纳武利尤单抗(Nivolumab) - 药物靶点：PD-1_在研适应症：胃食管交界处恶性肿瘤，晚期肝细胞癌，不可切除的肝细胞癌_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Nivolumab (Genetical Recombination)、Nivolumab (genetical recombination) (JAN)、Nivolumab (USAN/INN)

+ [15]

靶点

PD-1

作用方式

抑制剂

作用机制

PD-1抑制剂(细胞程序性死亡-1抑制剂)

治疗领域

肿瘤免疫系统疾病消化系统疾病+ [13]

在研适应症

胃食管交界处恶性肿瘤晚期肝细胞癌不可切除的肝细胞癌+ [500]

非在研适应症

异戊酸血症获得性免疫缺陷综合征复发性急性淋巴细胞白血病+ [110]

原研机构

Ono Pharmaceutical Co., Ltd.

Bristol Myers Squibb Co.

在研机构

National Cancer Institute

Ono Pharmaceutical Co., Ltd.

Bristol Myers Squibb Co.

+ [28]

非在研机构

Vedanta Biosciences, Inc.

Navire Pharma, Inc.

The University of Texas Southwestern Medical Center

+ [15]

权益机构

Nektar Therapeutics

NeoImmuneTech, Inc.

Vedanta Biosciences, Inc.

+ [22]

最高研发阶段批准上市

首次获批日期

日本 (2014-07-04),

食管癌黑色素瘤

最高研发阶段(中国)批准上市

特殊审评优先审评 (美国)、突破性疗法 (美国)、快速通道 (美国)、加速批准 (美国)、孤儿药 (美国)、突破性疗法 (中国)、附条件批准 (中国)、孤儿药 (日本)、优先审评 (澳大利亚)、优先审评 (中国)

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结构/序列

Sequence Code 93681H

来源: *****

Sequence Code 93684L

来源: *****

关联

1,874

项与纳武利尤单抗相关的临床试验

CTRI/2025/02/079994

/ Not yet recruiting临床2期IIT

Phase 2 study evaluating the addition of immune-sensitizing radiotherapy and biomarker-driven low-dose nivolumab in locally advanced resectable gastroesophageal junction/gastric cancers - NISaRGA

开始日期2026-02-05

申办/合作机构

Tata Memorial Centre

NCT07011550

/ Not yet recruiting临床2期IIT

Phase 2, Single-arm Trial of BMS-986340 in Association With Nivolumab, Trifluridine/Tipiracil and Bevacizumab for Patients Refractory to Standard of Care Treatment and With Microsatellite-stable Colorectal Cancer

To learn if the drug combination of BMS-986340, nivolumab, trifluridine/tipiracil, and bevacizumab can help to control advanced or metastatic MSS-CRC.

开始日期2025-11-30

申办/合作机构

The University of Texas MD Anderson Cancer Center

NCT06794229

/ Not yet recruiting临床2期IIT

A Phase II, Open-label, Single-arm Study of nEoadjuvant Zanzalintinib (XL092) Plus nivoLumab in Patients With lOcally Advanced and/or inopeRable clEar Cell Renal Cell Carcinoma With or Without Non-measurable Metastasis (EXPLORE-RCC)

All subjects will receive zanzalintinib 100mg orally (PO) once daily plus nivolumab standard of care dosing (i.e., 240mg IV every 2 weeks or 480mg IV every 4 weeks) for a total of 12 weeks, followed by restaging scan/evaluation for surgical operability and an adaptive approach that includes (1) surgical resection if the participant is eligible for surgery (Cohort A), (2) up to 48 weeks total (from Cycle 1 Day 1) of zanzalintinib plus nivolumab if the participant has partial response or stable disease but remains inoperable (Cohort B1), or (3) stopping protocol mandated treatment to receive standard of care systemic therapy and continue follow up per protocol if the participant has disease progression (Cohort B2).

开始日期2025-11-01

申办/合作机构

Hoosier Cancer Research Network

[+2]

100 项与纳武利尤单抗相关的临床结果

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100 项与纳武利尤单抗相关的转化医学

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100 项与纳武利尤单抗相关的专利（医药）

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10,599

项与纳武利尤单抗相关的文献（医药）

2025-12-31·Human Vaccines & Immunotherapeutics

State of the art of adjuvant immunotherapy in urothelial cancer: New developments and upcoming changes

Review

作者: Marchetti, Andrea ; Mollica, Veronica ; Piazza, Pietro ; Mottaran, Angelo ; Rosellini, Matteo ; Danielli, Linda ; Ricci, Costantino ; Tassinari, Elisa ; Schiavina, Riccardo ; Massari, Francesco ; Santoni, Matteo

In recent years, several clinical trials focused on the potential role of immune-checkpoint inhibitors (ICIs) in the adjuvant treatment of muscle-invasive urothelial cancer (UC). Heretofore, only the anti-programmed death protein 1 (anti-PD1) nivolumab received European Medical Agency (EMA) approval for cisplatin-unfit patients. In our work, we deeply analyzed the results of the three pivotal studies in view of the rapidly evolving therapeutic advanced UC's scenario. Furthermore, there are several ongoing research to investigate ICIs and other emerging immune agents in this setting; results are awaited. Additionally, current efforts have been made to assess the role of these agents in earlier disease settings, particularly in high-risk non-muscle-invasive bladder cancer (NMIBC). In our review, we analyzed the potential role of predictive and/or prognostic biomarkers that may improve patient selection and treatment efficacy. To conclude, we highlighted the upcoming changes that could redefine the standard of care for patients with early-stage UC.

2025-12-31·OncoImmunology

Final 3-year results from the EVIDENS study, an observational study of nivolumab in non-small cell lung cancer

Article

作者: Debieuvre, Didier ; Brellier, Florence ; Asselain, Bernard ; Auliac, Jean-Bernard ; Khalife, Yaacoub ; Cotté, François-Emery ; Barlesi, Fabrice ; Moro-Sibilot, Denis ; Pérol, Maurice ; Bombaron, Pierre ; Dixmier, Adrien ; Raspaud, Christophe ; Audigier-Valette, Clarisse ; Benoit, Nicolas

EVIDENS was a prospective, non-interventional, longitudinal study conducted in non-small cell lung cancer (NSCLC) patients receiving nivolumab in France. It recruited adults with pathologically confirmed NSCLC who initiated nivolumab between October 2016 and November 2017; the final results are reported here. Primary outcomes included baseline characteristics and 36-month overall survival (OS). Secondary outcomes included progression free survival (PFS), objective response rate (ORR), safety and health-related quality of life (HRQoL; assessed regardless of nivolumab continuation or interruption). Overall, 1423 patients were included in the analysis population (median age 66 years; non-squamous histology 69.1%; stage IV disease 91.5%; brain metastases 19.9%). Almost all patients (99.7%) had received prior chemotherapy, and most patients received nivolumab as second-line (73.5%) or later (26.1%) therapy. The 36-month OS rate was 19.7% (95% confidence interval [CI] 17.5-22.0); OS was significantly shorter in patients with squamous versus non-squamous tumors (9.8 [95% CI 8.6-11.2] months vs 11.8 [95% CI 10.2-13.2] months; p = 0.005). The 36-month PFS rate was 8.8% (95% CI 7.3-10.4). The 12-month investigator-assessed best ORR in the overall population was 20.4%. Eastern Cooperative Oncology Group performance status, smoking status, tumor histology, disease stage and liver metastasis independently predicted survival. Grade 3 and 4 treatment-related adverse events were reported in 8.0% and 0.8% of patients, respectively; eight treatment-related deaths occurred (0.005%). HRQoL was maintained with slight improvement throughout the study, without statistical significance. These results confirm that the real-world effectiveness and safety of nivolumab in these patients is similar to that observed in clinical trials.

2025-12-31·Human Vaccines & Immunotherapeutics

PD-1/PD-L1 inhibitors related adverse events: A bibliometric analysis from 2014 to 2024

Article

作者: Chang, Lei ; Lu, Wenping ; Zhang, Dongni ; Mei, Heting ; Zhuo, Zhili ; Cui, Yongjia ; Yu, Zongliang ; Song, Qingya

Programmed cell death-1 (PD-1) inhibitors and programmed cell death ligand 1 (PD-L1) inhibitors are considered effective alternatives for the primary treatment of recurrent metastatic cancers. However, they can induce various adverse events affecting multiple organ systems, potentially diminishing patients' quality of life, and even leading to treatment interruptions. Adverse events related to PD-1/PD-L1 inhibitors differ from those associated with CTLA-4 inhibitors and are more commonly observed in the treatment of solid tumors. This study aimed to address the knowledge gap regarding adverse events related to PD-1/PD-L1 inhibitors. A visual bibliometric network was constructed using VOSviewer, CiteSpace, R software, and the Web of Science Core Collection (WoSCC) to quantitatively analyze this research field. Future research directions were also explored. The USA ranked first in publication count and total citations. Over time, publication types transitioned from case reports to clinical trials. Research on for nivolumab was the most prevalent. The spectrum of cancers treated by PD-1/PD-L1 inhibitors expanded beyond melanoma and lung cancer to include renal cell carcinoma, esophageal cancer, and others. Common adverse events included pneumonitis, myasthenia gravis, and vitiligo. There was a significant increase in multi-phase clinical trials and studies related to biomarkers. This study offers valuable insights for potential collaborators and institutions, highlighting trends in the study of adverse events related to PD-1/PD-L1 inhibitors. The management of these adverse events has become more refined and standardized. Biomarker research and multi-phase clinical trials are likely to be key areas of focus in future studies.

3,261

项与纳武利尤单抗相关的新闻（医药）

2025-07-17

·BioArt

Cancer Cell | 非小细胞肺癌中的亚克隆性免疫逃逸

撰文 | 楚雨荨对于大多数癌症患者而言，免疫治疗在临床上仅有部分响应，这表明肿瘤内的免疫压力或敏感性并非均质。不同肿瘤区域在免疫细胞浸润的程度、新生抗原的表达以及T细胞受体库（T cell receptorrepertoire）等方面存在显著差异，异质性肿瘤区域可能由外部因素（例如基质屏障影响免疫细胞浸润、免疫抑制微环境等）驱动和内部因素（基因组不稳定性、分支型肿瘤演化等）所致。因此，异质性肿瘤个体中的亚克隆之间在免疫逃逸能力上存在自身固有的差异。但仅通过描述性数据（如基因组测序、转录组分析等），目前仍难以评估单个肿瘤亚克隆实际具备的免疫逃逸能力。近日，来自伦敦弗朗西斯·克里克研究所Charles Swanton团队、荷兰癌症研究所Emile E. Voest和伦敦大学学院Sergio A. Quezada在Cancer Cell杂志上发表了文章 Subclonal immune evasion in non-small cell lung cancer，基于团队前期在病人个体水平上建立的自体类器官-T细胞共培养体系【1】，建立了一套患者来源的可以评估T细胞对肿瘤不同亚克隆应答情况的研究平台，首次在单克隆分辨率下实现了对免疫逃逸现象的直接功能性验证，研究结果表明（1）不同肿瘤亚克隆在其免疫逃逸能力上存在内在差异；（2）提供了一种能够前瞻性发现和分离患者体内免疫逃逸亚克隆的方法，提示亚克隆癌症进化持续塑造癌细胞的免疫逃逸特性。接受免疫检查点抑制剂（ICB）治疗的非小细胞肺癌（NSCLC）患者往往很少出现完全响应的临床反应【2，3】，因此，制定能够实现完全缓解肿瘤的治疗策略是一个主要的临床挑战。NSCLC具有高度的肿瘤内异质性【4】，这种异质性如何影响免疫逃逸机制尚不明确。目前基于基因组和转录组学的描述性研究难以准确识别具有免疫逃逸能力的肿瘤亚克隆，同时，缺乏功能性验证平台来评估亚克隆水平的免疫相互作用。研究团队利用TRACERx肺癌进化研究（一项基于原发及转移性非小细胞肺癌多区域取样的前瞻性研究）中的3名患者的11个不同肿瘤区域样本，建立了81个平行的类器官克隆亚系（clonal organoid sublines），通过与自体肿瘤浸润淋巴细胞（TIL）的共培养实验发现，取样区域不同的肿瘤类器官在诱发T细胞反应方面存在显著差异，同一肿瘤区域同时存在引起强烈T细胞识别（热肿瘤）和仅产生有限激活（冷肿瘤）的亚克隆系，结果表明即使在同一区域内，不同亚克隆系也表现出明显的免疫逃逸能力异质性。通过对不同患者肿瘤亚克隆系类器官的全外显子测序（WES）和转录组测序分析发现，免疫逃逸和非逃逸的肿瘤亚群代表着具有独特进化历史的遗传学上不同的亚克隆，在系统发育树上分属不同分支。通过NY-ESO-1和MART-1肽段配对的T细胞受体-抗原系统，进一步发现亚克隆免疫逃逸涉及依赖或不依赖于抗原的机制，并且类器官-T细胞共培养平台可用于区分这些机制。对于其中无法获得足够的自体TIL的患者，通过类器官-NK细胞共培养体系，发现肿瘤类器官诱导NK细胞激活方面的显著差异，并与MHC-I的高表达呈负相关关系。令人意外的是，尽管进行了全面的基因组和转录组学特征分析，研究者们发现仅凭描述性数据无法准确识别具有免疫逃逸能力的肿瘤亚克隆，免疫逃逸相关基因的突变分析、PD-L1表达水平检测以及在转录水平的差异表达分析均未能预测逃逸表型。最后，研究者们通过多重免疫荧光技术揭示了不同免疫逃逸机制的局部免疫成分，结果表明，T细胞逃逸类器官来源区域表现出结构化肿瘤细胞巢，而非T细胞逃逸区域表现出肿瘤细胞混乱、广泛坏死以及伴随中性粒细胞和明显的CD8+ T细胞的浸润。巨噬细胞在T细胞逃逸区域主要局限于基质，在非T细胞逃逸区域则与肿瘤细胞直接混合，提示复杂的微环境可能为免疫敏感的肿瘤克隆提供额外的免疫逃逸途径。综上，这项研究建立的类器官-T细胞共培养平台能够在单克隆分辨率下功能性识别免疫逃逸肿瘤细胞亚克隆，揭示肿瘤通过亚克隆异质性而非单一机制实现免疫逃逸。未来需扩大样本规模并在更多癌种中验证该平台的通用性，同时建立与临床免疫治疗响应的直接关联以指导个性化治疗策略。原文链接：https://doi.org/10.1016/j. ccell.2025.06.012制版人：十一参考文献1. Dijkstra, K.K., Cattaneo, C.M., Weeber, F., Chalabi, M., van de Haar, J., Fanchi, L.F., Slagter, M., van der Velden, D.L., Kaing, S., Kelderman, S., et al. (2018). Generation of Tumor-Reactive T Cells by Co-culture of Peripheral Blood Lymphocytes and Tumor Organoids. Cell 174, 1586– 1598.e12. https://doi.org/10.1016/j.cell.2018.07.009.2. Borghaei, H., Paz-Ares, L., Horn, L., Spigel, D.R., Steins, M., Ready, N.E., Chow, L.Q., Vokes, E.E., Felip, E., Holgado, E., et al. (2015). Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer. N. Engl. J. Med. 373, 1627–1639. https://doi.org/10.1056/ NEJMoa1507643.3. Gandhi, L., Rodrı´guez-Abreu, D., Gadgeel, S., Esteban, E., Felip, E., De Angelis, F., Domine, M., Clingan, P., Hochmair, M.J., Powell, S.F., et al. (2018). Pembrolizumab plus Chemotherapy in Metastatic Non-Small- Cell Lung Cancer. N. Engl. J. Med. 378, 2078–2092. https://doi.org/10. 1056/NEJMoa1801005.4. Enfield, K.S.S., Colliver, E., Lee, C., Magness, A., Moore, D.A., Sivakumar, M., Grigoriadis, K., Pich, O., Karasaki, T., Hobson, P.S., et al. (2024). Spatial Architecture of Myeloid and T Cells Orchestrates Immune Evasion and Clinical Outcome in Lung Cancer. Cancer Discov.14, 1018–1047. https://doi.org/10.1158/2159-8290.CD-23-1380.学术合作组织（*排名不分先后）战略合作伙伴（*排名不分先后）·转载须知【原创文章】BioArt原创文章，欢迎个人转发分享，未经允许禁止转载，所刊登的所有作品的著作权均为BioArt所拥有。BioArt保留所有法定权利，违者必究。BioArtMedPlants人才招聘近期直播推荐

免疫疗法临床研究

2025-07-14

·Business Wire

Invenra Welcomes Dr. Alan J. Korman to Its Scientific Advisory Board

MADISON, Wis.--(BUSINESS WIRE)--Invenra, a biotechnology company specializing in next-generation multispecific antibody discovery and development, is pleased to announce the appointment of Dr. Alan J. Korman, PhD, FAIO, to its Scientific Advisory Board (SAB). Dr. Korman brings a wealth of experience in immuno-oncology, having played a pivotal role in the development of groundbreaking cancer immunotherapies. Dr. Korman is currently CSO and a member of the Board of Directors of Bluesphere Bio, a clinical stage biotech company in Pittsburgh, PA. Most recently, he served as Senior Vice President of Human Immunology at Vir Biotechnology. Prior to that, he served as Vice President for Immuno-Oncology Discovery at Bristol-Myers Squibb (BMS), where he led the development of biologics for tumor immunotherapy. During his tenure at BMS and Medarex, Dr. Korman contributed to the development of three approved oncology drugs: ipilimumab (anti-CTLA-4), nivolumab (anti-PD-1), and relatlimab (anti-LAG-3), as well as their combination, pioneering the use of immune checkpoint blockade in cancer therapy. Dr. Korman earned his PhD in Cellular and Developmental Biology from Harvard University and was a Whitehead Fellow at the Whitehead Institute at the Massachusetts Institute of Technology. He also served as a staff scientist at the Institut Pasteur before transitioning to the biotechnology sector. In addition to his new role on Invenra’s SAB, Dr. Korman is also the founder of Spice Biotechnologies, a company focused on developing next-generation checkpoint therapeutics. "We are thrilled to welcome Dr. Korman to our Scientific Advisory Board," said Dr. Roland Green, Co-Founder, CEO, and Chairman of Invenra. "His extensive experience in developing transformative immunotherapies aligns perfectly with Invenra's mission to collaborate with and support biotech and pharmaceutical companies of all sizes globally. We look forward to his valuable insights and contributions as we continue to empower our partners to advance innovative therapeutics." Dr. Korman joins SAB members Dr. Paul Sondel and Dr. Jonathan Davis, whose knowledge and guidance have supported Invenra’s research and development. Dr. Paul Sondel, MD, PhD, is the Reed and Carolee Walker Professor in Pediatric Oncology at the University of Wisconsin–Madison. With a distinguished career in cancer immunotherapy, Dr. Sondel has led lab, translational, and clinical research within the UW Carbone Cancer Center. His work has significantly advanced the understanding and application of immunotherapeutic strategies, including the development of FDA-approved treatments for high-risk neuroblastoma. Dr. Jonathan Davis, PhD, brings over 20 years of experience in the life sciences industry, focusing on protein and antibody engineering, as well as bispecific and multispecific antibody platform development. Prior to joining the Invenra SAB, Dr. Davis was Vice President of Innovation and Strategy for Invenra where he focused on optimization of the B-Body Platform, the development of antibody libraries, and refinements to screening methodology and throughput. Prior to Invenra, he was a Principal Scientist at Bristol-Myers Squibb, where he contributed to biologic drug design, including the development of a trispecific HIV biotherapeutic. Prior to that, he worked at EMD Serono, where he developed a variety of novel biologic drug platforms. "The collective expertise of Drs. Korman, Sondel, and Davis positions Invenra as a key collaborator and service provider, driving the discovery and development of multispecific antibody-based therapeutics in partnership with biotech and pharmaceutical companies worldwide," added Dr. Green. "Their combined knowledge and experience will be invaluable as we continue to support our partners in bringing novel treatments to patients in need." For more information about Invenra and its Scientific Advisory Board, please visit invenra.com. About Invenra Invenra Inc. is a biotechnology company specializing in next-generation multispecific antibody discovery and development. Its proprietary B-Body® platform enables the rapid generation of highly developable bispecifics and now supports both Rapid Bispecific Discovery Services—delivering lead panels in as little as four months—and B-Body Express™, which quickly produces high-quality bispecifics from partner-provided sequences. Invenra’s newly launched T-Body™ platform expands these capabilities for efficient expression, correct chain pairing, and robust assembly of trispecific constructs. Invenra partners globally with pharmaceutical and biotech companies to accelerate therapeutic antibody programs from discovery through preclinical development.

高管变更免疫疗法

2025-07-14

·医药地理

111 亿美元！BMS 就 PD-L1/VEGF 双抗与 BioNTech 达成合作

6 月 2 日，百时美施贵宝（BMS）与 BioNTech 共同宣布达成一项全球性合作协议，双方将联合开发及商业化 BioNTech 旗下双特异性抗体候选药物 BNT327（原Biotheus的 PM8002），用于多种实体瘤治疗。根据协议内容，BioNTech 与 BMS 将协同推进这一临床候选药物的开发进程，这一合作动态在生物医药行业引发广泛关注。在合作的具体条款方面，BMS 将向 BioNTech 支付 15 亿美元的首付款，并在 2028 年前完成总计 20 亿美元的非或有性周年付款。此外，BioNTech 还有望获得最高达 76 亿美元的开发、监管及商业里程碑付款。在药物的开发与商业化模式上，双方将联合推进 BNT327 作为单药疗法及与其他产品联合疗法的开发工作。同时，两家企业均有权自主开展 BNT327 在更多适应症及联合疗法中的研究，包括将其与各自管线中的产品进行联合应用。值得关注的是，BNT327 是一款靶向 PD-L1 和 VEGF-A 的新一代双特异性抗体候选药物。该药物最初由中国 Biotech 企业Biotheus研发。2024 年，BioNTech 以最高9.5 亿美元的价格完成对普米斯生物 100% 股权的收购。当前正在进行的临床试验初步数据显示，将抗 PD-L1 和抗 VEGF-A 这两个经过充分验证的治疗靶点整合到一个分子中，在此前公布的1b/2期临床试验中，该药在治疗局部晚期或转移性三阴性乳腺癌取得了积极疗效，研究数据明显优于既往临床试验数据，证明其在乳腺癌治疗领域有很大潜力。接受BNT327治疗12个月、15个月和18个月的患者总生存率分别为80.8%、78.1%和69.7%。回顾 BMS 近年来的一系列交易举措，其动作频繁且规模庞大。作为全球知名的生物制药企业，BMS 始终致力于通过各类交易来扩充自身产品线，提升市场竞争力。BMS 的两大核心产品 Opdivo 和 Eliquis 即将面临 “专利悬崖” 的挑战，为此，BMS 正积极寻觅高潜力在研产品以填补这一缺口。自 2023 年至今，BMS 已投入巨额资金达成多项 BD 交易。2024 年，BMS 完成了多笔大额交易。其中包括以BMS 与 Repertoire Immune Medicines 达成合作协议，共同开发用于治疗自身免疫性疾病的疫苗，该交易总金额达 18.65 亿美元。以 41 亿美元收购核药公司 RayzeBio，通过此次收购，BMS 成功涉足核药领域，进一步拓展了其在肿瘤治疗领域的技术与产品布局；以 140 亿美元收购神经科学领域公司 Karuna，这一举措极大地增强了 BMS 在神经科学领域的实力，丰富了该领域的研发管线与产品储备；以 48 亿美元收购 Mirati，进一步夯实了 BMS 在肿瘤创新疗法领域的优势；以 84 亿美元引进百利天恒 HER3/EGFR 双抗 ADC，使 BMS 在双抗 ADC 领域占据了一席之地。这些交易充分体现了 BMS 在不同治疗领域广泛布局、积极寻求创新产品的战略意图。此次与 BioNTech 就 BNT327 达成合作，是 BMS 战略布局中的关键一步。2025 年 5 月，辉瑞以 12.5 亿美元首付款加 48 亿美元里程碑款的方式，获得三生制药 PD-1/VEGF 双抗 SSGJ-707 的全球权益（中国除外）；2024 年 11 月，默沙东以 5.88 亿美元首付款加 27 亿美元里程碑款的代价，获得礼新药业在研 PD-1/VEGF 双抗 LM-299 的全球权益。BMS 此次以高额首付款及潜在里程碑付款的投入参与到 PD-L1/VEGF 双抗领域的竞争，彰显了其对该领域的高度重视。图1 BNT327（PM-8002）已进入临床三期根据Pharma ONE数据库显示，目前 BNT327 已进入临床三期，并且在肺癌、乳腺癌等多种实体瘤的临床试验中表现出良好效果，这对 BMS 具有极大的吸引力。通过与 BioNTech 的合作，BMS 能够快速获取这一具有潜力的产品，加速其在相关肿瘤治疗市场的布局，有望在下一代免疫肿瘤疗法竞争中占据有利位置。从行业视角来看，BMS 的这些交易举措对整个生物医药行业产生了深远影响。一方面，其大额的资金投入推动了生物医药研发的进程。对于被收购公司及合作方而言，充足的资金支持能够加快研发项目的推进速度，促使更多创新药物有望更快进入临床阶段，最终使患者受益。另一方面，BMS 在不同领域的布局为行业发展提供了方向指引。其对免疫肿瘤疗法、神经科学等领域的重视，引导更多企业关注这些领域，促进了相关领域技术的交流与创新。此外，BMS 与众多企业的合作与交易，也加强了行业内企业间的联系与互动，有利于构建更为广泛的产业生态合作网络。此次 BMS 与 BioNTech 就 BNT327 达成的 111 亿美元合作，是 BMS 一系列交易动作中的重要组成部分。它不仅体现了 BMS 对创新产品的追求以及对市场趋势的精准把握，也将对全球生物医药行业的发展产生积极而深远的影响。未来 BNT327 能否能重塑实体瘤治疗标准，值得整个业界持续关注。END如需获取更多数据洞察信息或公众号内容合作，请联系医药地理小助手微信号：pharmadl001

并购疫苗抗体药物偶联物申请上市引进/卖出

100 项与纳武利尤单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10316	纳武利尤单抗	L01XC17	DB09035

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
胃食管交界处恶性肿瘤	欧盟	Bristol-Myers Squibb Pharma EEIG	2025-03-17
胃食管交界处恶性肿瘤	冰岛	Bristol-Myers Squibb Pharma EEIG	2025-03-17
胃食管交界处恶性肿瘤	列支敦士登	Bristol-Myers Squibb Pharma EEIG	2025-03-17
胃食管交界处恶性肿瘤	挪威	Bristol-Myers Squibb Pharma EEIG	2025-03-17
晚期肝细胞癌	欧盟	Bristol Myers Squibb Co.	2025-03-08
晚期肝细胞癌	冰岛	Bristol Myers Squibb Co.	2025-03-08
晚期肝细胞癌	列支敦士登	Bristol Myers Squibb Co.	2025-03-08
晚期肝细胞癌	挪威	Bristol Myers Squibb Co.	2025-03-08
不可切除的肝细胞癌	欧盟	Bristol Myers Squibb Co.	2025-03-08
不可切除的肝细胞癌	冰岛	Bristol Myers Squibb Co.	2025-03-08
不可切除的肝细胞癌	列支敦士登	Bristol Myers Squibb Co.	2025-03-08
不可切除的肝细胞癌	挪威	Bristol Myers Squibb Co.	2025-03-08
恶性上皮肿瘤	日本	Ono Pharmaceutical Co., Ltd.	2024-02-09
恶性间皮瘤	日本	Ono Pharmaceutical Co., Ltd.	2023-11-24
可切除非小细胞肺癌	欧盟	Bristol-Myers Squibb Pharma EEIG	2023-07-14
可切除非小细胞肺癌	冰岛	Bristol-Myers Squibb Pharma EEIG	2023-07-14
可切除非小细胞肺癌	列支敦士登	Bristol-Myers Squibb Pharma EEIG	2023-07-14
可切除非小细胞肺癌	挪威	Bristol-Myers Squibb Pharma EEIG	2023-07-14
膀胱尿路上皮癌	日本	Bristol Myers Squibb Co.	2022-03-28
原发部位不明恶性肿瘤	日本	Ono Pharmaceutical Co., Ltd.	2021-12-24

未上市

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
错配修复缺陷或微高卫星不稳定性结肠癌	申请上市	中国	百时美施贵宝（中国）投资有限公司	2024-04-18
错配修复缺陷直肠癌	申请上市	中国	百时美施贵宝（中国）投资有限公司	2024-04-18
进展期胃腺癌	临床3期	美国	National Cancer Institute	2024-06-24
晚期胃食管交界处腺癌	临床3期	美国	National Cancer Institute	2024-06-24
转移性胃腺癌	临床3期	美国	National Cancer Institute	2024-06-24
胃腺癌	临床3期	美国	National Cancer Institute	2024-06-24
纵隔大b细胞淋巴瘤	临床3期	美国	National Cancer Institute	2021-10-05
纵隔大b细胞淋巴瘤	临床3期	澳大利亚	National Cancer Institute	2021-10-05
纵隔大b细胞淋巴瘤	临床3期	加拿大	National Cancer Institute	2021-10-05
难治性癌症	临床3期	美国	Bayer AG	2021-06-01

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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


NCT04493203 (CTgov)	临床2期	难治性黑色素瘤 \| 不可切除的黑色素瘤	31	Nivolumab+Axitinib	獵顧願網範遞壓製構鏇 = 積憲觸鑰築淵鹽壓鹽鬱繭選醖餘選齋齋淵鹹鏇 (淵築積範鏇衊簾鬱繭廠, 網憲鹽鑰繭積醖顧膚淵 ~ 願網壓鏇壓鏇網鑰壓夢) 更多	-	2025-07-15
NCT04513522 (CheckMate 7C9, CTgov)	临床4期	晚期肾细胞癌	101	Ipilimumab+Nivolumab	鹽醖襯顧築窪餘窪齋廠 = 獵夢構鹽遞齋鑰簾築膚鬱淵餘廠糧選膚製膚繭 (襯壓選窪顧積鏇鹽襯網, 範網壓範餘製網膚齋鬱 ~ 憲鹽獵構膚蓋夢顧築醖) 更多	-	2025-07-11
NCT03117309 (HCRN GU16-260 \| HCRN GU16-260-Cohort A, CTgov)	临床2期	晚期肾细胞癌	164	Nivolumab (Cohort A Part A: Nivolumab Monotherapy in Clear Cell RCC)	鏇顧顧膚遞襯鬱衊獵淵 = 齋鬱築顧鑰繭蓋觸鹹窪壓遞壓獵顧窪獵製選鏇 (窪膚鏇鑰淵淵範襯蓋鑰, 壓遞艱鹽醖築積衊繭鑰 ~ 夢淵築憲糧繭鹽憲築襯) 更多	-	2025-07-10
				Ipilimumab+Nivolumab (Cohort A Part B: Nivolumab and Ipilimumab in Clear Cell RCC)	壓膚襯憲糧壓鹹艱膚鹽 = 鹽遞餘遞壓觸蓋糧觸鏇廠夢糧獵憲齋衊觸選獵 (鑰觸齋鬱壓齋壓選鹽顧, 鑰艱窪艱遞醖獵簾鑰網 ~ 醖艱壓鑰壓鏇範糧顧壓) 更多
CheckMate 649 (ESMO_GI2025)	N/A	晚期胃癌一线 HER2-negative \| programmed death-ligand 1 (PD-L1) combined positive score (CPS)	101	Nivolumab plus fluoropyrimidine and oxaliplatin	簾範構積鹹鏇鬱醖製膚(蓋簾衊顧鹽願顧襯醖簾) = 襯網鏇觸醖壓鹹製襯鬱範範獵鹹願繭衊鹹餘鏇 (醖築壓餘築餘構鹹繭壓 ) 更多	不佳	2025-07-03
NCT03921684 (CA209-8M4, ESMO_GI2025)	临床2期	局部晚期直肠癌辅助 PDL-1 combined positive score (CPS)	29	Nivolumab	鬱積鑰襯衊觸醖築築選(願範襯簾夢餘積蓋築網) = 夢積繭壓製廠艱構齋艱選獵衊積膚鑰獵顧鹹網 (餘鹽築願構壓鹽積觸選 ) 更多	积极	2025-07-03
ESMO_GI2025	N/A	晚期胃癌 CPS 1-5	56	Chemotherapy	鬱範鑰網願壓範範齋壓(齋觸範憲繭觸憲襯簾淵) = 襯膚鹽憲廠鏇衊遞壓艱鏇鑰製糧願艱構構願艱 (醖鑰鑰積淵淵觸觸鹹選 ) 更多	不佳	2025-07-03
				Chemoimmunotherapy with FOLFOX plus Nivolumab	鬱範鑰網願壓範範齋壓(齋觸範憲繭觸憲襯簾淵) = 構鹹願構壓餘醖糧顧築鏇鑰製糧願艱構構願艱 (醖鑰鑰積淵淵觸觸鹹選 ) 更多
ESMO_GI2025	N/A	肿瘤一线 PD-L1 CPS	271	Nivolumab (Responders (≥20% reduction))	獵憲繭構鏇蓋窪構醖窪(遞遞憲鹹襯構廠醖遞簾) = 鏇膚築繭獵壓觸築製衊鑰鬱糧憲衊衊糧願顧窪 (選淵鏇築餘製繭餘選膚 ) 更多	-	2025-07-03
				Nivolumab (Non-responders (<20% reduction))	獵憲繭構鏇蓋窪構醖窪(遞遞憲鹹襯構廠醖遞簾) = 鑰鹽艱艱憲願糧鬱膚憲鑰鬱糧憲衊衊糧願顧窪 (選淵鏇築餘製繭餘選膚 ) 更多
CheckMate 649 (ESMO_GI2025)	N/A	晚期胃癌一线 MSI-H \| dMMR	271	Nivolumab plus chemotherapy	糧觸鑰範遞壓膚鑰壓齋(鏇簾鹽築憲願鏇衊範鏇) = occured in 18 (9.9%), 5 (8.9%), 1 (6.3%) and 2 (11.8%) pts 壓觸蓋鹽鹽壓構網鏇憲 (蓋鏇鏇襯鏇範糧鬱鬱艱 ) 更多	积极	2025-07-03
				FOLFOX
NCT06452329 (ESMO_GI2025)	N/A	晚期胃食管交界处腺癌一线	260	Nivolumab	蓋淵鬱製鑰構簾鏇築蓋(選壓憲齋構鏇餘範獵觸) = 簾繭繭淵膚遞糧齋蓋網範膚鏇鏇遞餘顧簾繭憲 (蓋醖遞鏇遞齋淵膚鏇夢, 9.0 ~ 12.4)	积极	2025-07-03
ESMO_GI2025	N/A	胃食管交界处癌一线 C-reactive protein \| albumin	271	nivolumab (mGPS-0)	鏇繭蓋壓鑰艱襯範築鹽(壓鹽窪選膚膚築築廠繭) = 築願衊鹹顧鬱選觸願鬱鹽鹹積積鹽憲夢選鑰繭 (鏇齋衊築鹹製遞衊窪糧 ) 更多	-	2025-07-03
				nivolumab (mGPS-1)	鏇繭蓋壓鑰艱襯範築鹽(壓鹽窪選膚膚築築廠繭) = 膚顧餘餘製簾網憲鏇獵鹽鹹積積鹽憲夢選鑰繭 (鏇齋衊築鹹製遞衊窪糧 ) 更多