Gemogenovatucel-T

Ascentage Pharma (NASDAQ: AAPG; HKEX: 6855) today announced that results from two clinical studies of the Bcl-2 selective inhibitor lisaftoclax (APG-2575) and the MDM2-p53 inhibitor alrizomadlin (APG-115), two key drug candidates in the company’s apoptosis-targeted pipeline, have been selected for presentations at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. These presentations will include an oral report featuring updated results from a Phase Ib/II study of a lisaftoclax combination regimen in patients with myeloid malignancies.The ASCO Annual Meeting showcases the most cutting-edge research in clinical oncology and state-of-the-art advanced cancer therapies and is the world’s most influential and prominent scientific gathering of the clinical oncology community, bringing together more than 40,000 oncology professionals from across the globe. This year’s ASCO Annual Meeting will take place both online and in-person at McCormick Place, Chicago, IL, the United States, on May 30–June 3 (local time).Dr. Yifan ZhaiChief Medical Officer of Ascentage Pharma“We are honored to return to the ASCO Annual Meeting for the eighth consecutive year to present the latest data on our novel assets and highlight the strength of our clinical development and global innovation. We look forward to sharing an oral presentation on a lisaftoclax combination regimen in patients with treatment-naïve or prior venetoclax-exposed myeloid malignancies and a readout on alrizomadlin in patients with advanced adenoid cystic carcinoma or other solid tumors. These presentations reflect our deep focus on advancing global clinical development of our key assets in order to bring more treatment options to patients as soon as possible.”The clinical studies to be presented at this year’s ASCO Annual Meeting are as follows：Phase 1b/2 study of lisaftoclax (APG-2575) combined with azacitidine (AZA) in patients (pts) with treatment-naïve (TN) or prior venetoclax (VEN)-exposed myeloid malignanciesAbstract#: 6505Format: Oral PresentationSession Title: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and AllotransplantDate and Time: Monday June 2, 2025, 3:00 PM-6:00 PM, Central Time (Tuesday June 3, 2025, 4:00 AM-7:00 AM, Beijing Time)Principal Authors: Michael Francis Leahy, MBChB, Royal Perth Hospital, Australia; Shaun Fleming, MBBS(Hons), PhD, The Alfred Hospital & Australian Centre for Blood Diseases, Australia; Patricia Kropf, MD, Novant Health Cancer Institute, United States, et al.A phase 2 study of novel MDM2 inhibitor alrizomadlin (APG-115) with or without toripalimab in patients (pts) with advanced adenoid cystic carcinoma (ACC) or other solid tumors.Abstract#: 6102Format: Poster PresentationSession Title: Head and Neck CancerDate and Time: Monday June 2, 2025, 9:00 AM-12:00 PM, Central Time (Monday June 2, 2025, 10:00 PM – 1:00 AM the next day, Beijing Time)Principal Authors: Ye Guo, MD, Department of Medical Oncology, Shanghai East Hospital, China; Ning Li, MD, Chinese Academy of Medical Sciences Cancer Hospital, China; Xing Zhang, MD, Melanoma and Sarcoma Medical Oncology Unit, Sun Yat-sen University Cancer Center, China; Meiyu Fang, MD, Department of Rare Cancer & Head and Neck Medical Oncology, Cancer Hospital of the University of Chinese Academy of Sciences, China; Shuhang Wang, MD, Chinese Academy of Medical Sciences Cancer Hospital, China, et al.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 approved in China, with all of its approved indications included in the China National Reimbursement Drug List (NRDL). Meanwhile, a New Drug Application (NDA) for another one of Ascentage Pharmas key drug candidates, the novel Bcl-2 selective inhibitor lisaftoclax (APG-2575), has been accepted and granted a Priority Review designation by the China Center for Drug Evaluation.To date, Ascentage Pharma has obtained a total of 16 Orphan Drug Designations from the US FDA and 1 Orphan Designation from the European Medicines Agency of the European Union 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, Merck, AstraZeneca, Pfizer and Innovent; and research and development relationships with leading research institutions such as Mayo Clinic, Dana-Farber Cancer Institute, National Cancer Institute (NCI) 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 fulfill its mission of addressing unmet clinical needs in China and around the world for the benefit of more patients.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 final prospectus for its U.S. initial public offering, filed with the SEC on January 24, 2025 and the Form 20-F filed with the SEC on April 16, 2025, and other filings with the SEC that the Company made or makes from time to time, and with respect to non-U.S. investors only, 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 Stock Exchange of Hong Kong Limited 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 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.

点击“蓝字”关注我们编者按随着2型糖尿病（T2DM）人群的持续增长，生活方式干预成为糖尿病管理的重要手段。近年来，睡眠模式，尤其是“午睡”，越来越受到研究者关注。尽管午睡被普遍视为一种缓解疲劳、促进健康的习惯，最新研究却揭示出其在糖尿病人群中可能存在的双刃剑效应：一方面短时午睡可能带来认知与代谢的益处，另一方面过长的午睡则可能与胰岛素抵抗、糖尿病的发生乃至心血管不良事件密切相关。近期一项发表Diabetes Res Clin Pract杂志的研究结果表明[1]，经常白天小睡与糖尿病患者发生主要不良心血管事件（MACE）和死亡的风险显著增加有关，尤其是那些每天总睡眠时间超过10小时以及患有严重糖尿病的患者。午睡时长与T2DM发生风险呈J型曲线关系多项流行病学研究和荟萃分析一致指出，午睡时长与T2DM之间呈现非线性关联，表现为J型曲线关系。一项荟萃结果表明[2]，白天睡眠时长和T2DM发生风险之间呈J型曲线关系，较长的午睡时间（≥60分钟）与T2DM发生风险相关，而较短的午睡时间（<60分钟）则与T2DM的风险增加无明显相关性。国内一项大样本横断面研究显示[3]，较长时间的习惯性午睡与中国老年人群中空腹血糖受损（IFG）和糖尿病的发生风险相关 ，而较短的午睡持续时间（<30分钟）对IFG 和糖尿病的发生风险影响不明显，经过对年龄、性别、婚姻状况、教育水平、慢性疾病史、饮酒习惯、吸烟习惯、夜间睡眠时长、BMI及身体活动等多种因素的校正后，发现午睡时间≥90分钟仍与IFG及糖尿病有关联。机制方面，午睡时间过长可能打破生物昼夜节律，干扰葡萄糖代谢；同时，交感神经激活、慢性低度炎症状态及能量消耗减少等多重生理效应共同促成胰岛素抵抗状态的形成[4]。另有研究指出，午睡与较高的体重指数（BMI）和腰围正相关，而这两个因素本身就是T2DM的重要独立危险因子[5]。值得注意的是，午睡的代谢影响存在明显的人群差异。研究表明，午睡与T2DM的风险在女性，尤其是绝经后女性中更为显著。研究发现，在45~54岁女性中，午睡时间与糖尿病发病风险呈剂量依赖关系[6]。其发病机制或许与雌激素水平下降所导致的胰岛素抵抗加剧、睡眠质量下降以及情绪障碍等因素密切相关。此外，老年人因夜间睡眠质量下降更倾向于日间补觉，而这种“代偿性午睡”可能造成昼夜节律紊乱和睡眠片段化，加剧代谢紊乱[6]。在糖尿病管理中，对这类人群进行睡眠习惯的主动评估与干预，具有重要意义。午睡与糖尿病并发症风险：MACE与死亡率的上升趋势午睡不仅与T2DM的发病和控制有关，更值得关注的是它与糖尿病患者心血管不良事件及死亡率之间的关联。该项前瞻性研究纳入了来自英国生物样本库的21129例糖尿病患者，所有患者在基线时均未出现MACE和癌症[1]。研究者通过基线问卷收集了患者习惯性日间小睡和睡眠时长的数据。采用Cox比例风险回归模型评估日间小睡与MACE、全因死亡率和CVD特异性死亡率之间的关系。结果表明，在平均11.9年的随访中，共发现5611例MACE病例、3854例全因死亡和1839例CVD死亡，与“从不/很少午睡”者相比，“经常午睡”者的MACE风险增加39%，卒中风险增加57%，心肌梗死风险增加44%，心力衰竭风险增加33%，全因死亡风险增加28%，CVD死亡风险增加33%。进一步分析发现，这种风险在某些特定人群中更为显著，例如夜间睡眠时长≥10小时、T2DM病程≥5年、HbA1c≥7%、合并糖尿病并发症或使用胰岛素治疗者。联合分析表明，午睡时间过长和糖尿病病情严重者之间存在协同作用，这在心肌梗死、心力衰竭等终点事件中尤为突出。值得注意的是，该研究对多种混杂因素进行了调整，包括BMI、饮食习惯、社会经济状态、慢性炎症指标（如CRP）等，因此结果的稳健性较强。这也是目前为数不多的大样本、长随访、糖尿病人群专属的睡眠研究之一，为临床提供了有价值的实践指导。潜在机制探析：为何午睡可能对T2DM患者心血管“有害”？在T2DM人群中，日间午睡时间延长可能通过多重机制促进MACE和死亡风险的上升[1]。首先，午睡行为与24小时血压变异性（BPV）增加密切相关，BPV升高已被证实是卒中和高血压的重要预测因子。其次，习惯性午睡者往往伴有更高水平的胰岛素抵抗与HbA1c，午睡时间的延长也与代谢综合征发生率升高显著相关。此外，午睡可能通过促进动脉粥样硬化的进展，加剧冠心病、心力衰竭等心血管疾病的风险。老年T2DM人群中常见的“虚弱状态”也与频繁午睡呈正相关，该状态本身即为CVD及死亡的重要独立危险因素。同时，午睡者心律失常（如房颤、室性早搏）发生率升高，进一步增加卒中及心源性猝死风险。研究亦发现，午睡行为与腹型肥胖显著相关，而腹部脂肪沉积是T2DM与心血管疾病的共同代谢基础。最后，午睡后的急性体位改变可能诱导血小板聚集与促凝状态上升，增加血栓形成倾向。上述机制可能协同作用，解释了T2DM患者中午睡行为与MACE及全因死亡风险显著增加之间的因果联系。糖尿病患者的午睡建议：从“睡多久”到“睡得对”在T2DM患者中，应对午睡行为进行规范管理与个体化指导，以减少其可能带来的心血管不良结局风险[1,6]。首先，应合理控制午睡的频率和时间，避免形成每日或经常性午睡的习惯。若确有午睡需求，推荐将时间限制在30分钟以内，尽量避免超过1小时，尤其是在夜间睡眠时间已较长（≥10小时）的人群中更需注意。其次，午睡干预应结合患者的个体特征，如年龄、性别、糖尿病病程、血糖控制水平以及是否存在并发症等，制定差异化的行为管理策略。例如，对于糖尿病病程较长、HbA1c水平较高或使用胰岛素治疗的患者，其午睡行为与主要MACE风险的关联更为显著，建议在随访中加强监测和干预。此外，应从整体上优化患者的睡眠结构。应优先改善夜间睡眠质量，避免日间过度小睡以代偿夜间睡眠不足。研究发现，过长的总睡眠时间（夜间+午睡）与MACE和全因死亡风险呈正相关，因此对睡眠的干预应立足于24小时的整体睡眠模式评估。同时，午睡行为也应纳入糖尿病患者日常随访与生活方式干预的范畴，临床医务人员评估饮食、运动、用药依从性时，还应主动询问患者日间睡眠情况，助其建立健康作息。最后，对于高风险人群，特别是老年人、绝经后女性以及夜间睡眠时间较长者，应加强午睡相关知识的健康宣教，提升其对午睡行为潜在代谢与心血管风险的认知，以促进其自我管理能力的提升。总的来看，科学、适度、个体化的午睡管理，应成为T2DM患者生活方式干预中的一项重要内容。结语午睡原本是一种简单、广泛存在的生活行为，但在糖尿病及心血管高风险人群中，却可能蕴含着不容忽视的代谢隐患。这项队列研究表明，习惯性白天小睡与T2DM患者较高的MACE及死亡风险显著相关，尤其在睡眠超10小时且有严重糖尿病并发症的患者中。这一发现为糖尿病管理政策的制定提供了重要参考，表明减少小睡的时长与频率可能有助于降低糖尿病患者的心血管风险。参考文献（上下滑动可查看）1.Yang XH, et al.Diabetes Res Clin Pract. 2025;222:1120672.YAMADA T,SHOJIMA N,YAMAUCHI T,et al. Scientific Report, 2016,6:38075.3.FANG W,LI Z,WU L, et al.Sleep Medicine,2013,14(10):950-954.4.Liu R, et al. Sleep Med. 2018;45:106–113.5.Papandreou C,et al. J Clin Med. 2019;8(7):1053.6.魏晓艺，等。午睡和糖尿病的关系研究进展。护理研究，2020,34(16): 2920-2923声明：本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。最新《国际糖尿病》读者专属微信交流群建好了，快快加入吧！扫描左边《国际糖尿病》小助手二维码（微信号：guojitnb），回复“国际糖尿病读者”，ta会尽快拉您入群滴！（来源：《国际糖尿病》编辑部）版权声明版权属《国际糖尿病》所有。欢迎个人转发分享。其他任何媒体、网站未经授权，禁止转载。