A Randomized Phase II Trial of Sacituzumab Govitecan (SG) and Bevacizumab Versus Standard of Care Carboplatin, Pegylated Liposomal Doxorubicin (PLD) and Bevacizumab in Patients With Platinum-Sensitive Ovarian Cancer That Has Progressed on Prior Maintenance PARP Inhibitor Therapy

This phase II trial compares the effect of sacituzumab govitecan and bevacizumab to standard care (carboplatin, pegylated liposomal doxorubicin, and bevacizumab) in patients with ovarian cancer that has come back after an initial response to platinum therapy (platinum-sensitive), that has progressed after poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitor maintenance therapy (recurrent), and that has a mutation in the BRCA1 or BRCA2 genes or is homologous recombination deficient. Sacituzumab govitecan is a monoclonal antibody, called sacituzumab, linked to a drug called govitecan. Sacituzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as TROP2 receptors, and delivers govitecan to kill them. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It also blocks a certain enzyme needed for cell division and DNA repair. Liposomal doxorubicin is a form of the anticancer drug doxorubicin that is contained inside very tiny, fat-like particles. Liposomal doxorubicin may have fewer side effects and work better than other forms of the drug. Giving sacituzumab govitecan and bevacizumab may kill more tumor cells than standard care (carboplatin, pegylated liposomal doxorubicin, and bevacizumab) in patients with recurrent platinum-sensitive ovarian cancers that have BRCA1/2 mutations or homologous recombination deficiency.

开始日期2026-09-10

申办/合作机构

National Cancer Institute

NCT07393555

/ Not yet recruiting临床2期IIT

A Randomized Phase II Study of Sacituzumab Govitecan Alone, Ivonescimab Alone, or Sacituzumab Govitecan and Ivonescimab in Participants With Previously-Treated Actionable Genomic Alteration Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Sub-Study)

This phase II Expanded Lung-MAP treatment trial compares how well sacituzumab govitecan alone, ivonescimab alone, or sacituzumab govitecan in combination with ivonescimab works in treating patients with non-small cell lung cancer (NSCLC) that has come back after a period of improvement (recurrent) or is stage IV and has a change in at least 1 of these genes: ALK, EGFR, HER2 (ERBB2), MET, NTRK, RET, and ROS1. This type of gene change is called an actionable genomic alteration (AGA), which means certain treatments can target the change to fight the cancer. Sacituzumab govitecan is a monoclonal antibody, called sacituzumab, linked to a toxic drug called SN-38. Sacituzumab govitecan is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of tumor cells, known as TROP2 receptors, and delivers SN-38 to kill them. Ivonescimab is a bispecific antibody that can bind to two different antigens at the same time. It binds to programmed cell death protein 1 (PD1), a protein found on the surface of T cells (a type of white blood cell) and vascular endothelial growth factor (VEGF), a protein found on the surface of tumor cells. Ivonescimab may strengthen the immune system and interfere with the ability of tumor cells to grow and spread. Giving a combination of sacituzumab govitecan and ivonescimab work better than either drug alone, and sacituzumab govitecan alone, ivonescimab alone, or sacituzumab govitecan and ivonescimab together may work better than standard treatments at shrinking NSCLC with an AGA.

开始日期2026-08-07

申办/合作机构

SWOG

[+1]

NCT07367178

/ Not yet recruiting临床2期

Phase II Study to Improve Sacituzumab Govitecan Tolerance With Atropine in Patients With Advanced Triple-Negative and Hormone Receptor-Positive/HER2-Negative Breast Cancer

The SATROPIN study is an international, multicenter, open-label, single-arm, phase II clinical trial to assess whether the use of prophylactic administration of atropine may prevent diarrhea in participants with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) or hormone receptor-positive/HER2-negative (HR(+)/HER2-) treated with sacituzumab govitecan.

开始日期2026-07-01

申办/合作机构

Medica Scientia Innovation Research SL

100 项与戈沙妥组单抗相关的临床结果

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100 项与戈沙妥组单抗相关的转化医学

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100 项与戈沙妥组单抗相关的专利（医药）

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2,360

项与戈沙妥组单抗相关的文献（医药）

2026-06-01·DRUGS

Sequential Use of Trastuzumab Deruxtecan and Sacituzumab Govitecan in Patients with Breast Cancer: A Pharmacological Approach to Support the Clinical Rationale

Review

作者: Mathijssen, Ron H J ; Bria, Emilio ; Curigliano, Giuseppe ; Danesi, Romano ; Inglese, Elvira ; Del Re, Marzia ; Blok, Erik J

Antibody-drug conjugates (ADCs) represent a major advance in breast cancer therapy, with trastuzumab deruxtecan and sacituzumab govitecan emerging as leading agents targeting distinct tumor antigens and employing different linker-payload designs. Trastuzumab deruxtecan is a second-generation HER2-directed ADC composed of trastuzumab linked via a cleavable tetrapeptide linker to the camptothecin derivative exatecan, a highly potent topoisomerase I inhibitor. Its high drug-to-antibody ratio (DAR 8:1), membrane-permeable payload, and efficient lysosomal release confer strong antitumor activity, including a robust bystander effect in HER2-low tumors. By contrast, sacituzumab govitecan is a TROP-2-targeted ADC conjugated through a hydrolysable CL2A linker to SN-38, the active metabolite of irinotecan. Sacituzumab govitecan features a high DAR (7.6:1) and allows extracellular as well as intracellular release of SN-38, enhancing bystander killing in tumors with heterogeneous TROP-2 expression, while maintaining a favorable toxicity profile due to the lower intrinsic potency of SN-38 relative to exatecan. Since both these ADCs are conjugated to topoisomerase I inhibitors, concerns about potential cross-resistance regarding their sequencing in clinical practice are being raised, and currently there is a lack of predictive biomarkers providing a rational basis for their sequential administration. Resistance mechanisms exhibit significant heterogeneity: resistance to trastuzumab deruxtecan has been associated with mutations in TOPO I and SLX4, impaired lysosomal function, and efflux via ABC transporters. In contrast, resistance to sacituzumab govitecan is linked to overexpression of multidrug resistance proteins, particularly BCRP-mediated efflux. Clinically, trastuzumab deruxtecan has shown substantial efficacy in both HER2-positive and HER2-low breast cancer, whereas sacituzumab govitecan has demonstrated efficacy across triple-negative and hormone receptor-positive/HER2-negative breast cancers. Collectively, these agents highlight how variations in target antigen, linker chemistry, and payload potency impact ADC activity, therapeutic index, and potential strategies for sequential treatment in advanced breast cancer.

2026-06-01·BREAST CANCER RESEARCH AND TREATMENT

Sacituzumab-induced severe or febrile neutropenia and G-CSF utilization and cost for advanced HER2-negative breast cancer: a single-center retrospective analysis

Article

作者: Yang, Heng ; Tam, Grace ; Waddell, Donald ; Freeman, Jincong Q ; Chen, Nan

Abstract:

Purpose:

Severe neutropenia (SN) and febrile neutropenia (FN) are clinically significant safety concerns of sacituzumab govitecan-hziy (SG). We sought to compare the rates of SN and FN from clinical trials to real-world experience, correlate factors with SN and FN, and quantify granulocyte colony-stimulating factor (G-CSF) use in HER2-negative (HER2-) metastatic breast cancer (mBC).

Methods:

We performed a retrospective analysis of patients treated with SG for advanced HER2- BC at a single US institution with a diverse patient population. The rates of SN and FN, stratified by receptor status, were compared to their respective phase III clinical trials. Multivariable logistic regression was used to evaluate factors associated with SN and FN.

Results:

Of 87 patients treated with SG, 10 patients received primary prophylaxis. Of the 77 patients who didn’t receive primary G-CSF prophylaxis, 49% and 3.9% patients developed SN and FN, respectively. SN and FN rates did not differ in the HR + /HER- mBC or mTNBC subgroups compared to clinical trials. Factors evaluated in this study were not shown to be associated with SN. Overall, 44% (38/87) required a dose interruption or reduction due to SN or FN. 11% (10/87) and 60% (52/87) received G-CSF as primary and secondary prophylaxis respectively, with a total G-CSF drug cost of $2.1 million.

Conclusions:

SG-induced SN and FN rates were similar to those reported in clinical trials, both in the HR + /HER- mBC and mTNBC groups. Due to small sample size, we did not identify any statistically significant risk factors of SG-associated SN. Our study provided insights into G-CSF use patterns and costs in real-world SG therapy.

2026-06-01·CLINICAL PHARMACOLOGY & THERAPEUTICS

Comparing the Efficacy of Various Treatment Strategies for Patients With Advanced Triple‐Negative Breast Cancer: An Umbrella Review

Review

作者: Jia, Shubing ; Ma, Xiaolan ; Xin, Tiantian ; Liu, Jirui ; Liu, Zhendong ; Gao, Mingyu ; Yang, Yue ; Gao, Tong ; Xiang, Rongwu ; Zhao, Mingyi

Chemotherapy (CT) remains the standard first‐line treatment for advanced triple‐negative breast cancer (aTNBC), despite the emergence of innovative therapies, including targeted therapies (TT) and immune checkpoint inhibitors (ICI). Studies have shown that the treatment strategies for aTNBC vary widely, with inconsistent efficacy across different treatment modalities. A comprehensive search was carried out in electronic databases, such as PubMed and Embase, for systematic reviews and randomized clinical trials (RCTs) that investigated the efficacy of TT, ICI, and CT to treat aTNBC until June 2025. Seventeen published meta‐analyses and 52 RCTs reporting the prognosis of the disease treated with TT, ICI, and CT in aTNBC patients were analyzed. It showed that in terms of prolonging PFS, both the TT group and the ICI group were superior to the CT group [ICI: HR = 0.81 (0.69, 0.94); TT: HR = 0.68 (0.62, 0.74)]. In terms of OS, the TT group was superior to the CT group [HR = 0.77 (0.68, 0.88)]. In the subgroup analysis of TT, compared with CT alone, both sacituzumab govitecan (SG) monotherapy and trilaciclib combined with chemotherapy (TRI_CT) significantly improved the time of PFS [SG: HR = 0.41 (0.30, 0.56); TRI_CT: HR = 0.62 (0.46, 0.86)] and OS [SG: HR = 0.48 (0.33, 0.70); TRI_CT: HR = 0.41 (0.28, 0.59)]. This umbrella review supports SG monotherapy and TRI_CT as the first choice for patients with aTNBC. Additionally, the review was rated as high‐quality evidence using AMSTAR 2, the credibility classification standard, and GRADE rating. The study is reported following the Preferred Reporting Items for Systematic Reviews and Meta‐analyses (PRISMA) guideline and is registered with PROSPERO: CRD420251034666.

2,271

项与戈沙妥组单抗相关的新闻（医药）

2026-06-08

·上海丰能数字健康技术研究院

【文献解读003】ＡＤＣ药物的抗体组成及其作用靶点研究进展

—— 基于《中国生物工程杂志》2022年综述的深度解读导语：从“魔法子弹”到临床现实抗体药物偶联物（ADC）自Paul Ehrlich的“魔法子弹”概念提出，历经百年才真正走入临床。截至目前，全球已有超过14款ADC药物获批上市，其在乳腺癌、血液肿瘤等领域展现出令人瞩目的疗效，尤其在HER2阳性乳腺癌治疗中改写了治疗格局。然而，ADC的研发绝非简单的“抗体+毒素”，其疗效受到抗体选择、连接子稳定性、载荷毒性及靶点特异性等多重因素的复杂制约。本文旨在深度解读厦门大学曾弘烨、宁文静、罗文新团队在《中国生物工程杂志》上发表的综述，系统梳理ADC药物中抗体的“选择之道”与靶点的“布局之术”，为理解这一领域提供一份详尽的蓝图。一、ADC药物：三元一体的精准制导系统 ADC的核心结构包括抗体、连接子和细胞毒性药物（载荷）。其作用机制的关键在于：抗体通过与肿瘤细胞表面特异性抗原结合，形成ADC-抗原复合物并被细胞内吞；随后在内体或溶酶体中，连接子断裂或抗体被降解，释放出小分子细胞毒药物，通过损伤DNA或抑制微管蛋白等方式杀死肿瘤细胞。值得注意的是，部分载荷具有“旁观者效应”，能够杀伤邻近抗原表达阴性的肿瘤细胞，这在一定程度上弥补了肿瘤异质性带来的挑战。二、三代技术迭代：从“不稳定”到“精准定点” ADC药物的发展历经了三个阶段。第一代以Mylotarg为代表，采用可裂解的腙键连接子，但因连接子不稳定、载荷易脱落导致毒性问题，曾于2010年撤市。第二代改进了连接子设计，代表药物如Kadcyla（不可裂解连接子）和Adcetris（可裂解连接子），提升了稳定性。第三代技术核心在于采用定点偶联技术，实现了药物抗体比（DAR）的高度均一性，显著提高了治疗指数与药代动力学特性，代表药物如Enhertu。药物名称靶点主要适应证连接子特性获批年份 gemtuzumab ozogamicin CD33 急性髓系白血病可清除（腙键） 2000/2017 brentuximab vedotin CD30 霍奇金淋巴瘤等可清除（val-cit） 2011 ado-trastuzumab emtansine HER2 HER2阳性乳腺癌不可清除（硫醚键） 2013 sacituzumab govitecan Trop-2 三阴性乳腺癌可清除（酸敏感） 2020 enfortumab vedotin Nectin-4 晚期尿路上皮癌可清除（val-cit） 2019 trastuzumab deruxtecan HER2 转移性HER2阳性乳腺癌可清除（四肽） 2019三、抗体的选择：从经典IgG到“新形态”设计抗体是ADC的“导航头”，其选择直接影响药物的特异性、内化效率和安全性。3.1 经典IgG亚型的权衡 IgG因其适中的分子量和较长的半衰期成为ADC载体的首选。其中，IgG1凭借其强效的抗体依赖性细胞毒性（ADCC）和补体依赖性细胞毒性（CDC），以及约60%的血清含量和21天的半衰期，是目前ADC药物最常用的亚型。然而，当靶点在正常组织也有表达时，为降低ADCC/CDC带来的副作用，则可能优先考虑免疫原性较低的IgG2或IgG4亚型。此外，从鼠源、嵌合、人源化到全人源化抗体的进化，核心目的是降低免疫原性，延长半衰期。3.2 新型抗体的创新探索为了克服传统单抗的局限，多种新型抗体被用于ADC构建：*双特异性抗体：可同时结合两个不同抗原或一个抗原的两个表位，能更特异地靶向肿瘤细胞，保护正常组织。例如，针对HER2的双特异性ADC药物ZW49正在临床试验中。*前抗体（Probody）：通过在抗体上连接掩蔽肽，使其在正常组织中失活，只在肿瘤微环境被特异性蛋白酶切割后才被激活，从而大幅提高治疗窗口，降低脱靶毒性。*抗体片段（如scFab,纳米抗体）：更小的分子量带来更好的实体瘤渗透性。例如，上市药物Moxetumomab pasudotox就使用了scFv片段。纳米抗体（VHH）平台在药物递送方面展现出独特潜力。四、靶点的选择：从血液瘤到实体瘤的全面布局理想的ADC靶点应具备：肿瘤特异性高表达、与抗体结合后能高效内化、表达相对稳定不易突变。目前ADC药物靶点已从血液肿瘤相关抗原（如CD33, CD30）扩展至多种实体瘤靶点。4.1 当前重点实体瘤靶点解析靶点代表药物主要适应证关键临床数据（举例） HER2 Enhertu, RC48 乳腺癌、胃癌、尿路上皮癌等 RC48治疗晚期尿路上皮癌II期：mPFS 6.9月，mOS 13.9月 EGFR MRG003, ABT-414 NSCLC、头颈癌、脑胶质瘤等 MRG003针对EGFR阳性实体瘤的I/II期试验进行中 Trop-2 Sacituzumab govitecan (SG) 三阴性乳腺癌、NSCLC等 SG治疗mTNBC III期：ORR 35%，mOS 12.1月 vs 6.7月叶酸受体α Mirvetuximab soravtansine (MIRV) 铂耐药卵巢癌 FORWARD I III期：ORR更高，安全性更优（次要终点） Nectin-4 Enfortumab vedotin 晚期尿路上皮癌 EV-301 III期：mOS 12.88月 vs 8.97月 (HR 0.70) 组织因子(TF) Tisotumab vedotin 复发/转移性宫颈癌 innovaTV 204 II期：ORR 24%，mDOR 8.3月4.2 新兴与探索中的靶点除了上述靶点，HER3（克服EGFR抑制剂耐药）、MUC1（多种上皮癌过表达）、ROR1（正常组织低表达，肿瘤信号通路关键）、以及肿瘤基质成分（如TEM8、活化血小板上的GPIIb/IIIa）等，都成为ADC药物研发的新方向。尤其值得关注的是，针对肿瘤基质的非内化ADC药物，通过靶向肿瘤微环境而非肿瘤细胞本身，为克服肿瘤异质性和内化障碍提供了新思路。核心要点总结与展望 ADC技术已迈入第三代：定点偶联技术带来的均一DAR值，是提升疗效和安全性的关键进步，Enhertu等药物的成功印证了这一点。抗体设计远不止经典IgG：双特异性抗体、前抗体、纳米抗体等“新形态”抗体旨在提升肿瘤特异性、改善渗透性、降低系统毒性，代表了ADC的未来发展方向。靶点选择呈现多元化趋势：从成熟的HER2、Trop-2到新兴的TF、ROR1，ADC药物正覆盖更广泛的肿瘤类型。同时，靶向肿瘤基质等非内化策略为“不可成药”靶点提供了可能。我国ADC研发加速追赶：荣昌生物的RC48已获批，MRG003、MRG002等多款国产ADC进入临床后期，部分企业已布局创新靶点，有望在未来全球ADC市场中占据重要地位。挑战犹存，机遇并存：药物递送效率、靶点异质性、获得性耐药等问题依然严峻。未来的研究需在优化现有组件的同时，积极探索全新的抗体形式、连接子技术和作用机制，如开发免疫刺激型ADC或与其他疗法（如免疫检查点抑制剂）的联合策略，以实现更持久的临床获益。参考文献: [1] Strebhardt K, Ullrich A. Paul Ehrlich's magic bullet concept: 100 years of progress. Nature Reviews Cancer, 2008, 8(6): 473-480. [2] Joubert N, Beck A, Dumontet C, et al. Antibody-drug conjugates: the last decade. Pharmaceuticals (Basel), 2020, 13(9): 245. [3] Jin Y M, Schladetsch M A, Huang X T, et al. Stepping forward in antibody-drug conjugate development. Pharmacology & Therapeutics, 2022, 229: 107917. [4] Beck A, Goetsch L, Dumontet C, et al. Strategies and challenges for the next generation of antibody-drug conjugates. Nature Reviews Drug Discovery, 2017, 16(5): 315-337. [5] Bardia A, Hurvitz S A, Tolaney S M, et al. Sacituzumab govitecan in metastatic triple-negative breast cancer. The New England Journal of Medicine, 2021, 384(16): 1529-1541. [6] Sheng X N, Yan X Q, Wang L, et al. Open-label, multicenter, phase II study of RC48-ADC, a HER2-targeting antibody-drug conjugate, in patients with locally advanced or metastatic urothelial carcinoma. Clinical Cancer Research, 2021, 27(1): 43-51. [7] Powles T, Rosenberg J E, Sonpavde G P, et al. Enfortumab vedotin in previously treated advanced urothelial carcinoma. The New England Journal of Medicine, 2021, 384(12): 1125-1135. [8] Coleman R L, Lorusso D, Gennigens C, et al. Efficacy and safety of tisotumab vedotin in previously treated recurrent or metastatic cervical cancer (innovaTV 204/GOG-3023/ENGOT-cx6): a multicentre, open-label, single-arm, phase 2 study. The Lancet Oncology, 2021, 22(5): 609-619. [9] 徐曾弘烨，宁文静，罗文新. ADC药物的抗体组成及其作用靶点研究进展. 中国生物工程杂志, 2022, 42(5): 69-80. [10] 相关临床试验注册号 (NCT编号) 等。

2026-06-08

·今日头条

中国创新药业领军企业有那些

中国创新药业已形成清晰梯队，第一梯队以全球化全能龙头为主，第二梯队为Biotech创新标杆，第三梯队是传统药企转型先锋。以下为核心领军企业与关键信息（按影响力与全球化程度排序）：一、第一梯队：全球化全能创新龙头（市值超3000亿） 1. 百济神州（688235.SH/06160.HK） - 核心优势：全球研发+全球临床+全球商业化完整体系，海外收入占比超60%，已规模化盈利 - 明星产品：泽布替尼（BTK抑制剂，全球年销超80亿美元，首个年销破500亿国产创新药）、替雷利珠单抗（PD-1，美国上市） - 研发投入：2025年155.08亿元，行业第一，研发费用率40.57% 2. 恒瑞医药（600276.SH/01276.HK） - 核心优势：国内创新药绝对龙头，从仿制药成功转型，研发投入连续多年A股第一 - 明星产品：卡瑞利珠单抗（PD-1，年销约60亿元）、达尔西利（CDK4/6抑制剂）、SHR-A1811（HER2-ADC，获FDA突破性疗法） - 研发实力：2024年研发投入82.28亿元，累计超440亿元；自研管线163项（全球第13位，中国第一）二、第二梯队：Biotech创新标杆（市值500-2000亿） 3. 信达生物（01801.HK） - 核心优势：单抗领域领导者，商业化能力强，与礼来等国际巨头深度合作 - 明星产品：信迪利单抗（PD-1，国内首个纳入医保的PD-1）、贝伐珠单抗生物类似药、阿达木单抗生物类似药 - 研发方向：双抗、ADC、细胞治疗等前沿领域，多款产品处于III期临床 4. 荣昌生物（688331.SH/09995.HK） - 核心优势：ADC技术国内领先，维迪西妥单抗成为首个出海的国产ADC药物 - 明星产品：维迪西妥单抗（HER2-ADC，用于胃癌、尿路上皮癌）、泰它西普（治疗系统性红斑狼疮） - 国际化：维迪西妥单抗获FDA批准上市，海外授权收入快速增长 5. 君实生物（688180.SH/01877.HK） - 核心优势：国内首个PD-1获批企业，新冠中和抗体研发领先 - 明星产品：特瑞普利单抗（PD-1，国内首个获批的国产PD-1）、埃特司韦单抗（新冠中和抗体） - 研发方向：PD-1联合疗法、双抗、小分子药物等，布局肿瘤、自免、感染等领域 6. 诺诚健华（688428.SH/09969.HK） - 核心优势：BTK抑制剂领域专家，奥布替尼全球竞争力强 - 明星产品：奥布替尼（BTK抑制剂，用于淋巴瘤、多发性硬化症） - 研发方向：聚焦肿瘤和自免疾病，多款高选择性靶向药物处于临床阶段三、第三梯队：传统药企转型先锋（市值400-800亿） 7. 中国生物制药（01177.HK） - 核心优势：研发投入大，2025年达58.7亿元，产品线丰富，覆盖肿瘤、肝病、心脑血管等领域 - 明星产品：安罗替尼（多靶点抗血管生成抑制剂）、派安普利单抗（PD-1） - 转型特点：通过自研+并购双轮驱动，快速扩充创新药管线 8. 复星医药（600196.SH/02196.HK） - 核心优势：全球化布局，通过复星凯特布局CAR-T细胞治疗领域 - 明星产品：汉利康（利妥昔单抗生物类似药）、复必泰（新冠疫苗）、瑞基奥仑赛注射液（CAR-T，国内首个获批） - 研发投入：2025年达59.13亿元，研发管线覆盖肿瘤、代谢、感染等领域 9. 科伦药业（002422.SZ） - 核心优势：大输液龙头转型创新药，ADC和肿瘤小分子领域进展迅速 - 明星产品：KL-A167（PD-L1抑制剂）、SKB264（TROP2-ADC，授权默沙东） - 研发特点："仿创结合"，仿制药提供稳定现金流，创新药聚焦高壁垒领域 10. 百利天恒（688506.SH） - 核心优势：ADC和双抗领域黑马，研发强度高（2025年研发投入25.14亿元，研发强度85.79%） - 明星产品：BL-B01D1（EGFR×HER3双抗ADC，用于肺癌）、BL-M02D1（PD-L1×TGFβ双抗） - 国际化：海外授权进展顺利，2025年海外授权收入同比增长300% 四、其他值得关注的创新药企 - 康方生物（09926.HK）：双抗领域领先，卡度尼利单抗（PD-1×CTLA-4双抗）国内首个获批 - 海思科（002653.SZ）：传统药企转型典范，避开PD-1内卷，聚焦糖尿病等领域 - 艾力斯（688578.SH）：肺癌领域专家，伏美替尼（第三代EGFR-TKI）表现优异 - 传奇生物（06127.HK）：CAR-T领域龙头，西达基奥仑赛获FDA批准上市核心特征总结 1. 研发投入持续加码：2025年5家药企研发投入超30亿元，百济神州以155亿元遥遥领先 2. 全球化加速：百济神州、信达生物等海外收入占比不断提升，多款产品获FDA批准 3. 技术路线多元化：从PD-1/PD-L1单抗向ADC、双抗、PROTAC、细胞治疗等前沿领域拓展 4. 商业化能力分化：恒瑞、百济神州等已实现规模化盈利，部分Biotech仍处于亏损阶段

2026-06-08

·Firstwordpharma

Gilead's lung cancer bid for Trodelvy hits wall, but HIV studies deliver better news

Gilead Sciences and Merck & Co. began the week with a mixed clinical scorecard.In back-to-back announcements Monday, the partners revealed they are discontinuing a Phase III study testing Gilead's TROP2-directed antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan-hziy) in combination with Merck's Keytruda (pembrolizumab) in lung cancer, while at the same time touting the success of their experimental once-weekly HIV pill in two other late-stage trials.The oncology setback throws a wrench into Gilead's expansion plans for Trodelvy, which is currently approved for two forms of breast cancer and for urothelial cancer. Lung cancer is a key target, but success so far has been uneven; the Phase III EVOKE-01 trial testing the TROP2 ADC as monotherapy against docetaxel in second-line non–small-cell lung cancer (NSCLC) failed in 2024.'Numerical improvement'Meanwhile, the earlier mid-stage EVOKE-02 trial suggested that combining the drug with Keytruda could be promising in newly diagnosed patients, but that momentum doesn't appear to have carried into Phase III. As a result, the companies have decided to halt the EVOKE-03 trial (also known as KEYNOTE-D46).The study, which was testing the combo against Keytruda monotherapy, enrolled previously untreated metastatic NSCLC patients whose tumours expressed high levels of PD-L1. The decision followed a review by an external data monitoring committee, which found that although the Trodelvy-Keytruda combination produced a "numerical improvement" in progression-free survival, it failed to achieve statistical significance. The committee also concluded that the probability of achieving a significant overall survival benefit at the final analysis was "unlikely." No new safety signals were identified.The companies said there are no changes to other ongoing Trodelvy or Merck studies. The Trodelvy-Keytruda pairing was tested in the triple-negative breast cancer ASCENT-04 and ASCENT-05 studies in the first-line metastatic and high-risk adjuvant settings, respectively.Non-inferiority to Biktarvy, ARTWhile the oncology programme stumbled, Gilead and Merck delivered more encouraging news involving their ongoing HIV partnership.The investigational once-weekly single-tablet regimen combining Gilead's capsid inhibitor lenacapavir with Merck's islatravir, a nucleoside reverse transcriptase translocation inhibitor, met the primary endpoint in both Phase III ISLEND-1 and ISLEND-2 studies of virologically suppressed patients at week 48.In ISLEND-1, the regimen was found to be statistically non-inferior to Gilead's Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide), while ISLEND-2 showed non-inferiority against a range of standard-of-care daily oral antiretroviral therapy (ART) regimens. Safety findings were generally similar to the comparator treatments.The companies said they intend to file the data with regulators around the world for what could become the first once-weekly oral treatment option for people with HIV.Lenacapavir is already on the market as Sunlenca for multi-drug-resistant HIV and Yeztugo as a twice-yearly preventive shot. In April, the FDA approved a once-daily single-tablet regimen combining islatravir with doravirine under the name Idvynso for adults with virologically suppressed HIV-1.

临床3期临床结果上市批准

100 项与戈沙妥组单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	戈沙妥组单抗	L01	DB12893

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
转移性三阴性乳腺癌	欧盟	Gilead Sciences Ireland UC	2021-11-22
转移性三阴性乳腺癌	冰岛	Gilead Sciences Ireland UC	2021-11-22
转移性三阴性乳腺癌	列支敦士登	Gilead Sciences Ireland UC	2021-11-22
转移性三阴性乳腺癌	挪威	Gilead Sciences Ireland UC	2021-11-22
乳腺癌	瑞士	Gilead Sciences, Inc.	2021-09-09
HR阳性/HER2阴性乳腺癌	澳大利亚	Gilead Sciences Pty Ltd.	2021-09-06
尿路上皮癌	美国	Gilead Sciences, Inc.	2021-04-13
三阴性乳腺癌	美国	Gilead Sciences, Inc.	2020-04-22

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
转移性乳腺癌	申请上市	中国	云顶药业（苏州）有限公司	2021-05-17
广泛期小细胞肺癌	临床3期	美国	Gilead Sciences, Inc.	2025-04-04
广泛期小细胞肺癌	临床3期	中国	Gilead Sciences, Inc.	2025-04-04
广泛期小细胞肺癌	临床3期	日本	Gilead Sciences, Inc.	2025-04-04
广泛期小细胞肺癌	临床3期	阿根廷	Gilead Sciences, Inc.	2025-04-04
广泛期小细胞肺癌	临床3期	澳大利亚	Gilead Sciences, Inc.	2025-04-04
广泛期小细胞肺癌	临床3期	比利时	Gilead Sciences, Inc.	2025-04-04
广泛期小细胞肺癌	临床3期	巴西	Gilead Sciences, Inc.	2025-04-04
广泛期小细胞肺癌	临床3期	加拿大	Gilead Sciences, Inc.	2025-04-04
广泛期小细胞肺癌	临床3期	法国	Gilead Sciences, Inc.	2025-04-04

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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


NCT04527991 (TROPiCS-04, CTgov)	临床3期	不可切除的尿路上皮癌	711	Sacituzumab govitecan-hziy (Sacituzumab Govitecan-hziy (SG))	觸鹹鬱憲衊壓鹹艱構襯(繭襯蓋鏇願膚憲蓋壓鑰) = 蓋蓋構蓋積艱鏇構願鏇廠製鬱夢衊鬱構膚餘製 (鹽夢製齋鏇艱遞願鬱鹹, 夢齋襯鬱築醖醖廠網醖 ~ 積鬱製鹽窪繭構醖艱艱) 更多	-	2026-06-02
				Paclitaxel+Vinflunine+Docetaxel (Treatment of Physician's Choice)	觸鹹鬱憲衊壓鹹艱構襯(繭襯蓋鏇願膚憲蓋壓鑰) = 鏇鑰衊糧網製憲鏇窪餘廠製鬱夢衊鬱構膚餘製 (鹽夢製齋鏇艱遞願鬱鹹, 範繭構衊鏇鏇範鹹願簾 ~ 壓鏇淵選鹹獵鑰鏇鬱顧) 更多
NCT06963905 (SIMONE, ASCO2026)	临床1期	转移性三阴性乳腺癌二线 PD-L1 positive	60	Sacituzumab govitecan plus nivolumab	衊夢鹹築顧壓繭積獵壓(憲膚醖壓淵鬱築廠鬱窪) = 獵憲憲顧糧衊鹹襯構願鹹獵築齋窪艱鏇蓋糧壓 (簾糧憲衊齋壓餘鬱壓蓋 ) 更多	积极	2026-05-29
				Sacituzumab govitecan plus nivolumab and relatlimab	鹹網鹽鹽範遞積齋衊蓋(餘顧憲製餘願製願製網) = 構膚製醖衊蓋廠繭獵夢蓋繭窪築膚鹹齋憲衊選 (鏇積網憲築窪網願範醖 ) 更多
NCT05840211 (ASCENT-07, ASCO2026)	临床3期	转移性乳腺癌 HER2 IHC0	292	Sacituzumab govitecan (SG) (HER2 IHC0)	選積獵獵獵願積蓋範糧(鹹鑰醖鑰窪齋憲鹹膚蓋) = 鹽鏇夢積廠夢餘觸淵選艱網鏇築網窪顧醖積構 (艱壓憲願糧製窪繭夢網, 8.2 ~ 10.4) 更多	积极	2026-05-29
				Chemotherapy (TPC) (HER2 IHC0)	選積獵獵獵願積蓋範糧(鹹鑰醖鑰窪齋憲鹹膚蓋) = 廠餘糧衊衊網蓋鹽觸艱艱網鏇築網窪顧醖積構 (艱壓憲願糧製窪繭夢網, 6.3 ~ 10.4) 更多
NCT06065371 (ASCO2026 \| ASCO_GI2026)	临床1期	胃肠道肿瘤	20	Sacituzumab govitecan + Capecitabine	鏇艱窪壓廠鑰鑰範窪築(蓋願顧願網製鑰鏇衊顧) = 製觸夢鹹餘襯選衊襯鹽顧淵鑰網獵襯艱範遞鹽 (製選繭範鹹襯衊範衊獵 )	积极	2026-05-29
ASCO2026	N/A	HER2-negative	306	Sacituzumab govitecan (SG) (Triple-negative (TN))	鏇願願願網網壓壓構鏇(壓齋醖積遞窪齋艱齋顧) = 遞壓顧淵夢醖齋顧獵艱窪繭鏇襯壓廠窪鏇衊鹹 (齋繭鹽築製觸襯夢蓋壓 ) 更多	积极	2026-05-29
				Trastuzumab deruxtecan (T-DXd) (Triple-negative (TN))	鏇願願願網網壓壓構鏇(壓齋醖積遞窪齋艱齋顧) = 膚顧構繭築鏇築鑰淵蓋窪繭鏇襯壓廠窪鏇衊鹹 (齋繭鹽築製觸襯夢蓋壓 ) 更多
NCT05382286 (ASCENT-04, ASCO2026)	临床3期	PD-L1阳性三阴性乳腺癌一线 PD-L1+ \| tBRCA WT \| HER2 IHC 0 ... 更多	443	Sacituzumab govitecan (SG) + pembrolizumab (pembro)	簾憲衊構艱鑰鹹觸窪鹹(鬱繭鏇廠鏇鏇繭築鹽襯) = 鹽餘醖蓋鑰壓餘膚蓋構膚蓋顧簾簾範醖鬱壓鏇 (鑰鏇築簾鬱構繭製鹹淵, 7.4 ~ 19.4) 更多	积极	2026-05-29
				Gemcitabine + carboplatin or Taxane + pembrolizumab (pembro)	簾憲衊構艱鑰鹹觸窪鹹(鬱繭鏇廠鏇鏇繭築鹽襯) = 構鏇選蓋選淵鹹衊淵構膚蓋顧簾簾範醖鬱壓鏇 (鑰鏇築簾鬱構繭製鹹淵, 0.0 ~ 10.9) 更多
NCT05833867 (RAD-SG, ASCO2026)	临床1期	非肌层浸润性膀胱肿瘤	14	Sacituzumab govitecan (Muscle Invasive Bladder Cancer)	憲鬱廠襯淵衊鑰鹽壓窪(壓夢遞構壓網網鑰築鬱) = 壓廠顧顧遞鏇願齋齋築鬱築糧簾鹽壓簾艱夢遞 (鹽夢淵蓋鬱餘艱築鏇艱 ) 更多	积极	2026-05-29
NCT05226117 (SURE-01, ASCO2026)	临床2期	肌层浸润性膀胱癌新辅助 TROP2 expression	44	Sacituzumab govitecan	壓夢鹽夢願鏇鬱蓋簾獵(鹹鹽網鹹糧願鏇鬱夢鹹) = 觸選選觸蓋廠窪網膚鹹選繭窪鑰鑰夢糧廠壓壓 (簾餘膚構蓋廠醖構餘壓, 16.7 ~ 45.2) 更多	积极	2026-05-29
NCT06028932 (ASCO2026)	临床2期	铂耐药性卵巢癌 Trop2	20	Sacituzumab govitecan	遞選鏇願簾鬱製鑰憲顧(壓積糧築廠構齋窪選獵) = 鹹願簾夢憲築蓋鑰襯夢餘網襯顧築繭膚壓觸齋 (範遞蓋糧積窪顧構糧範 ) 更多	积极	2026-05-29
NCT05382299 (ASCENT-03, ASCO2026)	临床3期	三阴性乳腺癌一线	558	Sacituzumab govitecan (SG)	夢願壓憲製夢繭糧糧廠(壓餘醖廠鹹淵窪構醖淵) = 網齋顧簾齋膚觸鏇憲願廠糧壓顧糧衊淵簾窪鬱 (糧積蓋築範艱觸廠繭糧, 65 ~ 76) 更多	积极	2026-05-29
				Chemotherapy (chemo)	夢願壓憲製夢繭糧糧廠(壓餘醖廠鹹淵窪構醖淵) = 蓋艱淵窪觸膚鏇構淵簾廠糧壓顧糧衊淵簾窪鬱 (糧積蓋築範艱觸廠繭糧, 53 ~ 65) 更多