Olverembatinib

Ascentage Pharma (NASDAQ: AAPG; HKEX: 6855) today announced that two of its proprietary novel drugs have been included in the 2025 Chinese Society of Clinical Oncology (CSCO) Guidelines.Lisaftoclax (APG-2575), the company’s investigational novel oral Bcl-2 selective inhibitor, received its first recommendation in the CSCO Guidelines for the Diagnosis and Treatment of Lymphoid Malignancies.Olverembatinib, the company’s novel next-generation tyrosine kinase inhibitor (TKI), received an upgraded recommendation in the CSCO Guidelines for the Diagnosis and Treatment of Leukemias in Children and Adolescent, and retained its recommendations in the CSCO Guidelines for the Diagnosis and Treatment of Hematological Malignancies.Bcl-2 inhibitor lisaftoclax (APG-2575) receives its first CSCO Guidelines recommendationAs the world’s second Bcl-2 inhibitor to submit a New Drug Application (NDA) and the first China-developed Bcl-2 inhibitor to submit an NDA and receive Priority Review designation in China, lisaftoclax (APG-2575), supported by its robust clinical data, has been recommended in the CSCO 2025 Guidelines for the Diagnosis and Treatment of Lymphoid Malignancies, as a monotherapy for the treatment of patients with relapsed/refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). This is the first CSCO Guidelines recommendation for lisaftoclax (APG-2575), making it the only China-developed Bcl-2 inhibitor recommended in the CSCO Guidelines. This marks a milestone achieved by Ascentage Pharma in advancing the development of this innovative drug to bring meaningful benefit to patients as well as a major breakthrough in the field of hematological malignancies.Prof. Jun MaHarbin Institute of Hematology and OncologyThese CSCO Guidelines recommendations for lisaftoclax (APG-2575) indicate recognition of the drug’s robust data by a top medical association in China. In the data, lisaftoclax (APG-2575) monotherapy showed a high overall response rate and a fast onset of action that can enable rapid disease control. Moreover, the incidence of tumor-lysis syndrome in patients treated with lisaftoclax (APG-2575) was far lower than was shown in the early data of other Bcl-2 inhibitors, highlighting a favorable tolerability profile that could potentially change the clinical risk management in CLL/SLL. We look forward to lisaftoclax (APG-2575)’s approval in China through the Priority Review pathway, which will bring this innovative therapeutic to patients in need.In November 2024, the NDA for lisaftoclax (APG-2575) monotherapy for the treatment of R/R CLL/SLL was accepted and granted the Priority Review designation by the Center for Drug Evaluation (CDE) of China National Medical Product Administration (NMPA). Globally, lisaftoclax (APG-2575) is being evaluated in two registrational Phase III studies for the treatment of CLL/SLL, including an international registrational Phase III study of lisaftoclax (APG-2575) combined with a BTK inhibitor in patients with CLL/SLL who had previously received BTK inhibitors (the GLORA Trial); and an international registrational Phase III study evaluating lisaftoclax (APG-2575) combined with acalabrutinib, versus immunochemotherapy in treatment-naïve patients with CLL/SLL (the GLORA-2 Trial). These studies were designed to further broaden the treatment window of lisaftoclax (APG-2575).The first China-approved BCR-ABL inhibitor olverembatinib receives an upgraded recommendation in the CSCO GuidelinesIn the CSCO 2025 Guidelines for the Diagnosis and Treatment of Leukemias in Children and Adolescent, the recommendation for olverembatinib for the treatment of children with Ph+ ALL who harbor the T315I BCR-ABL1 kinase domain mutation was upgraded to Level I, thus opening a whole new chapter for olverembatinib in pediatric hematology.Prof. Xiaofan Zhuthe Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical SciencesAs a China-developed third-generation TKI, olverembatinib has achieved a major breakthrough in the treatment of children with Ph+ ALL. In the CSCO 2025 Guidelines, the recommendation for olverembatinib in the treatment of patients with Ph+ ALL who harbor the T315I BCR-ABL1 kinase domain mutation or are intolerant to dasatinib has been upgraded to Level I, an update that reflects the drug’s promising clinical utility. Looking ahead, we hope to see more studies further evaluating olverembatinib’s long-term efficacy and searching for more optimized combinations of the drug that can bring greater hope for curative care to children with Ph+ ALL.In the CSCO 2025 Guidelines for the Diagnosis and Treatment of Hematological Malignancies, olverembatinib retained a number of major recommendations which solidified the drug’s vital role in the treatment of CML. In chronic-phase CML (CML-CP), olverembatinib retained a Level I recommendation for the treatment of all lines of T315I mutant CML-CP; a Level I recommendation for the second-line treatment of patients who had failed first-line treatment with nilotinib or dasatinib and the third-line treatment of patients who are intolerant to and/or failed on two or more TKIs. In progressive-phase CML, olverembatinib retained a Level I recommendation as a treatment option for patients with T315I mutant CML-AP, and those who progressed from CML-CP to CML-AP, or from CML-CP/AP to CML-BP. Moreover, the CSCO 2025 Guidelines emphasized olverembatinib’s advantages in addressing a range of BCR::ABL1 mutations (including T315I, V299L, F317L/V/I/C, T315A, Y253H, E255K/V, and F359C/V/I) and any other mutation (including complex/compound mutations).In Ph+ ALL, olverembatinib has retained its Level I recommendation for response induction and the treatment of relapsed/refractory patients.Olverembatinib is a novel drug developed by Ascentage Pharma with support from China’s National Major New Drug Development Program. As the first approved third-generation BCR-ABL inhibitor in China, olverembatinib is indicated for the treatment of adult patients with TKI-resistant CML-CP or -AP harboring the T315I mutation; and adult patients with CML-CP resistant to and/or intolerant of first- and second-generation TKIs. Furthermore, all approved indications of olverembatinib have been included in the China National Reimbursement Drug List (NRDL) which has greatly improved the drug’s accessibility to patients. Olverembatinib is being jointly commercialized in China by Ascentage Pharma and Innovent Biologics.Dr. Yifan ZhaiChief Medical Officer of Ascentage PharmaCSCO Guidelines are among the most recognized clinical guidelines in China, providing crucial guidance to Chinese physicians on the diagnosis and treatment of malignancies. The recommendations for both olverembatinib and lisaftoclax (APG-2575) in the updated guidelines are a testament to our strong and innovative pipeline. In particular, the CSCO Guidelines’ very first recommendations for lisaftoclax (APG-2575), the second Bcl-2 inhibitor to reach NDA submission anywhere in the world, reflect the clinical experts’ forward-looking recognition of this innovative drug, providing much needed new guidance to clinical practices and the answer to a major treatment gap. Meanwhile, we are greatly encouraged by the Guidelines’ upgraded recommendation for olverembatinib in pediatric patients with ALL.In the future, we hope to see additional positive clinical data that can pave the way for upgraded recommendations for these two innovative drugs. We will continue to accelerate the clinical development and commercialization of our drug candidates for the benefit of more patients.*Lisaftoclax (APG-2575) and olverembatinib are investigational drugs and not yet approved in the US.About Ascentage PharmaAscentage Pharma is a global, integrated biopharmaceutical company engaged in discovering, developing and commercializing therapies to address global unmet medical needs primarily in hematological malignancies. Ascentage Pharma has been listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code 6855.HK since October 2019 and has also been listed on the Nasdaq Global Market under the ticker symbol “AAPG” since January 2025.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 TKIs that target kinase mutants emergent during cancer treatment. Ascentage Pharma is also the only company in the world with active clinical programs targeting all known key apoptosis regulators.Olverembatinib, one of the company’s lead assets, is already approved in China with all of its approved indications included into the China National Reimbursement Drug List (NRDL). Meanwhile, a New Drug Application (NDA) for another one of Ascentage Pharma’s key drug candidates, the novel Bcl-2 selective inhibitor lisaftoclax (APG-2575), has already been accepted and granted the Priority Review designation by the China CDE.To date, Ascentage Pharma has obtained a total of 16 ODDs from the US FDA and 1 Orphan Designation from the EMA of the EU for 4 of the company’s investigational drug candidates. 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; and research and development relationships with leading research institutions such as Dana-Farber Cancer Institute, Mayo Clinic, National Cancer Institute and the University of Michigan.The company has built a talented team with a wealth of global experience in the discovery and development of innovative drugs and fully functional commercial manufacturing and Sales & Marketing teams. One pivotal aim of Ascentage Pharma is to continuously strengthen its R&D capabilities and accelerate its clinical development programs, in order to fulfil its mission of addressing unmet clinical needs in China and around the world for the benefit of more patients.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.

2025年4月15日，中国上海——第31届全国肿瘤防治宣传周首日，全球领先的制药企业礼来制药和中国创新药企信达生物、和黄医药齐聚上海，共话本土医药创新发展，探索加速惠及中国肿瘤患者的新模式。二十载深耕，礼来是中国肿瘤创新发展坚定的参与者与同行者。与信达生物、和黄医药等本土创新生物医药企业逾十载深度合作，不仅成就了多款具有影响力的突破性创新药物的问世，更为中国肿瘤患者带来了生命希望与福祉，为“健康中国”建设贡献力量。中国药科大学附属上海高博肿瘤医院院长李进教授，礼来中国总裁兼总经理德赫兰女士，礼来全球高级副总裁、礼来中国药物开发及医学事务中心负责人王莉博士，信达生物创始人、董事会主席、首席执行官俞德超博士，和黄医药首席执行官兼首席科学官苏慰国博士，礼来全球副总裁、礼来中国药物开发及医学事务中心首席医学官迟海东博士，礼来中国副总裁、抗肿瘤事业部负责人尹航先生等嘉宾出席活动。二十载深耕助力中国肿瘤事业高质量发展中国是癌症负担最沉重的国家之一，国家癌症中心最新数据显示，2022年我国新发癌症病例达482.47万例，新增死亡病例达 257.42万例 。“健康中国”行动明确提出，到2030年我国总体癌症5年生存率不低于46.6% 。这一系列目标和数据彰显了国家对癌症防控的高度重视和对治疗方案创新的迫切需求。中国药科大学附属上海高博肿瘤医院院长李进教授指出：“近年来，中国在肿瘤领域的创新持续加速，涌现出越来越多具有国际影响力的成果。跨国企业与本土力量齐头并进的广泛投入，不仅加速了全球前沿多中心临床研究落地中国，也让创新疗法更快惠及患者。我们期待这种开放与合作持续深化，帮助中国患者第一时间受益于创新疗法，亦让世界看到中国创新力量的崛起。”肿瘤是礼来重要的战略治疗领域之一。20年来，礼来在肿瘤领域积极探索以创新驱动的多元化业务模式，聚焦靶向治疗、免疫治疗以及克服肿瘤耐药药物的研发，已在中国获批上市9款创新药物，涵盖乳腺癌、肺癌、消化道肿瘤、血液肿瘤等10大癌种 ，并与本土战略伙伴建立了一条覆盖临床研究、生产质量到商业运营的端到端合作价值链。礼来中国总裁兼总经理德赫兰女士表示：“在中国，肿瘤给无数患者和家庭带来了沉重的负担。我们深知，患者不仅需要新的治疗选择，也期待更好的生活质量。礼来始终致力于为中国患者提供高质量的创新药物，并努力让这些药物更快地惠及更多患者。礼来是长期主义的践行者，我们将继续坚定地参与本土创新生态的建设，希望与本土伙伴紧密合作，真正解决患者的未尽之需，为中国肿瘤防治事业及整个社会的发展创造价值。”  礼来全球高级副总裁、礼来中国药物开发及医学事务中心负责人王莉博士表示：“礼来在肿瘤治疗领域拥有深厚的研发积淀，我们深刻理解中国市场的独特性和肿瘤患者需求的多样性，致力于通过扎实、确凿的临床研究推动肿瘤治疗进步。目前，中国已被正式纳入礼来全球早期临床研究计划，实现与全球研发体系的无缝对接。礼来也在持续加快研发步伐，带来更多卓越的创新治疗方案，帮助广大患者延续生命、提高生活质量。”十余载砥砺共进赋能本土创新，惠泽患者礼来致力于成为中国医疗保健领域的重要战略伙伴，与信达生物、和黄医药等本土创新生物医药企业的战略合作已结出累累硕果，为中国患者带来了多款高质量、可负担的创新药物。达伯舒®（信迪利单抗注射液）是礼来和信达生物在中国共同开发的具有国际品质的创新PD-1抑制剂，双方以此为起点，已建立起一个由中国创新药企与全球制药巨头之间的全面战略合作，其范围涵盖新药研发、临床研究、生产质量和市场销售等。信达生物创始人、董事会主席、首席执行官俞德超博士表示：“信达生物致力于开发老百姓用得起的高质量生物药。十年来，我们与礼来不断深化互信，拓展合作领域和范围，以科学创新、造福患者为共同追求，将信达对于中国健康医疗产业的深刻理解与研发、生产以及商业化的综合能力，与礼来全球前沿的科学洞见和宝贵经验相结合，实现优势互补。未来我们将继续探索更加多元的合作模式，提升药物可及性与可负担性，力争让患者用得上、用得起更多比肩乃至超越国际水平的中国创新药。”爱优特®（呋喹替尼胶囊）是礼来中国肿瘤产品组合中首个获批的肿瘤靶向治疗药物。2013年10月礼来与和黄医药达成战略合作，共同开发呋喹替尼， 2018年呋喹替尼在中国获批上市，为晚期结直肠癌患者提供新的治疗选择。如今，呋喹替尼亦相继在包括美国、欧洲、日本等在内的全球主要市场获批上市。和黄医药首席执行官兼首席科学官苏慰国博士表示：“和黄医药自成立以来一直坚持‘自主创新’和‘全球同步’两大战略原则，以开放姿态拥抱并积极参与全球创新，是最早与礼来建立战略合作的本土药企之一。这段长期合作不仅孕育了我们引以为傲的创新成果，也验证了中国创新走向世界的可行性。和黄医药将致力于把本土创新带向国际舞台，实现更多‘中国新’到‘全球新’，为全球市场提供优质的‘中国方案’。”近年来，礼来加速推进肿瘤领域的战略布局，不断拓展创新版图。2023年，礼来成功收购Point Biopharma，获得全球领先的放射性配体疗法平台，2025年1月收购Scorpion Therapeutics获得其PI3Kα抑制剂相关项目。2024年10月，礼来在北京成立中国医学创新中心。2025年3月礼来中国首个创新加速平台 —— 礼来北京创新孵化器（Lilly Gateway Labs, LGL）正式投入运营，致力于识别并支持那些处于早期研发阶段的高潜力生物技术企业。凭借这一系列前瞻性举措，礼来正躬身入局，积极推动肿瘤精准诊疗新时代的加速到来。关于信达生物- 滑动查看更多介绍 -“始于信，达于行”，开发出老百姓用得起的高质量生物药，是信达生物的使命和目标。信达生物成立于2011年，致力于研发、生产和销售肿瘤、自身免疫、代谢、眼科等重大疾病领域的创新药物，让我们的工作惠及更多的生命。公司已有15个产品获得批准上市，它们分别是信迪利单抗注射液（达伯舒®），贝伐珠单抗注射液（达攸同®），阿达木单抗注射液（苏立信®），利妥昔单抗注射液（达伯华®），佩米替尼片（达伯坦®），奥雷巴替尼片（耐立克®）， 雷莫西尤单抗注射液（希冉择®），塞普替尼胶囊（睿妥®），伊基奥仑赛注射液（福可苏®），托莱西单抗注射液（信必乐®），氟泽雷塞片（达伯特®），匹妥布替尼片(捷帕力®)，己二酸他雷替尼胶囊（达伯乐®），利厄替尼片（奥壹新®）和替妥尤单抗N01注射液（信必敏®）。目前，同时还有3个品种在NMPA审评中，5个新药分子进入III期或关键性临床研究，另外还有15个新药品种已进入临床研究。公司已与礼来、罗氏、赛诺菲、Adimab、Incyte和MD Anderson 癌症中心等国际合作方达成30多项战略合作。信达生物在不断自研创新药物、谋求自身发展的同时，秉承经济建设以人民为中心的发展思想。多年来，始终心怀科学善念，坚守“以患者为中心”，心系患者并关注患者家庭，积极履行社会责任。公司陆续发起、参与了多项药品公益援助项目，让越来越多的患者能够得益于生命科学的进步，买得到、用得起高质量的生物药。截至目前，信达生物患者援助项目已惠及20余万普通患者，药物捐赠总价值36亿元人民币。信达生物希望和大家一起努力，提高中国生物制药产业的发展水平，以满足百姓用药可及性和人民对生命健康美好愿望的追求。详情请访问公司网站：www.innoventbio.com或公司领英账号：Innovent Biologics。关于礼来制药- 滑动查看更多介绍 -礼来制药是一家致力于通过科学创新改善人类健康水平，惠及全球患者的医药公司。作为医疗健康行业的领军者，礼来制药拥有近150年的历史。今天，我们的药物已帮助全球数千万人。运用生物技术、化学和基因医学的力量，我们的科学家正在积极推动新的医学进展，以应对严峻的全球健康挑战。重新定义糖尿病与肥胖疗法，减少肥胖对人体的长期影响；助力阿尔茨海默病的防治行动；为一系列威胁人类健康的免疫性疾病提供解决方案；以及将难以治愈的癌症转变为可控的疾病。礼来制药迈向健康世界的每一步，都源自于我们“致力于让数百万患者生活得更美好”的信念。这包括致力于解决全球多重挑战的创新临床试验，同时确保药物的可及性和可负担性。如果需要了解更多关于礼来制药的信息，请登录：www.lilly.com。关于商标和商品名- 滑动查看更多介绍 -本文中提及的所有商标或商品名称均为礼来制药公司所有，若提及其他公司的商标或商品名称，其所有权则归各自所有者所有。为便于阅读，本文中提及的商标和商品名未标注®和™符号，但这并不意味着礼来制药或（在适用情况下）其他各自所有者不会在适用法律允许的最大范围内主张对这些商标和商品名的权利。我们使用或展示其他公司的商标和商品名，并非暗示与这些公司存在任何关系或意味获得这些公司的背书或赞助。关于礼来制药和信达生物的战略合作 - 滑动查看更多介绍 -礼来制药与信达生物拥有长期的战略合作关系，双方已建立起一个由中国创新药企与全球制药巨头之间的全面战略合作，其范围涵盖新药研发，临床研究，生产质量和市场销售等，旨在加速并积极推进创新药物惠及更多全球患者。2015年3月，双方达成了一项生物技术药物开发合作，在中国共同开发和商业化包括达伯舒®（信迪利单抗注射液）在内的肿瘤药物，该合作亦是迄今为止中国生物制药企业与跨国药企之间最大的合作之一。2015年10月，双方宣布再次拓展已建立的药物开发合作，增加三个新型肿瘤治疗抗体。2019年8月，双方合作扩展至糖尿病及代谢领域，信达生物获授权在中国开发和商业化礼来的一个潜在全球领先新型临床阶段GCG/GLP-1药物。2020年8月，礼来制药与信达生物宣布扩大信迪利单抗的战略合作。2022年3月，礼来制药宣布深化与信达生物在肿瘤领域的合作，礼来授予信达生物希冉择®（雷莫西尤单抗注射液）和睿妥®（塞普替尼胶囊）在中国大陆获批后独家商业化权利，以及授予信达生物享有捷帕力®（匹妥布替尼片）未来在中国大陆商业化权利的优先谈判权。2024年12月，礼来制药与信达生物就捷帕力®（匹妥布替尼片）在中国大陆的商业化达成合作授权。关于礼来制药与和黄医药的战略合作- 滑动查看更多介绍 -礼来制药与和黄医药的合作渊源起始于2007年，双方缔结药品开发合作伙伴关系。2013年，礼来与和黄医药达成战略合作协议，共同致力于呋喹替尼在中国的开发和销售。2018年，爱优特®（呋喹替尼胶囊）获中国国家药监局批准用于治疗转移性结直肠癌。 参考文献：1.Han B, Zheng R, Zeng H, Wang S, Sun K, Chen R, Li L, Wei W, He J. Cancer incidence and mortality in China, 2022. J Natl Cancer Cent. 2024 Feb 2;4(1):47-53. doi: 10.1016/j.jncc.2024.01.006. PMID: 39036382; PMCID: PMC11256708.2.《健康中国行动—癌症防治行动实施方案（2023—2030年）》3. 阿贝西利片说明书；信迪利单抗注射液说明书；呋喹替尼胶囊说明书；塞普替尼胶囊说明书；匹妥布替尼片说明书；雷莫西尤单抗注射液说明书；利妥昔单抗注射液说明书；注射用培美曲塞二钠说明书；注射用盐酸吉西他滨说明书