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更新于：2025-07-14
Raludotatug deruxtecan
更新于：2025-07-14
概要
基本信息
非在研机构- |
最高研发阶段临床2/3期 |
首次获批日期- |
最高研发阶段(中国)临床2/3期 |
特殊审评孤儿药 (欧盟) |
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结构/序列
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Sequence Code 695523149H
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Sequence Code 695523152L
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关联
9
项与 Raludotatug deruxtecan 相关的临床试验NCT06780098
KEYMAKER-U01 Substudy 01I: A Phase 2, Randomized, Umbrella Study With Rolling Arms of Investigational Agents in Participants With Previously Treated Stage IV Squamous Non-small Cell Lung Cancer (NSCLC)
Researchers are looking for other ways to treat metastatic squamous non-small cell lung cancer (NSCLC). Squamous NSCLC is cancer that starts in squamous cells, which are flat cells that line the inside of the airways in the lungs. Metastatic means the cancer has spread to other parts of the body.
Standard treatment (usual treatment) for metastatic squamous NSCLC is immunotherapy with or without chemotherapy. Immunotherapy is a treatment that helps the immune system fight cancer. Chemotherapy is medicine that destroys cancer cells or stops them from growing. However, standard treatment may not work or may stop working to treat metastatic squamous NSCLC.
Researchers want to learn if study treatments that are antibody drug conjugates (ADCs) can treat metastatic squamous NSCLC that did not respond (get smaller or go away) to standard treatment. An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells.
The main goals of this study are to learn about:
* The cancer response to the study treatments compared to chemotherapy
* The safety of the study treatments and if people tolerate them
This study is one of the substudies being conducted under one pembrolizumab umbrella master protocol (MK-3475-U01/KEYMAKER-U01).
Standard treatment (usual treatment) for metastatic squamous NSCLC is immunotherapy with or without chemotherapy. Immunotherapy is a treatment that helps the immune system fight cancer. Chemotherapy is medicine that destroys cancer cells or stops them from growing. However, standard treatment may not work or may stop working to treat metastatic squamous NSCLC.
Researchers want to learn if study treatments that are antibody drug conjugates (ADCs) can treat metastatic squamous NSCLC that did not respond (get smaller or go away) to standard treatment. An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells.
The main goals of this study are to learn about:
* The cancer response to the study treatments compared to chemotherapy
* The safety of the study treatments and if people tolerate them
This study is one of the substudies being conducted under one pembrolizumab umbrella master protocol (MK-3475-U01/KEYMAKER-U01).
开始日期2025-05-28 |
申办/合作机构 |
NCT06780085
KEYMAKER-U01 Substudy 01H: A Phase 2, Randomized, Umbrella Study With Rolling Arms of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC)
Researchers are looking for new ways to treat metastatic nonsquamous non-small cell lung cancer (NSCLC) that has been treated before. Metastatic means the cancer has spread to other parts of the body. Nonsquamous means the cancer did not start in squamous cells, which are flat cells that line the inside of the lungs.
Standard treatment (usual treatment) for NSCLC is surgery, then immunotherapy with or without chemotherapy after surgery. Immunotherapy is a treatment that helps the immune system fight cancer. Chemotherapy is a medicine that works to destroy cancer cells or stop them from growing.
However, standard treatment may not work or may stop working for some people. Researchers want to know if 2 antibody drug conjugates (ADCs) can help treat metastatic nonsquamous NSCLC that did not respond (get smaller or go away) to treatment. An ADC attaches to specific targets on cancers cells and delivers treatment to destroy those cells.
Researchers will compare 2 different ADCs (the study treatments) to chemotherapy in this study. The goals of this study are to learn:
* About the safety of the study treatments and if people tolerate them
* How many people have the cancer respond to the study treatments
Standard treatment (usual treatment) for NSCLC is surgery, then immunotherapy with or without chemotherapy after surgery. Immunotherapy is a treatment that helps the immune system fight cancer. Chemotherapy is a medicine that works to destroy cancer cells or stop them from growing.
However, standard treatment may not work or may stop working for some people. Researchers want to know if 2 antibody drug conjugates (ADCs) can help treat metastatic nonsquamous NSCLC that did not respond (get smaller or go away) to treatment. An ADC attaches to specific targets on cancers cells and delivers treatment to destroy those cells.
Researchers will compare 2 different ADCs (the study treatments) to chemotherapy in this study. The goals of this study are to learn:
* About the safety of the study treatments and if people tolerate them
* How many people have the cancer respond to the study treatments
开始日期2025-05-13 |
申办/合作机构 |
NCT06843447
A Phase 1b/2 Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Raludotatug Deruxtecan With or Without Other Anticancer Investigational Agents in Participants With High-grade Serous Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Who Have Relapsed After Prior Platinum-based Chemotherapy
Researchers are looking for other ways to treat relapsed high-grade serous ovarian cancer. Relapsed means the cancer came back after treatment. High-grade means the cancer cells grow and spread quickly. Serous means the cancer started in the cells that cover the ovaries, the lining of the belly, or in the fallopian tubes.
Standard treatment (usual treatment) for people with relapsed high-grade serous ovarian cancer may include:
* Chemotherapy, which is a treatment that uses medicine to destroy cancer cells or stop them from growing
* Targeted therapy, which is a treatment that works to control how specific types of cancer cells grow and spread
Raludotatug deruxtecan (R-DXd) is a study treatment that is an antibody drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. Researchers want to know if R-DXd is safe to take with standard treatment and if people tolerate them together.
Standard treatment (usual treatment) for people with relapsed high-grade serous ovarian cancer may include:
* Chemotherapy, which is a treatment that uses medicine to destroy cancer cells or stop them from growing
* Targeted therapy, which is a treatment that works to control how specific types of cancer cells grow and spread
Raludotatug deruxtecan (R-DXd) is a study treatment that is an antibody drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. Researchers want to know if R-DXd is safe to take with standard treatment and if people tolerate them together.
开始日期2025-04-15 |
申办/合作机构 |
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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100 项与 Raludotatug deruxtecan 相关的专利（医药）
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13
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: Liu, Shuangxi ; Yin, Sicheng ; Zhang, Yifan ; Zhang, Wenbo ; Yang, Tong ; Shen, Keyu ; Zhu, Shulei ; Xie, Qian ; Gao, Bei ; Wu, Yinghan ; Song, Ruiwen ; Cao, Xuemei ; Qiu, Xuefei ; Cheng, Zhiyang ; Wang, Baoxia ; Zhao, Teng ; Xu, Jun ; Wu, Jingsong ; Li, Weinan ; Guo, Qingsong ; Wang, Lei ; 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·BIOORGANIC CHEMISTRY
Novel antibody-drug conjugates based on DXd-ADC technology
Review
作者: Chen, Yuchen ; Ye, Qiang ; Hu, Xuefang ; Bai, Lan ; Shi, Jianyou ; Ren, Zhiwen ; Chen, Rong ; Hu, Yuan
In recent years, antibody-drug conjugate (ADC) technology, which uses monoclonal antibodies (mAbs) to specifically deliver effective cytotoxic payloads to tumor cells, has become a promising method of tumor targeted therapy. ADCs are a powerful class of biopharmaceuticals that link antibodies targeting specific antigens and small molecule drugs with potent cytotoxicity via a linker, thus enabling selective destruction of cancer cells while minimizing systemic toxicity. DXd is a topoisomerase I inhibitor that induces DNA damage leading to cell cycle arrest, making it an option for ADC payloads. The DXd-ADC technology, developed by Daiichi Sankyo, is a cutting-edge platform that produces a new generation of ADCs with improved therapeutic metrics and has shown significant therapeutic potential in various types of cancer. This review provides a comprehensive assessment of drugs developed with DXd-ADC technology, with a focus on mechanisms of action, pharmacokinetics studies, preclinical data, and clinical outcomes for DS-8201a, U3-1402, DS-1062a, DS-7300a, DS-6157a, and DS-6000a. By integrating existing data, we aim to provide valuable insights into the current therapeutic status and future prospects of these novel agents.
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.
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项与 Raludotatug deruxtecan 相关的新闻（医药）2025-07-02
欢迎关注凯莱英要闻7月1日，中国药物临床试验登记与信息公示平台更新了一项第一三共/默沙东登记的B7-H3 ADC药物Ifinatamab Deruxtecan相关III期临床研究，该试验为在前线转移性去势抵抗性前列腺癌（mCRPC）受试者中比较Ifinatamab Deruxtecan与多西他赛的有效性和安全性。Ifinatamab Deruxtecan也成为首个启动前列腺癌适应症III期临床的 B7-H3 ADC。该试验是一项名为 IDeate-Prostate01 的国际多中心、随机、平行、开放性的III期研究，主要终点指标为总生存期（OS）以及影像学无进展生存期（rPFS），次要终点包含TFST、OR、DOR等多项指标。目标入组患者数量为国内216人，国外1440人。Ifinatamab deruxtecan (I-DXd，DS-7300a)是一款潜在 first-in-class 靶向 B7-H3 的 ADC。该药采用第一三共独有的 DXd ADC 技术设计，由人源化抗 B7-H3 IgG1 单克隆抗体通过可裂解四肽连接子与拓扑异构酶 I 抑制剂有效载荷（一种依喜替康衍生物，DXd）连接组成。目前，Ifinatamab deruxtecan是全球研发进展最快的B7-H3 ADC，在小细胞肺癌、非小细胞肺癌、前列腺癌、食管癌、黑色素瘤等多个热门肿瘤领域均进行探索，其中小细胞肺癌、食管癌、前列腺癌均已进入临床III期试验阶段。数据来源：Insight数据库2023年10月，默沙东与第一三共宣布就三款ADC候选药物：patritumab deruxtecan（HER3-DXd）、ifinatamab deruxtecan（I-DXd）和raludotatug deruxtecan（R-DXd）达成价值220亿美元的全球（除日本外）开发和商业化协议。B7-H3B7-H3（又称CD276）是一种Ⅰ型跨膜糖蛋白，属于B7超家族中的一员，在单核细胞和粒细胞及人体正常组织中均无表达，而在一些树突状细胞、T 细胞、自然杀伤（NK） 细胞和B 细胞上有表达是近年来新发现的免疫检查点。该靶点不仅可通过抑制免疫系统促成肿瘤细胞的免疫逃逸，还可通过一些非免疫途径介导肿瘤的转移、耐药、血管生成从而促进癌症进展。同属于B7家族的还有：B7-1（CD80）、B7-2（CD86）、B7-DC（PD-L2或CD273）、B7-H1（PD-L1或CD274）、B7-H2（ICOSLG）、B7-H4（VTCN1）、B7-H5（VISTA）、B7-H6（NCR3LG1）和 B7-H7（HHLA2）。B7家族被证明为T细胞激活中的共刺激或共抑制分子，其配体和受体在适应性免疫反应和恶性肿瘤中发挥关键作用。B7-H3靶点的研发可谓命途多舛，MacroGenics的B7-H3单抗曾因发生患者死亡而叫停针对头颈鳞癌的III期临床试验。如今也有接近60个项目处于非积极或不活跃状态。但这并没有阻拦各大企业对这一热门靶点的探索。现在，针对B7-H3靶点的单抗、双抗、融合蛋白、CAR-T疗法的开发都在进行中，最火热的仍属ADC。目前在研B7-H3靶点药物超过200个，ADC药物也接近70个，进入临床阶段的有20个。尚无获批上市的产品。国内企业中，翰森制药、宜联生物、映恩生物、信达生物、迈威生物、石药集团、百济神州等知名药业皆有所布局。医药交易方面，针对B7-H3靶点药物的交易达到14项，其中ADC就占11项之多。交易金额最大的属两笔国内企业与MNC巨头的授权许可。· 2023年12月，GSK与翰森制药达成全球独家授权许可协议（除大中华区外），以17.1亿美元引进翰森制药HS-20093。· 2023年4月，BioNTech与映恩生物达成独家许可合作协议，以16.7亿美元引进DB-1303（HER2）及DB-1311（B7-H3）两款药物。PD-(L)1与B7H3 ADC的双抗与联用近年来，PD-1+ADC 联合疗法在多种肿瘤一线治疗中表现十分亮眼。Ifinatamab deruxtecan作为B7-H3研发前列的领头者，在2024年4月，就启动了联合罗氏PD-L1抗体Atezolizumab，在小细胞肺癌患者中开展1/2期临床试验，计划入组总人数为149例。同样，还开展了联合帕博利珠单抗治疗一线局部晚期不可切除/转移性食管癌的I/II期临床试验。今年年初，宜联生物宣布与阿斯利康建立临床研究合作，共同探索YL201（靶向B7H3的抗体偶联药物）与度伐利尤单抗（抗PD-L1免疫检查点抑制剂）联用，治疗多种实体瘤的潜力。双方将共同启动一项多中心、开放性、I/Ib期研究，旨在评估YL201联合度伐利尤单抗在实体肿瘤患者中的安全性、有效性和药代动力学。翰森制药也在2025年正式启动HS-20093和PD-L1抗体Adebrelimab、EGFR抗体Cetuximab、前列腺去势药物恩杂鲁胺(Enzalutamide)等多种药物治疗实体瘤的I期试验。映恩生物与BioNTech达成交易的DB-1311也在2025年登记新的Ib/II期临床研究，联合PDL1/VEGF双抗BNT327用于治疗晚期肺癌。而映恩生物自身的DB-1419作为B7-H3/PD-L1双抗ADC也于陆续在国内外获批临床，用于治疗晚期/转移性实体瘤。感谢关注、转发，转载授权、加行业交流群，请加管理员微信号“queenachuen”。“在看”点一下
抗体药物偶联物临床3期临床成功临床结果临床2期
2025-07-02
·求实药社
来源：Insight数据库近日，CDE 官网显示，齐鲁制药注射用 QLS5133 获批临床，用于晚期实体瘤。这是齐鲁制药第 3 款获批临床的 ADC 药物。来源：CDE 官网QLS5133 是一款靶向 CDH6 的 ADC 药物，基于齐鲁自主研发的新型拓扑异构酶-1 （TOPO 1）抑制剂 QLS6917 平台，通过位点特异性偶联技术开发而成，DAR 值为 8。来源：AACR 2025齐鲁在 2025 AACR 大会上公布了 QLS5133 的临床前数据，结果显示。与 DS-6000a 相比，QLS5133 表现出更高的亲和力和内化率。在多项包含卵巢癌和肾细胞癌的 CDH6 表达人癌细胞系异种移植研究中，QLS5133 治疗可显著诱导肿瘤消退。Insight 数据库显示，目前全球有 6 款 CDH6 ADC 在研，进入临床的有 5 款。来源：Insight 数据库免责声明：文章内容仅供参考，不构成投资建议。投资者据此操作，风险自担, 关于对文中陈述、观点判断保持中立，不对所包含内容的准确性、可靠性或完整性提供任何明示或暗示的保证。请读者仅作参考，并请自行承担全部。联系我们IND 2025展位火热销售中！扫码立即咨询电话：13816031174（同微信）赞助形式包括但不仅限于演讲席位、会场展位、会刊彩页、晚宴赞助、会议用品宣传等。点击此处“阅读全文”咨询更多精彩！
AACR会议抗体药物偶联物临床申请申请上市
2025-06-27
近日，先声药业旗下的抗肿瘤创新药公司先声再明与美国生物制药公司NextCure宣布，双方就共同开发针对CDH6靶点的新型抗体偶联药物（ADC）新药SIM0505达成总额达7.45亿美元的合作协议。SIM0505目前正在中国进行1期临床试验，NextCure计划于2025年Q3在美国启动临床试验。尽管网上对这一消息评价大多都很积极，但二级市场对此却持消极态度，消息公布的第一个交易日，先声股价即下跌超10%。究其原因，从多个角度来看，这笔交易都属于资产“贱卖”。1、交易细节尽管交易双方在公告中都刻意回避具体细节，但因为NextCure是美国NASDAQ上市公司，其有义务向美国证券监管部门（SEC）公开交易细节。根据SEC披露的交易细节，该交易的首付款为1200万美元。第二笔付款为500万美元，触发条件是符合条件的融资事件发生或2025/12/31中的更早者。第三笔付款为价值100万美元的NextCure股票或现金，触发条件为SIM0505启动临床2期试验。接下来的付款为最高1.665亿美元开发和监管里程碑付款，以及最高5.35亿美元的销售里程碑付款。此外，NextCure还有权以最高2550万美元的开发和监管里程碑，利用先声再明的ADC平台开发一款ADC产品。不难看出，该交易的首付款+近期（2-3年）付款共1800万美元，而这个金额及交易总额都明显低于近2年出海的国内（处于相似开发阶段的）ADC产品的对应金额（表1）。表1. 近2年国内临床前/Ph1 ADC资产出海交易2、NextCureNextCure是由I/O领域先驱、PD-L1的发现者、美国耶鲁大学陈列平教授于2015年创立的，致力于开发下一代肿瘤免疫疗法。2016年1月，NextCure完成6700万美元A轮融资；2018年11月NextCure完成9300万美元B轮融资；2019年5月，NextCure正式在纳斯达克IPO上市，募资8600万美元。FIND-IO是NextCure的核心技术平台，通过高效识别驱动功能性免疫反应的新型细胞表面蛋白分子相互作用，快速开发和推进创新疗法，以恢复肿瘤微环境 (TME)或其它疾病部位中抑制性髓系细胞群、T细胞亚群或其它细胞群的正常免疫功能，即为“免疫正常化疗法”。2018年11月，NextCure与礼来达成1500万美元的合作协议，礼来通过使用NextCure专有的FIND-IO平台开发免疫肿瘤治疗。与此同时，NextCure使用FIND-IO平台发现了新靶点Siglec-15，并开发了其单抗（NC318），成为NextCure首个进入临床的药物。2019年11月，NextCure公布了NC318的1/2期临床阶段性数据，业界对其治疗PD-1抗体耐药患者寄予厚望，NextCure股价因此暴涨248%，市值冲过20亿美元大关（图1）。图1. NextCure股价走势图2022年12月，NextCure宣布由于疗效问题，全面终止其核心管线Siglec-15单抗NC318的开发工作。2023年3月，NextCure宣布裁员约37%，缩减研发管线，将资源投入到LAIR-2 Fc融合蛋白（NC410）以及与Legochem Biosciences合作的B7H4 ADC新药（LNCB74）上。而目前，NextCure的管线仅剩两款ADC药物，分别是上述的LNCB74及先声的SIM0505。而NextCure的股价在与先声的交易宣布后又进一步下跌了30%，目前市值仅剩1300万美元。一家十年前成立的明星I/O公司，如今沦落为靠引进项目“苟延残喘”的ADC公司，再次感叹创新药的十年河东十年河西。此外，据NextCure披露的财报显示，截至2025年Q1，其手头现金储备约5590万美元，仅够维持公司运营至2026年下半年。而在与先声的交易完成后，其现金储备将进一步减少，加上SIM0505的临床试验费用，在没有额外融资的情况下，公司可能在不到12个月内即将面临现金流断裂的窘境。NextCure目前市值显著低于其现金储备，从一个侧面反映了市场对其管线仅存的两款产品的悲观态度，特别是今年1月刚刚进入临床1期的LNCB74（B7H4-MMAE）。就在今年2月，由于临床疗效的原因，辉瑞宣布终止其B7H4-MMAE（Felmetatug vedotin）的进一步开发。3、ADC平台据先声再明于2024年10月公开的CDH6-ADC专利（WO2024213128）显示，其ADC平台沿用了第一三共的马来酰亚胺连接抗体半胱氨酸以及GGFG作为Linker（图2A）。图2. A：先声再明Linker/Payload；B：Exatecan；C：DXd；D：恒瑞；E：艾伯维；F：宜联；G：Seagen Payload结构示意图而先声的Payload结合了恒瑞与Seagen的设计（图2D&G），即在喜树碱的10/11号位引入亚甲二氧环，在7号位引入环丙基。而使用类似Payload的还有艾伯维（图2E）及宜联（图2F），目前有多款ADC（如ABBV-400、YL202等等）处于不同临床开发阶段。SIM0505已完成首批5例患者的给药，分为1.6 mpk与3.2 mpk两个剂量组。早期数据表明，1.6 mpk低剂量组已有患者达到部分缓解（PR），且整个队列尚未观察到任何间质性肺病（ILD）或≥3级治疗相关不良事件（TEAE）。在临床1期研究（NCT05029882）的剂量递增阶段，ABBV-400（cMET-ADC）的爬坡剂量范围为1.6-6.0mg/kg q3w，确定的最大耐受剂量（MTD）为3.0mg/kg q3w。在剂量扩展阶段，2.4mg/kg q3w和3.0mg/kg q3w剂量的ABBV-400具有可耐受和可管理的安全性特征，且抗肿瘤活性颇有前景。相对于3.0mg/kg，2.4mg/kg的长期耐受性似乎有改善，相对剂量强度较高，治疗相关不良事件发生率较低，因此2.4mg/kg很可能被定为推荐的2期剂量（RP2D）。YL202（Her3-ADC）在中、美同步开展的1期临床爬坡（已披露）共计入组55人，累计爬坡7个剂量组，剂量范围为0.5-5.5mg/kg Q3W，其中5.5mg/kg剂量组：出现一例DLT事件，为三级粒缺伴发热；4.0mg/kg剂量组：出现2例受试者因中性粒和血细胞减少死亡。目前，YL202集中在3.0mg/kg及以下剂量水平进行开发。据此推测，SIM0505可能需要在3.2 mpk剂量上下做更多的剂量探索以获得RP2D。4、CDH6-ADCCDH6（Cadherin 6）又名K-钙黏蛋白，属于II型钙粘蛋白，由三个不同结构域组成，一个含有五个钙粘蛋白序列的胞外结构域（ECD），一个跨膜区和一个胞内尾巴组成（图3）。图3. CDH6结构示意图CDH6在众多恶性肿瘤（如卵巢癌、小细胞肺癌、肾癌）中高表达，与CDH6蛋白表达水平低或缺失的病例相比，CDH6蛋白的过量表达预后更差。最早在临床探索CDH6-ADC的是诺华的NOV-13(HKT288)，这是一款以微管抑制剂DM1为Payload的ADC，但因为毒性原因而止步于临床1期。目前处于临床阶段的CDH6-ADC前两位的，分别是默沙东与第一三共的DS-6000（图4A）及普众发现与昂阔医药的AMT-707（CUSP06）（图4B），分别处于临床3期及1期。图4. A：DS-6000；B：CUSP-06结构示意图此外，翰森的CDH6-ADC（HS-20124）已于2024年10月启动临床1期；齐鲁的CDH6-ADC（QLS5133）已于今年4月申请IND。5、现金流先声再明全称为海南先声再明医药股份有限公司，成立于2020年12月，主要在抗肿瘤领域（细胞疗法以及基因诊断及治疗技术除外）从事药品的研发、制造及销售。2021-2022年，先声再明实现年收入分别为11.75亿元、13.48亿元；税前亏损分别为3.29亿元、4.85亿元。2023-2024年，先声再明的年收入分别为15.76亿元、12.98亿元；税前亏损不详。先声再明作为一个含着银汤匙出生的”富二代“，在成立之初就有多款上市产品及丰富的研发管线。但从其历年财务数据可以看出，先声再明其实是一个”负二代“，其一直处于亏损状态，并且由于2024年的收入大幅下滑，预计其亏损显著加大。2024年2月，先声再明完成9.7亿人民币融资。其中，国投招商（先进制造）领投8亿元，中深新创投资1亿元，杏泽资本投资5000万美元，中和资本投资2000万元。此次融资投前估值75亿元，投后估值84.7亿元。由于先声再明是先声药业剥离的子公司，而受先声药业完全控股，这种股权结构在一级市场融资应该比较困难（很可能需要签对赌协议）。因此猜测，先声再明承受了来自董事会、投资人的巨大压力，要缩小亏损以达到扭亏为盈的目标，并为未来上市奠定基础。这也许能解释先声再明“贱卖”资产的原因，以较低的现金价格将自己的第一款（尚未得到充分临床验证的）ADC药物卖给一家很可能没有足够资金完成临床1期试验的美国Biotech。共建Biomedical创新生态圈！如何加入BiG会员？
抗体药物偶联物引进/卖出临床2期IPO临床1期
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 输卵管癌 | 临床3期 | 美国 | 2024-02-27 | |
| 输卵管癌 | 临床3期 | 美国 | 2024-02-27 | |
| 输卵管癌 | 临床3期 | 美国 | 2024-02-27 | |
| 输卵管癌 | 临床3期 | 日本 | 2024-02-27 | |
| 输卵管癌 | 临床3期 | 日本 | 2024-02-27 | |
| 输卵管癌 | 临床3期 | 日本 | 2024-02-27 | |
| 输卵管癌 | 临床3期 | 澳大利亚 | 2024-02-27 | |
| 输卵管癌 | 临床3期 | 澳大利亚 | 2024-02-27 | |
| 输卵管癌 | 临床3期 | 澳大利亚 | 2024-02-27 | |
| 输卵管癌 | 临床3期 | 巴西 | 2024-02-27 |
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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 |
|---|
临床1期 | 42 | R-DXd at 4.8 mg/kg | 鑰淵襯糧窪廠蓋鬱鹽顧(艱鏇窪夢夢築艱餘餘網) = 艱窪壓廠鏇餘願衊觸簾 艱憲廠齋選積範製製獵 (襯壓窪衊衊蓋構網繭遞 ) 更多 | 积极 | 2023-10-22 | ||
R-DXd at 6.4 mg/kg | 鑰淵襯糧窪廠蓋鬱鹽顧(艱鏇窪夢夢築艱餘餘網) = 蓋獵製鹹糧壓醖製鹽醖 艱憲廠齋選積範製製獵 (襯壓窪衊衊蓋構網繭遞 ) 更多 | ||||||
临床1期 | 50 | 膚鹹獵襯憲繭鹽憲網夢(網遞構繭遞範顧積齋顧) = 淵顧鏇齋構膚襯鹽願範 艱衊簾鹽製鬱觸齋醖壓 (遞憲襯窪鹽製積襯醖製, 32 ~ 61) 更多 | 积极 | 2023-10-22 | |||
临床1期 | 22 | 淵遞膚憲選壓構網糧蓋(製襯鏇壓獵夢繭鏇積積) = 餘鑰廠願鑰範夢製鹹衊 膚鬱夢繭選築構齋獵壓 (窪獵膚範窪網餘鏇廠製 ) 更多 | 积极 | 2022-06-02 |
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