A Phase II Study of Elacestrant, an Oral Selective Estrogen Receptor Degrader (SERD) Combined With Everolimus in Patients With Recurrent or Metastatic ER-Positive (ER+) Endometrial Cancer (ELAVERA)

This phase II trial tests how well elacestrant with everolimus works for the treatment of estrogen receptor (ER) positive endometrial cancer that has come back after a period of improvement (recurrent), 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). Estrogen can cause the growth of cancer cells. Elacestrant lowers the amount of estrogen made by the body. This may help stop the growth of cancer cells that need estrogen to grow. Everolimus is in a class of medications called kinase inhibitors. It is also a type of angiogenesis inhibitor. Everolimus works by stopping cancer cells from reproducing and by decreasing blood supply to the cancer cells. Giving elacestrant with everolimus may be effective for treating patients with recurrent, advanced or metastatic ER positive endometrial cancer.

开始日期2026-12-18

申办/合作机构

Jonsson Comprehensive Cancer Center

[+1]

NCT07753954

/ Not yet recruiting临床2期IIT

Imaging to Re-evaluate Elacestrant Clinical Application

The goal of this clinical trial is to evaluate whether elacestrant, an oral selective oestrogen receptor degrader, can improve outcomes in patients with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer without detectable ESR1 mutation after progression on endocrine therapy plus a CDK4/6 inhibitor.
The study aims to answer two key questions:
* Does [18F]-fluor-oestradiol positron emission tomography/computed tomography (18F-FES-PET/CT) result (homogeneous vs. heterogeneous) determine the efficacy of elacestrant in participants with advanced/metastatic ER-positive breast cancer and ESR1-mut-nd?
* Does 18F-FES-PET/CT imaging predict patient outcomes, including progression-free survival, overall survival, or tumor response?
There is no comparison group in this study. All participants receive elacestrant. Researchers will compare outcomes in people who have different levels of estrogen-receptor heterogeneity on FES-PET/CT imaging.
Participants in the study will:
* Take elacestrant 345 mg orally once a day, in 28-day treatment cycles (the dose may be lowered to 258 mg if needed due to side effects).
* Undergo 18F-FES-PET/CT and 18F-FDG-PET/CT imaging both at the beginning of the study and as part of routine clinical evaluation every 8 weeks
* Undergo blood sample collection every 8 weeks
* If selected for a sub-study, undergo an additional FES-PET/CT scan 4 weeks after starting treatment

开始日期2026-09-13

申办/合作机构

Jules Bordet Institute

[+2]

NCT07766018

/ Recruiting临床2期

A Phase 2 Open-Label, Single-Arm, Multicenter Trial to Evaluate the Efficacy and Safety of Elacestrant Monotherapy for the Treatment of Japanese Participants With ER+/HER2- Advanced or Metastatic Breast Cancer With ESR1-mutation Following CDK4/6 Inhibitor Therapy

This is a multicenter, open-label, Phase 2 bridging study to evaluate the efficacy and safety of elacestrant in Japanese post-menopausal women and men with estrogen receptor positive (ER+)/human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer with estrogen receptor 1 gene mutation (ESR1-mut) whose disease has relapsed or progressed on at least 1 and no more than 2 prior lines of endocrine therapy for metastatic breast cancer, which must have included cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) therapy in combination with fulvestrant or an aromatase inhibitor.

开始日期2026-08-18

申办/合作机构

Stemline Therapeutics, Inc.

100 项与艾拉司群相关的临床结果

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100 项与艾拉司群相关的转化医学

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100 项与艾拉司群相关的专利（医药）

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123

项与艾拉司群相关的文献（医药）

2026-10-15·JOURNAL OF CLINICAL INVESTIGATION

Selective estrogen receptor degraders and their effect on the breast cancer immune microenvironment

Review

作者: Young, Kristen S. ; Fanning, Sean W.

One in eight women will be diagnosed with breast cancer in their lifetime. Most breast cancers express estrogen receptor α (ERα) and depend on its signaling, which promotes tumor growth, survival, and metastatic spread through hormone-dependent transcriptional reprogramming. Selective estrogen receptor degraders/downregulators (SERDs), such as fulvestrant (faslodex), which was FDA approved in 2002, are second-line endocrine therapies for the treatment of advanced metastatic disease. Tumors containing activating hotspot mutations in ESR1 (the gene encoding ERα) retain some sensitivity to fulvestrant but require higher doses to achieve inhibition of the mutant receptor. Substantial efforts to develop next-generation SERDs with improved pharmacology over fulvestrant have led to the FDA approval of the first-in-class orally available SERD elacestrant (Orserdu), followed by imlunestrant (Inluriyo), and the anticipated approval of several more therapies. Excitingly, recent studies show that in addition to their previously described antitumoral mechanisms, SERDs also act by increasing antitumor immunity. In this Review, we detail the current SERD clinical landscape and our emerging understanding of the interplay among SERDs, breast cancer cells, and the tumor immune microenvironment.

2026-10-01·ESMO Open

Outcomes of elacestrant in patients with ER-positive, HER2-negative, ESR1-mutated metastatic breast cancer who received prior endocrine therapy and cyclin-dependent kinase inhibitor in a real-world setting

Article

作者: Sears, E ; Maitland, J ; García-Sáenz, J Á ; Bayona, R Sanchez ; Harbeck, N ; Kuemmel, S ; Pistilli, B ; Wasserman, T ; Okines, A ; Rea, D ; Kloss, S ; Curigliano, G ; Ignatiadis, M ; De Laurentiis, M

BACKGROUND:

Real-world data analyses show durable benefits with elacestrant, with or without prior treatment with cyclin-dependent kinase 4/6 inhibitor (CDK4/6i). This cohort focused on patients with ER-positive/HER2-negative estrogen receptor 1 (ESR1)-mutated metastatic breast cancer (mBC) treated with elacestrant after at least one line of endocrine therapy (ET) combined with CDK4/6i (N = 281).

PATIENTS AND METHODS:

Claims data from the Komodo Research Dataset linked with Foundation Medicine clinical-genomics data were used. Primary outcome was median time-to-next-treatment (mTTNT).

RESULTS:

In patients with ER-positive/HER2-negative ESR1-mutated mBC who received one to two prior lines of ET + CDK4/6i (n = 108), mTTNT with elacestrant was 8.2 months [95% confidence interval (CI) 6.0-12.2]. In patients who received one to two prior lines of ET + CDK4/6i for ≥12 months (n = 85), mTTNT was 9.0 months (95% CI 7.7-13.7), including an mTTNT of 12.2 months (95% CI 9.0-not reached) in those who received one prior line of ET (n = 31). In patients with liver and/or lung metastasis (n = 169), mTTNT was 6.9 months (95% CI 5.8-8.3), whereas it was 7.4 months (95% CI 5.6-12.9) in patients with brain metastasis (n = 68). In patients with coexisting ESR1- and phosphoinositide 3-kinase-pathway-mutated tumors (n = 115), mTTNT was 6.1 months (95% CI 5.0-8.1).

CONCLUSIONS:

Elacestrant showed durable benefits in patients with ER-positive/HER2-negative ESR1-mutated mBC previously exposed to at least one line of ET + CDK4/6i, reinforcing the role of elacestrant as a potential first-choice option for patients with endocrine-sensitive tumors.

2026-09-01·Molecular Diagnosis & Therapy

Standardized Analytical Verification of ctDNA ESR1 Mutation Testing in Metastatic HR+/HER2− Breast Cancer: A European Multicentre Study Using dPCR and NGS-Based Liquid Biopsy

Article

作者: Sardinha, Ruth ; Guarneri, Valentina ; García-Murillas, Isaac ; Zazo, Sandra ; Prieto-Potin, Ivan ; Vanden Bempt, Isabelle ; Rocco, Elena Guerini ; Pepe, Francesco ; Pérez-Buira, Sandra ; Boscolo Bragadin, Andrea ; Swift, Claire ; Carvajal, Nerea ; Venetis, Konstantinos ; Fusco, Nicola ; Adorisio, Riccardo ; Russo, Gianluca ; Malapelle, Umberto ; Scimone, Claudia ; Rojo, Federico ; Indraccolo, Stefano ; Renders, Demi

INTRODUCTION:

Activating ESR1 mutations are a major mechanism of resistance to aromatase inhibitors in hormone receptor-positive, HER2-negative metastatic breast cancer (mBC). International guidelines, including those from ASCO, NCCN, and ESMO, recommend liquid biopsy as the preferred approach for ESR1 mutation testing at progression on endocrine therapy, with digital PCR (dPCR) and next-generation sequencing (NGS) as the preferred analytical platforms. Although elacestrant was approved by the U.S. Food and Drug Administration together with Guardant360® Dx as its companion diagnostic, European regulatory frameworks allow the use of validated in-house assays for ESR1 testing, which are increasingly being implemented across clinical laboratories. To support the clinical implementation of ESR1 testing and improve analytical standardization in routine practice, we performed a European multicentre analytical verification study using dPCR- and NGS-based liquid biopsy workflows.

METHODS:

Six referral institutions participated in this study. All laboratories verified dPCR workflows and four also verified NGS-based assays using standardized reference materials containing clinically relevant ESR1 mutations. Limit of detection (LoD) and limit of blank (LoB) were determined in each laboratory according to locally validated workflows following CLSI-based verification procedures. Analytical sensitivity and specificity were assessed across platforms, focusing on the two most frequently tested ESR1 hotspot mutations, p.Y537S and p.D538G. Total DNA input ranged from 10 to 30 ng per reaction for dPCR assays, while NGS input followed platform-specific requirements.

RESULTS:

LoD values ranged from 0.01% to 0.07% variant allele frequency (VAF) for dPCR assays and from 0.01% to 0.1% for NGS-based workflows, depending on platform characteristics and DNA input. Limit of blank values were low across laboratories, with minimal background signal detected in plasma samples from healthy donors. Comparable analytical performance was observed across different platforms when assays were performed under validated laboratory conditions.

DISCUSSION:

These results demonstrate that both dPCR and NGS-based liquid biopsy workflows can be successfully implemented for ESR1 mutation testing in routine clinical practice using locally validated assays. This multicentre verification study provides practical guidance on assay verification, DNA input requirements, and key analytical parameters required to ensure reliable ESR1 mutation detection across different European laboratories. Robust analytical verification of ESR1 testing may improve diagnostic reliability and support personalized treatment strategies for patients with hormone receptor-positive, HER2-negative metastatic breast cancer.

449

项与艾拉司群相关的新闻（医药）

2026-10-27

·Firstwordpharma

Menarini bets $1.1B on Georgiamune's preclinical oral immunotherapy

Italy's Menarini has struck a global licensing deal with US biotech Georgiamune centred on GIM-621, a preclinical-stage small molecule designed to harness the immune system against several types of solid tumours.Georgiamune will receive $45 million in upfront and near-term payments, with the deal's total value reaching $1.1 billion if the potential first-in-class drug clears a series of milestones. The biotech is also eligible for royalties on future sales."This programme is a strong complement to our solid tumour portfolio, and our established oncology development and commercial capabilities position us well to accelerate its progress," stated Elcin Barker Ergun, chief executive at Menarini, in a release Thursday.The Italian pharma's oncology portfolio includes the oral selective oestrogen receptor degrader (SERD) Orserdu (elacestrant) for breast cancer, and Elzonris (tagraxofusp), a CD123-directed cytotoxin and fusion protein for blastic plasmacytoid dendritic cell neoplasm.Stemline Therapeutics, Menarini's wholly owned oncology subsidiary, will gain exclusive worldwide rights to develop, manufacture and commercialise GIM-621. The companies haven't revealed its molecular target or specific indications, nor did they give a timeline as to when the programme would move into clinical testing.Georgiamune, whose work focuses on mechanisms governing immune activation, suppression and homeostasis, is advancing three clinical-stage programmes of its own. These include GIM-407, an oral regulatory T-cell (Treg) activator for autoimmune diseases; GIM-531, an oral Treg inhibitor in oncology; and GIM-122, a dual-functioning antibody being developed for oncology as well.The Maryland-based biotech completed a $75-million series A round in 2023.

引进/卖出免疫疗法

2026-10-26

·动脉网

Georgiamune与 Menarini集团就首创新类口服免疫肿瘤药物 GIM-621达成独家全球许可与合作协议Georgiamune and Menarini Group Enter Exclusive Global License and Collaboration Agreement for GIM-621, a First-in-Class Oral Immuno-Oncology Agent

GIM-621 is a preclinical-stage, first-in-class oral small molecule immunotherapy with potential application across multiple solid tumors. GIM-621 是一款处于临床前阶段的同类首创口服小分子免疫疗法，具有在多种实体瘤中应用的潜力。Georgiamune to receive $45 million in upfront and near-term payments, as part of a total deal value of up to $1.1 billion, plus royalties. Georgiamune 将获得4,500万美元的预付款及近期付款，作为总交易价值高达11亿美元（另加特许权使用费）的一部分。FLORENCE, Italy and GAITHERSBURG, Md. 意大利佛罗伦萨和马里兰州盖瑟斯堡, ，Oct. 22, 2026 2026年10月22日/PRNewswire/ -- TheMenarini Group ('Menarini'), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. ('Stemline'), a wholly-owned subsidiary of the Menarini Group focused on bringing transformational oncology treatments to cancer patients, along with Georgiamune Inc., a clinical-stage biotechnology company discovering and developing first-in-class therapies that reprogram immune signaling pathways to treat cancer and autoimmune diseases, today announced an exclusive worldwide license and collaboration agreement for GIM-621.. /美通社/ -- 国际领先的制药与诊断公司美纳里尼集团（“美纳里尼”），及其专注于为癌症患者提供变革性肿瘤治疗的全资子公司Stemline Therapeutics, Inc.（“Stemline”），连同临床阶段生物技术公司Georgiamune Inc.（该公司致力于发现和开发首创疗法，通过重编程免疫信号通路来治疗癌症和自身免疫性疾病），今日宣布就GIM-621达成一项全球独家许可与合作协议。GIM-621 is a preclinical-stage first-in-class oral small molecule immunotherapy with potential application across multiple solid tumors. It is one of multiple therapeutic candidates generated from Georgiamune's research into novel mechanisms governing immune activation, suppression and homeostasis. GIM-621 是一款处于临床前阶段的同类首创口服小分子免疫疗法，具有在多种实体瘤中应用的潜力。它是 Georgiamune 公司基于对调控免疫激活、抑制及稳态的新机制的研究而开发的多个候选治疗药物之一。Under the terms of the license and collaboration agreement, Stemline receives an exclusive, worldwide license to develop, manufacture and commercialize GIM-621. Georgiamune will receive $45 million in upfront and near-term payments. Georgiamune is also eligible for preclinical, development, regulatory and commercial milestone payments, for a total potential deal value of up to $1.1 billion, plus royalties.. 根据许可与合作协议的条款，Stemline 获得开发、生产和商业化 GIM-621 的独家全球许可。Georgiamune 将获得 4,500 万美元的预付款及近期付款。Georgiamune 还有资格获得临床前、开发、监管和商业里程碑付款，交易总潜在价值高达 11 亿美元，外加特许权使用费。'At Georgiamune, we are focused on uncovering novel mechanisms that control immune-cell function and translating that biology into first-in-class medicines across autoimmune disease and oncology,' said Samir N. Khleif, M.D., Founder and Chief Executive Officer of Georgiamune. 'GIM-621 is one of multiple programs to emerge from that work, alongside three programs already in clinical development across autoimmune disease and oncology. Georgiamune 创始人兼首席执行官 Samir N. Khleif 博士表示：“在 Georgiamune，我们致力于揭示调控免疫细胞功能的新机制，并将这些生物学发现转化为针对自身免疫性疾病和肿瘤学的首创药物。GIM-621 是源自这一工作的多个项目之一，与此同时，我们还有三个项目已在自身免疫性疾病和肿瘤学领域进入临床开发阶段。”This agreement brings Menarini's global oncology development and commercial capabilities to GIM-621 while allowing Georgiamune to continue advancing a broad pipeline built on distinct immune mechanisms.'. 该协议将美纳里尼的全球肿瘤研发和商业化能力赋予GIM-621，同时允许Georgiamune继续推进基于独特免疫机制的广泛产品管线。'We are delighted to partner with Georgiamune, a company with deep expertise in immuno-oncology which has led to the discovery of GIM-621, a first-in-class oral immunotherapy with promise across multiple solid tumors,' said Elcin Barker Ergun, CEO of the Menarini Group. 'This program is a strong complement to our solid tumor portfolio, and our established oncology development and commercial capabilities position us well to accelerate its progress. 美纳里尼集团首席执行官埃尔钦·巴克·埃尔贡表示：“我们很高兴与在免疫肿瘤学领域拥有深厚专业知识的Georgiamune公司合作，这一合作促成了GIM-621的发现。GIM-621是一种首创的口服免疫疗法，在多种实体瘤治疗中展现出广阔前景。该项目有力地补充了我们的实体瘤产品组合，而我们在肿瘤学开发和商业化方面的成熟能力，也将为我们加速其进展提供有力支撑。”We look forward to working closely with the Georgiamune team to unlock the full potential of this innovative approach to benefit patients with cancer.'. 我们期待与 Georgiamune 团队紧密合作，充分释放这一创新方法的潜力，以造福癌症患者。About Georgiamune 关于 GeorgiamuneGeorgiamune is a clinical-stage biotechnology company discovering and developing first-in-class therapies designed to reprogram immune signaling pathways to treat cancer and autoimmune disease. The company's research focuses on novel mechanisms that govern T-cell activation, regulatory T-cell function and immune homeostasis. Georgiamune 是一家处于临床阶段的生物技术公司，致力于发现并开发首创疗法，旨在通过重编程免疫信号通路来治疗癌症和自身免疫性疾病。该公司的研究聚焦于调控 T 细胞活化、调节性 T 细胞功能以及免疫稳态的新颖机制。Georgiamune has three clinical-stage programs: GIM-407, an oral Treg activator in autoimmune disease; GIM-122, a dual-functioning antibody in oncology; and GIM-531, an oral Treg inhibitor in oncology. Georgiamune is also advancing a broader pipeline of preclinical candidates across oncology and autoimmune disease, including GIM-621. Georgiamune 拥有三个处于临床阶段的项目：GIM-407，一种用于自身免疫性疾病的口服调节性T细胞（Treg）激活剂；GIM-122，一种用于肿瘤治疗的双功能抗体；以及 GIM-531，一种用于肿瘤治疗的口服调节性T细胞（Treg）抑制剂。Georgiamune 还在推进更广泛的临床前候选药物管线，涵盖肿瘤学和自身免疫性疾病领域，其中包括 GIM-621。The company was founded by Dr. Samir N. Khleif based on discoveries from his laboratory into mechanisms that control immune responses. For more information, visit . 该公司由萨米尔·N·赫莱夫博士创立，基于其实验室在控制免疫反应机制方面的发现。欲了解更多信息，请访问。www.georgiamune.com www.georgiamune.com. 。About The Menarini Group 关于美纳里尼集团The Menarini Group is a leading international pharmaceutical and diagnostics company, with a turnover of $5.5 billion and over 17,000 employees. Menarini is focused on therapeutic areas with high unmet needs with products for cardiology, oncology, pneumology, gastroenterology, infectious diseases, diabetology, inflammation, and analgesia. 美纳里尼集团是一家领先的国际制药和诊断公司，营业额达55亿美元，拥有超过17,000名员工。美纳里尼专注于存在高度未满足需求的治疗领域，其产品涵盖心脏病学、肿瘤学、肺病学、胃肠病学、传染病、糖尿病学、炎症和镇痛等领域。With 18 production sites and 9 Research and Development centers, Menarini's products are available in 140 countries worldwide. For further information, please visit . 美纳里尼拥有18个生产基地和9个研发中心，其产品遍布全球140个国家。如需更多信息，请访问。www.menarini.com www.menarini.com. 。About Stemline Therapeutics Inc. 关于 Stemline Therapeutics Inc.Stemline Therapeutics, Inc. ('Stemline'), a wholly-owned subsidiary of the Menarini Group, is a commercial-stage biopharmaceutical company focused on bringing transformational oncology treatments to patients. Stemline commercializes elacestrant, an oral endocrine therapy indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy, in the U.S., Europe, and other global regions. Stemline Therapeutics, Inc.（“Stemline”）是美纳里尼集团（Menarini Group）的全资子公司，是一家处于商业化阶段的生物制药公司，专注于为患者带来具有变革意义的肿瘤治疗药物。Stemline 在美国、欧洲及其他全球地区商业化推广 elacestrant，这是一种口服内分泌疗法，适用于治疗雌激素受体（ER）阳性、人表皮生长因子受体 2（HER2）阴性、ESR1 突变的晚期或转移性乳腺癌的绝经后女性或成年男性患者，且这些患者在至少接受过一线内分泌治疗后出现疾病进展。Stemline also commercializes tagraxofusp-erzs, a novel targeted therapy directed to CD123, for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an aggressive hematologic cancer, in the United States, Europe, and other global regions. In addition, Stemline commercializes selinexor, an XPO1 inhibitor for multiple myeloma, in Europe. Stemline 还在美国、欧洲及其他全球地区商业化 tagraxofusp-erzs，这是一种针对 CD123 的新型靶向疗法，适用于患有母细胞性浆细胞样树突状细胞肿瘤（BPDCN，一种侵袭性血液癌症）的患者。此外，Stemline 还在欧洲商业化 selinexor，这是一种用于多发性骨髓瘤的 XPO1 抑制剂。The company is also conducting multiple label-expansion studies with elacestrant and tagraxofusp in breast and hematologic cancer indications, respectively, and has an extensive clinical pipeline of additional drug candidates in various stages of development for a host of solid and hematologic cancers.. 该公司还在开展多项标签扩展研究，分别针对乳腺癌和血液肿瘤适应症，使用elacestrant和tagraxofusp。此外，它还拥有广泛的临床管线，包括处于不同开发阶段的多种候选药物，用于应对多种实体瘤和血液肿瘤。21 二十一% %more press release views with 更多新闻稿浏览量，借助Request a Demo 申请演示

引进/卖出免疫疗法

2026-10-25

·今日头条

美纳里尼医药集团解析：集团概况与下属企业全览

美兰诺为音译俗称，集团标准名称为美纳里尼（Menarini）集团，是意大利百年民营跨国医药集团，也是欧洲头部制药企业之一，1886年创立，总部坐落于佛罗伦萨，业务覆盖全球140个国家，员工约18000人，布局处方药研发生产、肿瘤创新药、体外诊断、生物药代工四大板块，核心治疗领域包含肿瘤、心血管、呼吸、消化、内分泌，拥有18处全球生产基地，是意大利本土规模第一的药企。一、核心一级全资子集团与核心业务平台 1. Berlin‑Chemie 柏林化学集团最重要的海外收购主体、中东欧业务支柱，总部德国柏林，深耕心血管、糖尿病、呼吸、消化道仿制药与特色原研药，拥有独立生产工厂和注册体系，是美纳里尼进入德、俄、东欧市场的核心载体。 2. Stemline Therapeutics 美国全资肿瘤生物子公司，是集团肿瘤创新管线核心平台。主打血液肿瘤、晚期乳腺癌靶向药，核心产品包括Elacestrant（口服雌激素受体靶向药，商品名Orserdu）、Tagraxofusp（Elzonris，BPDCN罕见血液病唯一获批药物）、Selinexor，负责北美、欧美肿瘤药物商业化与临床开发。 3. Menarini Silicon Biosystems（MSB）集团诊断技术核心子公司，专注稀有细胞检测、液体活检技术，标志性产品CellSearch循环肿瘤细胞CTC检测系统，也是全球最早获得FDA批准的循环肿瘤细胞检测平台，用于乳腺癌、前列腺癌、骨髓瘤无创监测，打造“药物+伴随诊断”协同模式。 4. Menarini Biotech 集团生物药专项平台，拥有单抗、重组蛋白规模化生产车间，既自研生物技术新药，也对外提供生物药CDMO代工服务，是集团布局大分子药物的核心基地。 5. Menarini Ricerche 美纳里尼总部直属新药研究院，集团全球早期研发中枢，负责小分子创新药、新适应症、药物制剂的发现、临床前研究与工艺开发，统筹全球研发管线规划。 6. A. Menarini Farmaceutica Internazionale Srl 意大利本土核心制药主体，承担本土药品生产、质量管控、欧洲注册申报，是集团自有品种的主要生产运营主体。二、中国区下属企业（亚太板块） 1. 美纳里尼（中国）投资有限公司美纳里尼亚太区总部，位于上海，统筹国内战略、医学事务、市场准入、投资布局。 2. 美纳里尼贸易（上海）有限公司国内商业化运营主体，负责进口药品报关、分销、学术推广、经销商管理，是集团药品落地国内市场的执行主体。三、欧洲各区域全资运营公司（区域销售&本地化注册） 1. Laboratorios Menarini（西班牙）：南欧老牌子公司，伊比利亚半岛市场运营主体； 2. Menarini France SAS：法国市场子公司，负责法国药品上市与学术推广； 3. Menarini Hellas（希腊）：东南欧运营平台； 4. Menarini Portugal：葡萄牙市场主体； 5. Menarini Benelux（比荷卢）：比利时、荷兰、卢森堡区域运营； 6. Menarini Stemline各国分公司：法国、德国、英国Stemline分支，专项负责肿瘤药区域商业化。四、配套支撑类下属单位 1. A.Menarini Manufacturing Logistics and Services：集团全球供应链、生产后勤、仓储物流管理主体； 2. A. Menarini Newtech Srl：药物制剂新技术、包装工艺研发子公司； 3. Lodichem S.r.l：精细医药中间体、原料药配套研发企业，支撑制剂原料供给。补充说明：集团在东南亚、拉美、中东均设有多家当地分销与注册子公司，大多为区域轻资产商务主体；同时拥有多家临床CRO合作参股企业，不属于集团全资控股，不计入上表。五、集团业务格局与竞争特点美纳里尼区别于很多大型药企，坚持家族私有、利润持续再投入研发的模式，没有上市。业务上传统普药稳住现金流，重点押注肿瘤赛道与液体活检诊断，通过持续并购补齐管线。它的特色是“仿创结合+诊断协同”：Berlin‑Chemie的成熟处方药提供稳定营收，Stemline和Silicon Biosystems承担创新增长，形成治疗药物+伴随诊断的差异化优势。短板在于创新药管线数量少于欧美头部MNC，国内市场布局起步相对晚，核心产品以进口引进为主，本土化研发和国内自研管线较少。小结历经一百多年扩张，美纳里尼依靠分区域、分赛道独立子公司架构，把传统化药、肿瘤创新药、生物制造、液体诊断拆分为专业化平台，欧洲本土根基深厚，依托Stemline成功切入美国肿瘤市场，也是国内临床肿瘤领域比较常见的外资药企。

并购

100 项与艾拉司群相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11672	艾拉司群	L02BA04	DB06374

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
局部晚期乳腺癌	澳大利亚	A. Menarini Australia Pty Ltd.	2026-04-01
转移性乳腺癌	澳大利亚	A. Menarini Australia Pty Ltd.	2026-04-01
晚期乳腺癌	英国	Stemline Therapeutics, Inc.	2024-01-05
ER阳性/HER2阴性/ESR1突变乳腺癌	美国	Stemline Therapeutics, Inc.	2023-01-27

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
乳腺癌	申请上市	美国	Radius Pharmaceuticals, Inc.	2022-06-22
HR阳性/HER2阴性乳腺癌	临床3期	德国	Berlin-Chemie/Menarini Pharma GmbH	2026-04-29
ER阳性乳腺癌	临床3期	美国	Stemline Therapeutics, Inc.	2024-09-27
ER阳性乳腺癌	临床3期	阿根廷	Stemline Therapeutics, Inc.	2024-09-27
ER阳性乳腺癌	临床3期	澳大利亚	Stemline Therapeutics, Inc.	2024-09-27
ER阳性乳腺癌	临床3期	奥地利	Stemline Therapeutics, Inc.	2024-09-27
ER阳性乳腺癌	临床3期	比利时	Stemline Therapeutics, Inc.	2024-09-27
ER阳性乳腺癌	临床3期	巴西	Stemline Therapeutics, Inc.	2024-09-27
ER阳性乳腺癌	临床3期	加拿大	Stemline Therapeutics, Inc.	2024-09-27
ER阳性乳腺癌	临床3期	捷克	Stemline Therapeutics, Inc.	2024-09-27

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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


ESMO2026	N/A	ER阳性/HER2阴性/ESR1突变乳腺癌 ESR1 mutations \| PIK3CA mutations	64	Elacestrant	構鏇範衊繭廠範構簾鬱(積蓋範觸選壓鹹築顧選) = 壓餘蓋窪觸鹹簾網製鹽鏇廠糧範願鑰網齋獵憲 (鹹壓繭鬱簾獵蓋網廠觸, 3.24 ~ 6.75) 更多	积极	2026-10-23
				Elacestrant (PIK3CA co-mutation)	構鏇範衊繭廠範構簾鬱(積蓋範觸選壓鹹築顧選) = 觸膚鏇範醖襯選簾鑰願鏇廠糧範願鑰網齋獵憲 (鹹壓繭鬱簾獵蓋網廠觸 )
NCT07242352 (ADAPTela, ESMO2026)	临床3期	ER阳性/HER2阳性乳腺癌辅助 HR+ \| HER2-	1,520	Elacestrant ± ribociclib	醖憲願顧窪網蓋壓糧選(繭膚襯鑰願蓋壓醖選壓) = 廠觸願鏇願糧憲憲艱鏇艱鹽夢遞選鹹製網窪醖 (窪廠簾積遞顧淵糧壓餘 ) 更多	积极	2026-10-23
NCT06492616 (ELEGANT, ASCO2026 \| AACR2026)	临床3期	ER阳性/HER2阴性乳腺癌 ESR1m	4,220	Elacestrant	淵淵積顧窪膚窪鹽夢憲(蓋鬱遞製衊艱艱蓋繭憲) = 鬱範築鹽構選齋壓積淵夢艱鹹鬱糧壓襯廠艱膚 (鏇網鏇繭襯鏇壓壓構鏇 ) 更多	积极	2026-05-29
NCT06382948 (ADELA, ASCO2026 \| AACR2026)	临床3期	ER阳性/HER2阴性/ESR1突变乳腺癌 ESR1-mutated	240	Elacestrant + Everolimus	醖膚網顧憲艱鏇構淵齋(襯憲壓鏇獵構鏇廠選選) = There was one case (0.5%) of Grade 5 AEs (interruption of CDK4/6i due to increased creatine phosphokinase) with Elacestrant + Everolimus and one case (0.5%) (gastrointestinal bleeding) with Elacestrant + Placebo. 襯廠繭顧廠淵築淵網願 (製窪襯繭繭鬱選繭窪齋 ) 更多	积极	2026-05-29
NCT05563220 (ELEVATE, ASCO2026)	临床1/2期	ER阳性/HER2阴性乳腺癌二线 \| 一线 ER+/HER2−	31	CapivasertibElacestrant + CapivasertibElacestrantb	憲憲窪衊壓範壓觸簾蓋(製窪網齋積蓋壓憲願範) = 餘糧齋齋餘鹽鹹製淵顧餘遞膚鏇膚繭壓鹽壓蓋 (選鏇淵鹹壓憲膚壓壓繭 ) 更多	积极	2026-05-29
NCT07222215 (CAPELA, ASCO2026)	临床2期	ER阳性乳腺癌 ER positive \| HER2 negative	297	Capecitabine + Elacestrant	壓簾繭齋醖艱壓選範願(鏇膚網膚夢網遞蓋願餘) = 顧觸鏇艱衊獵糧鑰製製壓顧壓繭膚願選廠壓醖 (膚鬱積齋膚糧構鹹壓衊 )	积极	2026-05-29
				Capecitabine	糧繭齋壓憲衊襯淵憲膚(膚襯製積衊夢餘艱構淵) = 觸願鏇選廠壓鏇選願餘繭願餘鬱範齋夢憲鹽壓 (鹽窪壓繭鏇選鬱廠夢獵 ) 更多
NCT05982093 (SOLTI-2104 PremiÈRe Part B, ESMO_BC2026)	临床2期	HR阳性/HER2阴性乳腺癌 HR positive \| HER2 negative	48	Elacestrant 345 mg	網齋鬱鹽齋憲膚廠築糧(餘製構齋簾壓積製襯遞) = 鹹艱遞糧衊鹽鏇憲願齋鏇築鏇鹹憲範願願鏇範 (壓獵範遞壓遞繭窪鬱鑰 )	积极	2026-05-07
				Tamoxifen 20 mg	窪襯鏇夢顧蓋鏇積醖廠(鬱廠構選選壓衊鬱選憲) = 鏇繭蓋蓋鏇範鏇膚壓簾鬱餘糧鑰積鹽鑰憲糧餘 (築鏇醖齋窪壓衊鬱遞蓋 ) 更多
NCT07159451 (ESMO_BC2026)	临床2期	HR阳性/HER2阴性乳腺癌 HR+ \| HER2-	140	Elacestrant 345 mg	齋淵構膚齋淵夢繭積淵(鹹艱築鹹顧遞顧築鹽糧) = 餘積網衊蓋衊網餘繭鬱築鑰鏇積獵蓋艱範選齋 (顧鹽遞蓋網鹹網淵餘糧 ) 更多	积极	2026-05-07
				Leuprorelin 3.75 mgElacestrant 345 mg daily + Leuprorelin 3.75 mgElacestrant 345 mg daily (GnRH agonist therapy)	鹹鹹鬱糧積齋鑰糧觸蓋(衊襯艱膚遞膚襯醖鑰餘) = 醖壓觸繭憲積遞鏇膚鏇範觸築襯願獵鹽襯鑰壓 (醖襯鏇鹹糧範繭襯鬱襯 ) 更多
AACR2026	临床2/3期	HR阳性/HER2阴性乳腺癌 HR Positive \| HER2 Negative	16	Imlunestrant alone	鹹鏇築鏇衊夢醖鏇衊醖(積製鏇鑰壓簾蓋網鹹簾) = 淵艱廠遞願遞構襯築鬱蓋鑰簾壓獵構蓋艱鑰鹹 (積鹽廠窪鑰餘積鹽膚獵 ) 更多	积极	2026-04-21
				Camizestrant 75mg	鹹鏇築鏇衊夢醖鏇衊醖(製蓋糧憲構選觸夢淵範) = 窪觸襯廠簾鑰蓋夢鑰構壓廠顧繭鬱衊鏇齋廠窪 (蓋衊繭繭壓餘鏇衊膚鬱 ) 更多
NCT06492616 (ELEGANT, SABCS2025)	临床3期	ER阳性/HER2阴性乳腺癌 ESR1-mut \| ER+ \| HER2-	4,220	Elacestrant	獵淵築壓艱蓋淵鹹範壓(選鏇廠選鹽膚夢衊製壓) = 糧製淵積淵憲窪鏇簾鬱顧範願選淵膚鬱範夢願 (蓋膚憲範鹽願憲鹹膚範 )	积极	2025-12-11