A Phase 3, Open-Label, Multicenter, Randomized Study of Raludotatug Deruxtecan (MK-5909, R-DXd) With or Without Bevacizumab Versus Standard-of-Care Platinum-Based Doublet Chemotherapy With or Without Bevacizumab in Participants With Advanced Platinum-Sensitive High-Grade Serous or High-Grade Endometrioid Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Who Have Progressed During First-Line PARPi Maintenance (ENGOT-ov107 / GOG-3142 / REJOICE-Ovarian05)

Researchers are looking for new ways to treat advanced, high-grade ovarian cancer (OC). Advanced means the cancer has spread to other parts of the body (metastatic) and may not be removed with surgery. High-grade means the cancer cells grow and spread quickly. This trial includes types of OC that started in cells that cover the ovaries, in the lining of the belly, or in the fallopian tubes.
The usual treatment for high-grade OC may include one or both of these:
* Chemotherapy, which is a treatment that uses medicine to destroy cancer cells or stop them from growing.
* Bevacizumab, which is a targeted therapy that works to control how specific types of cancer cells grow and spread and targets tumor blood vessels.
Researchers want to learn about the trial medicine, raludotatug deruxtecan (also called R-DXd or MK-5909), when given with and without bevacizumab and how participants respond to it. R-DXd is an antibody drug conjugate (ADC). An ADC is a type of medicine that attaches to a specific target on cancer cells and delivers treatment to destroy those cells.
The goals of this trial are to learn if participants who receive R-DXd, with or without bevacizumab, live longer overall and without their cancer growing or spreading compared to those who receive usual treatment.

开始日期2026-10-05

申办/合作机构

Merck Sharp & Dohme LLC

[+1]

NCT07791732

/ Not yet recruiting临床3期

A Phase 3, Multicenter, Randomized, Open-Label Trial of Raludotatug Deruxtecan With or Without Bevacizumab as Maintenance Therapy Versus Standard of Care in Participants With First Recurrence Platinum-Sensitive, High-Grade Serous or Endometrioid Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (REJOICE-Ovarian03)

The primary purpose of the study is to evaluate the efficacy of R-DXd with or without bevacizumab as maintenance therapy compared with standard of care (SOC) in participants with platinum-sensitive ovarian cancer (PSOC) as measured by progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR).

开始日期2026-10-01

申办/合作机构

Daiichi Sankyo Co., Ltd.

[+1]

NCT07776691

/ Recruiting临床3期

A Phase 3, Randomized, Open-label Study of Raludotatug Deruxtecan (MK-5909, R-DXd) Maintenance Treatment With or Without Bevacizumab Versus Standard of Care in Participants With Newly-Diagnosed Advanced Non-HRD-Positive Ovarian Cancer Following First-line Platinum-based Chemotherapy (ENGOT-ov102/MITO/GOG-3141/ REJOICE-Ovarian 04)

Researchers are looking for new ways to treat ovarian cancer (OC). Current treatment for OC may start with surgery to remove as much of the cancer as possible. After surgery, people may receive chemotherapy. After chemotherapy, standard care options may include:
Maintenance treatment, which is used after another therapy to keep the cancer from growing, spreading, or coming back. Bevacizumab is a targeted therapy used as standard maintenance treatment. Targeted therapy works to control how specific types of cancer cells grow and spread.
Observation, which is watching to see if cancer grows or worsens. The study medicine, raludotatug deruxtecan- R-DXd, is a targeted therapy. The goal of this study is to learn if people who receive R-DXd maintenance treatment with or without bevacizumab live longer without the cancer getting worse than people who receive standard care.

开始日期2026-09-18

申办/合作机构

Merck Sharp & Dohme LLC

[+1]

100 项与 Raludotatug deruxtecan 相关的临床结果

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100 项与 Raludotatug deruxtecan 相关的转化医学

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项与 Raludotatug deruxtecan 相关的文献（医药）

2024-11-14·JOURNAL OF MEDICINAL CHEMISTRY

Evaluation of Double Self-Immolative Linker-Based Antibody–Drug Conjugate FDA022-BB05 with Enhanced Therapeutic Potential

Article

作者: Yin, Sicheng ; Liu, Shuangxi ; Zhang, Yifan ; Yang, Tong ; Zhang, Wenbo ; Shen, Keyu ; Xie, Qian ; Zhu, Shulei ; Gao, Bei ; Wu, Yinghan ; Song, Ruiwen ; Cao, Xuemei ; Qiu, Xuefei ; Cheng, Zhiyang ; Wang, Baoxia ; Zhao, Teng ; Xu, Jun ; Wu, Jingsong ; Li, Weinan ; Wang, Lei ; Guo, Qingsong ; Lu, Wei

Typical antibody-drug conjugates (ADCs) with valine-alanine linkage, often conjugated with the amino group in payloads, face challenges when interacting with hydroxyl group-containing payloads. Herein, we introduced a transformative Val-Ala-based double self-immolative linker-payload platform, reshaping ADCs by optimizing hydroxyl group-containing payload integration. Utilizing this platform, FDA022-BB05 was successfully conjugated with the hydroxyl group-containing payload DXd using trastuzumab (FDA022) as the monoclonal antibody (mAb). FDA022-BB05 demonstrated enhanced stability, effective cathepsin B sensitivity, reduced cell proliferation, increased bystander killing, and targeted delivery. Notably, acute toxicity evaluations in diverse preclinical models indicated favorable safety profiles and tolerability, with a broad therapeutic index in HER2-positive and -negative xenografts. Overall, these compelling findings support the promising therapeutic potential of FDA022-BB05, emphasizing the significance of diverse linker-payload platform strategies. This ADC is a valuable addition to targeted cancer therapy development, currently advancing through phase I clinical trials.

2024-10-01·MOLECULAR CANCER THERAPEUTICS

FZ-AD005, a Novel DLL3-Targeted Antibody–Drug Conjugate with Topoisomerase I Inhibitor, Shows Potent Antitumor Activity in Preclinical Models

Article

作者: Wu, Jinsong ; Lu, Wei ; Shen, Jiafei ; Zhao, Teng ; Gao, Bei ; Yang, Tong ; Song, Ruiwen ; Xie, Qian ; Guo, Qingsong ; Lou, Sensen ; Zhang, Yifan ; Zhu, Shulei ; Li, Weinan ; Wang, Lei

Abstract:

Delta-like ligand 3 (DLL3) is overexpressed in small cell lung cancer (SCLC) and has been considered an attractive target for SCLC therapy. Rovalpituzumab tesirine was the first DLL3-targeted antibody–drug conjugate (ADC) to enter clinical studies. However, serious adverse events limited progress in the treatment of SCLC with rovalpituzumab tesirine. In this study, we developed a novel DLL3-targeted ADC, FZ-AD005, by using DXd with potent cytotoxicity and a relatively better safety profile to maximize the therapeutic index. FZ-AD005 was generated by a novel anti-DLL3 antibody, FZ-A038, and a valine–alanine (Val–Ala) dipeptide linker to conjugate DXd. Moreover, Fc-silencing technology was introduced in FZ-AD005 to avoid off-target toxicity mediated by FcγRs and showed negligible Fc-mediated effector functions in vitro. In preclinical evaluation, FZ-AD005 exhibited DLL3-specific binding and demonstrated efficient internalization, bystander killing, and excellent in vivo antitumor activities in cell line–derived xenograft and patient-derived xenograft models. FZ-AD005 was stable in circulation with acceptable pharmacokinetic profiles in cynomolgus monkeys. FZ-AD005 was well tolerated in rats and monkeys. The safety profile of FZ-AD005 was favorable, and the highest nonseverely toxic dose was 30 mg/kg in cynomolgus monkeys. In conclusion, FZ-AD005 has the potential to be a superior DLL3-targeted ADC with a wide therapeutic window and is expected to provide clinical benefits for the treatment of patients with SCLC.

2024-05-01·Analytica chimica acta

Quantifying payloads of antibody‒drug conjugates using a postcolumn infused-internal standard strategy with LC‒MS

Article

作者: Yen-Shen Lu ; Wen-Chi Chang ; Ching-Hua Kuo ; Hsiao-Wei Liao ; Ching-Hung Lin ; Chih-Ning Cheng ; I-Chun Chen

BACKGROUND:

Antibody‒drug conjugates (ADCs) are innovative biopharmaceutics consisting of a monoclonal antibody, linkers, and cytotoxic payloads. Monitoring circulating payload concentrations has the potential to identify ADC toxicity; however, accurate quantification faces challenges, including low plasma concentrations, severe matrix effects, and the absence of stable isotope-labeled internal standards (SIL-IS) for payloads and their derivatives. Previous studies used structural analogs as internal standards, but different retention times between structural analogs and target analytes may hinder effective matrix correction. Therefore, a more flexible approach is required for precise payload quantification.

RESULTS:

We developed an LC‒MS/MS method incorporating a postcolumn-infused internal standard (PCI-IS) strategy for quantifying payloads and their derivatives of trastuzumab emtansine, trastuzumab deruxtecan, and sacituzumab govitecan, including DM1, MCC-DM1, DXd, SN-38, and SN-38G. Structural analogs (maytansine, Lys-MCC-DM1, and exatecan) were selected as PCI-IS candidates, and their accuracy performance was evaluated based on the percentage of samples within 80%-120% quantification accuracy. Compared to the approach without PCI-IS correction, exatecan enhanced the accuracy performance from 30-40%-100% for SN-38 and DXd, while maytansine and Lys-MCC-DM1 showed comparable accuracy for DM1 and MCC-DM1. This validated PCI-IS analytical method showed superior normalization of matrix effect in all analytes compared to the conventional internal standard approach. The clinical application of this approach showed pronounced differences in DXd and SN-38 concentrations before and after PCI-IS correction. Moreover, only DXd concentrations after PCI-IS correction were significantly higher in patients with thrombocytopenia (p = 0.037).

SIGNIFICANCE:

This approach effectively addressed the issue of unavailability of SIL-IS for novel ADC payloads and provided more accurate quantification, potentially yielding more robust statistical outcomes for understanding the exposure-toxicity relationship in ADCs. It is anticipated that this PCI-IS strategy may be extrapolated to quantify payloads and derivatives in diverse ADCs, thereby providing invaluable insights into drug toxicity and fortifying patient safety in ADC usage.

404

项与 Raludotatug deruxtecan 相关的新闻（医药）

2026-10-02

·BioSpace

Daiichi Sankyo and AstraZeneca Enter into Clinical Trial Collaboration with Summit Therapeutics to Evaluate Datroway® in Combination with Ivonescimab Across Multiple Tumor Types

TOKYO--(BUSINESS WIRE)--Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/NYSE: AZN) have entered into a clinical trial collaboration agreement with Summit Therapeutics Inc. (Nasdaq: SMMT) to evaluate Datroway ® (datopotamab deruxtecan) in combination with ivonescimab across multiple tumor types including lung and breast cancers. The companies intend to begin with a phase 3 trial in first-line triple negative breast cancer (TNBC). Datroway is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca. “At Daiichi Sankyo, we are focused on maximizing the potential of our DXd antibody drug conjugate portfolio through innovative combinations and strategic collaborations that support the continued advancement of our pipeline,” said John Tsai, MD, Global Head, R&D, Daiichi Sankyo. “We are encouraged by the opportunity to explore ivonescimab in combination with Datroway to potentially deliver clinically meaningful benefit to patients.” “Central to our strategy to transform cancer outcomes is harnessing the power of immunotherapy and antibody drug conjugate combinations to drive deeper, more durable responses,” said Susan Galbraith, Executive Vice President, Oncology Hematology R&D, AstraZeneca. “We believe the combination of Datroway and ivonescimab has the potential to make a meaningful difference in multiple tumor types including lung and breast cancers.” “We believe this collaboration with Daiichi Sankyo and AstraZeneca reflects increasing conviction in ivonescimab’s potential as a foundational next-generation immunotherapy and advances our ambition for ivonescimab to become the global PD-1/VEGF partner of choice for novel combinations,” said Maky Zanganeh, President and Co-Chief Executive Officer, Summit Therapeutics. “Beginning with a phase 3 study in first-line triple negative breast cancer, this collaboration represents an important expansion of Summit’s global development program into breast cancer and a path for additional solid tumor settings.” Under the terms of the agreement, each company will contribute their respective compound for the planned combination trials, which will be sponsored by AstraZeneca or Daiichi Sankyo. AstraZeneca, Daiichi Sankyo and Summit will each contribute to trial costs, and each company will retain development and commercial rights to their respective medicines. Ivonescimab is a novel, potential first-in-class bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. About Datroway Datroway (datopotamab deruxtecan; datopotamab deruxtecan-dlnk in the U.S. only) is a TROP2 directed ADC. Designed using the proprietary DXd ADC Technology of Daiichi Sankyo, Datroway is one of seven DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca’s ADC scientific platform. Datroway is comprised of a humanized anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. Datroway (6 mg/kg) is approved in more than 30 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy based on the results from the TROPION-Breast02 trial. Datroway (6 mg/kg) is approved in more than 45 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HR positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease based on the results from the TROPION-Breast01 trial. Datroway (6 mg/kg) is approved in Brazil, Russia, Singapore and the U.S. for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy based on the results from TROPION-Lung05 and TROPION-Lung01 trials. Continued approval for this indication in the U.S. may be contingent upon verification and description of clinical benefit in a confirmatory trial. About the Datroway Clinical Development Program A comprehensive global clinical development program is underway with more than 20 trials evaluating the efficacy and safety of Datroway across multiple cancers, including non-small cell lung cancer (NSCLC), TNBC and urothelial cancer. The program includes eight phase 3 trials in lung cancer, five phase 3 trials in breast cancer and one phase 3 and one phase 2/3 trial in urothelial cancer evaluating Datroway as a monotherapy and in combination with other cancer treatments in various settings. About the Daiichi Sankyo and AstraZeneca Collaboration Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize Enhertu ® in March 2019 and Datroway in July 2020 , except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of Enhertu and Datroway. About the ADC Portfolio of Daiichi Sankyo The Daiichi Sankyo ADC portfolio consists of nine ADCs in clinical development crafted from ADC technology discovered in-house by Daiichi Sankyo. The DXd ADC Technology platform of Daiichi Sankyo consists of seven ADCs in clinical development where each ADC is comprised of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADCs include Enhertu and Datroway, which are being jointly developed and commercialized globally with AstraZeneca, and ifinatamab deruxtecan (I-DXd), raludotatug deruxtecan (R-DXd) and patritumab deruxtecan (HER3-DXd), which are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA. DS-3939 and DS3790 are being developed by Daiichi Sankyo. Additional ADCs being developed by Daiichi Sankyo include DS3610, which consists of an antibody attached to a novel payload that acts as an agonist of STING, and DS1025, which consists of a CD25 directed antibody attached to an immuno-oncology optimized cytotoxic payload. Ifinatamab deruxtecan, raludotatug deruxtecan, patritumab deruxtecan, DS-3939, DS3610, DS3790 and DS1025 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established. About Daiichi Sankyo Daiichi Sankyo (TSE: 4568) is a global healthcare company committed to becoming a trusted healthcare innovator, transforming the lives of people through its strength in science and technology. The company discovers and develops new standards of care to address diverse medical needs to fulfill its purpose of contributing to the enrichment of quality of life around the world. With a strategic focus on oncology, Daiichi Sankyo is advancing an industry-leading antibody drug conjugate portfolio along with identifying new breakthrough generating technologies to deliver practice-changing medicines to patients, healthcare professionals and society. For more information, please visit . Contacts MEDIA CONTACTS: G lobal: Jennifer Brennan jennifer.brennan@daiichisankyo.com + 1 908 900 3183 (mobile) Japan: DS-PR_jp@daiichisankyo.com INVESTOR RELATIONS CONTACT: DaiichiSankyoIR_jp@daiichisankyo.com

免疫疗法引进/卖出临床3期抗体药物偶联物上市批准

2026-09-30

·凯莱英生物市场部

ADC 3.0时代：瑞银报告解读ADC后续竞争法则与亚太机遇

当下，抗体偶联药物（ADC）正经历从“概念验证”到“精准调控”的关键时刻。瑞银近日发布深度研究报告《亚太聚焦：ADC 3.0时代》对全球2300余个ADC项目进行了系统性梳理，首次提出了ADC 3.0的技术框架，并对亚太地区主要ADC开发企业的竞争格局与投资价值进行了全面评估。一直以来，ADC被形象地称为"生物导弹"，瑞银在报告中复盘了全球超过2300个ADC 项目（含已终止），提出了清晰的技术代际划分：技术创新层面，ADC3.0 的关键点分布在载荷、连接子、分子构型三个角度：载荷创新：下一代TOP1抑制剂、非TOP1类毒素；双载荷ADC；STING/TLR 激动剂的免疫刺激 ADC；蛋白降解分子。连接子与偶联技术：从单纯追求血液中稳定、胞内裂解，走向定点偶联、亲水间隔臂、肿瘤微环境条件性裂解连接子，解决高DAR下分子聚集、提前清除的痛点，改善CMC工艺，实现DAR高度均一。新型分子构型：双抗ADC等，用于抗原内吞效率低、肿瘤高度异质性的靶点。二、市场图景：2030年有望冲击660亿美元 2025年全球ADC市场规模约171亿美元，2021–2025年复合年增长率（CAGR）高达32%，其中第一三共的Enhertu贡献了最大销售额。瑞银预测：2030年全球ADC市场约370亿美元-660亿美元，并且认为科伦博泰的芦康沙妥珠单抗（sac-TMT）预计对增量贡献最大。值得关注的是，当前尚无ADC生物类似药上市，技术壁垒和复杂监管要求仍然较高，为ADC市场提供了额外的发展窗口期。就算像罗氏Kadcyla这样的初代ADC，威胁也往往源于下一代创新产品（如Enhertu）的竞争，而非生物类似药的冲击。据报告统计，全球累计开发ADC项目超过2334 个，HER2（>150 个）、TROP2（81个）、B7‑H3（38 个）是管线最为拥挤的三大靶点。中国企业已经成为全球ADC研发核心力量，报告判断中国开发的ADC陆续获得 FDA、EMA批准上市只是时间问题。热门靶点竞争概况： HER2：Enhertu的统治地位短期内难以撼动。多数在研HER2 ADC仍使用TOP1载荷。其专利保护至2033年，在超过15000名患者中积累的临床证据极为充分，竞品若要抢占份额，需要头对头证明优效且ILD显著更低，这一门槛极高。 TROP2：吉利德Trodelvy、第一三共Datroway、科伦博泰sac‑TMT 在这一靶点已实现商业验证，构成了第一梯队。吉利德的Trodelvy在乳腺癌中疗效较好，但在NSCLC的EVOKE-01试验中未达到OS终点；第一三共的Datroway虽在TROPION-Lung01中改善了PFS，但OS未达统计学显著。默沙东/科伦博泰的sac-TMT则在OptiTROP-Lung05中展现出强劲数据。整体在适应症扩展竞争相当激烈。 B7‑H3：尚无获批产品，多个项目正在快速推进。宜联生物 YL201 已在今年7月申报上市，成为国内首个申报上市的B7-H3 ADC药物。第一三共的I‑DXd 已在美国申报上市，并获得优先审评。 CDH6：第一三共的R‑DXd是唯一进入III期的药物，其他竞争对手尚处于 I 期阶段。 HER3：赛道格局发生显著转变，双抗ADC正在挤压单靶点 HER3 ADC的市场空间。百利天恒的 iza‑bren(EGFR×HER3）已成为全球首个获批双抗ADC，市场前景广阔。 Nectin‑4：安斯泰来的Padcev建立了很高临床壁垒，未来5‑6年内完全替代Padcev难度很大。靶点赛道的重要演进方向是从传统 MMAE 载荷切换为 TOP1 载荷，解决 Padcev 耐药后治疗需求。 CLDN18.2：市场重心逐步由胰腺癌转向胃癌。安斯泰来的 Vyloy 在胃癌确立地位，信达的IBI343治疗晚期胃癌的III期临床也已达终点，并于今年6月提交上市申请。三、亚太 ADC 企业的竞争定位与核心看点瑞银在几大靶点之外，明确给出了诸多重点关注的ADC领域亚太公司：科伦博泰：瑞银认为市场尚未充分认知 sac‑TMT 由默沙东主导的 17 项全球 III 期临床试验价值，这些试验覆盖肺癌、乳腺癌等多个肿瘤领域，是管线资产中最核心的驱动因素。映恩生物：公司在WCLC 2026上展示了鼓舞人心的SCLC数据（ADC联合双抗组合），但投资者认为数据尚处早期阶段。瑞银认为BioNTech主导的全球III期临床启动将成为关键催化剂。信达生物：市场普遍认为 CLDN18.2、HER2 等管线相对拥挤，但其早期ADC管线（包括EGFR/B7H3 ADC、EGFR/c-MET双载荷ADC等）的价值被有所低估。 LigaChem Bio：股价年初至今大幅回调，对外授权交易落地慢于预期；当前主要反映 HER2、TROP2 传统管线，平台下其他新型ADC资产几乎未被估值。第一三共：Enhertu是奠定全球ADC地位的龙头；但TROP2和B7-H3等靶点竞争加剧，市场预期有所回落，Datroway面临激烈竞争。安斯泰来：Vyloy 建立了CLDN18.2 赛道基础，其他新型ADC的开发具有高度差异化潜力。翰森制药：B7‑H3 ADC、B7‑H4 ADC具备先发优势，绑定GSK、罗氏的全球研发能力；但下一代差异化 ADC 的开发能力仍然有限。小结 ADC产业已经走过依靠高DAR实现疗效扩张的2.0时代，ADC3.0不再追求 “毒素越强越好”，而是转向疗效‑安全窗口的精细化平衡。几百亿美元的市场空间背后，竞争不再只是靶点扎堆，而是载荷、连接子、偶联技术、生物标志物、临床方案的综合比拼。亚太尤其是中国创新企业，凭借丰富管线、频繁的BD授权，已经成为全球ADC变革的重要力量。但管线数量不等于临床成功，拥挤靶点容易陷入同质化价格竞争；真正具备长期价值的，是能够解决未满足临床需求，在III期证实治疗的差异化产品。同时， ADC 生物类似药受专利、CMC、监管多重约束，不会快速冲击成熟大单品，原研企业仍拥有较长时间窗口去推进一线、围手术期、联合治疗的发展。参考资料： 1.UBS. Global Biopharmaceuticals APAC Focus: ADC 3.0: Widening the efficacy and safety window [R]. 25 September 2026.

抗体药物偶联物生物类似药上市批准

2026-09-29

·科学网

40亿美元豪赌，三年三次受挫：默克押注ADC，等得起2028吗？

凤凰涅槃医药观察本文同步发表于公众号：凤凰涅槃之路【资产征集｜全球药企BD需求持续更新】目前有多家美国及欧洲药企正在寻找可授权创新药资产，覆盖肿瘤、皮肤、神经、免疫、罕见病及505(b)(2)等方向。 1｜美国专科药企肿瘤｜皮肤科要求：II期完成或可直接商业化；面向美国市场；不接受505(b)(2)及生物改良品。 2｜欧洲上市药企｜505(b)(2)改剂型｜改给药途径｜缓释｜复方｜即用型注射剂｜老药新适应症优先：心血管｜疼痛｜CNS｜医院注射剂要求：活性成分已获美国或欧盟批准，可授出全球权利。 3｜欧洲大型药企｜神经与免疫神经：癫痫｜慢性神经痛｜帕金森｜ALS｜MS｜神经肌肉疾病等免疫：重症自身免疫与炎症｜新靶点/新机制｜免疫重置模态：小分子｜抗体｜基因/RNA药物｜细胞治疗阶段不限，优先已有PoC数据。 4｜欧洲大型药企｜肿瘤与罕见神经肿瘤：血液瘤｜脑瘤｜肺癌｜消化道肿瘤｜罕见癌｜肉瘤等模态：单抗｜ADC｜双/三抗｜TCE｜小分子罕见神经：ALS｜SMA｜DMD｜HD｜难治性癫痫｜Rett｜Angelman等模态：寡核苷酸｜小分子｜抗体。 📩 如有符合条件的资产，欢迎联系。匹配项目将进一步对接海外药企。WeChat：15901988028 2026年9月，Merck与第一三共宣布撤回B7-H3 ADC ifinatamab deruxtecan（I-DXd）在美国的BLA。该申请原计划走加速批准路径，用于铂类化疗后进展的广泛期小细胞肺癌（ES-SCLC）。三年前，Merck希望用三款DXd ADC补上Keytruda之后的增长曲线；三年后，其中两款核心资产先后遇阻，而最早可能兑现收入的时间正在被推向2028年前后。一、I-DXd不是没疗效，而是现有数据不足以换来提前上市 I-DXd的II期数据并不差。IDeate-Lung01共纳入187例患者，12 mg/kg剂量组确认ORR达到48.2%，中位缓解持续时间5.3个月，中位PFS 4.9个月，中位OS 10.3个月。对于既往接受过治疗、预后较差的ES-SCLC，这组数据足以证明药物具有临床活性。问题在于，FDA认为现有数据尚不足以支持加速批准。Merck和第一三共因此撤回申请，继续等待III期IDeate-Lung02。这件事反映的是一个越来越现实的监管变化：单臂II期加高ORR，已经很难像过去那样轻松换来一张提前上市的门票。 ES-SCLC也不再是无药可用的市场。Amgen的DLL3×CD3双抗Imdelltra已经上市，并进一步拿到随机III期生存数据。在这种情况下，新药不仅要证明“有效”，还要回答一个更难的问题：相对于已有治疗，究竟改善了什么"看起来有效"和"可以获批"之间，差的往往就是一个对照组。二、2023年的三款ADC，如今已有两款先后遇阻 2023年10月，Merck与第一三共签下当年最受关注的ADC合作之一，围绕HER3-DXd、I-DXd和CDH6 ADC R-DXd展开全球共同开发和商业化。交易潜在总额最高可达220亿美元，Merck承担了数十亿美元级别的前期投入。当时Enhertu已经证明DXd平台的价值，而Merck必须在Keytruda专利悬崖到来之前找到新的肿瘤业务支柱。与其从头搭建ADC平台，不如直接买入一组已经进入临床开发的资产。但此后的进展并不顺利。HER3-DXd在2024年因第三方生产设施检查问题收到FDA的完整回复函（CRL，即不予批准并要求补充材料）；2025年，确证性III期HERTHENA-Lung02又未能在OS上达到统计学显著性，美国申请随后撤回。如今I-DXd的ES-SCLC加速批准路径也暂时走不通。第三款R-DXd仍在开发中，I-DXd在前列腺癌、食管鳞癌和SCLC的III期也还在推进。但从时间表看，多项关键研究的主要完成时间已经落到2028年前后。对一笔2023年签下的巨额交易来说，资本回报周期明显被拉长了。三、大额BD交易的风险结构现在判断Merck“买错了”还太早。真正值得复盘的，是当年交易中风险和时间是如何被定价的。三款资产靶点不同，但都来自DXd平台，制造与供应也主要由第一三共承担。这样的组合可以分散单一靶点失败的风险，却无法完全切断平台、制造、监管策略和开发执行层面的共同风险。HER3-DXd先碰到CMC问题，随后又遇到III期终点问题；I-DXd此次则暴露出对加速批准证据门槛的判断风险。这也是大型BD交易最容易被忽略的一点：资产数量增加，并不意味着风险一定同比下降。如果底层平台、开发体系和供应链高度相关，三个项目并不等于三个完全独立的赌注。对卖方而言，这同样值得思考。买家真正支付的，不是一个漂亮靶点或一组Phase II数据本身，而是风险调整后的未来现金流。临床阶段、竞争格局、监管路径和时间窗口，最后都会反映到首付款和里程碑结构里。四、中国B7-H3 ADC正在改变这场竞争的节奏 I-DXd遇阻的同时，B7-H3赛道的竞争格局已经发生变化。GSK从翰森制药引进的B7-H3 ADC risvutatug rezetecan（Ris-Rez），已经在中国III期研究中取得阳性结果：中位OS 18.5个月，对照组topotecan为10.3个月，死亡风险下降54%。过去，中国项目更多以早期资产、区域权益或价格优势进入全球BD视野；现在，一部分中国项目已经开始拿着随机III期和OS数据参与全球竞争。在B7-H3这条赛道上，Merck和第一三共原本希望用单臂II期数据抢时间，而Ris-Rez已经先拿到了随机III期生存数据。谁最终领先仍要看全球开发和监管结果，但至少在证据成熟度上，双方的位置已经不像两年前那样清晰。五、真正值得投资人盯住的是时间成本 I-DXd并没有出局。SCLC III期仍在推进，前列腺癌和食管鳞癌也保留着进入市场的可能；R-DXd同样还有机会。因此，现在给这笔交易盖棺定论并不合适。但投资人应该重新计算一件事：时间。Keytruda在美国的核心专利保护将在2028年前后进入关键节点，而第一三共合作中的多项III期结果也集中在这一时期。Merck当初花重金买ADC，不只是为了买几款药，更是在买Keytruda之后的时间窗口。因此，这笔交易最后值不值，不只取决于哪一款药能够上市，也取决于它们何时上市。医药行业最贵的从来不只是失败的临床试验。真正昂贵的是花了钱买时间，最后却没能把时间变成领先。而这，才是Merck这笔ADC豪赌走到中场后最值得观察的地方。往期推荐美国拟放行大部分中美药品授权交易，意味着什么？礼来33.5亿美元押注诺诚健华：这次买的不是一款药 AI 拿走86%的VC资金，Biotech怎么办？药未获批，3.16亿美元先锁定未来版税 AI巨头开始亲自做实验：Claude母公司Anthropic进军生物医药罗氏10亿美元押注双抗筛选平台：30万种组合里寻找下一代免疫药诺和诺德14亿美元押注Orbis：口服宏环药物开始抢生物药市场数百亿美元涌向中国创新药：辉瑞、BMS、阿斯利康为何集体“抢管线”？ 120亿美元赌错了吗？诺华Avidity并购遭遇三期重挫诺华折戟，Lp(a)赛道要重估了吗？礼来28.75亿美元押注“精准清除自身抗体” Flagship又出手：3500万美元押注“暗蛋白组+AI” 两款心脏病新药，打起了专利战细胞治疗赛道全景：谁在赚钱，谁在烧钱，谁在赌未来？ AI制药20年：烧掉数百亿美元之后，谁真正赚到了钱？渤健最高10亿美元收购RayThera：同一支团队三次创业、三次退出永远在黎明前：溶瘤病毒七十年沉浮与下一次机会 ADC的进化：从重磅炸弹到技术平台 RDC赛道全景解析：ADC之后，放射性药物正在重写肿瘤治疗 DAC赛道全景解析：当精准递送遇上蛋白降解 AOC赛道全景深度解析：ADC之后，下一个百亿美元治疗模态是谁？资本为何重新押注RNA？从RNA Editing到RNA Therapeutics的下一轮竞赛

100 项与 Raludotatug deruxtecan 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D13069	-	-	-

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
卵巢浆液性肿瘤	临床3期	-	Daiichi Sankyo Co., Ltd.	2026-10-01
铂敏感性输卵管癌	临床3期	-	Daiichi Sankyo Co., Ltd.	2026-10-01
铂敏感性卵巢癌	临床3期	-	Daiichi Sankyo Co., Ltd.	2026-10-01
输卵管癌	临床3期	美国	Merck Sharp & Dohme LLC	2026-09-18
HRD 阳性卵巢癌	临床3期	美国	Merck Sharp & Dohme LLC	2026-09-18
HRD 阳性卵巢癌	临床3期	以色列	Merck Sharp & Dohme LLC	2026-09-18
铂耐药性输卵管癌	临床3期	美国	Merck Sharp & Dohme LLC	2024-02-27
铂耐药性输卵管癌	临床3期	美国	Daiichi Sankyo Co., Ltd.	2024-02-27
铂耐药性输卵管癌	临床3期	中国	Merck Sharp & Dohme LLC	2024-02-27
铂耐药性输卵管癌	临床3期	中国	Daiichi Sankyo Co., Ltd.	2024-02-27

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06161025 (REJOICE-Ovarian01, ASCO2026)	临床3期	铂耐药性卵巢癌 CDH6 expression	600	R-DXd 5.6 mg/kg	選齋壓鏇鏇憲蓋鏇簾簾(獵廠鏇範衊夢艱齋鹽廠) = 襯鑰鬱獵積積蓋築願構繭簾壓積選鑰鑰製獵膚 (膚鹽衊壓積積憲簾膚鏇, 42.9 ~ 57.1) 更多	积极	2026-05-29
NCT04707248 (REJOICE-Ovarian01, ASCO2026)	临床1/2期	铂耐药性卵巢癌 CDH6 expression	286	Raludotatug deruxtecan 5.6 mg/kg Q3W	鹽醖選襯憲鬱鏇蓋繭築(觸鑰觸製範憲鏇鹹積積) = Higher R-DXd or DXd payload exposure was associated with an increase in drug-related TEAEs, including Grade ≥3 (G3+) AEs, any-grade ILD, G2+ gastrointestinal AEs (nausea/vomiting), G3+ cytopenias (anemia, neutropenia, thrombocytopenia), and AEs leading to dose reduction. 窪簾壓衊鹹糧鏇鹽選糧 (選簾觸淵繭獵糧遞選網 ) 更多	积极	2026-05-29
NCT04707248 (REJOICE-PanTumor01, ASCO_GU2026)	临床2期	泌尿生殖系统肿瘤 \| 妇科疾病 CDH6	40	R-DXd 5.6 mg/kg (Cervical Cancer)	鏇餘簾範蓋鑰積鹽蓋衊(淵蓋範遞觸糧選膚壓簾) = 襯窪製糧選積窪範網憲膚廠醖憲觸壓網窪簾構 (蓋遞艱壓網艱觸範積範 )	积极	2026-02-26
				R-DXd 5.6 mg/kg (Non-HGSOC)	鏇餘簾範蓋鑰積鹽蓋衊(淵蓋範遞觸糧選膚壓簾) = 鹹齋鑰夢簾鏇鏇窪壓構膚廠醖憲觸壓網窪簾構 (蓋遞艱壓網艱觸範積範 )
NCT06161025 (REJOICE-Ovarian01, ESMO 12025 \| ESMO 22025) 人工标引	临床2期	铂耐药性输卵管癌 \| 铂类耐药性原发性腹膜癌 \| 铂耐药性卵巢癌	107	R-DXd (4.8 mg/kg)	獵積願選顧壓蓋築夢鏇(繭夢襯構鏇醖壓獵鹹醖) = 簾窪夢襯顧艱鑰網鹽齋觸襯願襯齋壓廠願構壓 (膚選鹹淵鹽積膚衊製獵, 27.9 ~ 61.9) 更多	积极	2025-10-17
				R-DXd (5.6 mg/kg)	獵積願選顧壓蓋築夢鏇(繭夢襯構鏇醖壓獵鹹醖) = 遞製繭積繭餘觸鹹憲觸觸襯願襯齋壓廠願構壓 (膚選鹹淵鹽積膚衊製獵, 32.9 ~ 67.1) 更多
NCT06780085 (KEYMAKER-U01, ESMO2025)	临床2期	转移性非小细胞肺癌	240	R-DXd 5.6 mg/kg Q3W	鹽夢醖構繭鏇積鑰艱衊(夢鑰觸顧鹹遞膚選蓋簾) = 醖選窪齋構淵鑰廠鏇夢窪壓製醖淵壓鏇積製獵 (憲製夢夢艱醖簾蓋遞鹹 )	积极	2025-10-17
				I-DXd 12 mg/kg Q3W	鹽夢醖構繭鏇積鑰艱衊(鹽淵醖製築顧遞遞顧選) = 鏇製壓淵齋壓顧憲蓋衊鑰餘鹽製餘鑰餘鏇選蓋 (窪積壓糧襯積鏇遞鑰齋 ) 更多
NCT04707248 (Corporate Publications) 人工标引	临床1期	卵巢癌	50	Raludotatug deruxtecan	獵鏇艱鬱餘獵鹹糧壓鑰(願鏇築鑰簾願製艱鑰製) = 齋膚齋願製壓獵齋襯觸蓋齋齋積鏇齋壓願襯觸 (鏇鏇齋鑰鏇範鹽積構餘, 32 ~ 61) 更多	积极	2023-10-22
NCT04707248 (ESMO 12023 \| ESMO 22023) 人工标引	临床1期	卵巢癌	42	R-DXd at 4.8 mg/kg	蓋製顧範糧範簾積壓鹹(衊選繭憲鏇糧網淵鬱製) = 壓艱獵遞鹽窪醖衊範艱顧構艱簾築範壓襯鏇廠 (衊膚窪淵遞遞鏇願鏇範 ) 更多	积极	2023-10-22
				R-DXd at 6.4 mg/kg	蓋製顧範糧範簾積壓鹹(衊選繭憲鏇糧網淵鬱製) = 襯艱醖淵獵簾選襯繭觸顧構艱簾築範壓襯鏇廠 (衊膚窪淵遞遞鏇願鏇範 ) 更多
NCT04707248 (ASCO2022) 人工标引	临床1期	卵巢癌 \| 晚期肾细胞癌	22	DS-6000a	鏇繭遞餘壓廠蓋願窪夢(鑰齋醖鹽齋構選窪憲鏇) = 繭觸醖壓衊積窪廠壓鏇艱艱襯遞蓋鑰鏇憲觸壓 (窪窪醖齋襯遞鏇蓋鬱製 ) 更多	积极	2022-06-02