Rinatabart Sesutecan(Rinatabart Sesutecan) - 药物靶点：FOLR1 x Top I_在研适应症：铂敏感性卵巢癌，复发性子宫内膜癌，输卵管癌_专利_临床

概要

基本信息

药物类型

ADC

别名

Rina-S、GEN1184、PRO 1184

+ [2]

靶点

FOLR1 x Top I

作用方式

拮抗剂、抑制剂

作用机制

FOLR1拮抗剂(叶酸受体α拮抗剂)、TOP1抑制剂(DNA拓扑异构酶I抑制剂)

治疗领域

肿瘤内分泌与代谢疾病泌尿生殖系统疾病+ [4]

在研适应症

铂敏感性卵巢癌复发性子宫内膜癌输卵管癌+ [17]

非在研适应症-

原研机构

金麦安博生物制药（苏州）有限公司

在研机构

金麦安博生物制药（苏州）有限公司

Genmab A/S

非在研机构-

权益机构

Genmab A/S

金麦安博生物制药（苏州）有限公司

最高研发阶段临床3期

首次获批日期-

最高研发阶段(中国)临床3期

特殊审评突破性疗法 (美国)、突破性疗法 (中国)、快速通道 (美国)

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结构/序列

使用我们的ADC技术数据为新药研发加速。

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Sequence Code 1116840435H

来源: *****

Sequence Code 1116840436L

来源: *****

关联

7

项与 Rinatabart Sesutecan 相关的临床试验

NCT07564141

/ Not yet recruiting临床3期

A Randomized, Open-label, Phase 3 Study of Rina-S ± Bevacizumab Versus Investigator's Choice of Platinum-Based Chemotherapy ± Bevacizumab as 2L Treatment in Participants With Recurrent Platinum-Sensitive Ovarian Cancer

This Phase 3 study will be conducted in different countries around the world with up to about 688 participants.
The purpose of this study is to evaluate how well Rina-S works against ovarian cancer in combination with or without bevacizumab and how it compares to an investigator's choice of platinum-based chemotherapy with or without bevacizumab.
Participants will receive either:
* Rina-S monotherapy (by itself),
* Rina-S plus bevacizumab,
* investigator's choice chemotherapy (by itself) (standard of care), or
* investigator's choice chemotherapy plus bevacizumab (standard of care).
No participants will be given placebo. Participants will participate in 1 of 2 arms.
The treatment duration will be different for every participant. If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep getting study treatment for as long as the study is open.
Participants will be asked to attend 1 to 3 visits at the study clinic for each cycle (duration of cycle is 3 or 4 weeks, depending on medication received). During visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity and imaging) to monitor whether the study treatment is safe and effective.
The overall study duration (including screening, treatment, and follow-up) will be different for every participant.

开始日期2026-07-01

申办/合作机构

Genmab A/S

NCT07539311

/ Recruiting临床2期

A Phase 2, Open-label, Multicohort, Study of Rinatabart Sesutecan (Rina S) in Participants With Advanced Gastrointestinal (GI) Cancers

This Phase 2 study will be conducted in different countries around the world with up to about 160 participants.
The purpose of this study is to evaluate how well Rina-S works against GI cancers.
The medication in this study is Rina-S monotherapy (by itself; no other cancer treatments). All participants will receive active drug; no one will be given placebo.
Participation in the study will require visits to the study site(s). During site visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity, imaging/X-rays) to monitor whether the study treatment is safe and effective.
The duration of the study will be different for every participant, but an average study duration of 22 months is expected for participants. This will include a treatment period (expected to last an average of 12 months), plus data collection periods before and after treatment. Participants will be asked to attend 1 to 5 visits at the study clinic for each cycle (duration of an individual cycle is 21 days). If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep getting study treatment for as long as the study is open.

开始日期2026-05-11

申办/合作机构

Genmab A/S

NCT07225270

/ Recruiting临床3期

A Randomized, Open-Label, Phase 3 Study of Rinatabart Sesutecan (Rina-S) Plus Standard of Care Versus Standard of Care as Maintenance Treatment After 2L Platinum-Based Doublet Chemotherapy in Participants With Recurrent Platinum-Sensitive Ovarian Cancer (PSOC)

This Phase 3 study will be conducted in different countries around the world with up to about 528 participants.
The purpose of this study is to evaluate how well Rina-S works against ovarian cancer in combination with available standard of care therapy that is already approved and used for ovarian cancer.
Participants will receive either Rina-S monotherapy (by itself), Rina-S plus bevacizumab, bevacizumab (standard of care) by itself, or no treatment (only monitoring, also standard of care). No participants will be given placebo. Participants will participate in 1 of 2 arms.
The treatment duration will be different for every participant. If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep getting study treatment for as long as the study is open.
Participants will be asked to attend 1 to 3 visits at the study clinic for each cycle (duration of cycle is 3 weeks). During visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity and imaging) to monitor whether the study treatment is safe and effective. The overall study duration (including screening, treatment, and follow-up) for each participant will be different for every participant.

开始日期2026-04-03

申办/合作机构

Genmab A/S

100 项与 Rinatabart Sesutecan 相关的临床结果

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100 项与 Rinatabart Sesutecan 相关的转化医学

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100 项与 Rinatabart Sesutecan 相关的专利（医药）

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235

项与 Rinatabart Sesutecan 相关的新闻（医药）

2026-05-26

·BioSpace

Genmab to Highlight Advances Across Its Oncology Portfolio at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and the European Hematology Association (EHA) 2026 Congress

Media Release COPENHAGEN, Denmark; May 21, 2026 Twenty-three abstracts will highlight the versatility and strength of Genmab’s portfolio and pipeline, including data from the comprehensive epcoritamab development program, including 4 oral presentations Three abstracts will show the ongoing clinical trial evaluations of the safety and efficacy of Genmab’s investigational late-stage medicines, rinatabart sesutecan and petosemtamab Data evaluating epcoritamab will demonstrate outcomes across monotherapy, combination regimens and fixed-duration use, including outpatient administration and use in earlier lines of treatment Genmab A/S (Nasdaq: GMAB ) announced today that 23 abstracts, including 20 abstracts evaluating epcoritamab, a subcutaneous T-cell engaging bispecific antibody, will be presented or published at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL, from May 29-June 2, and at the European Hematology Association (EHA) 2026 Congress in Stockholm, Sweden, from June 11-14. Key presentations at ASCO and EHA will highlight data evaluating the potential utility of epcoritamab across multiple settings, including as a monotherapy, in combination regimens, in fixed-duration use and in earlier lines of therapy. Oral sessions will feature the first presentation of the full results from the Phase 3 EPCORE ® DLBCL-1 trial comparing epcoritamab monotherapy to investigator’s choice chemotherapy in patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL), as well as additional data from the Phase 3 EPCORE ® FL-1 trial evaluating epcoritamab in combination with rituximab and lenalidomide (R 2 ) versus R 2 alone in patients with R/R follicular lymphoma (FL). Additional presentations will include real-world evidence and health economic and outcomes research data, as well as overviews of trials-in-progress evaluating late-stage medicines. “This year at ASCO and EHA, Genmab will once again present data highlighting the depth and breadth of the epcoritamab development program, including encouraging results across multiple treatment settings for patients with B-cell malignancies. These findings underscore the versatility of epcoritamab as a monotherapy, in combination regimens and as a potential core therapy across the spectrum of B-cell malignancies,” said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. “Additional presentations and publications at ASCO will further reflect our commitment to advancing other antibody-based therapeutics.” All abstracts accepted for presentation and publication have been published and may be accessed online via the ASCO Meeting Library and EHA Open Access Library . Abstracts accepted for presentation at ASCO: Epcoritamab: Abstract Number Abstract Title Type of Presentation Date/Time of Presentation 7002* Phase 2 trial of epcoritamab in combination with rituximab-mini CVP for older unfit/frail or anthracycline-ineligible adult patients with newly diagnosed diffuse large B-cell lymphoma: Interim futility analysis Oral presentation Saturday, May 30, 3:00 PM-6:00 PM CDT 7061 Epcoritamab (epcor) + chemoimmunotherapy (CIT) in patients (pts) with relapsed/refractory large B cell lymphoma (R/R LBCL) eligible for autologous stem cell transplant (ASCT): Pooled results from Arms 4 and 10 of EPCORE NHL-2 Poster Monday, June 1, 9:00 AM-12:00 PM CDT e19003 NHL-6: Phase 2 study of subcutaneous (SC) epcoritamab as outpatient treatment for 2L+ relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) Publication Only NA *Investigator-led trial Rinatabart sesutecan (Rina-S ® ): Abstract Number Abstract Title Type of Presentation Date/Time of Presentation TPS5646 RAINFOL-03 (ENGOT-EN-31/GOG-3128): A phase 3, open-label, randomized study of Rinatabart sesutecan vs investigator’s choice of chemotherapy in patients with endometrial cancer after platinum-based chemotherapy and programmed death ligand 1 inhibition Poster Monday, June 1, 9:00 AM-12:00 PM CDT TPS5641 RAINFOL-04 (ENGOT-OV96/GOG-3134): A phase 3, open-label, randomized study of Rinatabart sesutecan plus standard of care (SOC) vs SOC as maintenance treatment after second-line platinum-based chemotherapy in patients with recurrent platinum-sensitive ovarian cancer Poster Monday, June 1, 9:00 AM-12:00 PM CDT Petosemtamab: Abstract Number Abstract Title Type of Presentation Date/Time of Presentation TPS8662 Petosemtamab plus pembrolizumab as first-line (1L) treatment of PD-L1 high metastatic non-small cell lung cancer (NSCLC): Global phase 2 trial Poster Sunday, May 31, 9:00 AM-12:00 PM CDT Abstracts accepted for presentation at EHA: Epcoritamab: Abstract Number Abstract Title Type of Presentation Date/Time of Presentation S229 Clinically Relevant Subgroup Analysis from the Randomized Phase 3 EPCORE FL-1 Trial: Treatment (Tx) Effect of Epcoritamab with Lenalidomide and Rituximab (R2) in R/R Follicular Lymphoma (FL) Oral Presentation Thursday, June 11, 16:45-18:00 CEST S235 Results From EPCORE DLBCL-1: Randomized Phase 3 Study of Epcoritamab (Epcor) Vs Investigator’s Choice Chemoimmunotherapy (CIT) in Patients with Relapsed/Refractory Large B-cell Lymphoma (R/R LBCL) Oral Presentation Friday, June 12, 17:15-18:30 CEST S153* Fixed Duration Venetoclax Plus Epcoritamab Shows Favorable Tolerability and High Response Rates with Early Molecular Responses in R/R CLL/SLL: Interim Analysis of the Randomized HOVON 165/AETHER Trial Oral Presentation Sunday June 14, 11:00-12:15 CEST *Investigator-led trial PF977 Sustained Remissions Beyond 4 Years with Epcoritamab Monotherapy: Long-term Follow-up Results from the Pivotal EPCORE NHL-1 Trial in Patients with Relapsed or Refractory Large B-cell Lymphoma Poster Friday, June 12, 18:45-19:45 CEST PF1007 Epcoritamab + R-mini-chop Results in 2-year Remissions and High MRD-negativity Rates in Elderly Patients with Newly Diagnosed DLBCL: Results from the EPCORE NHL-2 Trial Poster Friday, June 12, 18;45-19:45 CEST PF1069 Reduced CD20 Expression and Intratumoral CD3+ T Cells Following Epcoritamab Treatment Are Associated with Progressive Disease in a Subset of Diffuse Large B-cell Lymphoma and Follicular Lymphoma Poster Friday, June 12, 18:45-19:45 CEST PF1081 Pharmacodynamic Biomarkers Support the Clinical Benefit of Epcoritamab Plus Rituximab and Lenalidomide (R2) in Patients with Relapsed/Refractory Follicular Lymphoma (R/R FL): Analyses from EPCORE FL-1 Poster Friday, June 12, 18:45-19:45 CEST PS2035 Anchored Matching-adjusted Indirect Comparison of Epcoritamab, Lenalidomide, and Rituximab Vs Tafasitamab, Lenalidomide, and Rituximab in Relapsed/Refractory Follicular Lymphoma: EPCORE FL-1 Vs Inmind Poster Saturday, June 13, 18:45-19:45 CEST PS2042 Comparative Effectiveness of Epcoritamab, Lenalidomide, and Rituximab in EPCORE FL-1 Vs Real-world Chemoimmunotherapy in Relapsed/Refractory Lymphoma Poster Saturday, June 13, 18:45-19:45 CEST PS2052 Comparative Analyses of Epcoritamab in Combination with Lenalidomide and Rituximab Vs Obinutuzumab and Bendamustine in Relapsed/Refractory Follicular Lymphoma Poster Saturday, June 13, 18:45-19:45 CEST PS2070 Epcoritamab + Chemoimmunotherapy in Patients with Relapsed/Refractory Large B-cell Lymphoma Eligible for Autologous Stem Cell Transplant: Pooled Results from Arms 4 And 10 of EPCORE NHL-2 Poster Saturday, June 13, 18:45-19:45 CEST PS2082 Fixed-duration Epcoritamab Monotherapy Induces High Response and MRD-negativity Rates in Elderly Patients with Newly Diagnosed Large B-cell Lymphoma and Comorbidities: Results from EPCORE DLBCL-3 Poster Saturday, June 13, 18:45-19:45 CEST PS2086 Epcoritamab in Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL): Insights from the Real-world Epcoritamab Patient Characteristics and Outcomes Research (Real-epcor) Study Poster Saturday, June 13, 18:45-19:45 CEST PS2497 Epcoritamab Plus Lenalidomide and Rituximab Improves or Preserves Health-related Quality of Life in Patients with Relapsed/Refractory Follicular Lymphoma Who Had High Symptom Burden or Adverse Events Poster Saturday, June 13, 18:45-19:45 CEST NA Epcoreal: A Prospective Observational Trial-in-progress of Epcoritamab in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma and Follicular Lymphoma Publication Only NA NA Epcoritamab With Lenalidomide and Rituximab in Chinese Patients with Relapsed or Refractory Follicular Lymphoma: A Subgroup Analysis from the Phase 3 Epcore FL-1 Trial Publication Only NA NA Cost Per Complete Responder for Epcoritamab + Lenalidomide and Rituximab (R2) Vs Tafasitamab + R2 in Relapsed or Refractory Follicular Lymphoma: A US Medicare Perspective Publication Only NA The safety and efficacy of epcoritamab, Rina-S and petosemtamab have not been established for these investigational uses. About Epcoritamab Epcoritamab is an IgG1-bispecific antibody created using Genmab's proprietary DuoBody ® technology and administered subcutaneously. Genmab's DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells. i Epcoritamab (approved under the brand name EPKINLY ® in the U.S. and Japan, and TEPKINLY ® in the EU) has received regulatory approval in certain lymphoma indications in several territories. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Both companies will pursue additional international regulatory approvals for the investigational R/R FL indication and additional approvals for the R/R DLBCL indication. Genmab and AbbVie continue to evaluate epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes several ongoing Phase 3, open-label, randomized trials, among them a trial evaluating epcoritamab in combination with R-CHOP in adult patients with newly diagnosed DLBCL ( NCT05578976 ), a trial evaluating epcoritamab in combination with lenalidomide compared to chemotherapy infusion in patients with R/R DLBCL ( NCT06508658 ), and a trial evaluating epcoritamab in combination with lenalidomide and rituximab (R 2 ) compared to chemoimmunotherapy in patients with previously untreated FL ( NCT06191744 ). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit for more information. Please see local country prescribing information for all labeled indication and safety information. About Rinatabart Sesutecan (Rina-S; GEN1184 ) Rina-S; GEN1184 is an investigational ADC. It is composed of a novel human monoclonal antibody directed at FRα, a hydrophilic protease-cleavable linker, and exatecan, a topoisomerase I inhibitor payload. The clinical development program for Rina-S continues to expand, with multiple ongoing Phase 3 studies in patients with ovarian and endometrial cancer, alongside evaluation in other tumor types with unmet needs. The safety and efficacy of rinatabart sesutecan have not been established. Please visit for more information. About Petosemtamab (GEN1158) Petosemtamab is an investigational bispecific antibody targeting the epidermal growth factor receptor (EGFR) and the leucine-rich repeat containing G-protein-coupled receptor 5 (LGR5). By engaging both receptors, petosemtamab is designed to inhibit EGFR signaling and trigger EGFR degradation selectively in LGR5+ cancer stem-like cells to support multiple anti-tumor mechanisms, including enhanced immune-mediated activity. It is currently being investigated in head and neck squamous cell carcinoma (HNSCC) and other solid tumors, including colorectal cancer (CRC) and non-small cell lung cancer (NSCLC). The safety and efficacy of petosemtamab have not been established. Please visit for more information. About Genmab Genmab is an international biotechnology company dedicated to improving the lives of people with cancer and other serious diseases through innovative antibody medicines. For over 25 years, its passionate, innovative and collaborative team has advanced a broad range of antibody-based therapeutic formats, including bispecific antibodies, antibody–drug conjugates (ADCs), immune-modulating antibodies and other next-generation modalities. Genmab’s science powers eight approved antibody medicines, and the company is advancing a strong late-stage clinical pipeline, including wholly owned programs, with the goal of delivering transformative medicines to patients. Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X . Contact: David Freundel, Senior Director, Global Communications & Corporate Affairs T: +1 609 613 0504; E: dafr@genmab.com Andrew Carlsen, Vice President, Head of Investor Relations T: +45 3377 9558; E: acn@genmab.com This Media Release contains forward looking statements. The words “believe,” “expect,” “anticipate,” “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at . Genmab does not undertake any obligation to update or revise forward looking statements in this Media Release nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law. Genmab A/S and/or its subsidiaries own the following trademarks: Genmab ® ; the Y-shaped Genmab logo ® ; Genmab in combination with the Y-shaped Genmab logo ® ; HuMax ® ; DuoBody ® ; HexaBody ® ; DuoHexaBody ® , HexElect ® and KYSO ® . EPCORE ® , EPKINLY ® , TEPKINLY ® and their designs are trademarks of AbbVie Biotechnology Ltd. RAINFOL™ and Rina-S® are trademarks of ProfoundBio, U.S., Co. and Genmab (Suzhou) Co., Ltd. i Engelberts PJ, Hiemstra IH, de Jong B, et al. DuoBody-CD3xCD20 induces potent T-cell-mediated killing of malignant B cells in preclinical models and provides opportunities for subcutaneous dosing. EBioMedicine. 2020;52:102625. DOI: 10.1016/j.ebiom.2019.102625. Media Release no. 06 CVR no. 2102 3884 LEI Code 529900MTJPDPE4MHJ122 Genmab A/S Carl Jacobsens Vej 30 2500 Valby Denmark Attachment 052126_MR_06_ASCO_EHA 2026

临床3期免疫疗法临床2期ASCO会议上市批准

2026-05-24

·一点资讯

纳克生物FRα抗体：赋能ADC药物研发的关键组件

在靶向治疗领域，叶酸受体α（Folate Receptor Alpha, FRα）已成为抗体偶联药物（ADC）研发的重要靶点之一。目前，全球已有多个FRα靶向ADC进入临床开发阶段，其中ImmunoGen的Elahere（mirvetuximab soravtansine）已于2022年获FDA加速批准，用于治疗FRα高表达的铂耐药晚期卵巢癌。然而，该疗法仅覆盖部分患者群体，仍有大量未满足的临床需求，为新一代FRα ADC的研发提供了广阔空间。在此背景下，高质量、经实验验证的起始物料成为决定早期研发成效的关键要素。作为专注于生命科学领域的生物科技企业，纳克生物FRα抗体解决方案凭借其在蛋白表达、细胞株构建及纳米抗体定制方面的技术积累，正成为众多药企与科研机构推进FRα靶向药物开发的重要合作伙伴。 FRα靶点热度持续攀升，临床管线进入快速发展期 FRα是一种在多种实体瘤中高表达而在正常组织中低表达的跨膜糖蛋白，尤其在卵巢癌、子宫内膜癌、非小细胞肺癌等癌种中呈现过表达特征。这一独特的表达谱使其成为ADC药物的理想靶点。近期临床研究数据显示，FRα靶向药物在多个临床试验中展现出潜力。艾伯维公布的Mirvetuximab Soravtansine联合卡铂治疗铂敏感卵巢癌的II期临床数据显示，客观缓解率达到较高水平。与此同时，阿斯利康在中国启动了AZD5335的III期临床试验，将入组标准扩展至FRα低表达患者群体。此外，普方生物的PRO-1184、百奥泰的BAT8006、礼来的LY4170156等多款候选药物也已进入III期阶段，适应症从卵巢癌逐步拓展至肺癌、乳腺癌和间皮瘤等。这一发展的管线格局表明，FRα靶向治疗正从单点突破迈向多维拓展，而研发效率的提升高度依赖于可靠、标准化的早期工具链。 FRα靶向ADC药物研发进展概览纳克生物FRα抗体：全面的技术支撑体系杭州纳克生物科技有限公司（Nanogram Biotechnology Co., Ltd.）是一家集自主研发、品牌代理与技术服务于一体的生物科技企业。公司深耕生命科学、生物医药、医疗诊断及分析检测等核心领域，构建了产品与服务相结合的业务模式。针对FRα这一热点靶点，纳克生物推出了涵盖重组蛋白、稳定表达细胞株及定制化抗体的全链条解决方案：高纯度FRα重组蛋白：采用优化的哺乳动物表达系统，实现包括跨膜区在内的全长FRα蛋白的可溶性表达与高纯度纯化，适用于ELISA、SPR、流式细胞术等多种应用场景； FRα稳定表达细胞株：基于HEK293和CHO背景构建，表达水平稳定、批次一致性高，可用于抗体筛选、亲和力测定及功能验证；定制化FRα抗体开发：依托纳米抗体发现平台，可提供兔单抗、鼠单抗及人源化抗体的定制服务，支持Fc工程化改造以适配ADC偶联需求。纳克生物在高难度跨膜蛋白表达纯化领域积累了一定经验，其技术团队对FRα的构象稳定性、糖基化修饰及抗原表位暴露等关键参数具有理解，确保所提供的组件在研发场景中具备功能性。服务模式创新：全流程可追溯的一站式体验区别于传统试剂供应商，纳克生物建立了线上线下一体化的服务流程。客户可通过官网或专属客服提交项目需求，系统自动生成唯一项目编号，实现从订单确认、技术委托、实验执行到售后反馈的全链条数字化管理。公司为每个重点项目配备项目协调人员，定期汇报进度，确保沟通高效、问题及时响应。这种专项定制与定期跟进的服务机制，已在多家CRO、高校实验室及生物科技企业的合作中得到应用。纳克生物服务支持体系行业趋势与未来展望随着ADC技术平台的不断发展，FRα靶点的研发正从有效性验证转向优化改进。下一代FRα ADC的研发聚焦多个方向：突破表达阈值限制以覆盖更多患者；优化连接子与载荷以扩大治疗窗口；拓展至新适应症等。这些创新对起始物料的质量提出更高要求。纳克生物秉持科技赋能生命的理念，将持续投入FRα及相关靶点的工具开发。公司计划推出FRα/Fc融合蛋白、生物素标记版本等产品，进一步满足研发阶段的需求。对于研究人员而言，选择经过实验验证的纳克生物FRα抗体及相关组件，是提升研发效率的务实选择。在FRα靶向疗法迈向临床应用的过程中，高质量的基础工具将成为创新突破的重要基础。

抗体药物偶联物临床3期临床2期加速审批临床结果

2026-05-21

·ir.genmab.com

Genmab to Highlight Advances Across Its Oncology Portfolio at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and the European Hematology Association (EHA) 2026 Congress

Media ReleaseCOPENHAGEN, Denmark; May 21, 2026 Twenty-three abstracts will highlight the versatility and strength of Genmab’s portfolio and pipeline, including data from the comprehensive epcoritamab development program, including 4 oral presentations Three abstracts will show the ongoing clinical trial evaluations of the safety and efficacy of Genmab’s investigational late-stage medicines, rinatabart sesutecan and petosemtamab Data evaluating epcoritamab will demonstrate outcomes across monotherapy, combination regimens and fixed-duration use, including outpatient administration and use in earlier lines of treatment Genmab A/S (Nasdaq: GMAB) announced today that 23 abstracts, including 20 abstracts evaluating epcoritamab, a subcutaneous T-cell engaging bispecific antibody, will be presented or published at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL, from May 29-June 2, and at the European Hematology Association (EHA) 2026 Congress in Stockholm, Sweden, from June 11-14. Key presentations at ASCO and EHA will highlight data evaluating the potential utility of epcoritamab across multiple settings, including as a monotherapy, in combination regimens, in fixed-duration use and in earlier lines of therapy. Oral sessions will feature the first presentation of the full results from the Phase 3 EPCORE® DLBCL-1 trial comparing epcoritamab monotherapy to investigator’s choice chemotherapy in patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL), as well as additional data from the Phase 3 EPCORE® FL-1 trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) versus R2 alone in patients with R/R follicular lymphoma (FL). Additional presentations will include real-world evidence and health economic and outcomes research data, as well as overviews of trials-in-progress evaluating late-stage medicines. “This year at ASCO and EHA, Genmab will once again present data highlighting the depth and breadth of the epcoritamab development program, including encouraging results across multiple treatment settings for patients with B-cell malignancies. These findings underscore the versatility of epcoritamab as a monotherapy, in combination regimens and as a potential core therapy across the spectrum of B-cell malignancies,” said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. “Additional presentations and publications at ASCO will further reflect our commitment to advancing other antibody-based therapeutics.” All abstracts accepted for presentation and publication have been published and may be accessed online via the ASCO Meeting Library and EHA Open Access Library. Abstracts accepted for presentation at ASCO: Epcoritamab: *Investigator-led trial Rinatabart sesutecan (Rina-S®): Petosemtamab: Abstracts accepted for presentation at EHA: Epcoritamab: *Investigator-led trial The safety and efficacy of epcoritamab, Rina-S and petosemtamab have not been established for these investigational uses. About Epcoritamab Epcoritamab is an IgG1-bispecific antibody created using Genmab's proprietary DuoBody® technology and administered subcutaneously. Genmab's DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells.i Epcoritamab (approved under the brand name EPKINLY® in the U.S. and Japan, and TEPKINLY® in the EU) has received regulatory approval in certain lymphoma indications in several territories. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Both companies will pursue additional international regulatory approvals for the investigational R/R FL indication and additional approvals for the R/R DLBCL indication. Genmab and AbbVie continue to evaluate epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes several ongoing Phase 3, open-label, randomized trials, among them a trial evaluating epcoritamab in combination with R-CHOP in adult patients with newly diagnosed DLBCL (NCT05578976), a trial evaluating epcoritamab in combination with lenalidomide compared to chemotherapy infusion in patients with R/R DLBCL (NCT06508658), and a trial evaluating epcoritamab in combination with lenalidomide and rituximab (R2) compared to chemoimmunotherapy in patients with previously untreated FL (NCT06191744). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit www.clinicaltrials.gov for more information. Please see local country prescribing information for all labeled indication and safety information. About Rinatabart Sesutecan (Rina-S; GEN1184)Rina-S; GEN1184 is an investigational ADC. It is composed of a novel human monoclonal antibody directed at FRα, a hydrophilic protease-cleavable linker, and exatecan, a topoisomerase I inhibitor payload. The clinical development program for Rina-S continues to expand, with multiple ongoing Phase 3 studies in patients with ovarian and endometrial cancer, alongside evaluation in other tumor types with unmet needs. The safety and efficacy of rinatabart sesutecan have not been established. Please visit https://clinicaltrials.gov/ for more information. About Petosemtamab (GEN1158)Petosemtamab is an investigational bispecific antibody targeting the epidermal growth factor receptor (EGFR) and the leucine-rich repeat containing G-protein-coupled receptor 5 (LGR5). By engaging both receptors, petosemtamab is designed to inhibit EGFR signaling and trigger EGFR degradation selectively in LGR5+ cancer stem-like cells to support multiple anti-tumor mechanisms, including enhanced immune-mediated activity. It is currently being investigated in head and neck squamous cell carcinoma (HNSCC) and other solid tumors, including colorectal cancer (CRC) and non-small cell lung cancer (NSCLC). The safety and efficacy of petosemtamab have not been established. Please visit https://clinicaltrials.gov/ for more information. About Genmab Genmab is an international biotechnology company dedicated to improving the lives of people with cancer and other serious diseases through innovative antibody medicines. For over 25 years, its passionate, innovative and collaborative team has advanced a broad range of antibody-based therapeutic formats, including bispecific antibodies, antibody–drug conjugates (ADCs), immune-modulating antibodies and other next-generation modalities. Genmab’s science powers eight approved antibody medicines, and the company is advancing a strong late-stage clinical pipeline, including wholly owned programs, with the goal of delivering transformative medicines to patients. Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X. Contact: David Freundel, Senior Director, Global Communications & Corporate AffairsT: +1 609 613 0504; E: dafr@genmab.com Andrew Carlsen, Vice President, Head of Investor RelationsT: +45 3377 9558; E: acn@genmab.comThis Media Release contains forward looking statements. The words “believe,” “expect,” “anticipate,” “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Media Release nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law. Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; HexaBody®; DuoHexaBody®, HexElect® and KYSO®. EPCORE®, EPKINLY®, TEPKINLY® and their designs are trademarks of AbbVie Biotechnology Ltd. RAINFOL™ and Rina-S® are trademarks of ProfoundBio, U.S., Co. and Genmab (Suzhou) Co., Ltd. i Engelberts PJ, Hiemstra IH, de Jong B, et al. DuoBody-CD3xCD20 induces potent T-cell-mediated killing of malignant B cells in preclinical models and provides opportunities for subcutaneous dosing. EBioMedicine. 2020;52:102625. DOI: 10.1016/j.ebiom.2019.102625. Media Release no. 06CVR no. 2102 3884LEI Code 529900MTJPDPE4MHJ122 Genmab A/SCarl Jacobsens Vej 302500 ValbyDenmark Attachment 052126_MR_06_ASCO_EHA 2026

免疫疗法临床3期上市批准ASCO会议

100 项与 Rinatabart Sesutecan 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
铂敏感性卵巢癌	临床3期	美国	Genmab A/S	2026-04-03
铂敏感性卵巢癌	临床3期	日本	Genmab A/S	2026-04-03
复发性子宫内膜癌	临床3期	美国	Genmab A/S	2025-11-28
复发性子宫内膜癌	临床3期	日本	Genmab A/S	2025-11-28
复发性子宫内膜癌	临床3期	澳大利亚	Genmab A/S	2025-11-28
复发性子宫内膜癌	临床3期	比利时	Genmab A/S	2025-11-28
复发性子宫内膜癌	临床3期	加拿大	Genmab A/S	2025-11-28
复发性子宫内膜癌	临床3期	芬兰	Genmab A/S	2025-11-28
复发性子宫内膜癌	临床3期	挪威	Genmab A/S	2025-11-28
复发性子宫内膜癌	临床3期	波兰	Genmab A/S	2025-11-28

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临床结果

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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


NCT05579366 (RAINFOL-01, GlobeNewswire \| NEWS) 人工标引	临床1/2期	晚期子宫内膜癌	64	Rina-S 100 mg/m^2Rina-S 100 mg/m^2	網願鏇顧簾衊築憲膚製(艱製願鹹窪簾艱觸選築) = 鑰範憲膚構壓襯積糧鹹鏇壓築構憲醖糧積構衊 (鑰簾憲獵製鏇壓鏇鑰繭, 28.2 ~ 71.8) 更多	积极	2025-06-02
				Rina-SRina-S 120 mg/m^2	網願鏇顧簾衊築憲膚製(艱製願鹹窪簾艱觸選築) = 築鬱艱糧膚願積蓋顧餘鏇壓築構憲醖糧積構衊 (鑰簾憲獵製鏇壓鏇鑰繭, 29.8 ~ 64.9) 更多
NCT05579366 (GCT1184-01, ASCO2025) 人工标引	临床1/2期	晚期子宫内膜癌	64	Rina-S 100 mg/m2Rina-S 100 mg/m2	艱齋構遞網壓網構膚蓋(鏇鬱窪鹹構繭選襯獵糧) = 蓋築夢獵艱壓糧糧窪遞簾築鏇醖製鏇鏇齋壓積 (齋顧願簾醖鑰顧構齋衊 ) 更多	积极	2025-05-30
				Rina-SRina-S 120 mg/m2	艱齋構遞網壓網構膚蓋(鏇鬱窪鹹構繭選襯獵糧) = 齋願觸簾鹹鹹製構鑰鹽簾築鏇醖製鏇鏇齋壓積 (齋顧願簾醖鑰顧構齋衊 ) 更多
NCT06619236 (phase 3 study, ASCO2025)	临床3期	铂耐药性卵巢癌 folate receptor alpha (FRα)	-	Rinatabart sesutecan (Rina-S) 120 mg/m² IV Q3W	襯憲窪鏇醖襯齋膚憲廠(糧膚餘遞艱願蓋構範蓋) = 獵構壓襯衊顧艱餘壓鹹構觸遞遞觸襯糧鏇壓壓 (範鹽鬱積網製齋製觸壓, 26 ~ 74)	积极	2025-05-30
NCT05579366 (RAINFOL-01, PipelineReview) 人工标引	临床1/2期	卵巢癌	40	Rina-S 120 mg/m^2	選簾築遞鑰網積構製衊(獵夢簾鹹積艱鏇鏇網艱) = 願觸獵簾壓淵願窪鏇齋鏇齋遞壓鬱顧淵齋網構 (網觸製鹽齋鏇淵獵餘願, 30.8 ~ 78.5) 更多	积极	2025-03-17
				Rina-S 100 mg/m^2	選簾築遞鑰網積構製衊(獵夢簾鹹積艱鏇鏇網艱) = 夢範鹽餘膚獵廠觸範窪鏇齋遞壓鬱顧淵齋網構 (網觸製鹽齋鏇淵獵餘願, 7.8 ~ 45.4) 更多
NCT05579366 (NEWS) 人工标引	临床1/2期	原发性腹膜癌 \| 卵巢上皮癌 \| 输卵管癌	42	Rina-S 100 mg/m2	觸顧夢衊醖糧築齋糧遞(積廠鏇膚網構遞鑰繭遞) = 構窪蓋鹹鑰廠積齋廠願廠夢餘窪網艱鑰憲鏇蓋 (鏇齋願獵襯夢網襯膚糧 ) 更多	积极	2024-09-23
				Rina-S 120 mg/m2	觸顧夢衊醖糧築齋糧遞(積廠鏇膚網構遞鑰繭遞) = 網積顧醖獵壓繭繭壓遞廠夢餘窪網艱鑰憲鏇蓋 (鏇齋願獵襯夢網襯膚糧 ) 更多
NCT05579366 (PRO1184-001, ESMO2024) 人工标引	临床1/2期	卵巢癌 \| 子宫内膜癌二线 \| 末线 \| 三线 Folate receptor alpha Positive	101	Rina-S 100 mg/m2	窪廠願鏇構膚窪淵窪構(壓繭範選製廠衊醖鹽窪) = For Part A pts treated at 100 or 120 mg/m2 (n=35), the most common (≥20%) treatment-related adverse events (TRAEs) were nausea (n=20, 57%), neutropenia (n=18, 51%), leukopenia (n=16, 46%), anemia (n=15, 43%), thrombocytopenia (n=11, 31%), and vomiting (n=9, 26%); most events were Grade 1/2. The most common (≥10%) ≥ Grade 3 TRAEs were neutropenia (n=12, 34%), anemia (n=9, 26%), leukopenia (n=8, 23%), and thrombocytopenia (n=5, 14%). No ocular toxicity or interstitial lung disease was observed. The emerging safety profile of Rina-S in Part B is consistent with Part A. 壓製鹹鏇鑰願壓夢簾鏇 (鑰鹽醖網襯壓積糧艱遞 )	积极	2024-09-15
				Rina-S 120 mg/m2
NCT05579366 (PRO1184-001, SITC 12023 \| SITC 22023) 人工标引	临床1/2期	局部晚期恶性实体瘤 \| 转移性实体瘤末线 FRα expression	36	Rinatabart sesutecan (60 mg/m2-120 mg/m2)	繭鏇淵遞網膚鑰獵鹽顧(齋構鏇鬱顧醖網襯繭選) = Most treatment-related adverse events (TRAEs) are classified as grade 1 or 2. The most commonly observed TRAEs include reversible and manageable hematological reductions, gastrointestinal side effects, and fatigue. 選鑰繭襯壓餘憲遞簾憲 (鏇鏇鏇鬱範餘範廠艱淵 )	积极	2023-11-02
				Rinatabart sesutecan (No FRα expression in ovarian cancer and endometrial cancer)