在30 mg/kg剂量下实现了肿瘤的完全消退， ORR达到100%。与西达本胺的联合用药进一步协同增强了抗肿瘤作用。机制研究表明，APG-5918可通过调控PRC2复合物活性，诱导细胞凋亡和细胞周期阻滞，从而发挥抗肿瘤作用；与西达本胺联合使用后，上述效应进一步增强。这些研究结果为APG-5918作为单药或与HDAC抑制剂联合用于TCL治疗的临床开发提供了有力的科学理论依据。关于亚盛医药亚盛医药是一家综合性的全球生物医药企业，致力于研发创新药，以解决肿瘤等领域全球患者尚未满足的临床需求。2019年10月28日，公司在香港联交所主板挂牌上市，股票代码：6855.HK；2025年1月24日，公司在美国纳斯达克证券交易所挂牌上市，股票代码：AAPG。亚盛医药已建立丰富的创新药产品管线，包括抑制Bcl-2和 MDM2-p53 等细胞凋亡通路关键蛋白的抑制剂；新一代针对癌症治疗中出现的激酶突变体的抑制剂等。公司核心品种耐立克®是中国首个获批上市的第三代BCR-ABL抑制剂，且获批适应症均被成功纳入国家医保药品目录。目前，亚盛医药正在开展耐立克®一项获美国FDA许可的全球注册III期临床研究（POLARIS-2），用于治疗既往接受过治疗的慢性髓细胞白血病慢性期（CML-CP）成年患者。此外，耐立克®联合治疗新诊断费城染色体阳性急性淋巴细胞白血病（Ph+ ALL）患者和治疗琥珀酸脱氢酶（SDH）缺陷型胃肠道间质瘤（GIST）患者的全球注册III期研究正在开展中。公司另一重磅品种，新型Bcl-2选择性抑制剂APG-2575（Lisaftoclax）的新药上市申请（NDA）已获CDE受理，并被纳入优先审评。目前，亚盛医药正在开展APG-2575（Lisaftoclax）四项注册III期临床研究，分别为获美国FDA许可的治疗经治慢性淋巴细胞白血病/小淋巴细胞淋巴瘤（CLL/SLL）患者的全球注册III期临床研究（GLORA）；治疗初治CLL/SLL患者的全球注册III期临床研究；一线治疗新诊断老年或体弱急性髓系白血病（AML）的全球注册III期临床研究；以及治疗新诊断中高危骨髓增生异常综合征（MDS）患者的注册III期研究。截至目前，公司4个在研新药共获16项FDA和1项欧盟孤儿药资格认定，2项FDA快速通道资格以及2项FDA儿童罕见病资格认证。凭借强大的研发能力，亚盛医药已在全球范围内进行知识产权布局，并与武田、默沙东、阿斯利康、辉瑞、信达等领先的生物制药公司，以及梅奥医学中心（Mayo Clinic）、丹娜法伯癌症研究院（Dana-Farber Cancer Institute）、美国国家癌症研究所（NCI）和密西根大学等学术机构达成全球合作关系。亚盛医药已在原创新药研发与临床开发领域建立经验丰富的国际化人才团队，以及成熟的商业化生产与市场营销团队。亚盛医药将不断提高研发能力，加速推进公司产品管线的临床开发进度，真正践行"解决中国乃至全球患者尚未满足的临床需求"的使命，以造福更多患者。前瞻性声明本新闻稿包含根据美国《1995年私人证券诉讼改革法案》，以及经修订的《1933年证券法》第27A条和《1934年证券交易法》第21E条所界定的前瞻性陈述。除历史事实陈述外，本新闻稿中的所有内容均可能构成前瞻性陈述，包括亚盛医药对未来事件、经营成果或财务状况所发表的意见、预期、信念、计划、目标、假设或预测。这些前瞻性陈述受到诸多风险和不确定性的影响，具体内容已在亚盛医药向美国证券交易委员会（SEC）提交的文件中详细说明，包括2025年1月21日提交的经修订的F-1表格注册说明书和2025年4月16日提交的20-F表格中的"风险因素"和"关于前瞻性陈述及行业数据的特别说明"章节、2019年10月16日提交的首次发行上市招股书中的“前瞻性声明”、“风险因素”章节，以及我们不时向SEC或HKEX提交的其他文件。这些因素可能导致实际业绩、运营水平、经营成果或成就与前瞻性陈述中明示或暗示的信息存在重大差异。本前瞻性声明中的陈述不构成公司管理层的利润预测。因此，该等前瞻性陈述不应被视为对未来事件的预测。本新闻稿中的前瞻性陈述仅基于亚盛医药当前对未来发展及其潜在影响的预期和判断，且仅代表截至陈述发表之日的观点。无论出现新信息、未来事件或其他情况，亚盛医药均无义务更新或修订任何前瞻性陈述。本文仅作为亚盛医药新闻发布，用于披露公司最新业务进展，并非广告用途。文中所涉药物信息仅供医疗卫生专业人士参考，不构成对任何药物的商业推广或对诊疗方案的推荐。如您想了解更多疾病或药物信息，请咨询医疗卫生专业人士。