Lisaftoclax

亚盛医药（纳斯达克代码：AAPG；香港联交所代码：6855）今日宣布，公司原创1类新药Bcl-2抑制剂利生妥®（通用名：利沙托克拉，研发代号：APG-2575）获国家药品监督管理局（NMPA）药品审评中心（CDE）纳入“突破性治疗品种”名单，用于联合阿可替尼治疗成人初治慢性淋巴细胞白血病/小淋巴细胞淋巴瘤（CLL/SLL）成人患者。   突破性治疗品种 通常被授予用于防治严重危及生命或者严重影响生存质量的疾病、且尚无有效防治手段或者与现有治疗手段相比有足够证据表明具有明显临床优势的创新药或者改良型新药等。对于被纳入突破性治疗品种的药物，CDE将优先配置资源进行沟通交流，加强指导并促进药物研发进程；申请人经评估符合相关条件的，也可以在申请产品上市许可时提出附条件批准申请和优先审评审批申请。突破性治疗品种的审评政策将加快具有重大临床价值、临床急需的创新药或者改良型新药的开发与上市。 CLL/SLL是一种成熟B淋巴细胞克隆增殖性肿瘤，多发于老年患者，全球每年新增病例超过10万例1。近年来在中国的发病率呈上升趋势，且部分患者具有发病年龄低、肿瘤侵袭性高等特点2。 在CLL/SLL治疗领域，免疫化疗和BTK抑制剂已作为一线治疗选择并获得了较好的反应率和生存结局，但仍存在一定局限性。对于部分患者，特别是一些伴有del(17p)/TP53突变、复杂核型、IGHV无突变等高危因素的患者，免疫化疗疗效有限，即便是BTK抑制剂单药治疗，也面临缓解深度不足、长期安全性不够理想的问题，且该方案要求持续治疗，一旦治疗失败，患者后续可选择的再治疗手段十分有限，且效果不佳。因此，临床急需开发固定疗程联合治疗策略，在提高疗效及缓解深度的同时减少不良反应发生。目前国内存在较大的、未被满足的临床需求。   利生妥®是亚盛医药自主研发的新型口服Bcl-2选择性抑制剂，于2025年7月在中国获批上市，用于既往经过至少一种含BTK抑制剂在内的系统治疗的成人CLL/SLL患者。利生妥®为中国首个获批上市的国产原创Bcl-2抑制剂，也是全球首个上市的单药治疗BTK抑制剂经治CLL/SLL的Bcl-2抑制剂。目前，亚盛医药正在开展利生妥®的四项全球注册III期临床研究。其中一项全球注册III期临床研究（GLORA-2），旨在探索利生妥®联合阿可替尼一线治疗CLL/SLL的临床潜力。 翟一帆博士 亚盛医药首席医学官 此次利生妥®纳入突破性治疗品种，是对该联合方案在初治CLL/SLL领域临床潜力的肯定，也印证了这一临床需求的迫切性。我们将继续努力，加速推进利生妥®相关适应症的全球临床开发，早日惠及更多患者。 参考资料 Yao, Y., Lin, X., Li, F., et al. The global burden and attributable risk factors of chronic lymphocytic leukemia in 204 countries and territories from 1990 to 2019: analysis based on the global burden of disease study 2019. Biomed Eng Online. 2022 Jan 11;21(1):4. DOI: 10.1186/s12938-021-00973-6 刘澎. 复旦大学附属中山医院慢性淋巴细胞白血病/小淋巴细胞淋巴瘤诊疗规范（2018）[J].中国临床医学, 2018, 25(1): 157-160. DOI: 10.12015/j. issn.1008-6358.2018.20180 关于亚盛医药 亚盛医药（纳斯达克代码：AAPG；香港联交所代码：6855）是一家综合性的全球生物医药企业，致力于研发、生产和商业化创新药，以解决肿瘤领域全球患者尚未满足的临床需求。公司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以及蛋白降解剂。 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，已获批用于治疗伴有T315I突变的慢性髓细胞白血病慢性期（CML-CP）和加速期（CML-AP）患者，以及对一代和二代TKI耐药和/或不耐受的CML-CP成年患者。该药物所有获批适应症均已被纳入中国国家医保药品目录（NRDL）。目前，亚盛医药正在开展耐立克®三项全球注册III期临床研究，分别为：获美国FDA和欧洲EMA许可的评估耐立克®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POLARIS-1研究；获美国FDA和欧洲EMA许可的评估耐立克®治疗经治CML-CP成年患者的POLARIS-2研究；评估耐立克®治疗SDH-缺陷型GIST患者的POLARIS-3研究。 公司另一重磅品种利生妥®是一款用于治疗多种血液系统恶性肿瘤的新型Bcl-2抑制剂。利生妥®已获中国国家药品监督管理局（NMPA）批准，用于治疗既往至少接受过一种包括布鲁顿酪氨酸激酶（BTK）抑制剂在内的系统治疗的成人慢性淋巴细胞白血病/小淋巴细胞淋巴瘤（CLL/SLL）患者。目前，亚盛医药正在开展利生妥®四项全球注册III期临床研究，分别为：获美国FDA和欧洲EMA许可的评估利生妥®联合BTK抑制剂治疗既往接受BTK抑制剂治疗超过12个月且应答不佳的CLL/SLL患者的GLORA研究；评估利生妥®一线治疗初治CLL/SLL患者的GLORA-2研究；评估利生妥®一线治疗新诊断老年或不耐受的AML患者的GLORA-3研究；以及获美国FDA和欧洲EMA许可的评估利生妥®一线治疗新诊断中高危MDS患者的GLORA-4研究。 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、阿斯利康、默沙东、辉瑞、信达等众多领先的生物制药公司达成全球合作，同时与丹娜法伯癌症研究院、梅奥医学中心、美国国家癌症研究所和密西根大学等学术机构建立研发合作关系。如需了解更多信息，请访问 https://ascentage.com/ 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2026年4月29日提交的20-F表格中截止2025年12月31日的年度报告中的”风险因素”和”关于前瞻性声明的警示声明”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。

Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855) announced today that lisaftoclax (APG-2575), the Company’s novel Bcl-2 inhibitor, has been granted a Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA), in combination with acalabrutinib, for the treatment of treatment-naïve adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Breakthrough Therapy Designation BTDs are granted to innovative drugs or modified new drugs intended for the prevention or treatment of serious, life-threatening diseases or conditions that severely impair quality of life, for which there is no effective treatment, or where sufficient existing evidence demonstrates significant clinical advantages over currently available treatment options. Drug candidates that are granted BTDs receive priority from the CDE for communications and development guidance to accelerate drug development. Furthermore, if the applicant meets the relevant conditions after evaluation, it may apply for Priority Review status and conditional approval when submitting a New Drug Application (NDA) in China. Overall, the BTD pathway is designed to accelerate the development and review of innovative drugs and modified new drugs that offer significant clinical value or address urgent unmet clinical needs. CLL/SLL is a clonal proliferative malignancy of B lymphocytes that predominantly affects older adults, with more than 100,000 new cases worldwide each year.1 In recent years, the incidence of CLL/SLL in China has been increasing, with some patients presenting at a younger age and with more aggressive disease.2 In CLL/SLL, immunochemotherapy and BTK inhibitors have been used as first-line treatment options and have achieved favorable response rates and survival outcomes, although certain limitations remain. Immunochemotherapy has limited efficacy in some patients, particularly in those with high-risk features such as del(17p)/TP53 mutations, complex karyotypes, and unmutated IGHV. BTK inhibitor monotherapy, which is an approved standard of care treatment, also has limitations, including insufficient depth of response and concerns regarding long-term safety, and requires continuous treatment. Once treatment fails, patients have very limited subsequent treatment options, with generally poor outcomes. Therefore, there remains an urgent clinical need for fixed-duration combination strategies that improve efficacy and depth of response while reducing adverse events. Lisaftoclax is a novel, oral, selective Bcl-2 inhibitor developed by Ascentage Pharma. In July 2025, lisaftoclax was approved in China for the treatment of adult patients with CLL/SLL who had previously received at least one systemic therapy including a BTK inhibitor. Lisaftoclax is the first China-developed Bcl-2 inhibitor approved in China and the second Bcl-2 inhibitor approved globally. Ascentage Pharma is currently conducting four global registrational Phase III trials of lisaftoclax. One of these studies, GLORA-2, is a global registrational Phase III trial evaluating the clinical potential of lisaftoclax in combination with acalabrutinib as a first-line treatment for CLL/SLL. Yifan Zhai, M.D., Ph.D. Chief Medical Officer of Ascentage Pharma This BTD recognizes the clinical potential of Lisaftoclax in combination with acalabrutinib for patients with treatment-naïve CLL/SLL and the urgent unmet need in this setting. Moving forward, we are continuing to accelerate the global clinical development of lisaftoclax across relevant indications and are striving to bring this treatment to more patients as quickly as possible. References Yao, Y., Lin, X., Li, F., et al. The global burden and attributable risk factors of chronic lymphocytic leukemia in 204 countries and territories from 1990 to 2019: analysis based on the global burden of disease study 2019. Biomed Eng Online. 2022 Jan 11;21(1):4. DOI: 10.1186/s12938-021-00973-6 刘澎. 复旦大学附属中山医院慢性淋巴细胞白血病/小淋巴细胞淋巴瘤诊疗规范（2018）[J].中国临床医学, 2018, 25(1): 157-160. DOI: 10.12015/j. issn.1008-6358.2018.20180 In the United States, lisaftoclax (APG-2575) is an investigational compound and has not been approved by the US FDA. The combination of lisaftoclax and acalabrutinib is investigational and has not been approved in any market. About Ascentage Pharma Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855) (“Ascentage Pharma” or the “Company”) is 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. The Company has built a rich pipeline of innovative drug products and candidates that include inhibitors targeting key proteins in the apoptotic pathway, such as Bcl-2 and MDM2-p53, next-generation kinase inhibitors, and protein degraders. The Company’s first approved product, 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). Ascentage Pharma is currently conducting an FDA- and EMA-cleared registrational Phase III trial, called POLARIS-2, of olverembatinib for CML, as well as FDA- and EMA-cleared registrational Phase III trials for patients with newly diagnosed Ph+ ALL, called POLARIS-1, and SDH-deficient GIST patients, called POLARIS-3. The Company’s second approved product, lisaftoclax, is a novel Bcl-2 inhibitor for the treatment of various hematologic malignancies. Lisaftoclax has been approved by China’s National Medical Products Administration (NMPA) for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received at least one systemic therapy including Bruton’s tyrosine kinase (BTK) inhibitors. The Company is currently conducting four global registrational Phase III trials: the FDA- and EMA- cleared GLORA study of lisaftoclax in combination with BTK inhibitors in patients with CLL/SLL previously treated with BTK inhibitors for more than 12 months with suboptimal response; the GLORA-2 study in patients with newly diagnosed CLL/SLL; the GLORA-3 study in newly diagnosed, elderly and unfit patients with AML; and the FDA- and EMA-cleared GLORA-4 study in patients with newly diagnosed higher risk 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 Statements This 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 “Cautionary note regarding forward-looking statements” in its Annual Report on Form 20-F for the year ended December 31, 2025, filed with the SEC on April 29, 2026, 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 where the Company’s ordinary shares are listed it has made or it makes 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 press release 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.