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更新于：2026-08-06

Sacituzumab govitecan-hziy

戈沙妥组单抗

更新于：2026-08-06

概要

基本信息

药物类型

ADC

别名

hRS7-SN38 antibody drug conjugate、Isactuzumab govitecan、Sacituzumab Govitecan

+ [13]

靶点

Top I x Trop-2

作用方式

抑制剂

作用机制

TOP1抑制剂(DNA拓扑异构酶I抑制剂)、Trop-2抑制剂(肿瘤相关钙信号传感器2抑制剂)

治疗领域

肿瘤皮肤和肌肉骨骼疾病内分泌与代谢疾病+ [8]

在研适应症

转移性三阴性乳腺癌乳腺癌HR阳性/HER2阴性乳腺癌+ [78]

非在研适应症

胶质母细胞瘤多形性胶质母细胞瘤肝细胞癌+ [4]

原研机构

Immunomedics, Inc.

在研机构

Gilead Sciences, Inc.云顶新耀香港有限公司

云顶药业（苏州）有限公司

+ [11]

非在研机构

Merck Sharp & Dohme Corp.Everest Medicines II Ltd.

权益机构

Seagen, Inc.

BSP Pharmaceuticals SpA

Gilead Sciences, Inc.

+ [7]

最高研发阶段批准上市

首次获批日期

美国 (2020-04-22),

三阴性乳腺癌

最高研发阶段(中国)批准上市

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

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结构/序列

使用我们的ADC技术数据为新药研发加速。

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查看完整样例数据

Sequence Code 27958L

来源: *****

Sequence Code 319372635H

来源: *****

关联

145

项与戈沙妥组单抗相关的临床试验

NCT07504588

/ Not yet recruiting临床2期IIT

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

NCT07151586

/ Not yet recruiting临床2期IIT

A Phase 2, Multicenter, Randomized, Open-label Trial Assessing Sacituzumab-govitecan and Trastuzumab-deruxtecan Combinations in an Alternating Regimen for Patients With Metastatic or Locally Advanced HER2-low Triple-negative Breast Cancer

This is a phase II, multicentre, open-label, randomised controlled trial (patients are randomly assigned to one treatment arm or the other) evaluating two treatment strategies (sacituzumab govitecan and trastuzumab deruxtecan in an alternative schema or sacituzumab govitecan alone) in patients with locally advanced or metastatic triple-negative breast cancer.
The goal is to answer the question: Does alternating sacituzumab goveitecan (SG) and trastuzumab deruxtecan (T-DXd) improve survival in patients with HER2-low metastatic triple-negative breast cancer compared to continuing treatment with SG alone?

开始日期2026-09-01

申办/合作机构

UNICANCER

NCT07178730

/ Not yet recruiting临床3期

NeoAdjuvant Dynamic Marker - Adjusted Personalized Therapy Comparing Sacituzumab Govitecan+Pembrolizumab vs. SoC Chemotherapy in Clinical Stage II-III, Triple-negative Early Breast Cancer

TNBC is a heterogeneous disease with distinct pathological, genetic, and clinical features among subtypes. Treatment results for high-risk primary TNBC remain poor compared to other breast cancer subtypes. Preoperative chemotherapy is the standard of care for patients with stage II or III primary TNBC. Multiple lines of clinical evidence demonstrate that TNBC patients who achieve a pCR to NACT, (ypT0/is ypN0), have an excellent long-term prognosis. A meta-analysis of individual patient data confirmed a strong association of pCR after NACT with improved long-term event-free survival (EFS, hazard ratio [HR] 0.24) and overall survival (OS, HR 0.16) benefit. Taxane- and anthracycline-based neoadjuvant regimens generally result in pCR rates between 25-50% [REFs], whereas the addition of platinum increases pCR rates to approximately 50-55%.
The KEYNOTE-522 trial has demonstrated that the addition of the immune-checkpoint inhibitor PEM to anthracycline- (AC), taxane- and platinum-based NACT resulted in a significant increase in pCR rates to nearly 65%, associated with a significant reduction of recurrences (EFS, HR 0.65 at 5 years) and improvement of OS (HR 0.66). Based on these results, the KEYNOTE-522 regimen has been approved by the FDA and EMA and has become the standard of care for patients with stage II or III TNBC.
Despite this significant progress, two major questions remain unresolved which will be investigated in the ADAPT-TN-IV trial:
1. Do all patients require the full 6 months of NACT as per KEYNOTE-522 or is there a subgroup of patients who are sufficiently treated with 12 weeks of NACT plus PEM?
2. Can incorporation of ADCs into the KEYNOTE-522 regimen improve response and outcomes in patients without an optimal early response? The outcome of patients with residual disease after 24 weeks of NACT and PEM remains suboptimal and there is an urgent need for more effective strategies. ADCs such as SG have demonstrated superior efficacy compared to standard chemotherapy in metastatic TNBC, resulting in substantially higher response rates and improved progression-free (PFS) and OS. Combination studies of ADCs and immunotherapy in metastatic TNBC have demonstrated significant activity, suggesting possible synergistic activity It is therefore a logical next step to investigate, whether the incorporation of SG in the NACT regimen can improve pCR rates and EFS results in patients who have residual clinical disease after 12 weeks of NACT with CARBO/PAC + PEM.

开始日期2026-08-30

申办/合作机构

Gilead Sciences, Inc.

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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2,335

项与戈沙妥组单抗相关的文献（医药）

2026-07-15·BIOCONJUGATE CHEMISTRY

Rapid and Efficient Antibody–Drug Conjugate Design Using Mechanistic Bottom-Up Modeling from In Vitro to Human

Article

作者: Sweeney-Lasch, Stanley ; Kolmar, Harald ; Kahl, Jan-Philip ; Hecht, Stefan ; Lindroos, Tatu ; Stein, Judith ; Anderl, Jan ; Kaempffe, Anna ; Krug, Michael

Antibody-drug conjugates (ADCs) are complex molecules, and many fail clinically despite promising preclinical data. Here, a modular, bottom-up modeling strategy employing mechanistic PK-PD models was developed to translate ADC efficacy and toxicity from bench to bedside and to guide ADC design. The models handle various antigens, payloads, and ADCs, validated using six ADCs (Enhertu, Kadcyla, Trodelvy, RC48, RN927C, and Datroway). Using determined cellular distribution of payloads/ADCs, payload killing parameters, and systemic parameters (assay volume, cell doubling time), ADC in vitro potency was predicted with 94.64% accuracy within a 2-fold range. Incorporating ADC and payload pharmacokinetic parameters enables prediction of in vivo efficacy comparable to cell line- and patient-derived xenograft data from the literature. Scaling parameters from mouse to human (PK, tumor volume, and tumor doubling time) led to the reproduction of clinical efficacy trends. Beyond efficacy, the approach predicts key hematologic toxicities such as neutropenia and thrombocytopenia, demonstrated for Kadcyla and Enhertu. Application to the clinically failed RN927C demonstrated how our modeling approach could have flagged issues and enabled suggestions for design modifications to widen the therapeutic window and prevent the clinical failure. In conclusion, our presented modeling strategy delivers accurate efficacy and toxicity translation from in vitro to humans utilizing easily accessible parameters as the foundation and deepens understanding of ADCs and their individual components, thereby supporting ADC design and candidate and patient selection and accelerating ADC development.

2026-07-02·CANCER RESEARCH

Prolonged KRAS-MAPK Inhibition Induces Interferon Signaling That Promotes Cell State Transition and Confers Therapeutic Vulnerabilities

Article

作者: Ruzinova, Marianna B. ; Wang, Yu ; Geng, Yutong ; Chen, Timothy Hung-Po ; Tran, David D. ; Khawar, Iftikhar Ali ; Pereye, Ofejiro Blessing ; Liu, Peng ; Bulle, Ashenafi ; Li, Lin ; Bansod, Sapana ; Chen, Yali ; Li, Huaping ; Le, Son B. ; Lim, Kian-Huat ; Somani, Vikas Kumar ; Kurupi, Richard

Abstract:

Acquired resistance limits the therapeutic efficacy of KRAS-MAPK inhibitors in pancreatic ductal adenocarcinoma (PDAC). As transcriptional plasticity and epithelial-to-mesenchymal transition (EMT) have been implicated in resistance, we sought to study the molecular mechanisms driving these changes to uncover actionable vulnerabilities. Sustained KRAS-MAPK inhibition induced interferon (IFN) and NF-κB signaling and promoted cell state change mimicking an EMT state associated with drug resistance. Network analysis identified the IFN-inducible E3 ubiquitin ligase TRIM22 as a central regulator of this response. Mechanistically, TRIM22 promoted proteasomal degradation of IκBα, resulting in sustained NF-κB and EMT program activation that coincided with a basal-like transcriptional cell state. TRIM22 expression was driven by IRF1 and IRF9 following relief of ERK-mediated transcriptional repression during pathway inhibition. EMT induction was accompanied by marked upregulation of TROP2 (TACSTD2), an NF-κB target gene enriched in basal-like PDAC cell states. Combining TROP2-directed antibody–drug conjugate sacituzumab govitecan with KRAS or ERK inhibitors significantly suppressed PDAC tumor growth in xenograft models. Overall, prolonged KRAS-MAPK inhibition activates an IFN–TRIM22–NF-κB axis that drives EMT and therapeutic resistance in PDAC, while revealing TROP2 as a clinically actionable vulnerability to overcome acquired resistance.

Significance::

TRIM22 drives interferon-induced EMT and NF-κB–dependent TROP2 upregulation to drive resistance to KRAS-MAPK inhibition in pancreatic cancer, which can be overcome by combining sacituzumab govitecan with KRAS-MAPK inhibitors.

2026-07-01·iScience

The WEE1 inhibitor azenosertib broadly enhances efficacy of antibody-drug conjugates with topoisomerase I and microtubule inhibitor payloads

Article

作者: Chung, Heekyung ; Guo, Xiao ; Meric-Bernstam, Funda ; Cabrera, Erika ; Lackner, Mark R ; Harismendy, Olivier ; Lee, Catherine ; Kim, Doris ; Ma, Jianhui

Antibody-drug conjugates (ADCs) have transformed targeted cancer therapy, yet strategies to overcome resistance and enhance efficacy remain needed. Since ADCs exert anti-tumor effects via DNA damage or mitotic disruption, combining them with WEE1 inhibitors represents a rational approach. We investigated the selective WEE1 inhibitor azenosertib in combination with ADCs carrying topoisomerase I inhibitor (TOP1i) or microtubule inhibitor (MTI) payloads. Azenosertib enhanced the activity of free TOP1i agents and TOP1i-based ADCs (trastuzumab deruxtecan [T-DXd] and sacituzumab govitecan), increasing DNA damage and apoptosis, and extended the duration of response while overcoming T-DXd resistance in patient-derived xenografts. Synergistic effects were also observed with MTI agents and MTI-based ADCs (mirvetuximab soravtansine, tisotumab vedotin, and enfortumab vedotin), associated with exacerbated mitotic defects and prolonged mitotic arrest. All combinations enhanced efficacy and were well tolerated in vivo. These findings position azenosertib as a broadly applicable enhancer of cytotoxic-payload ADCs, offering a promising strategy for patients with advanced solid tumors.

2,548

项与戈沙妥组单抗相关的新闻（医药）

2026-08-05

·摩熵医药

抗病毒巨头Q2营收78亿美元，明星药Veklury暴跌81%！

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。 8月4日，吉利德公布2026年第二季度财报。总营收78亿美元，同比增长10%，超出市场预期的74亿美元。产品销售额（剔除Veklury）76亿美元，同增10%。但归母净利润为 -105亿美元，GAAP每股亏损8.45美元。截图来源：吉利德企业官网赚钱的业务在涨，花钱的步子更大。这是吉利德转型期的典型财务画像。 01 HIV依然是“现金牛”：PrEP季度首破10亿美元 HIV依然是吉利德最稳固的压舱石。二季度HIV产品销售额56.9亿美元，同比增长12%。核心产品Biktarvy贡献38亿美元，同增7%。一款已上市多年的单片复方方案，这个体量还在涨，说明市场拉力足够强。截图来源：吉利德2026年Q2财报 Descovy的PrEP适应症销售额约9.67亿美元，同增48%。加上Yeztugo的2.23亿美元，吉利德PrEP业务整体季度销售额首次突破10亿美元，同比翻倍。一个细分赛道，单季10亿美元——这个数字超过多数药企全部产品线一个季度的总收入。吉利德在这个赛道上的护城河已经不只是“先发优势”，而是药物发现、长效制剂、患者依从性管理的多维壁垒。管线还在加码： FDA已受理Yeztugo（lenacapavir）300mg片剂的补充新药申请，作为每周一次口服PrEP方案，PDUFA日期2027年2月2日；与默沙东合作的每周一次口服islatravir+lenacapavir方案，两项III期（ISLEND-1和ISLEND-2）均取得积极结果。全年HIV销售增长预期已上调至9%-10%。一个判断：HIV业务正在从“靠Biktarvy吃存量”转向“靠PrEP吃增量”的双引擎结构。 02 肿瘤业务：Trodelvy升级，CAR-T承压，ADC接棒肿瘤是吉利德过去几年最用力砸钱的方向。二季度表现喜忧参半。好消息是Trodelvy。这款TROP2 ADC二季度销售4.57亿美元，同增26%。6月，FDA批准其用于一线治疗mTNBC，不再限定PD-L1状态——适应症扩容直接打开了更大的患者池。目前Trodelvy已在全球60多个国家获批二线及以上mTNBC，50多个国家获批经治HR+/HER2-转移性乳腺癌。Trodelvy正在从一个“后线挽救药”变成“前线标准方案”。坏消息是细胞疗法。 Yescarta销售3.46亿美元（-12%），Tecartus为0.7亿美元（-24%），合计4.17亿美元，同比下降14%。截图来源：吉利德2026年Q2财报全球多款CAR-T疗法已获批上市，赛道正从蓝海急速转向红海。价格竞争加剧、适应症高度重叠。据摩熵医药数据库统计，全球获批上市的CAR-T药物已超过15款。从临床研发进度看，吉利德的KITE-772目前处于全球申请上市阶段，另有5款在研产品推进至Ⅰ期临床，1款进入Ⅲ期临床。截图来源：摩熵医药全球药物研发数据库（查数据.找摩熵）真正的战略看点不在已上市产品，而在管线端的两次重仓： 4月完成对Arcellx的收购，收获anito-cel——一种基于D-domain binder技术的CAR-T疗法，用于四线及以上复发/难治性多发性骨髓瘤，PDUFA日期定在12月23日。这可能是吉利德在细胞疗法赛道上的翻身仗。 5月完成对Tubulis的收购（前期31.5亿美元），补充下一代ADC资产。GS-8824（原TUB-040）是一款NaPi2b靶向拓扑异构酶I抑制剂ADC，在铂耐药卵巢癌I期临床中，选定剂量组确认ORR达61%，mPFS为11个月，血液学毒性较低。这套组合拳的逻辑很清晰：CAR-T守阵地，ADC拓疆土。但EVOKE-3的失败（Trodelvy+Keytruda一线NSCLC折戟）提醒一件事——ADC+IO联合的边界仍然存在，并非所有组合都能跑通。 03 肝病接棒新冠：Veklury退场，Livdelzi翻倍肝病业务二季度销售8.77亿美元，同比增长10%。增长核心是Livdelzi（seladelpar）——一款用于原发性胆汁性胆管炎（PBC）的药物，2024年获批，2026年Q2销售额1.67亿美元，同比翻倍以上。截图来源：吉利德2026年Q2财报另一亮点是Hepcludex，5月获FDA加速批准，成为美国首个且唯一获批治疗慢性丁型肝炎（HDV）的药物。HDV影响全球约1200万人，长期以来几乎没有有效治疗选择——这是典型的“小众但刚需”市场。另一边，Veklury（瑞德西韦）正在加速退场。二季度销售仅2300万美元，同比暴跌81%。新冠住院率持续下降，这款曾经的“明星药物”正走向终点。吉利德已将其全年销售预测从约6亿美元下调至约3亿美元。截图来源：吉利德2026年Q2财报一个时代的落幕，另一个时代的开启——从抗新冠到抗丁肝，吉利德在抗病毒领域完成了业务接力。结语吉利德正处在一个微妙的转折点。 HIV是现金牛，但它已不再是“一家HIV公司”。通过密集收购和管线推进，它正在把自己重新定义为一家横跨抗病毒、肿瘤和自免的多元化生物制药企业。这个转型的代价是账面上一百多亿美元的收购支出和单季105亿美元的巨额亏损。但如果anito-cel顺利上市、GS-8824推进到注册临床、Livdelzi和Trodelvy持续放量，这笔投资在未来三到五年内有可能转化为可观的收入增量。两重悬疑仍待解开：第一重：细胞疗法的竞争格局。 Yescarta和Tecartus连续下滑，CAR-T赛道正在从“蓝海”变成“红海”。anito-cel能否帮吉利德守住阵地，是2026年12月23日之前最大的问号。第二重：EVOKE-3的失败。 Trodelvy+Keytruda在一线NSCLC的折戟是一个清醒剂——ADC的边界仍然存在，并非所有联合都能跑通。从有管线到有产品、从有产品到有销售，每一步都伴随着淘汰率。 END 本文为原创文章，转载请留言获取授权点击阅读原文，申请摩熵医药企业版免费试用！

2026-08-05

·药事纵横

默沙东上半年业绩：K药仍保持增长

2026年8月4日，默沙东公布了2026年第二季度财务业绩。数据显示，公司全球总销售额达到166亿美元，同比增长5%（剔除汇率影响增长4%），其中制药业务销售额为147.6亿美元，同比增长5%，成为整体业绩增长的核心引擎。KEYTRUDA家族持续领跑，QLEX剂型初显锋芒作为默沙东的王牌产品，KEYTRUDA及新推出的皮下注射剂型KEYTRUDA QLEX合计实现销售额83.66亿美元，同比增长5%。其中，KEYTRUDA QLEX贡献了4.63亿美元的销售额，显示出新剂型在市场上的初步接纳度良好。业绩增长的主要驱动力来自早期适应症的全球扩张，包括三阴性乳腺癌、宫颈癌、头颈癌和膀胱癌等领域的广泛应用。同时，尿路上皮癌等转移性适应症的全球需求也在持续增加。在监管层面，默沙东本季度取得了多项关键进展：FDA批准KEYTRUDA联合WELIREG用于特定透明细胞肾细胞癌患者的辅助治疗，这是PD-1抑制剂与HIF-2α抑制剂在该领域的首个获批联合疗法；KEYTRUDA联合Padcev的适用范围也扩展至顺铂适用的肌肉浸润性膀胱癌患者术前术后治疗；此外，KEYTRUDA联合Trodelvy获批用于PD-L1阳性晚期三阴性乳腺癌的一线治疗。WINREVAIR增速惊人，LIPFENDRA获批开启新篇章肺动脉高压药物WINREVAIR本季度表现极为抢眼，销售额达5.88亿美元，同比暴增75%。增长主要受益于美国市场的持续渗透以及日本、欧洲等国际市场的早期上市放量。值得关注的是，默沙东在心血管领域迎来了近70年历史上的又一里程碑——FDA于7月批准了LIPFENDRA（enlicitide），这是首个且唯一的每日一次口服PCSK9抑制剂，用于降低高胆固醇血症成人的LDL-C。在两项III期临床试验中，LIPFENDRA在24周时将LDL-C较安慰剂显著降低了56%和59%。这一获批标志着默沙东在心血管代谢领域开启了全新增长曲线。疫苗业务分化明显，GARDASIL稳中有升疫苗板块中，GARDASIL/GARDASIL 9实现销售额11.69亿美元，同比增长4%，主要得益于亚太地区和欧洲的需求增长。CAPVAXIVE销售额为1.84亿美元，同比增长42%，受国际市场上市拉动明显。但VAXNEUVANCE同比下降35%，主要受竞争压力和公共部门采购节奏影响。其他重磅产品表现抗凝血逆转剂BRIDION销售额4.97亿美元，增长8%；抗巨细胞病毒药物PREVYMIS销售额2.95亿美元，增长29%，受益于新适应症的上市推广；肾癌药物WELIREG销售额2.71亿美元，猛增67%，在日本等市场的持续放量功不可没。值得注意的是，糖尿病药物JANUVIA/JANUMET销售额同比下降31%至4.29亿美元，主要受美国市场竞争加剧以及中国等市场仿制药冲击的影响。管线进展：肿瘤与HIV领域多点开花除了已上市产品的优异表现，默沙东的研发管线同样亮点频出。在肿瘤领域，sac-TMT（与科伦博泰合作开发的抗TROP2 ADC）在III期TroFuse-005试验中达到总生存期和无进展生存期双主要终点，针对的是铂类和免疫治疗失败的晚期子宫内膜癌患者。这是该ADC项目17项全球III期试验中的首个阳性结果。在HIV领域，默沙东与吉利德合作的每周一次口服治疗方案islatravir/lenacapavir公布了首个III期阳性结果，有望成为首个获批的口服每周一次HIV治疗药物。财务概览与展望尽管本季度GAAP每股亏损0.54美元，Non-GAAP每股亏损0.13美元，但亏损主因是收购Terns Pharmaceuticals产生的57亿美元一次性费用（每股2.31美元），而非经营层面的问题。基于上半年的强劲表现，默沙东上调了全年销售指引，预计2026年全年销售额在663亿至673亿美元之间，Non-GAAP每股收益预计为2.66至2.76美元。公司CEO Robert M. Davis表示："我们对战略的执行充满信心，将继续为患者带来福祉，并进一步增强长期增长轨迹。" 立即扫码加入药事纵横交流群

2026-08-05

·贝壳社

抗病毒王者Q2赚了526亿，昔日“明星药物”暴跌81%

贝壳社今日，吉利德公布2026年第二季度财报。其中，总收入78亿美元（约526亿元），产品销售额（除瑞德西韦）为76亿美元，同比增长10%。归母净利润为-105亿美元。 1 HIV基本盘 HIV仍然是吉利德的基本盘，但这个基本盘的含义正在发生变化。二季度吉利德HIV产品销售额57亿美元，同比增长12%。核心产品Biktarvy贡献了38亿美元，增长7%，作为一个已经上市多年的单片复方方案，这个数字说明它在市场上依然有拉力。但真正让人眼前一亮的是预防端：Descovy的PrEP适应症销售约9.67亿美元，同比增长48%。而吉利德在这个赛道上的领先优势，已经不是简单的先发优势，它在药物发现、长效制剂、患者依从性管理等多个维度上同时建立了壁垒。下一代产品管线同样在快速推进。FDA已接受Yeztugo（lenacapavir）300毫克片剂的新药补充申请，作为潜在的每周一次口服制剂，用于HIV暴露前预防（“PrEP”），预计在2027年2月2日给出审批决定；与默沙东合作的每周一次口服islatravir+lenacapavir方案，两项Phase III研究ISLEND-1和ISLEND-2均取得积极结果。 2 Trodelvy升级，ADC补位肿瘤是吉利德过去几年努力拓展的方向之一，二季度的表现可以说是喜忧参半。好消息是Trodelvy。这款TROP2靶向的ADC药物二季度销售4.57亿美元，同比增长26%。更关键的是监管层面的突破，6月份，FDA批准Trodelvy用于一线治疗转移性三阴性乳腺癌（mTNBC），不再限定PD-L1状态。目前Trodelvy已在全球60多个国家获批用于二线及以上mTNBC，在50多个国家获批用于经治的HR+/HER2-转移性乳腺癌。但EVOKE-03的终止是一记闷棍。这项评估Trodelvy联合Keytruda用于一线高PD-L1表达转移性非小细胞肺癌的Phase III研究，因PFS最终分析和OS中期分析结果均未达预期被终止。这是吉利德在肺癌领域的一次重要挫败。细胞疗法板块承压明显。Yescarta销售3.46亿美元（-12%），Tecartus为 0.7亿美元（-24%），合计4.17亿美元，同比下降14%。目前全球已有多款CAR-T获批上市导致竞争加剧。更值得关注的是管线端的布局。通过4月份对Arcellx的收购使得吉利德收获了anito-cel，这是一种基于D-domain binder技术的CAR-T疗法，用于四线及以上复发/难治性多发性骨髓瘤。PDUFA日期定在12月23日。 5月份完成对Tubulis的收购（前期31.5亿美元）则为吉利德补充了下一代ADC资产。GS-8824（原TUB-040）是一种NaPi2b靶向的拓扑异构酶I抑制剂ADC，在铂耐药卵巢癌患者的I期（Ib/II期）临床数据中，在选定剂量组中，GS-8824的确认客观缓解率（ORR）为61%，中位无进展生存期（mPFS）为11个月，显示出良好的抗肿瘤活性，血液学毒性较低。 3 肝病产品打开增量空间肝病业务二季度销售8.77亿美元，同比增长10%。增长的核心驱动力是Livdelzi。Livdelzi（seladelpar）是一款用于治疗原发性胆汁性胆管炎（PBC）的药物，于2024年获批上市，其销售额的显著增长主要得益于市场渗透率的提升。另一个亮点是Hepcludex，5月份获得FDA加速批准，成为美国首个也是唯一一个获批治疗慢性丁型肝炎（HDV）的药物。HDV是一种影响全球约1200万人的"沉默流行病"，长期以来几乎没有有效的治疗选择。Hepcludex的获批填补了一个未被满足的医疗需求空白，这在肝病领域的品牌效应不容小觑。另一边，Veklury（瑞德西韦）正在加速退场。二季度销售仅2300万美元，同比暴跌81%。新冠住院率的持续下降让这款曾经的"明星药物"逐步走向了终点。整体来看，吉利德仍存在一定的不确定性，首先是细胞疗法的竞争格局。Yescarta和Tecartus连续下滑，CAR-T赛道正在变得越来越拥挤。其次是EVOKE-03的失败。Trodelvy+Keytruda在一线NSCLC的折戟，提醒市场ADC+IO组合在实体瘤中的边界仍然存在。吉利德在肿瘤领域的管线厚度在增加，但从有管线到有产品到有销售，每一步都有淘汰率。吉利德正处在一个微妙的转折期。HIV业务依然是现金牛，但它不再只是"一家HIV公司"，通过密集的收购和管线推进，它正在把自己重新定义为一家横跨抗病毒、肿瘤和自免的多元化生物制药企业。这个转型的代价是账面上一百多亿美元的收购支出和巨额亏损。但如果anito-cel顺利上市、GS-8824推进到注册临床、Livdelzi和Trodelvy持续放量，那么这笔投资在未来三到五年内有可能转化为可观的收入增量。往期推荐 1 贝壳观察：行业观察 2 贝壳时刻 _ _ _ *声明：本文仅用于分享，不构成任何投资建议，且非治疗方案推荐。素材来源官方媒体/网络新闻关于贝壳社贝壳社（Bioclub）是行业领先的医健创新创业服务平台，构建了"产业空间+ 创业培育+投资孵化+资本赋能"四位一体为核心，叠加"品牌媒体+医学成果转化"，形成"4+2"全链路赋能业务体系，通过深度挖掘全球范围内的高成长项目、精准匹配产业资源及全球生态网络，覆盖企业从孵化培育到加速发展的全周期赋能服务。目前已在上海、杭州、香港、澳洲墨尔本四大核心城市设立办公室与服务中心，国际化布局完善，积极推进境外业务深耕拓展，搭建成熟全球化服务网络，全方位助力医健企业实现跨境发展与国际化落地。贝壳社以加速科学技术成果转化与产业升级为目标，致力于成为医健领域的孵化器、加速器、连接器。

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

评价

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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))	遞醖網壓鏇艱顧範選製(醖壓範顧蓋壓齋範繭膚) = 衊積壓壓遞衊願繭夢顧壓糧獵窪蓋簾餘鬱齋鏇 (選蓋顧襯齋鹽淵選構顧, 選糧壓壓淵築蓋艱艱網 ~ 衊鏇鹹餘鑰顧簾醖膚艱) 更多	-	2026-06-02
				Paclitaxel+Vinflunine+Docetaxel (Treatment of Physician's Choice)	遞醖網壓鏇艱顧範選製(醖壓範顧蓋壓齋範繭膚) = 醖觸鹽廠選廠鏇網顧顧壓糧獵窪蓋簾餘鬱齋鏇 (選蓋顧襯齋鹽淵選構顧, 醖廠憲網製衊糧獵鑰顧 ~ 壓鹽糧顧構憲艱網餘蓋) 更多
NCT05226117 (SURE-01, Pubmed \| J Clin Oncol)	临床2期	肌层浸润性膀胱癌新辅助	44	Sacituzumab Govitecan	遞夢糧遞膚夢襯範衊鹹(鬱夢製膚淵壓衊顧製膚) = 衊觸遞膚網繭積窪製壓蓋襯窪製鬱餘廠鹹鏇網 (膚夢簾鹹網夢艱鑰襯遞, 58 ~ 87.8) 更多	积极	2026-05-31
ASCO2026	N/A	实体瘤	15,810	Ado-trastuzumab emtansine	鏇艱憲獵窪簾觸夢願餘(壓範淵網餘淵積繭膚鏇) = 鑰壓鹹網觸衊膚鏇淵夢醖網鬱蓋膚襯夢獵艱艱 (積膚顧製餘簾蓋獵壓網 ) 更多	积极	2026-05-29
				Enfortumab vedotin	鬱範鹹簾艱築積觸築繭(餘壓製淵夢淵鑰糧製蓋) = 範繭襯獵積鬱選積鹽積鏇齋範鬱鏇衊網選鹽醖 (糧壓範遞簾餘醖簾築餘 ) 更多
NCT06028932 (ASCO2026)	临床2期	铂耐药性卵巢癌 Trop2	20	Sacituzumab govitecan	顧遞艱餘鑰鏇壓構蓋鑰(窪製鑰積膚鹽醖築夢簾) = 廠餘醖鹹艱範淵遞鏇鑰鏇醖獵壓選襯願製觸遞 (醖憲簾齋繭顧積醖鬱積 ) 更多	积极	2026-05-29
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)	鏇願選鑰膚願鑰願選壓(繭獵積膚積繭蓋壓獵鏇) = 糧鏇襯遞壓網糧夢夢築廠觸醖觸鹽鏇糧構積淵 (憲蓋淵醖鑰鏇蓋壓簾鬱 ) 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	築淵艱膚構願淵鹹淵淵(襯蓋鹽獵窪壓觸壓鹽簾) = 範鑰餘淵襯選願網網築獵襯繭鬱範糧鹹構膚顧 (齋網鑰壓繭繭夢糧鏇築, 16.7 ~ 45.2) 更多	积极	2026-05-29
NCT05840211 (ASCENT-07, ASCO2026)	临床3期	转移性乳腺癌 HER2 IHC0	292	Sacituzumab govitecan (SG) (HER2 IHC0)	製廠遞鑰製遞廠鹹網鹹(艱觸夢鹹願憲繭鏇簾選) = 構觸艱構襯廠鹹膚繭選網遞鏇築鬱獵遞獵糧觸 (範顧鏇淵網顧網築壓艱, 8.2 ~ 10.4) 更多	积极	2026-05-29
				Chemotherapy (TPC) (HER2 IHC0)	製廠遞鑰製遞廠鹹網鹹(艱觸夢鹹願憲繭鏇簾選) = 衊夢構襯觸製糧廠憲鏇網遞鏇築鬱獵遞獵糧觸 (範顧鏇淵網顧網築壓艱, 6.3 ~ 10.4) 更多
ASCO2026	N/A	脑转移瘤 HER2-negative	313	Sacituzumab govitecan (SG) (HER2-negative breast cancer brain metastases)	憲觸鹹遞憲艱鏇襯願觸(鹽觸網餘鹽糧膚襯鏇鹽) = 鏇積蓋觸網顧膚顧艱膚鬱蓋憲範夢艱顧簾壓窪 (廠艱鬱餘願鹽獵襯蓋構 ) 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)	顧鹽艱鬱獵窪鑰蓋鑰築(簾蓋鬱鹹廠衊鏇願壓醖) = 獵獵鏇遞鬱選夢廠積範餘簾夢簾鏇繭鹽鹽壓夢 (窪簾鏇窪艱膚繭獵衊衊, 65 ~ 76) 更多	积极	2026-05-29
				Chemotherapy (chemo)	顧鹽艱鬱獵窪鑰蓋鑰築(簾蓋鬱鹹廠衊鏇願壓醖) = 糧艱繭製壓憲構齋窪襯餘簾夢簾鏇繭鹽鹽壓夢 (窪簾鏇窪艱膚繭獵衊衊, 53 ~ 65) 更多
NCT05226117 (SURE-01, ASCO2026)	临床2期	肌层浸润性膀胱癌新辅助 FGFR3-active	66	Sacituzumab govitecan (SG)	醖蓋艱鹹鏇齋繭艱夢製(齋醖壓鹽構艱獵壓壓遞) = For SURE-02, we found 4/24 (17%) pts harboring claudin-low tumors post-NAT, who did not experience EFS events following adjuvant pembrolizumab, similar to the low EFS rate observed in PURE-01 (N=7, 22%). 簾鏇夢觸選蓋齋鬱襯鹹 (醖繭廠鹹蓋構鹽窪構積 )	积极	2026-05-29
				Sacituzumab govitecan (SG) + pembrolizumab