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).

开始日期2025-05-28

申办/合作机构

Merck Sharp & Dohme LLC

[+1]

NCT06780085

/ Recruiting临床2期

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

开始日期2025-05-13

申办/合作机构

Merck Sharp & Dohme LLC

[+1]

NCT06843447

/ Recruiting临床1/2期

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 other treatments and if people tolerate them together. They also want to learn how many people have the cancer respond (gets smaller or goes away) to the treatments.

开始日期2025-04-15

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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100 项与 Raludotatug deruxtecan 相关的专利（医药）

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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 ; Zhang, Wenbo ; Yang, Tong ; 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 ; 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）

2026-02-04

·Business Wire

DS3790 Enters Clinical Development as First DXd ADC in Hematology from Industry-Leading ADC Portfolio of Daiichi Sankyo

TOKYO & BASKING RIDGE, N.J.--(BUSINESS WIRE)--The first patient has been dosed in a first-in-human phase 1/2 trial evaluating DS3790 in patients with relapsed or refractory B-cell non-Hodgkin lymphoma. DS3790 is a specifically engineered, potential first-in-class CD37 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568). CD37 is a transmembrane protein that plays a role in regulating cell survival and is overexpressed on malignant B-cells, making it a promising therapeutic target.1 Currently, there are no CD37 directed therapies approved for any type of cancer. “The initiation of this trial of DS3790 with its novel CD37 target marks a significant milestone as our first DXd antibody drug conjugate in hematology,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “DS3790 expands our portfolio to seven DXd antibody drug conjugates, all developed using our in-house technology, underscoring our dedication to scientific innovation to create new medicines for patients with cancer.” About the Phase 1/2 Trial The multicenter, open-label, multi-cohort, first-in-human phase 1/2 trial will assess the safety and efficacy of DS3790 in patients with relapsed or refractory B-cell non-Hodgkin lymphoma. The first part of the trial (dose escalation) is evaluating DS3790 as a monotherapy to determine the recommended dose for expansion. The second part of the trial (dose expansion) will consist of multiple expansion cohorts to further evaluate DS3790 as a monotherapy. Following the assessment of preliminary safety and efficacy in the monotherapy part of the trial, subsequent cohorts will evaluate DS3790 in combination with other targeted therapies in both dose escalation and dose expansion phases. The trial will evaluate safety endpoints including dose-limiting toxicities and adverse events, as well as efficacy endpoints including overall response, disease control rate, duration of response, time to response, progression-free survival and overall survival. Pharmacokinetics and biomarker endpoints also will be assessed. The trial is expected to enroll approximately 420 patients across multiple sites globally, including Asia, Europe and North America. For more information, please visit ClinicalTrials.gov. About CD37 CD37 is a transmembrane protein that plays a role in regulating cell survival and is overexpressed in various B-cell hematological malignancies.1 B-cells, which are a type of white blood cell (B-lymphocyte) that help the body fight infection, can uncontrollably multiply and fail to function properly.2 Because of its high prevalence on B-cells, CD37 is considered a promising therapeutic target for the treatment of B-cell cancers.3 Currently, there are no CD37 directed therapies approved for any type of cancer. About B-cell Non-Hodgkin Lymphoma More than 604,000 cases of non-Hodgkin lymphoma were diagnosed in 2021, with approximately 267,000 deaths globally.4 B-cell non-Hodgkin lymphoma accounts for more than 85% of all non-Hodgkin lymphoma cases with a five-year survival rate of 74%.5 While advances in targeted therapies have improved outcomes in B-cell non-Hodgkin lymphoma, many patients with relapsed or refractory disease continue to face limited treatment durability and poor long-term survival.6 About DS3790 DS3790 is an investigational, potential first-in-class CD37 directed ADC. Designed using the proprietary DXd ADC technology of Daiichi Sankyo, DS3790 is comprised of a humanized anti-CD37 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. About the ADC Portfolio of Daiichi Sankyo The Daiichi Sankyo ADC portfolio consists of eight 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. An additional ADC being developed by Daiichi Sankyo is DS3610, which consists of an antibody attached to a novel payload that acts as an agonist of STING. Ifinatamab deruxtecan, raludotatug deruxtecan, patritumab deruxtecan, DS-3939, DS3610 and DS3790 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 is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical need. For more information, please visit www.daiichisankyo.com. References: Moore K, et al. J Pathol . 1987; 152 (1): 13-21. Mayo Clinic. Diffuse large B-cell lymphoma . Accessed November 2025. Payandeh Z, et al. Biotechnol Lett . 2018; 40 (11-12): 1459-66. Li T, et al. Ann Hematol . 2025; doi:10.1007/s00277-025-06559-9. Cleveland Clinic. Non-Hodgkin Lymphoma . Accessed November 2025. Ayyappan A, et al. J Hematol Oncol . 2019; 12 (82): 1.

抗体药物偶联物

2026-02-04

·同写意

当ADC巨头踩下刹车

100+全球先锋领袖现场开讲、50+顶尖新基建机构抢先入驻、1000+产业精英面对面链接，中国ADC和核药产业界规格最高、影响力最大、汇聚创新力量最全的年度品牌盛会！凭借革命性药物Enhertu一鸣惊人的第一三共，正在其“魔法子弹”的第二乐章里遭遇挑战。近日，第一三共宣布终止下一代ADC药物DS-9606的内部开发。这款曾被寄予厚望的ADC靶向CLDN6，原本是该公司新一代载荷平台mPBD的开山之作。意料之外无独有偶。作为第一三共与阿斯利康合作的另一款重要ADC药物Datroway，其关键III期临床试验数据再次被推迟公布，预计时间为2026年下半年。与第一三共形成对比的的是，另一边，全球制药巨头对ADC的布局却更显激进。 2026年初的JPM大会上，ADC与GLP-1并列为未来五年的核心增长引擎。东方证券分析指出，以默沙东、辉瑞为代表的巨头们，已将ADC，特别是与免疫疗法的联合使用，提升至前所未有的战略高度。先行者遭遇瓶颈，后来者却加速涌入，一场围绕技术、靶点和商业化策略的ADC激烈竞赛正在全球上演。 TONACEA 01 光环伴阴影 DS-9606是一款靶向CLDN6的ADC，搭载第一三共自主研发的mPBD载荷。这种抗癌化学物质能在肿瘤细胞DNA小沟形成共价交联，阻断细胞分裂并诱导死亡。第一三共曾规划多款搭载mPBD的ADC，DS-9606本应是该系列的首发临床产品。关于DS-9606的研发终止，第一三共研发负责人在财报电话会中表示，这并非技术平台失败。他们已证实DS-9606的应用价值，此前其I期临床在生殖细胞瘤等实体瘤中，展现出初步临床活性与良好的安全性特征。 “该领域仍有进一步开发空间，但基于产品线整体考量，我们决定不继续推进该领域的内部研发。”据悉，CLDN6主要对应生殖细胞瘤等罕见肿瘤，全球年发病率不足10万例。与上述信息同期公布的，还有第一三共2025财年（2025年4月-2026年4月）前三季度财报。数据显示，公司营收同比增长12.1%至1.53万亿日元（约102亿美元），核心营业利润2492亿日元，同比增长8.8%。该数据核心驱动力来自Enhertu与Datroway两款ADC，二者合计贡献营收5384亿日元（约34.42亿美元），占总营收35.1%，使第一三共成为全球ADC业务占比最高的药企。其中，Enhertu持续强势，该季度销售额达1880亿日元，前三季度累计销售额5068亿日元（约33.98亿美元），同比增长25.3%。按照自然年统计，Enhertu 2025年在全球范围内总共斩获6552亿日元（约43.73亿美元），同比增长24.97%。得益于HER2阳性乳腺癌、胃癌等适应症的渗透，该疗法已覆盖超过90个国家和地区。 Datroway作为2024年12月新上市的TROP2 ADC，前三季度累计销售额316亿日元（约2.12亿美元），单季145亿日元，环比增长52.9%，尚处于商业化初期。尽管基于第一三共DXd平台开发，Datroway的成药历程充满波折。2024年，因在二线非鳞状非小细胞肺癌治疗中未能显著改善患者总生存期，第一三共与合作伙伴阿斯利康撤回其上市申请。而Datroway另一项III期临床试验（Avanzar研究）的数据读出时间再次推迟。该研究旨在评估Datroway联合阿斯利康的Imfinzi一线治疗非小细胞肺癌的疗效，数据公布时间已从原计划的2025年下半年，先推迟至2026年上半年，现又延期至2026年下半年。官方解释推迟的主要原因是“临床事件发生速度低于预期”。不过2月3日，第一三共和阿斯利康宣布，Datroway的补充生物制品许可申请已获FDA受理，并被授予优先审评资格，用于治疗不适合接受PD-1/PD-L1抑制剂疗法的不可切除或转移性三阴性乳腺癌（TNBC）成人患者。FDA预计将于2026年第二季度做出监管决定。第一三共计划到2030年，通过至少4款ADC产品拓展多个适应症，覆盖全球约70万患者，较2025年的12万名患者实现近6倍增长。财报显示，第一三共前三季度研发投入3387亿日元，同比增长12.7%。截至目前，其DXd平台6款在研ADC中有2款上市（Enhertu、Datroway）、2款进入III期（I-DXd、R-DXd），其余2款（DS-3939、DS-3610）停留在早期临床阶段。此前，HER3靶点ADC Patritumab Deruxtecan，因III期总生存期未达到总生存期统计学显著终点，于2025年春季撤回上市申请，成为平台重大挫折。 TONACEA 02 野蛮生长第一三共调整步伐之际，跨国巨头加速卡位ADC赛道。今年JPM大会上，ADC已与GLP-1并列为全球头部MNC肿瘤领域的双核心增长引擎。阿斯利康、默沙东、辉瑞、罗氏、BMS等大多数TOP10药企，均将ADC提升至前所未有的战略高度。根据东方证券2026年1月发布的研报，全球MNC对ADC领域的研发投入正呈加速增长态势。2025-2026年期间，仅TOP5药企在ADC领域的研发与BD投入总额预计将突破200亿美元，较2023-2024年增长约40%，主要用于管线拓展、联合疗法开发及中国创新资产引进。默沙东的战略最具代表性。2023年，其以55亿美元拿下第一三共多款ADC合作权益。此前曾花费近14亿美元引进科伦博泰TROP2ADC芦康沙妥珠单抗，并将其置于肿瘤领域核心。截至2026年1月，默沙东围绕芦康沙妥珠单抗已启动十余项III期临床研究，其中9项为与Keytruda联用，覆盖肺癌、乳腺癌、子宫内膜癌等多个瘤种，是IO+ADC联用领域布局最积极的药企之一。值得一提的是，芦康沙妥珠单抗与帕博利珠单抗的联用，治疗一线治疗PD-L1阳性NSCLC的III期试验已达主要终点，PFS显著改善且OS呈获益趋势，获NMPA突破性疗法认定。公开数据显示，2025年全球新增ADC临床试验中联合疗法占比约58%。其中，IO+ADC（ADC+PD-1/PD-L1抑制剂）占所有联合疗法的68%，是最热门的联用策略。行业分析认为，二者可实现“靶向杀伤+免疫激活”协同效应，未来3-5年联用方案将占据ADC市场半壁江山。辉瑞ADC布局也紧密围绕IO+ADC联用，其与安斯泰来合作的Nectin-4 ADC药物Padcev联合Keytruda的方案已获批用于尿路上皮癌，目前正积极拓展该联用组合的新适应症；该公司重点在研ADC产品Sigvotatug Vedotin靶向ITGB6，正开展单药及联合Keytruda治疗非小细胞肺癌的临床研究。此外，辉瑞计划2026年启动引进的PD-1/VEGF双抗PF-08634404与Padcev等旗下ADC的联合III期临床试验，进一步落地IO+ADC布局策略。与此同时，一股来自东方的力量正迅速从“生力军”转变为“主力军”。 2025年，国内ADC领域海外授权、临床试验、获批品种均创新高。据西南证券数据，2025年国内ADC药物BD出海共取得首付款16.3亿美元，同比增长676.2%，总金额211.3亿美元，同比增长390.6%（包含信达生物10月组合包）。授权交易既覆盖HER2、TROP2等成熟靶点，也包含CDH6、ROR1等新兴靶点。例如，2025年2月，石药集团旗下子公司巨石生物的SYS6005与Radiance Biopharma达成超12亿美元授权，成为国内首个出海的ROR1 ADC。中国ADC创新质量也持续跃升。Antibodies to watch in 2026报告显示，2025年全球首次获批的19款抗体新药中，10款首次在中国获批，其中ADC就有3款。国内原研抗体药研发成本仅为美国的20%-30%，临床开发周期比欧美普遍短1-2年，效率优势突出。有创新药投资人表示，ADC是中国药企跻身全球竞争的关键突破口，成本与效率优势是核心支撑。 — 结语 — 随着越来越多玩家涌入，ADC行业正从早期的技术探索和资本追捧，进入一个以数据和临床差异化论英雄的新阶段。行业共识是，单纯的技术故事已经不够，真正的“临床价值”成为唯一的通行证。 2025年，ADC药物在全球范围内加速从后线治疗向一线及早期治疗阶段拓展，多个关键适应症申请获得突破，包括戈沙妥珠单抗用于TNBC一线治疗、德曲妥珠单抗用于HER2阳性早期乳腺癌辅助治疗等，为后续适应症申请奠定基础，推动ADC实现全治疗周期覆盖。从第一三共管线调整，到巨头加速布局，再到中国药企突围，ADC赛道竞争已白热化。未来，随着联用方案普及与新兴靶点突破，ADC的“魔法子弹”故事将续写。 3月26-27日，同写意第三年在成都医学城倾力打造“2026未来XDC新药大会”。作为中国ADC和核药产业界规格最高、影响力最大、汇聚创新力量最全的年度品牌盛会，届时将汇聚全球先锋领袖、顶尖新基建机构、产业精英...... 展位连续两年提前售罄，预定通道即日开启。报告席位、黄金展位、专业观众同步招募。错过今年，再等一年。立即锁定属于XDC的“未来席位”！参考文章： 1、JPM2026 |第一三共携7款ADC率先热场；医药魔方Info 2、DS-8201狂揽44亿美元，第一三共营收增长12% | 2025财报；药渡 3、Daiichi Sankyo Dumps Next-Gen ADC From Development Pipeline；biospace

抗体药物偶联物财报临床3期临床1期

2026-02-02

·北京奕和

奕和月报|医药行业本月大事记（2026.01）

点击蓝字关注我们以"投资生命，医奕生辉"为核心理念的精品投行，现专注于医药疫苗行业全产业链价值赋能，构建"并购重组+战略融资+产业BD"三位一体的服务生态。创始团队深耕医药并购领域十余载，持续为生物医药创新注入专业资本力量。 PART.01 本月管线最新进展医药管线时间节点公司医药种类最新进度2026/01 礼来 Brenipatide 注射液III期临床启动2026/01 第一三共 R-DXd（CDH6靶向抗体偶联药物）纳入突破性治疗品种2026/01 勃林格殷格翰 BI 765423单抗肺纤维化II期临床启动疫苗管线时间节点公司疫苗种类最新进度2026/01康希诺 24价肺炎球菌多糖结合疫苗（CRM197/破伤风类毒素）获CDE批准临床2026/01康泰生物吸附无细胞百白破（组分）联合疫苗（成人青少年及儿童用）IND获受理2026/01康华生物重组六价诺如病毒疫苗（毕赤酵母）I期临床启动2026/01智飞生物冻干乙型脑炎灭活疫苗（人二倍体细胞）IND获受理2026/01威斯克生物治疗性痤疮疫苗I期临床启动2026/01三叶草生物三联呼吸道疫苗II期临床启动2026/01华兰疫苗重组带状疱疹疫苗（CHO细胞）获CDE批准临床2026/01聚微生物 6 价 B 族链球菌（GBS）结合疫苗I期临床启动2026/01中国生物三价流感病毒裂解疫苗获批上市 1 全球首个！礼来GLP1R/GIPR双激动剂启动抑郁症III期临床 1月26日，礼来公司宣布其GLP1R/GIPR双激动剂Brenipatide（继替尔泊肽后第二款GLP-1/GIP双靶点药物）正式启动针对成年抑郁症的III期临床研究，这是全球首个进入抑郁症III期临床阶段的GLP-1类药物。关键临床信息：试验设计：III期、多中心、随机、双盲研究（RENEW-MDD-1），计划在全球招募1100名成人抑郁症患者（其中国内90人），评估其作为辅助治疗延迟疾病复发的效果与安全性；市场地位：作为全球首个进入抑郁症III期临床的GLP-1类药物，尚无同类产品进入此阶段。研发布局与前景：多适应症拓展：除抑郁症外，该药已在酒精使用障碍启动两项III期研究，并进入双相情感障碍、哮喘、尼古丁依赖的II期临床；市场潜力：GLP-1类药物市场巨大（替尔泊肽前三季度销售额达248亿美元），此次拓展至精神疾病领域，有望开辟全新治疗赛道。 2 康希诺生物24价肺炎球菌疫苗获批临床康希诺生物宣布，其自主研发的24价肺炎球菌多糖结合疫苗已获NMPA临床试验批准。该疫苗覆盖当前主要流行血清型，有望为肺炎球菌疾病防控提供更全面的保护。临床需求与技术突破：巨大疾病负担：肺炎链球菌是全球公共卫生重要威胁，每年导致约160万人死亡。在中国，每年约有55万名5岁以下儿童罹患肺炎球菌性肺炎。核心创新：疫苗采用双载体技术（CRM197/破伤风类毒素），覆盖24种血清型，拟适用于2月龄及以上人群，以应对日益严重的抗生素耐药问题。研发基础与战略意义：此次获批基于公司已上市的双载体PCV13i（优佩欣®）的技术积累。 PCV24的成功研发将进一步丰富公司在肺炎疫苗领域的高价次产品布局，提升对肺炎球菌性疾病的综合防控能力。 3 三叶草生物三联呼吸道疫苗进入II期临床 2026年1月12日，三叶草生物宣布其三联呼吸道联合疫苗SCB-1033（RSV+hMPV+PIV3）及二联苗SCB-1022在澳大利亚完成首批受试者入组，正式启动II期临床试验，旨在为老年人群提供同步预防三种呼吸道病毒的广谱保护。核心创新：进入II期临床的RSV+hMPV+PIV3三联苗，覆盖冬季主要流行病毒，无需佐剂，依托独有Trimer-Tag技术平台稳定抗原天然三聚体结构； I期数据显示：RSV中和抗体提升6-8倍，hMPV提升6-9倍，且无免疫干扰；临床进展： II期设计：针对60-85岁人群，随机、多中心研究，计划入组420人，评估安全性与免疫原性；技术优势：平台已通过新冠疫苗验证，可实现2000升规模化生产；市场前景：若成功将填补老年呼吸道病毒防护空白，赛诺菲曾以16亿美元收购类似资产，凸显赛道价值；公司同时拥有二联/三联临床资产，并探索RSV疫苗重复接种，构筑技术壁垒。 4 国产首款6价B族链球菌疫苗进入Ⅰ期临床 2026年初，苏州聚微生物科技有限公司自主研发的6价B族链球菌（GBS）结合疫苗正式启动Ⅰ期临床试验（登记号：CTR20255187）。该疫苗为国产首款覆盖六种血清型（Ia, Ib, II, III, IV, V）的GBS疫苗，可覆盖98%的临床分离株。核心机制与设计：采用白喉毒素无毒突变体（CRM197）作为载体蛋白，通过孕妇主动免疫，阻断GBS母婴垂直传播，预防新生儿肺炎、败血症等侵袭性疾病； Ⅰ期试验：计划入组80名18-49岁健康受试者，采用随机、盲法、安慰剂对照设计，评估安全性及免疫原性。临床需求与意义：全球约18%孕妇携带GBS，每年导致约32万新生儿感染、9万例死亡；目前全球尚无同类6价疫苗上市，若成功将填补国内空白，从源头降低新生儿感染风险。 PART.02 本月医药行业大事记特朗普药品直销平台因反回扣法规延迟上线法规担忧致上线延期特朗普政府推动的TrumpRx药品直销平台上线时间再度延迟。卫生与公众服务部监察长办公室近期发布合规指南，旨在指导药企在该平台上避免违反联邦反回扣法规。分析指出，法规风险是平台延期的主要原因，内部律师对此存在担忧。药企承诺高额折扣尽管存在法律风险，多家药企已承诺在平台提供大幅折扣。辉瑞率先宣布部分药物平均折扣达50%，阿斯利康三款吸入剂折扣幅度在96%至654%之间，赛诺菲部分糖尿病等药物平均折扣为61%。多数投保患者受益有限专家分析指出，平台对多数有保险的患者实际节省有限。联邦医疗保险D部分参保者因自付费用原本较低甚至为零，难以通过平台实现净储蓄。真正可能受益的是无保险或购买高免赔额保险计划的人群。法律指南虽设置了安全港条款，但平台具体上线时间仍未确定。尼帕病毒再现印度，致死率高达40%-70%且无特效药印度报告聚集性疫情近期，印度西孟加拉邦报告至少五例尼帕病毒确诊病例，包括三名护士、一名医生和一名医院工作人员，其中一名患者情况危重。卫生部门已对近100名密切接触者进行隔离观察，目前所有人无症状且检测阴性。病毒致死率高且传播途径多样尼帕病毒是人畜共患病毒，病死率高达40%至70%，目前全球尚无获批疫苗或特效疗法。感染者初期症状类似流感，可发展为致命脑炎或严重呼吸系统问题。病毒可通过食用被污染的生椰枣汁、接触受感染蝙蝠或人际密切接触传播。全球协作应对但仍存挑战流行病防范创新联盟已将尼帕病毒列为重点病原体，持续资助疫苗研发并推动建立国际抗体标准。然而，当前诊断方法在疫区难以推广，对无症状感染、保护性免疫机制及病毒毒株特性的认知仍存在科研空白。专家呼吁加强疫区监测与公众健康教育。 END 免责声明：本文由奕和整理、汇总、编写，谨供接收方作参考用途，并非作为也不应被视为在任何地区对任何企业的研究报告，不构成买卖、认购证券或其它金融工具及产品的邀请或保证。本文所提及的上市公司仅为示例，不代表任何投资分析或投资建议。接收方不应仅依靠本文、而应按照自己的判断作出投资决定，并在作出任何投资行动前咨询专业意见。本文所载资料的来源皆被奕和认为可靠，但奕和概不担保本文所含信息的准确性、完整性或新进度。本文所载的见解、分析、预测、推断和期望均截至本文的发表日期，且可能在未经事先通知的情况下调整。奕和不对因使用本文而承受的直接或间接损失承担任何责任。本文受到版权和资料全面保护。 FINANCE 扫码关注北京奕和投资生命医奕生辉

临床2期临床3期疫苗临床1期突破性疗法

100 项与 Raludotatug deruxtecan 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
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	美国	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
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	日本	Merck Sharp & Dohme LLC	2024-02-27
铂耐药性输卵管癌	临床3期	日本	Daiichi Sankyo Co., Ltd.	2024-02-27
铂耐药性输卵管癌	临床3期	澳大利亚	Merck Sharp & Dohme LLC	2024-02-27
铂耐药性输卵管癌	临床3期	澳大利亚	Daiichi Sankyo Co., Ltd.	2024-02-27
铂耐药性输卵管癌	临床3期	巴西	Daiichi Sankyo, Inc.	2024-02-27
铂耐药性输卵管癌	临床3期	加拿大	Merck Sharp & Dohme LLC	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


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)	窪夢齋製繭觸繭蓋繭網(顧簾遞齋糧積憲齋齋壓) = 製顧積顧膚網壓蓋壓繭廠襯膚鹹鬱積廠餘願顧 (齋製窪鹹糧鹹範製糧糧, 27.9 ~ 61.9) 更多	积极	2025-10-17
				R-DXd (5.6 mg/kg)	窪夢齋製繭觸繭蓋繭網(顧簾遞齋糧積憲齋齋壓) = 鏇艱鹽鑰範簾窪獵遞醖廠襯膚鹹鬱積廠餘願顧 (齋製窪鹹糧鹹範製糧糧, 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	糧繭簾選襯構築淵襯齋(鏇夢範繭選鹽壓範廠鹹) = 膚獵積獵鑰簾顧衊獵衊選壓簾窪膚蓋願窪鏇範 (簾廠襯獵襯鹽鏇壓窪襯 )	积极	2025-10-17
				I-DXd 12 mg/kg Q3W	糧繭簾選襯構築淵襯齋(築鏇淵遞鑰醖襯襯構醖) = 齋鹽餘衊顧廠鹹遞鏇蓋鏇醖選糧廠夢鏇蓋鹽窪 (鬱膚艱餘醖餘繭醖齋範 ) 更多
NCT04707248 (ESMO 12023 \| ESMO 22023) 人工标引	临床1期	卵巢癌	42	R-DXd at 4.8 mg/kg	襯顧蓋願顧鏇壓製積選(艱廠淵繭夢鏇膚鹹網鏇) = 淵顧襯衊窪範構廠衊壓繭鏇選廠選觸鬱網築顧 (襯繭衊選遞觸鏇鬱積夢 ) 更多	积极	2023-10-22
				R-DXd at 6.4 mg/kg	襯顧蓋願顧鏇壓製積選(艱廠淵繭夢鏇膚鹹網鏇) = 艱觸齋醖顧選蓋獵獵觸繭鏇選廠選觸鬱網築顧 (襯繭衊選遞觸鏇鬱積夢 ) 更多
NCT04707248 (Corporate Publications) 人工标引	临床1期	卵巢癌	50	Raludotatug deruxtecan	網餘餘範製齋簾鬱製壓(構遞繭顧簾衊簾艱艱選) = 網選鏇簾簾窪繭繭顧遞獵願淵鹹膚鏇願繭範製 (構憲夢鏇顧築廠衊廠選, 32 ~ 61) 更多	积极	2023-10-22
NCT04707248 (ASCO2022) 人工标引	临床1期	卵巢癌 \| 晚期肾细胞癌	22	DS-6000a	積膚齋衊顧網窪醖製鹽(夢醖願艱蓋淵獵鬱衊膚) = 範鏇積廠蓋範齋網選範遞襯選壓衊餘淵糧網製 (鹹襯顧遞製糧窪網網顧 ) 更多	积极	2022-06-02