A Global Multicenter, Double-blind, Randomized, Registrational Phase 3 Study of Lisaftoclax (APG-2575) in Combination With Azacitidine (AZA) in Patients With Newly Diagnosed Higher Risk Myelodysplastic Syndrome (HR-MDS) (GLORA-4).

A global multicenter, randomized, double-blind, placebo-controlled, pivotal phase III study. To evaluate overall survival (OS) of Lisaftoclax (APG-2575) combined with azacitidine (AZA) vs. placebo combined with azacitidine in newly diagnosed patients with HR-MDS.

开始日期2025-01-22

申办/合作机构

Ascentage Pharma Group, Inc.

NCT06182969

/ Recruiting临床1/2期

A Randomized, Double-blind, Placebo-controlled Phase I/II Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of APG-2575 in Patients with Mild-to-moderate Systemic Lupus Erythematosus.

To evaluate the safety, tolerability, pharmacokinetics and pharmacokinetics of multi-dose APG-2575 in mild-to-moderate systemic lupus erythematosus (SLE).

开始日期2024-08-09

申办/合作机构

Ascentage Pharma Group, Inc.

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100 项与力胜克拉相关的专利（医药）

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项与力胜克拉相关的文献（医药）

2023-07-05·Clinical cancer research : an official journal of the American Association for Cancer Research

Novel BCL-2 Inhibitor Lisaftoclax in Relapsed or Refractory Chronic Lymphocytic Leukemia and Other Hematologic Malignancies: First-in-Human Open-Label Trial.

Article

作者: Ailawadhi, Sikander ; Ahmad, Mohammad ; Davids, Matthew S ; Glass, Laura ; Yang, Dajun ; Chen, Zi ; Huang, Bo ; Liang, Eric ; Wang, Hengbang ; Men, Lichuang ; Li, Mingyu ; He, Zhicong ; Mekala, Divya J ; Collins, Mary C ; Parrondo, Ricardo ; Zhai, Yifan ; Yannakou, Costas K ; Fu, Lei Tommy ; Lasica, Masa ; Paulus, Aneel ; Chanan-Khan, Asher

PURPOSE:

This global phase I trial investigated the safety, efficacy, pharmacokinetics, and pharmacodynamics of lisaftoclax (APG-2575), a novel, orally active, potent selective B-cell lymphoma 2 (BCL-2) inhibitor, in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (R/R CLL/SLL) and other hematologic malignancies (HMs).

PATIENTS AND METHODS:

Maximum tolerated dose (MTD) and recommended phase II dose were evaluated. Outcome measures were safety and tolerability (primary) and pharmacokinetic variables and antitumor effects (secondary). Pharmacodynamics in patient tumor cells were explored.

RESULTS:

Among 52 patients receiving lisaftoclax, MTD was not reached. Treatment-emergent adverse events (TEAEs) included diarrhea (48.1%), fatigue (34.6%), nausea (30.8%), anemia and thrombocytopenia (28.8% each), neutropenia (26.9%), constipation (25.0%), vomiting (23.1%), headache (21.2%), peripheral edema and hypokalemia (17.3% each), and arthralgia (15.4%). Grade ≥ 3 hematologic TEAEs included neutropenia (21.2%), thrombocytopenia (13.5%), and anemia (9.6%), none resulting in treatment discontinuation. Clinical pharmacokinetic and pharmacodynamic results demonstrated that lisaftoclax had a limited plasma residence and systemic exposure and elicited rapid clearance of malignant cells. With a median treatment of 15 (range, 6-43) cycles, 14 of 22 efficacy-evaluable patients with R/R CLL/SLL experienced partial responses, for an objective response rate of 63.6% and median time to response of 2 (range, 2-8) cycles.

CONCLUSIONS:

Lisaftoclax was well tolerated, with no evidence of tumor lysis syndrome. Dose-limiting toxicity was not reached at the highest dose level. Lisaftoclax has a unique pharmacokinetic profile compatible with a potentially more convenient daily (vs. weekly) dose ramp-up schedule and induced rapid clinical responses in patients with CLL/SLL, warranting continued clinical investigation.

2023-02-01·Acta pharmacologica Sinica

Discovery and identification of a novel small molecule BCL-2 inhibitor that binds to the BH4 domain

Article

作者: Zheng, Ming-Yue ; Jiang, Hua-Liang ; Song, Jia ; Lu, Cheng-Hao ; Zhang, Ying-Hui ; Yang, Rui-Rui ; Fan, Zi-Sheng ; Chang, Jie ; Zhang, Su-Lin ; Zhou, Jing-Yi

The B-cell lymphoma 2 (BCL-2) protein family plays a pivotal role in regulating the apoptosis process. BCL-2, as an antiapoptotic protein in this family, mediates apoptosis resistance and is an ideal target for cell death strategies in cancer therapy. Traditional treatment modalities target BCL-2 by occupying the hydrophobic pocket formed by BCL-2 homology (BH) domains 1-3, while in recent years, the BH4 domain of BCL-2 has also been considered an attractive novel target. Herein, we describe the discovery and identification of DC-B01, a novel BCL-2 inhibitor targeting the BH4 domain, through virtual screening combined with biophysical and biochemical methods. Our results from surface plasmon resonance and cellular thermal shift assay confirmed that the BH4 domain is responsible for the interaction between BCL-2 and DC-B01. As evidenced by further cell-based experiments, DC-B01 induced cell killing in a BCL-2-dependent manner and triggered apoptosis via the mitochondria-mediated pathway. DC-B01 disrupted the BCL-2/c-Myc interaction and consequently suppressed the transcriptional activity of c-Myc. Moreover, DC-B01 inhibited tumor growth in vivo in a BCL‑2‑dependent manner. Collectively, these results indicate that DC-B01 is a promising BCL-2 BH4 domain inhibitor with the potential for further development.

2023-01-04·Clinical cancer research : an official journal of the American Association for Cancer Research

Lisaftoclax in Combination with Alrizomadlin Overcomes Venetoclax Resistance in Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia: Preclinical Studies

Article

作者: Zhang, Kaixiang ; Yang, Dajun ; Tang, Qiuqiong ; Xue, Sheng-Li ; Fang, Douglas D. ; Deng, Jing ; Yin, Yan ; Fu, Chengcheng ; Li, Na ; Wang, Qixin ; Zhou, Feng ; Zhai, Yifan

Abstract:

Purpose::

Despite approval of B-cell lymphoma (BCL)-2 inhibitor venetoclax for certain hematologic malignancies, its broader clinical benefit is curtailed by resistance. Our study aimed to determine if treatment with novel anticancer agents targeting BCL-2 and mouse double minute 2 (MDM2) could overcome venetoclax resistance in preclinical models.

Experimental Design::

Venetoclax-sensitive and venetoclax-resistant acute myeloid leukemia (AML) and acute lymphoblastic leukemia cells and xenograft models were used to evaluate antitumor effects and underlying mechanisms associated with combined BCL-2 inhibitor lisaftoclax (APG-2575) and MDM2 inhibitor alrizomadlin (APG-115).

Results::

The combination exhibited synergistic antiproliferative and apoptogenic activities in TP53 wild-type AML cell lines in vitro. This synergy was further exemplified by deep antitumor responses and prolonged survival in AML cell line–derived and patient-derived xenograft models. Interestingly, the combination treatment resensitized (to apoptosis) venetoclax-resistant cellular and mouse models established via chronic drug exposure or genetically engineered with clinically relevant BCL-2 gene mutations. Synergistic effects in reducing cellular viability and proliferation were also demonstrated in primary samples of patients with venetoclax-resistant AML treated with lisaftoclax and alrizomadlin ex vivo. Mechanistically, alrizomadlin likely primes cancer cells to BCL-2 inhibition-induced cellular apoptosis by downregulating expression of antiapoptotic proteins myeloid cell leukemia-1 and BCL–extra-large and upregulating pro-death BCL-2–associated X protein.

Conclusions::

Lisaftoclax in combination with alrizomadlin overcomes venetoclax resistance mediated by various mechanisms, including BCL-2 mutations. In addition, we posit further, putative molecular mechanisms. Our data rationalize clinical development of this treatment combination in patients with diseases that are insensitive or resistant to venetoclax.

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项与力胜克拉相关的新闻（医药）

2025-03-27

·PRNewswire

Innovent to Present Preclinical Data of Multiple Novel Molecules at the 2025 AACR Annual Meeting

SAN FRANCISCO and SUZHOU, China, March 26, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces that preclinical data on multiple novel bispecific antibodies as well as antibody-drug-conjugates (ADCs) from its oncology pipeline will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2025. The AACR Annual Meeting will take place from April 25 to April 30, 2025, in Chicago, Illinois. Late-Breaking Research: Immunology 2 Topic: Preclinical Data of IAR037, A Novel CD40/PD-L1 Bispecific Antibody for the Treatment of Advanced Solid Tumors Resistant to Immune Checkpoint Inhibitors Abstract Number: LB139 Presentation Time ：Monday Apr 28, 2025 9:00 AM - 12:00 PM Location: Poster Section 52 Late-Breaking Research: Clinical Research 1 Topic: Preclinical characterization of IBI3010, a FRα targeting biparatopic antibody-drug conjugate (ADC), for the treatment of FRα expressing tumors Abstract Number: LB222 Presentation Time ：Monday Apr 28, 2025 2:00 PM - 5:00 PM Location: Poster Section 53 Poster Session: Experimental and Molecular Therapeutics - New and Emerging Cancer Drug Targets Topic: IBI3019, a first-in-class EGFR/CDH17/CD16A tri-specific antibody, demonstrated potent efficacy against CRC and an excellent safety profile in preclinical studies Abstract Number: 4249 Presentation Time: Tuesday Apr 29, 2025 9:00 AM - 12:00 PM Location: Poster Section 17 Poster Board Number: 6 Poster Session: Experimental and Molecular Therapeutics - Therapeutic Approaches to Attack the Tumor Microenvironment Topic: IBI3026, a first-in-class anti-PD-1/IL-12 fusion protein, demonstrates the potential to be a new immuno-oncology therapy by releasing the break in immune response and strongly activating T and NK cells in the tumor microenvironment Abstract Number: 3118 Presentation Time: Monday Apr 28, 2025 2:00 PM - 5:00 PM Location: Poster Section 24 Poster Board Number: 2 Poster Session: Experimental and Molecular Therapeutics - Biochemical Modulators of Cancer / Differentiation Therapeutic Strategies Topic: IBI3014, a TROP2xPD-L1 bi-specific ADC integrating ADC killing with checkpoint blockade within one molecule, exhibits promising efficacy and safety in preclinical models Abstract Number: 344 Presentation Time: Sunday Apr 27, 2025 2:00 PM - 5:00 PM Location: Poster Section 16 Poster Board Number: 11 Poster Session: Experimental and Molecular Therapeutics - Biochemical Modulators of Cancer / Differentiation Therapeutic Strategies Topic: Trop2 and B7H4 bi-specific ADC with improved efficacy and safety for gynecologic cancers Abstract Number: 345 Presentation Time: Sunday Apr 27, 2025 2:00 PM - 5:00 PM Location: Poster Section 16 Poster Board Number: 12 Poster Session: Immunology - T Cell Engagers Topic: A 2+1 format MUC16 targeting T cell engager induces MUC16-dependent T cell activity and superior anti-tumor efficacy Abstract Number: 3510 Presentation Time: Monday Apr 28, 2025 2:00 PM - 5:00 PM Location: Poster Section 38 Poster Board Number: 18 Poster Session: Immunology - Modulation of Tumor Microenvironment: Modulation of Lymphocyte Influx Topic: A PD1-IFNα fusion protein, composed of an attenuated IFNα fused to a clinically validated PD1 mAb, induced PD1-dependent IFNα signaling and demonstrated superior anti-tumor efficacy Abstract Number: 4881 Presentation Time: Tuesday Apr 29, 2025 9:00 AM - 12:00 PM Location: Poster Section 40 Poster Board Number: 9 Poster Session: Experimental and Molecular Therapeutics - Novel Antitumor Agents 3 Topic: Olverembatinib* (HQP1351) in combination with lisaftoclax (APG-2575) overcomes venetoclax resistance in preclinical models of acute myeloid leukemia (AML) Abstract Number: 5652 Presentation Time: Tuesday Apr 29, 2025 2:00 PM – 5:00 PM Poster Session: Experimental and Molecular Therapeutics - Novel Antitumor Agents 3 Topic: Effects of olverembatinib* (HQP1351) in combination with BCL-2 inhibitor lisaftoclax (APG-2575) in T-cell acute lymphoblastic leukemia (T ALL) Abstract Number: 5648 Presentation Time: Tuesday Apr 29, 2025 2:00 PM – 5:00 PM * In July 2021, Innovent and Ascentage Pharma (6855.HK) reached the agreement regarding the joint development and commercialization of olverembatinib in China. Dr. Kaijie He, Vice President of Innovent, stated: "With the expansion and enhancement of Innovent Academy's technology platforms, our global R&D efforts are taking shape and accelerating global competitiveness, enabling the efficient generation of novel molecules with global potential. We are proud to showcase a batch of preclinical research findings at this year's AACR Annual Meeting, including multiple globally first-in-class bispecific antibodies, multi-specific antibodies, and antibody-drug conjugates (ADCs). These breakthroughs not only demonstrate our growing scientific capabilities but also reaffirm our commitment to delivering transformative therapeutic options for patients worldwide. Moving forward, we remain focused on innovation—optimizing precision targets and exploring novel mechanisms—to provide revolutionary solutions for some of the world's most challenging diseases and enable more patients to benefit from the rapid advancements in cutting-edge science." About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 15 products in the market. It has 3 new drug applications under regulatory review, 3 assets in Phase III or pivotal clinical trials and 16 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Statement: （1）Innovent does not recommend the use of any unapproved drug (s)/indication (s). （2）Ramucirumab (Cyramza®) and Selpercatinib (Retsevmo®) and Pirtobrutinib (Jaypirca®) were developed by Eli Lilly and Company. Forward-looking statement This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent Biologics ("Innovent"), are intended to identify certain of such forward-looking statements. The Company does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment and political, economic, legal and social conditions. The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialise or turn out to be incorrect. SOURCE Innovent Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

AACR会议抗体药物偶联物免疫疗法

2025-03-26

·药研网

AACR 2025 | 亚盛医药即将公布五项最新临床前进展

3月26日，亚盛医药宣布，公司共有五项临床前研究进展入选2025年美国癌症研究协会（AACR）年会。此次会议将于 2025 年 4 月 25 日至 30 日在美国芝加哥举行。亚盛医药本次将要展示的数据涉及公司五个品种，包括：原创1类新药奥雷巴替尼（商品名：耐立克®；研发代号：HQP1351） Bcl-2抑制剂APG-2575 FAK/ALK/ROS1三联酪氨酸激酶抑制剂APG-2449 胚胎外胚层发育蛋白（EED）抑制剂APG-5918 IAP拮抗剂AS03157 五项临床前研究的摘要信息如下：原创1类新药奥雷巴替尼（商品名：耐立克®；研发代号：HQP1351）奥雷巴替尼（HQP1351, 具备全球同类最优潜力的第三代BCR-ABL/TKI），已显示出良好的疗效和初步的安全性。奥雷巴替尼主要用于治疗伴有T315I突变的慢性髓细胞白血病（CML）慢性期（-CP）和加速期（-AP）患者，以及对第一代和第二代酪氨酸激酶抑制剂（TKI）耐药或不耐受的CML-CP患者。 2024年6月14日，亚盛医药就耐立克®（奧雷巴替尼）(HQP1351)与武田制药（Takeda）订立独家选择权协议，授予武田制药开发及商业化耐立克®（奧雷巴替尼）的全球权利，除中国内地、香港、澳门及中国台湾等地区外。 Olverembatinib (HQP1351) in combination with lisaftoclax (APG-2575) overcomes venetoclax resistance in preclinical models of acute myeloid leukemia (AML) 奥雷巴替尼（HQP1351）联合APG-2575在急性髓系白血病（AML）临床前模型中克服了维奈克拉耐药摘要编号：5652 分会场类别：实验性与分子疗法分会场标题：新型抗肿瘤药物3 展示时间：（美国中部时间）2025年4月29日，周二，下午14:00 - 17:00 （北京时间）2025年4月30日，周三，凌晨3:00 – 6:00 Bcl-2抑制剂APG-2575 APG-2575是亚盛自主研发的口服Bcl-2选择性抑制剂，通过选择性抑制Bcl-2蛋白，恢复肿瘤细胞的正常凋亡过程，从而达到治疗肿瘤的目的。该药物是全球第二个、国内首个进入关键注册临床阶段的Bcl-2抑制剂，具有全球Best-in-class潜力。 2024年11月17日，APG-2575的新药上市申请已经获国家药监局药品评审中心受理，纳入优先评审程序。目前已经上市的BCL-2抑制剂维奈克拉（Venetoclax），2023年销售额约为23亿美元，由艾伯维和罗氏联合开发的，已经获批用于治疗巴细胞白血病（CLL）、急性髓细胞白血病（AML）等血液系统恶性肿瘤。 Effects of olverembatinib (HQP1351) in combination with BCL-2 inhibitor lisaftoclax (APG-2575) in T-cell acute lymphoblastic leukemia (T‑ALL) 奥雷巴替尼（HQP1351）联合Bcl-2抑制剂APG-2575在 T 细胞急性淋巴细胞白血病（T-ALL）中的效果摘要编号：5648 分会场类别：实验性与分子疗法分会场标题：新型抗肿瘤药物3 展示时间：（美国中部时间）2025年4月29日，周二，下午14:00 - 17:00 （北京时间）2025年4月30日，周三，凌晨3:00 – 6:00 FAK/ALK/ROS1三联酪氨酸激酶抑制剂APG-2449 APG-2449是小分子FAK/ALK/ROS1三联激酶抑制剂，为国产第一个第三代ALK抑制剂。ALK抑制剂主要用于治疗非小细胞肺癌（NSCLC），特别是针对ALK融合基因阳性的患者。ALK融合基因在NSCLC中的突变率约为3%-7%，更多见于年轻、女性、不吸烟的肺腺癌患者中。 APG-2449, a novel focal adhesion kinase (FAK) inhibitor, enhances the antitumor activity of chemotherapy in preclinical models of small-cell lung cancer (SCLC) with activated FAK 新型黏着斑激酶（FAK）抑制剂APG-2449可增强化疗在FAK活化的小细胞肺癌（SCLC）临床前模型中的抗肿瘤活性摘要编号：1679 分会场类别：实验性与分子疗法分会场标题：癌症治疗的联合用药策略展示时间：（美国中部时间）2025年4月28日，周一，上午9:00 - 12:00 （北京时间）2025年4月28日，周一，晚上22:00 – 次日凌晨1:00 胚胎外胚层发育蛋白（EED）抑制剂APG-5918 具有全球BIC潜力的中国原研EED抑制剂，适应症有望横跨血液瘤、实体瘤和血红蛋白病（如镰刀型细胞贫血病和β-地中海贫血） Embryonic ectoderm development protein (EED) inhibitor APG-5918 exhibits potent antitumor activity and synergizes with androgen receptor (AR) inhibitor enzalutamide in preclinical prostate cancer (PCa) models 胚胎外胚层发育蛋白（EED）抑制剂APG-5918在前列腺癌（PCa）临床前模型中的抗肿瘤活性及其与雄激素受体（AR）抑制剂恩扎卢胺的协同作用研究摘要编号：446 分会场类别：实验性与分子疗法分会场标题：表观遗传学靶点展示时间：（美国中部时间）2025年4月27日，周日，下午14:00 - 17:00 （北京时间）2025年4月28日，周一，凌晨3:00 - 6:00 IAP拮抗剂AS03157 Discovery of AS03157 as a highly potent and orally active antagonist of inhibitor of apoptosis proteins (IAPs) 一种高效口服抗凋亡蛋白拮抗剂AS03157的发现摘要编号：5651 分会场类别：实验性与分子疗法分会场标题：新型抗肿瘤药物3 展示时间：（美国中部时间）2025年4月29日，周二，下午14:00 - 17:00 （北京时间）2025年4月30日，周三，凌晨3:00 - 6:00 亚盛医药管线一览 End 声明：本公众号所有发文章(包括原创及转载文章)系出于传递更多信息之目的，且注明来源和作者。本公众号欢迎分享朋友圈或大群，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载/商务/投稿 | 联系微信15618157102（sum_Gmi）商务合作稿件征集点击了解详情往期回顾 1 关张、破产、裁员 | 2024年生物药企的阴影 2 全球第一款司美格鲁肽咀嚼软糖上市！ 3 中国首个男性HPV疫苗获批上市!

AACR会议优先审批申请上市临床结果

2025-03-26

·美通社

【AACR 2025】亚盛医药宣布将在2025年美国癌症研究协会年会上公布五项最新临床前进展

美国马里兰州罗克维尔市和中国苏州 2025年3月26日 /美通社/ -- 致力于在血液肿瘤等领域开发创新药物的领先的生物医药企业——亚盛医药（纳斯达克代码：AAPG；香港联交所代码：6855）今日宣布，公司共有五项临床前研究进展入选2025年美国癌症研究协会（AACR）年会。此次会议将于 2025 年 4 月 25 日至 30 日在美国芝加哥举行。本次将要展示的数据涉及公司五个品种，包括：原创1类新药奥雷巴替尼（商品名：耐立克 ® ；研发代号：HQP1351）、Bcl-2抑制剂APG-2575、FAK/ALK/ROS1三联酪氨酸激酶抑制剂APG-2449、胚胎外胚层发育蛋白（EED）抑制剂APG-5918以及IAP拮抗剂AS03157。 AACR年会是推动抗肿瘤事业发展的重要平台，科学家、临床医生、医疗工作者、癌症幸存者、患者及倡导者每年齐聚一堂，分享和探讨抗肿瘤最新突破。从群体科学与预防，到癌症生物学、转化医学与临床研究，再到幸存者关怀与权益倡导，AACR 年会全方位展示了前沿的癌症科学与医学成果。亚盛医药五项临床前研究的摘要信息如下： Olverembatinib (HQP1351) in combination with lisaftoclax (APG-2575) overcomes venetoclax resistance in preclinical models of acute myeloid leukemia (AML) 奥雷巴替尼（ HQP1351）联合APG-2575在急性髓系白血病（AML）临床前模型中克服了维奈克拉耐药摘要编号：5652 分会场类别：实验性与分子疗法分会场标题：新型抗肿瘤药物3 展示时间：（美国中部时间）2025年4月29日，周二，下午14:00 - 17:00 （北京时间）2025年4月30日，周三，凌晨3:00 – 6:00 Effects of olverembatinib (HQP1351) in combination with BCL-2 inhibitor lisaftoclax (APG-2575) in T-cell acute lymphoblastic leukemia (T‑ALL) 奥雷巴替尼（ HQP1351）联合Bcl-2抑制剂APG-2575在 T 细胞急性淋巴细胞白血病（T-ALL）中的效果摘要编号：5648 分会场类别：实验性与分子疗法分会场标题：新型抗肿瘤药物3 展示时间：（美国中部时间）2025年4月29日，周二，下午14:00 - 17:00 （北京时间）2025年4月30日，周三，凌晨3:00 – 6:00 Embryonic ectoderm development protein (EED) inhibitor APG-5918 exhibits potent antitumor activity and synergizes with androgen receptor (AR) inhibitor enzalutamide in preclinical prostate cancer (PCa) models 胚胎外胚层发育蛋白（ EED）抑制剂APG-5918在前列腺癌（PCa）临床前模型中的抗肿瘤活性及其与雄激素受体（AR）抑制剂恩扎卢胺的协同作用研究摘要编号：446 分会场类别：实验性与分子疗法分会场标题：表观遗传学靶点展示时间：（美国中部时间）2025年4月27日，周日，下午14:00 - 17:00 （北京时间）2025年4月28日，周一，凌晨3:00 - 6:00 APG-2449, a novel focal adhesion kinase (FAK) inhibitor, enhances the antitumor activity of chemotherapy in preclinical models of small-cell lung cancer (SCLC) with activated FAK 新型黏着斑激酶（ FAK）抑制剂APG-2449可增强化疗在FAK活化的小细胞肺癌（SCLC）临床前模型中的抗肿瘤活性摘要编号：1679 分会场类别：实验性与分子疗法分会场标题：癌症治疗的联合用药策略展示时间：（美国中部时间）2025年4月28日，周一，上午9:00 - 12:00 （北京时间）2025年4月28日，周一，晚上22:00 – 次日凌晨1:00 Discovery of AS03157 as a highly potent and orally active antagonist of inhibitor of apoptosis proteins (IAPs) 一种高效口服抗凋亡蛋白拮抗剂 AS03157的发现摘要编号：5651 分会场类别：实验性与分子疗法分会场标题：新型抗肿瘤药物3 展示时间：（美国中部时间）2025年4月29日，周二，下午14:00 - 17:00 （北京时间）2025年4月30日，周三，凌晨3:00 - 6:00 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，为全球唯一在细胞凋亡通路关键蛋白领域均有临床开发品种的创新公司。目前公司已在中国、美国、澳大利亚及欧洲开展40多项临床试验，包括涉及主要品种的11项美国/全球注册临床试验（已完成/进行中），其中2项注册III期研究获FDA许可。公司核心品种耐立克 ® 已在中国获批上市，且获批适应症均被成功纳入国家医保药品目录。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。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。

AACR会议临床结果临床1期

100 项与力胜克拉相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
慢性淋巴细胞白血病	申请上市	中国	苏州亚盛药业有限公司	2024-11-16
小淋巴细胞淋巴瘤	申请上市	中国	苏州亚盛药业有限公司	2024-11-16
高危骨髓增生异常综合征	临床3期	美国	Ascentage Pharma Group, Inc.	2025-01-22
高危骨髓增生异常综合征	临床3期	中国	Ascentage Pharma Group, Inc.	2025-01-22
骨髓增生异常综合征	临床3期	中国	苏州亚盛药业有限公司	2025-01-22
急性髓性白血病	临床3期	中国	苏州亚盛药业有限公司	2024-06-11
急性髓性白血病	临床3期	中国	Ascentage Pharma Group, Inc.	2024-06-11
系统性红斑狼疮	临床2期	中国	苏州亚盛药业有限公司	2024-08-09
系统性红斑狼疮	临床2期	中国	Ascentage Pharma Group, Inc.	2024-08-09
复发性慢性淋巴细胞白血病	临床2期	中国	Ascentage Pharma Group, Inc.	2021-12-28

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04215809 (ASH2024) 人工标引	临床1期	慢性淋巴细胞白血病 \| 小淋巴细胞淋巴瘤	176	APG-2575	遞獵積壓襯窪遞鏇餘鏇(衊襯艱積襯願觸範餘齋) = Incidence and severity of TEAEs were similar across cohorts. Common (>10%) any-grade TEAEs in all cohorts combined were neutropenia (59 [33.5%]), diarrhea (38 [21.6%]), anemia (27 [15.3%]), and thrombocytopenia (26 [14.8%]). 膚範範窪窪蓋糧醖蓋簾 (願積鏇鹽簾鑰遞構積鬱 ) 更多	积极	2024-12-09
				APG-2575+Acalabrutinib
NCT04942067 (APG2575MU101, ASH2024) 人工标引	临床1/2期	多发性骨髓瘤 \| 免疫球蛋白轻链淀粉样变性	49	Lisaftoclax + pomalidomide + dexamethasone (Arm A)	願築簾夢構範蓋壓鬱壓(蓋艱衊廠範襯廠糧獵鹽) = 願鬱願鏇蓋淵鬱願觸繭鏇鑰願窪遞糧鑰網淵鹹 (製蓋醖顧鬱獵壓衊鏇淵 ) 更多	积极	2024-12-09
				lisaftoclax and daratumumab, lenalidomide, and dexamethasone (R/R MM + Arm B)	願築簾夢構範蓋壓鬱壓(蓋艱衊廠範襯廠糧獵鹽) = 壓衊襯蓋鏇壓淵簾廠膚鏇鑰願窪遞糧鑰網淵鹹 (製蓋醖顧鬱獵壓衊鏇淵 ) 更多
NCT04501120 (APG2575AC101, ASH2024) 人工标引	临床1/2期	骨髓增生异常综合征	49	Lisaftoclax Azacitidineazacitidine (R/R MDS)	淵糧顧範繭遞艱壓獵窪(壓鑰選淵選糧製糧醖膚) = 壓窪夢鹽淵簾艱壓廠廠醖網鏇襯網鹽窪餘膚艱 (憲鑰憲鏇網願艱遞餘廠 ) 更多	积极	2024-12-08
				Lisaftoclax Azacitidineazacitidine (TN MDS)	衊遞糧鑰觸選鹽觸觸觸 \| 淵糧顧範繭遞艱壓獵窪(蓋襯醖顧遞簾觸構醖簾) = 醖蓋鹹築鏇鹹艱蓋築壓壓範顧糧選蓋廠膚餘齋 (範壓艱選積構鹽簾齋鹹, 61.5 ~ 89.2) 更多
PRNewswire 人工标引	N/A	多发性骨髓瘤 \| 免疫球蛋白轻链淀粉样变性	44	APG-2575+泊马度胺+地塞米松 (MM)	醖糧遞膚獵鏇齋淵醖壓(襯觸製夢膚憲鹹鏇願觸) = 廠觸醖築獵構繭窪醖衊壓鹽醖顧壓淵壓鹽範夢 (鏇蓋廠糧艱壓壓鹽夢襯 ) 更多	积极	2024-06-18
				APG-2575+达雷妥尤单抗+来那度胺+地塞米松 (MM)	範顧積鑰範鹽鏇齋選衊(壓醖範餘選膚遞鏇觸醖) = 夢構範構憲壓鹹糧鏇範夢積製選壓網夢蓋壓獵 (餘範範網廠構夢醖製艱 )
NCT04501120 (ASCO2024) 人工标引	临床1/2期	复发性急性髓细胞白血病 \| 难治性急性髓细胞白血病	72	Lisaftoclax 400 mgAZA mg	鏇範範簾鹹窪獵壓選構(鹹獵觸簾壓艱製製糧築) = 鑰簾憲齋膚鹹醖觸壓繭醖顧膚選蓋積築築醖壓 (鹽膚壓製網餘夢築獵夢, 28.1 ~ 63.6) 更多	积极	2024-05-24
				Lisaftoclax 600 mgAZA mg	鏇範範簾鹹窪獵壓選構(鹹獵觸簾壓艱製製糧築) = 築膚憲簾網衊顧齋壓網醖顧膚選蓋積築築醖壓 (鹽膚壓製網餘夢築獵夢, 34.8 ~ 67.6) 更多
NCT04260217 (APG2575WU101, ASCO2024) 人工标引	临床1/2期	巨球蛋白血症 MYD88 Gene Mutation Negative \| MYD88 \| CXCR4	46	Lisaftoclax	齋艱網獵淵襯網壓觸遞(醖積醖鹽鏇顧淵獵窪壓) = 膚選糧顧鏇鑰醖艱廠艱繭齋選糧顧選簾膚膚積 (獵獵繭廠鬱鹹網願觸繭, 1 ~ 28) 更多	积极	2024-05-24
				Lisaftoclax + Ibrutinib	齋艱網獵淵襯網壓觸遞(醖積醖鹽鏇顧淵獵窪壓) = 襯淵製遞夢網簾製衊鏇繭齋選糧顧選簾膚膚積 (獵獵繭廠鬱鹹網願觸繭, 1 ~ 34) 更多
NCT04501120 (APG2575AC101, ASH2023) 人工标引	临床1/2期	髓系肿瘤 \| 急性髓性白血病 \| 骨髓增生异常综合征	115	Lisaftoclax monotherapy	獵膚積壓憲齋糧網範觸(遞夢築膚願簾衊窪鹹壓) = 簾窪積膚夢願願衊蓋壓觸窪積網網獵製鏇鹹製 (鑰簾壓觸積網膚構糧繭 ) 更多	积极	2023-12-10
				Lisaftoclax+LD-HHT (R/R AML)	獵膚積壓憲齋糧網範觸(遞夢築膚願簾衊窪鹹壓) = 獵衊構製選簾壓觸築糧觸窪積網網獵製鏇鹹製 (鑰簾壓觸積網膚構糧繭 ) 更多
NCT04942067 (APG-2575-MU101, ASH2023) 人工标引	临床1/2期	多发性骨髓瘤 \| 免疫球蛋白轻链淀粉样变性	30	Lisaftoclax + Pomalidomide + Dexamethasone (R/R MM)	糧壓餘齋範選願範獵襯(簾願鹹壓醖觸顧簾獵範) = 鬱顧遞糧鏇鑰製選壓願鑰構醖鏇繭夢醖淵襯膚 (衊獵積蓋鏇範鬱築鹽積 ) 更多	积极	2023-12-09
				Lisaftoclax + Daratumumab + Lenalidomide + Dexamethasone (R/R MM)	糧壓餘齋範選願範獵襯(簾願鹹壓醖觸顧簾獵範) = 醖築鬱衊願鹹鹽積醖築鑰構醖鏇繭夢醖淵襯膚 (衊獵積蓋鏇範鬱築鹽積 ) 更多
NCT04494503 \| NCT03913949 (APG-2575-CC101, ASH2023) 人工标引	临床1/2期	慢性淋巴细胞白血病	47	Lisaftoclax	網積鏇鹹簾膚鹹憲簾廠(製憲鬱觸淵蓋獵範繭壓) = 憲願壓簾醖憲繭糧衊蓋願願窪構簾築鏇糧窪簾 (鹽築繭築構糧醖製獵淵 ) 更多	积极	2023-12-09
NCT04260217 (ASCO 12023 \| ASCO 22023) 人工标引	临床1/2期	巨球蛋白血症	46	Lisaftoclax (BTKi-resistant/intolerant pts + Arm A)	膚觸顧獵築遞顧遞齋鹹(簾艱簾鏇醖鹽窪衊願繭) = At 1,200 mg, 1 DLT (grade 3 clinical TLS), due to pre-existing renal impairment, was reported. 淵積膚艱選獵蓋願網繭 (襯壓膚艱窪簾憲衊鹹簾 ) 更多	积极	2023-05-26
				Ibrutinib+Lisaftoclax (treatment-naïve pts + Arm B)