This phase I trial tests the safety, side effects, and best dose of abemaciclib in combination with 5-fluorouracil and how well it works in treating patients with colorectal cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and that has not responded to treatment (refractory). Abemaciclib, a type of cyclin-dependent kinase inhibitor, blocks certain proteins, which may help keep tumor cells from growing. 5-fluorouracil, a type of antimetabolite, stops cells from making deoxyribonucleic acid (DNA) and may kill tumor cells. Giving abemaciclib in combination with 5-fluorouracil may be safe, tolerable, and/or effective in treating patients with metastatic and refractory colorectal cancer.

开始日期2025-10-31

申办/合作机构

National Cancer Institute

NCT06498648

/ Suspended临床1/2期IIT

Phase I/II Study to Evaluate the Feasibility and Efficacy of Sequential Abemaciclib and Gemcitabine Treatment in Patients With Retinoblastoma (Rb)+ Sarcomas

This phase 1/2 trial tests the side effects and best dose of abemaciclib when added to gemcitabine and compares the effectiveness of that treatment to the usual treatment of gemcitabine with docetaxel for the treatment of patients with soft tissue sarcoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic) (phase 1) or patients with leiomyosarcoma or dedifferentiated liposarcoma (phase 2). Abemaciclib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. Docetaxel is in a class of medications called taxanes. It stops cancer cells from growing and dividing and may kill them. Giving abemaciclib with gemcitabine may be safe and effective when compared to treatment with gemcitabine and docetaxel for patients with advanced or metastatic soft tissue sarcoma or leiomyosarcoma or dedifferentiated liposarcoma.

开始日期2025-10-14

申办/合作机构

National Cancer Institute

NCT06810492

/ Not yet recruitingN/AIIT

A Single-arm Exploratory Study of the Efficacy and Safety of CDK4/6 Inhibitors in Combination with Endocrine Therapy in the Neoadjuvant Treatment of HR+/HER2- Early Breast Cancer

To explore the efficacy and safety of CDK4/6 inhibitors combined with endocrine neoadjuvant therapy for stage II-III HR-positive/HER2-negative breast cancer.
This study adopts a single-arm, open-label design, and plans to include 40 patients with stage II-III HR+/HER2- breast cancer.

开始日期2025-04-01

申办/合作机构

湖北省肿瘤医院（湖北省肿瘤研究所）

100 项与阿贝西利相关的临床结果

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100 项与阿贝西利相关的转化医学

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100 项与阿贝西利相关的专利（医药）

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1,441

项与阿贝西利相关的文献（医药）

2025-06-01·Clinical Genitourinary Cancer

CDK4/6 Inhibition With Abemaciclib in Patients With Previously Treated Advanced Renal Cell Carcinoma

Article

作者: Xu, Wenxin ; McGregor, Bradley A ; Kaelin, William G ; Choueiri, Toni K ; McDermott, David ; Xie, Wanling ; Berg, Stephanie A ; Signoretti, Sabina ; Viswanathan, Srinivas R

BACKGROUND:

Preclincal data provide a rationale for cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitors alone and in combination with HIF-2α inhibitors in treatment of clear cell renal cell carcinoma (ccRCC), with randomized phase 2 clinical trials currently open exploring the combination of palbociclib with belzutifan vs belzutifan in treatment resistant ccRCC (NCT05468697). However, single agent activity for CDK4/6 inhibitors in ccRCC has not been reported. In this multi-center phase 1b clinical trial (NCT04627064), we investigated the safety and efficacy of monotherapy with abemaciclib, an oral CDK4/6 inhibitor in patients with advanced pretreated RCC.

METHODS:

Adult patients with advanced RCC with a clear cell component and ECOG status of ≤ 2 progressing after at least 1 prior regimen including immunotherapy and a VEGFR TKI received abemaciclib 200 mg twice daily in 4-week cycles until progression or unacceptable toxicity. The primary objective was to evaluate the objective response rate (ORR) of abemaciclib with a secondary endpoint of safety. First imaging was performed after 8 weeks or 2 cycles. Response was assessed per RECIST 1.1 and toxicity graded per CTCAE v5.0.

RESULTS:

Eleven patients were enrolled between December 31, 2020 and October 03, 2023. Median age was 62 years (range 54-68); 73% (n = 8) had IMDC intermediate risk disease and 1 patient had translocation RCC with a clear cell component. Median number of prior therapies was 4 (range 1-9). ORR was 0% (0/11; 8 progressive disease, 1 stable disease stopping for clinical progression, 2 not evaluable with clinical progression). About 27% (n = 3) experienced grade ≥3 treatment-related adverse events (diarrhea n = 1, nausea n = 1, neutropenia n = 1).

CONCLUSION:

In patients with heavily pretreated metastatic RCC, abemaciclib monotherapy had no clinically meaningful activity without new toxicity signals. This data will offer important insight into interpretation of results for ongoing trials exploring CDK4/6 inhibition in combination with HIF-2α inhibitors and immunotherapy.

2025-05-01·Breast Cancer

The impact of axillary lymph-node dissection omission on adjuvant abemaciclib eligibility in HR-positive, HER2-negative breast cancer with positive sentinel lymph nodes

Article

作者: Nishikawa, Aya ; Yamada, Akimitsu ; Adachi, Shoko ; Narui, Kazutaka ; Endo, Itaru ; Oshi, Masanori ; Kawashima, Kei ; Ishikawa, Takashi ; Sasamoto, Mahato

BACKGROUND:

The MonarchE trial demonstrated the additional benefit of abemaciclib as an adjuvant endocrine therapy for high-risk patients with hormone receptor (HR)-positive HER2-negative breast cancer. Meanwhile, the ACOSOG Z0011 trial established the omission of axillary lymph-node dissection (ALND) as a standard practice in certain patients with positive sentinel lymph-node biopsy (SNB). However, as the MonarchE eligibility criteria include the presence of four or more lymph-node metastases, omitting ALND may hinder the assessment of abemaciclib eligibility in some cases.

METHODS:

The study population consisted of patients with clinically node-negative, HR-positive, HER2-negative breast cancer who underwent SNB at our institution between January 2008 and December 2021. The proportion of patients meeting the MonarchE cohort1 criteria, and the potential impact of ALND omission on abemaciclib eligibility were assessed.

RESULTS:

Among the 1537 patients, 189 underwent SNB followed by ALND due to the presence of one or more positive sentinel nodes. Of these, 69 (36.5%) were eligible for abemaciclib. Eligibility was uncertain without ALND in 138 patients. Among the 138 patients, 124 were candidates for ALND omission, including 11 who were found to have four or more metastatic lymph nodes after completing ALND.

CONCLUSIONS:

A few cases were identified in which abemaciclib eligibility was not properly determined due to ALND omission. This suggests that omitting ALND following SNB, when two of fewer positive nodes are detected, may not significantly impact the determination of abemaciclib eligibility.

2025-05-01·Breast Cancer

A prospective cohort study of abemaciclib-induced interstitial lung disease in metastatic breast cancer after chemotherapy

Article

作者: Nakayama, Sayuka ; Iwamoto, Takayuki ; Sugimoto, Naoya ; Nakayama, Takahiro ; Aihara, Tomohiko ; Mukai, Hirofumi ; Nagase, Hiroyuki ; Narui, Kazutaka ; Araki, Kazuhiro ; Kikawa, Yuichiro ; Taira, Naruto

BACKGROUND:

The safety of combination therapy with abemaciclib and hormone therapy in patients with hormone receptor-positive (HR +), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC) who were previously treated with chemotherapy for MBC remains unclear. Caution is required as the Pharmaceuticals and Medical Devices Agency (PMDA) and the U.S. Food and Drug Administration (FDA) have issued warnings about abemaciclib-induced interstitial lung disease (ILD).

METHODS:

This study was a secondary analysis of a prospective observational study involving patients who had previously undergone chemotherapy for HR + MBC. A certificated respiratory specialist reviewed the clinical information of patients who were suspected of having ILD to adjudicate abemaciclib-induced ILD and definitively diagnosed abemaciclib-induced ILD. In this study, the incidence, risk factors, and clinical course of interstitial lung disease (ILD) are reported.

RESULTS:

All cases of patients who received abemaciclib had no radiological evidence of ILD prior to abemaciclib treatment. The incidence of abemaciclib-induced ILD was 7.4% (n = 9/122). CTCAE grade 1/2 occurred in 77.8% (n = 7), with no grade 4/5 cases. The timing of ILD onset varied and our study did not identify any significant risk factors for abemaciclib-induced ILD. All cases of ILD ultimately were confirmed to be in remission or cured.

CONCLUSION:

In this multicenter prospective cohort study with a follow-up period of 3.3 years and a definition of ILD by a certified pulmonologist, we accurately evaluated abemaciclib-associated ILD after chemotherapy. The favorable clinical course of ILD indicate that abemaciclib treatment is an acceptable option for these MBC patients. However, because abemaciclib-induced ILD is difficult to predict, careful monitoring is required during abemaciclib treatment.

717

项与阿贝西利相关的新闻（医药）

2025-04-17

·PRNewswire

Caris Life Sciences to Showcase Research Highlighting the Value of Precision Oncology Collaboration at the American Association for Cancer Research Annual Meeting 2025

Caris Life Sciences to present 14 abstracts, inclusive of 2 oral presentations and 12 posters IRVING, Texas, April 17, 2025 /PRNewswire/ -- Caris Life Sciences® (Caris), a leading next-generation AI TechBio company and precision medicine pioneer, today announced that the company and collaborators within the Caris Precision Oncology Alliance™ (Caris POA) will collectively present 14 abstracts across 9 tumor types at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2025, from April 25-30, in Chicago, IL. "We are thrilled about the abstracts accepted for presentation at AACR this year, highlighting the importance of Caris' comprehensive molecular profiling and our Caris POA collaboration," said Caris EVP and Chief Medical Officer George W. Sledge, Jr., MD. "The findings represent a broad spectrum of cancer research by tumor type including gastro-esophageal, lung and pancreatic all utilizing Caris' comprehensive clinic-genomic datasets." "The variety of cancer research presenting at AACR this year demonstrates how Caris empowers clinicians by facilitating research, ultimately paving the way for advancements," said James Hamrick, MD, MPH, Chairman of the Caris Precision Oncology Alliance. "The findings illustrate how our collaborators in the Caris POA leverage real-world evidence to deepen our understanding of the mechanisms of cancer pathogenesis and improve outcomes of all patients affected by cancer." Minisymposium presentations include: Pre-operative abemaciclib in localized cisplatin-ineligible MIBC with tissue and ctDNA molecular response validation (CLONEVO) (Abstract Number CT127) April 28, 2:50-3 PM CT Kinase fusion landscape of pancreatic cancer (Abstract Number 3781) April 28, 3:40-3:55 PM CT Poster presentations include: Clinical, biologic, and immunogenic characteristics of gastro-esophageal cancers (GEC) harboring CLDN18::ARHGAP fusions (Poster Number 496/8) April 27, 2-5 PM CT Functional characterization of SMARCA4 genomic variants (Poster Number 674/7) April 27, 2-5 PM CT Targeting ATM modulates oncogenic pathways and amplifies chemotherapy efficacy in small cell lung cancer (Poster Number LB016/16) April 27, 2-5 PM CT Recurrent PRKCI gene fusions represent a drug target in gastric cancer and esophageal junction cancer (Poster Number 1474/10) April 28, 9 AM -12 PM CT Improving capability for biomarker discovery of glioblastoma-enriched poly-ligand profiling library using Aptamer Capture Microarrays (Poster Number 1895/25) April 28, 9 AM -12 PM CT Comprehensive molecular and immunological characterization of CLDN18.2 in pancreatic cancer (Poster Number 2026/28) April 28, 9 AM -12 PM CT FXIIIa-mediated transferrin sequestration drives cancer stem cell phenotype in colorectal cancer (Poster Number 2688/5) April 28, 2-5 PM CT Association of cyclin E1 expression with genomic instability in ovarian cancer (Poster Number 2846/13) April 28, 2-5 PM CT The ERBB4 exon skipping isoform JMA-CYT2 is the dominant isoform of ERBB4 gene fusions (Poster Number 4761/28) April 29, 9 AM -12 PM CT GPR171, a prognostic marker of improved survival in cervix cancer: A Deep South Consortium in Oncology (DSCO) Project (Poster Number LB261/10) April 29, 9 AM -12 PM CT Non-synonymous mutations in the IFN-γ pathway are predictive of response to immune checkpoint inhibition in NSCLC (Poster Number 7140/4) April 30, 9 AM – 12 PM CT The effects of socioeconomic deprivation on the tumor microenvironment of bladder cancer (Poster Number 7392/20) April 30, 9 AM -12 PM CT Poster and abstract summaries highlighting this research will be available onsite at Caris' booth #400. The full abstracts will be available on the Caris website following the presentation. The Caris POA includes 96 cancer centers, academic institutions, research consortia and healthcare systems, including 47 NCI-designated cancer centers, collaborating to advance precision oncology and biomarker-driven research. Caris and POA members work together to establish and optimize standards of care for molecular testing through innovative research to improve clinical outcomes for cancer patients. About Caris Life Sciences Caris Life Sciences® (Caris) is a leading next-generation AI TechBio company and precision medicine pioneer that is actively developing and delivering innovative solutions to revolutionize healthcare and improve the human condition. Through comprehensive molecular profiling (Whole Exome and Whole Transcriptome Sequencing) and the application of advanced AI and machine learning algorithms, Caris has created the large-scale, multimodal database and computing capability needed to analyze and further unravel the molecular complexity of disease. This convergence of sequencing power, big data and AI technologies provides a differentiated platform to deliver the next generation of precision medicine tools for early detection, diagnosis, monitoring, therapy selection and drug development. Caris was founded with a vision to realize the potential of precision medicine in order to improve the human condition. Headquartered in Irving, Texas, Caris has offices in Phoenix, New York, Cambridge (MA), Tokyo, Japan and Basel, Switzerland. Caris or its distributor partners provide services in the U.S. and other international markets. To learn more, please visit CarisLifeSciences.com. Caris Life Sciences Media: Corporate Communications [email protected] 214.294.5606 SOURCE Caris Life Sciences WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

2025-04-17

·医药魔方

辉瑞站在十字路口

千亿美元级别的GLP-1减重赛道，所有的制药巨头都不愿错失，但辉瑞的美梦率先破碎了。去年夏天，因每日2次口服Danuglipron缺乏竞争力且耐受性差，辉瑞将其舍弃并把最后希望寄托在每日1次口服Danuglipron上。遗憾的是，缓释剂型存在肝毒性隐忧，辉瑞只能选择彻底终止开发Danuglipron。这已是辉瑞在口服GLP-1赛道遭遇的第三次挫败。早在2023年，另一款候选药物Lotiglipron就因安全性问题被迫搁置。GLP-1赛道的研发挫败不过辉瑞业绩增长压力的冰山一角：多款拳头产品专利即将到期、核心业务滞涨、多项关键研发进展不及预期…这家“宇宙大药厂”如今正徘徊在找回增长方向的十字路口。辉瑞并未放弃减重市场辉瑞本可以更早在GLP-1赛道卡住身位。在GLP-1被认定为一种降糖物质之时，辉瑞就投资了持有GLP-1发现专利的初创公司Metabolic Biosystems[1]。但GLP-1的极短半衰期限制了其临床应用价值，辉瑞很快便撤离了。十余年后，辉瑞在几次并购交易（其中包括对惠氏的收购）[2-4]中一度将4款早期GLP-1药物收入囊中，但这些项目都没有引起辉瑞的关注，最后无疾而终。2015年，辉瑞重新加入GLP-1的角逐，通过与Sosei Heptares的合作收获了两款小分子GLP-1R激动剂——PF-07081532（即Lotiglipron）和PF-06954522。前者的结局已经揭晓——因导致受试者转氨酶水平升高被弃置，后者正在糖尿病和肥胖人群中开展I期研究。辉瑞追赶GLP-1热潮的渴望很明显，不仅积极寻求外部合作，还通过内部创新孵化了Danuglipron。只可惜两条路线都栽在了安全性问题上，拖慢了辉瑞进军减肥市场的步伐，使其在已经白热化的GLP-1竞争中可能落后竞争对手数年。尽管如此，辉瑞似乎不打算放弃这一潜力巨大的市场。在宣布终止开发Danuglipron的同时，辉瑞明确表示将“继续开发口服GIPR拮抗剂候选药物（PF-07976016）和其它早期肥胖项目”。就在两个月前的财报电话会议上，辉瑞研发总裁Chris Boshoff还提及过将Danuglipron作为PF-07976016潜在搭档的可能性[5]。随着Danuglipron被埋，辉瑞可能需要重新在外部寻找合适的GLP-1资产，以维持其在减重领域的战略布局。数据不错的口服GLP-1或是多靶点药物可能会进入辉瑞的战略考量范围，拥有II期在研产品的硕迪生物、Terns Pharmaceuticals、Viking Therapeutics等公司的股价已经应声先涨。中后期在研小分子GLP-1R激动剂GLP-1产品的布局竞赛如火如荼，罗氏、默沙东、阿斯利康等制药巨头已经用行动说明了对减肥市场的向往。就连已经在GLP-1领域占据领先地位的诺和诺德，也掷下重金买入联邦制药的GLP-1R/GCGR/GIPR激动剂UBT251。跨国药企GLP-1项目交易数量决胜未来的战役在GLP-1大赛道的接连滑铁卢，意味着辉瑞输掉了托举未来的有力筹码，而更紧迫的是，其他核心牌面的胜率似乎也有限，未来之路还不甚明朗。回顾2024年辉瑞交出的成绩单，全年营收虽然呈现同比7%的增长，保住了全球第一大制药巨头的头衔，但在繁荣的背面，危机一同显现。专利悬崖已逼近眼前。未来三年内，抗凝药阿哌沙班、乳腺癌疗法哌柏西利、前列腺癌药物恩扎卢胺等重磅产品将陆续失去市场独占期，可能造成170-180亿美元的收入损失。事实上，即便还未遭受仿制药的冲击，有很多产品的竞争力已在市场剧变中减弱。例如，哌柏西利的销售额出现下滑，此消彼长间CDK4/6赛道的头牌地位被礼来的阿贝西利夺走。此外，辉瑞疫苗板块的门面产品肺炎球菌疫苗沛儿系列增长停滞；RSV疫苗市场变数频生，致使刚上市第2年的Abrysvo销售额已开始缩水。辉瑞也从未回避专利悬崖的危机，它已未雨绸缪地在2020-2023年间加大了并购力度，以快速吸收外部的潜力产品管线。经过消化整合，重金收购的资产逐渐兑现价值。以430亿美元收购Seagen所获得的多款肿瘤产品在2024年贡献了超32亿美元收入；116亿美元收购Biohaven囊获的偏头痛药物瑞美吉泮带来12.63亿美元的增量收入。辉瑞首席执行官Albert Bourla还有更高的期待，他预计并购产品到2030年将贡献200亿美元的收入。也就是说，这不仅能填平专利悬崖带来的收入缺口，还可能会实现额外的增长。预期往往倾向美好的一面，现实却总是发生偏差。辉瑞上百亿美金重注ADC赛道的雄心已出现一丝裂痕。今年初，收购Seagen而来的B7-H4 ADC药物Felmetatug vedotin被辉瑞终止开发，导致10亿美元的无形资产减值。而在2023年的肿瘤日活动上，辉瑞曾把该药物视为乳腺癌领域的潜在增长驱动力之一。另一款明星产品Vepdegestrant同样被辉瑞寄予厚望，乃是其在PROTAC前沿赛道最倚重的竞争筹码。同类产品的竞速中，头顶潜在FIC光环的Vepdegestrant一直备受瞩目，近期公布的首个III期研究数据却浇灭了一些业内人士的期待，因为 Vepdegestrant未能达到总体意向治疗人群的无进展生存期（PFS）主要终点。不过，Vepdegestrant在ESR1突变患者群体中仍有突围希望。该突变是ER+/HER2-晚期乳腺癌患者发生获得性耐药的常见原因，约有40%的接受二线治疗的患者中存在ESR1突变。基因治疗赛道，辉瑞陷于研发与商业化双双失利的困局中。从杜氏肌营养不良症基因疗法Fordadistrogene movaparvovec的III期败北，到退回A型血友病基因疗法Giroctocogene fitelparvovec的全球权益，再到终止已上市的B型血友病基因疗法Fidanacogene elaparvovec的开发和商业化，辉瑞的基因治疗布局几近全面溃败。应对GLP-1赛道的屡次受挫与更多不确定因素交织的局面，辉瑞需要比以往任何时候都更加务实地制定战略决策。能否在创新效率、临床价值与市场空间之间找到新的平衡点，将决定这个巨头能否持续守住制药业王座。这场决胜未来的战役，或许比想象中更加复杂和艰难。- 上下滑动查看参考资料 - [1]https://www.labiotech.eu/in-depth/pfizer-glp-1-missed-opportunity/[2]https://www.fiercebiotech.com/biotech/press-release-pfizer-to-acquire-biorexis-pharmaceutical[3]https://www.pfizer.com/news/press-release/press-release-detail/pfizer_to_acquire_covx_to_extend_biotherapeutics_investment[4]https://www.pfizer.com/news/press-release/press-release-detail/pfizer_to_acquire_wyeth_creating_the_world_s_premier_biopharmaceutical_company[5]https://s28.q4cdn.com/781576035/files/doc_financials/2024/q4/PFE-USQ_Transcript_2025-02-04.pdf推荐阅读Genmab启示录：BD之王如何长成Biopharma？Copyright © 2025 PHARMCUBE. All Rights Reserved.欢迎转发分享及合理引用，引用时请在显要位置标明文章来源；如需转载，请给微信公众号后台留言或发送消息，并注明公众号名称及ID。免责申明：本微信文章中的信息仅供一般参考之用，不可直接作为决策内容，医药魔方不对任何主体因使用本文内容而导致的任何损失承担责任。

并购财报专利到期

2025-04-15

·信达生物

全国肿瘤防治宣传周 | 礼来与信达生物、和黄医药加速赋能医药创新，助力“健康中国”建设

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

免疫疗法放射疗法

100 项与阿贝西利相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10688	阿贝西利	L01XE50	DB12001

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
晚期乳腺癌	加拿大	Eli Lilly Canada, Inc.	2019-04-08
转移性乳腺癌	加拿大	Eli Lilly Canada, Inc.	2019-04-08
HR阳性HER2阴性淋巴结阳性乳腺癌	欧盟	Eli Lilly Nederland BV	2018-09-26
HR阳性HER2阴性淋巴结阳性乳腺癌	冰岛	Eli Lilly Nederland BV	2018-09-26
HR阳性HER2阴性淋巴结阳性乳腺癌	列支敦士登	Eli Lilly Nederland BV	2018-09-26
HR阳性HER2阴性淋巴结阳性乳腺癌	挪威	Eli Lilly Nederland BV	2018-09-26
HR阳性/HER2阴性乳腺癌	美国	Eli Lilly & Co.	2017-09-28

未上市

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
去势敏感前列腺癌	临床3期	美国	Eli Lilly & Co.	2022-04-14
去势敏感前列腺癌	临床3期	中国	Eli Lilly & Co.	2022-04-14
去势敏感前列腺癌	临床3期	日本	Eli Lilly & Co.	2022-04-14
去势敏感前列腺癌	临床3期	阿根廷	Eli Lilly & Co.	2022-04-14
去势敏感前列腺癌	临床3期	澳大利亚	Eli Lilly & Co.	2022-04-14
去势敏感前列腺癌	临床3期	比利时	Eli Lilly & Co.	2022-04-14
去势敏感前列腺癌	临床3期	巴西	Eli Lilly & Co.	2022-04-14
去势敏感前列腺癌	临床3期	加拿大	Eli Lilly & Co.	2022-04-14
去势敏感前列腺癌	临床3期	捷克	Eli Lilly & Co.	2022-04-14
去势敏感前列腺癌	临床3期	法国	Eli Lilly & Co.	2022-04-14

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临床结果

适应症

分期

评价

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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


Phase 2 study of letrozole, abemaciclib and metformin (AACR2025)	临床2期	复发性子宫内膜癌 ER positive \| RB1 \| CCNE1 ... 更多	25	Letrozole/Abemaciclib/Metformin	艱製願夢範廠繭鹹餘獵(壓衊願鏇襯醖襯窪範網) = 膚窪製淵糧構夢鑰壓醖齋窪餘積製襯鹹齋選顧 (鏇簾網鬱簾夢顧蓋獵淵, 14.9% ~ 53.5) 更多	积极	2025-04-29
NCT04975308 (EMBER-3, Pubmed \| N Engl J Med)	临床3期	晚期乳腺癌	874	Imlunestrant	蓋積衊構築鹽築醖網衊(鑰齋範齋觸鬱簾鹽繭鹽) = 餘簾餘膚廠構淵觸範網遞遞網製範製繭鏇獵積 (衊衊鏇遞蓋範鏇選築鬱 ) 更多	积极	2025-03-27
				Standard Therapy	蓋積衊構築鹽築醖網衊(鑰齋範齋觸鬱簾鹽繭鹽) = 製鏇觸壓簾淵憲構窪憲遞遞網製範製繭鏇獵積 (衊衊鏇遞蓋範鏇選築鬱 ) 更多
NCT05169567 (postMONARCH, CTgov)	临床3期	HR阳性/HER2阴性乳腺癌	368	Fulvestrant+Abemaciclib (Arm A: Abemaciclib Plus Fulvestrant)	觸艱製衊壓淵獵鹽鏇簾(淵鬱顧構鏇鹽餘構鑰窪) = 鹽願範鬱淵鹽壓憲繭獵鹹鑰窪壓鹹鏇壓窪觸糧 (鑰簾鏇夢簾糧觸憲襯觸, 衊顧獵網醖積願網繭觸 ~ 窪獵網膚鹹淵窪淵衊窪) 更多	-	2025-03-25
				Placebo+Fulvestrant (Arm B: Placebo Plus Fulvestrant)	觸艱製衊壓淵獵鹽鏇簾(淵鬱顧構鏇鹽餘構鑰窪) = 醖壓蓋憲簾獵夢觸鬱憲鹹鑰窪壓鹹鏇壓窪觸糧 (鑰簾鏇夢簾糧觸憲襯觸, 衊艱鑰淵鑰鏇鹽築壓範 ~ 鑰遞鏇遞壓廠齋積壓網) 更多
NCT05169567 (postMONARCH, Pubmed \| J Clin Oncol)	临床3期	晚期乳腺癌 ESR1 \| PIK3CA mutations	368	Abemaciclib + Fulvestrant	壓膚窪壓製網願窪鹽鬱(鬱廠鹹繭製積製鬱鏇顧) = 範網窪觸鏇鹽衊蓋鏇憲壓築觸獵窪艱廠鹹製製 (鏇鏇積蓋遞願衊積觸製, 5.6 ~ 8.6) 更多	积极	2025-03-20
				Placebo + Fulvestrant	壓膚窪壓製網願窪鹽鬱(鬱廠鹹繭製積製鬱鏇顧) = 製蓋鏇鏇選糧醖顧廠鹽壓築觸獵窪艱廠鹹製製 (鏇鏇積蓋遞願衊積觸製, 3.7 ~ 5.6) 更多
NCT04298983 (RAD 1805, CTgov)	临床2期	前列腺癌 \| 前列腺腺癌	9	Androgen deprivation therapy (ADT)+Abemaciclib 150 MG by mouth twice daily	製範鑰鏇簾築觸積範簾 = 簾網鬱蓋獵膚遞繭鹽遞簾齋鏇廠獵願廠繭衊積 (壓鬱鏇選鏇鏇蓋網獵獵, 鏇膚窪鑰淵蓋蓋糧鏇鑰 ~ 壓遞鬱膚夢憲選膚願遞) 更多	-	2025-03-19
NCT03706365 (CYCLONE 2, CTgov)	临床2/3期	转移性去势抵抗性前列腺癌	393	Prednisone+Abiraterone acetate+Abemaciclib (Abemaciclib)	壓遞蓋齋網獵觸構襯築(遞積鬱簾艱顧窪鏇選夢) = 顧餘齋簾鬱艱鏇築鹹鹽遞廠淵鬱願壓廠糧觸鹽 (衊窪遞觸網鬱憲鏇築襯, 觸願鬱鏇範窪積壓鬱糧 ~ 餘網顧網憲艱鬱築鹹壓) 更多	-	2025-03-06
				Placebo+Prednisone+Abiraterone acetate (Placebo)	壓遞蓋齋網獵觸構襯築(遞積鬱簾艱顧窪鏇選夢) = 醖網窪膚膚憲窪繭衊積遞廠淵鬱願壓廠糧觸鹽 (衊窪遞觸網鬱憲鏇築襯, 醖壓糧遞醖膚醖積窪夢 ~ 積齋膚鏇淵醖壓鹹艱觸) 更多
NCT04256941 (CTgov)	临床2期	转移性乳腺癌	4	Fulvestrant (Fulvestrant)	蓋構餘選鬱淵夢鏇襯積(膚艱齋襯構遞夢簾鏇遞) = 願觸製願憲衊繭築襯網糧積鹽製窪艱顧窪壓窪 (繭鏇簾鑰艱繭範鹽憲糧, 膚製膚範窪鏇製積鑰網 ~ 餘齋壓衊齋壓鬱獵觸蓋) 更多	-	2024-12-27
				fulvestrant+ribociclib (Kisqali)+abemaciclib (verzenio)+palbociclib (Ibrance) (Continuing AI After Randomization)	蓋構餘選鬱淵夢鏇襯積(膚艱齋襯構遞夢簾鏇遞) = 襯鑰獵壓築願憲網積艱糧積鹽製窪艱顧窪壓窪 (繭鏇簾鑰艱繭範鹽憲糧, 觸顧壓廠襯壓網壓糧壓 ~ 構範構範構簾網鏇網鹹) 更多
NCT04975308 (EMBER-3, Pubmed \| SABCS2024) 人工标引	临床3期	晚期乳腺癌	874	Imlunestrant	網網獵窪廠構鑰網壓觸(選鑰簾衊壓衊壓繭蓋鹹) = 積夢選糧艱簾構獵醖蓋鏇艱糧繭獵顧鏇糧艱選 (範鹹淵鏇艱鹽壓網鹹餘 ) 更多	积极	2024-12-11
				Standard therapy	網網獵窪廠構鑰網壓觸(選鑰簾衊壓衊壓繭蓋鹹) = 餘範淵襯遞範膚網艱繭鏇艱糧繭獵顧鏇糧艱選 (範鹹淵鏇艱鹽壓網鹹餘 ) 更多
NCT05563220 \| NCT05386108 (ELEVATE, SABCS2024) 人工标引	临床1/2期	ER阳性/HER2阴性乳腺癌 HER2 Negative	55	Elacestrant + Abemaciclib (all efficacy-evaluable)	觸艱鬱積衊觸廠顧鹽蓋(糧糧糧衊膚觸顧選餘製) = 糧願鹽壓襯網蓋淵鑰繭憲願壓艱鹽願壓築範淵 (鹹餘醖網鹹範蓋鹽襯願 )	积极	2024-12-10
				Elacestrant + Abemaciclib (ESR1-mut population)	觸艱鬱積衊觸廠顧鹽蓋(糧糧糧衊膚觸顧選餘製) = 鏇顧鹽壓簾鹹淵觸願艱憲願壓艱鹽願壓築範淵 (鹹餘醖網鹹範蓋鹽襯願 )
NCT05548127 (TACTIVE-U, GlobeNewswire) 人工标引	临床1期	ER阳性/HER2阴性乳腺癌三线	16	Vepdegestrant + Abemaciclib	範糧鑰衊選廠鹹鹹製壓(網積鹹觸齋窪糧壓遞壓) = None 鏇膚艱醖鑰鏇壓醖憲餘 (餘蓋繭餘繭築窪鹽鹹壓 ) 更多	积极	2024-12-10
				Vepdegestrant + Abemaciclib (mutant ESR1)