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/ -- The Menarini 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 Georgiamune

Georgiamune 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