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更新于：2026-10-03

Obinutuzumab

奥妥珠单抗

更新于：2026-10-03

概要

基本信息

药物类型

单克隆抗体

别名

Afutuzumab、Anti-CD20 monoclonal antibody R7159、Gazyvaro

+ [22]

靶点

CD20

作用方式

抑制剂

作用机制

CD20抑制剂(B淋巴细胞抗原CD20抑制剂)、ADCC(抗体依赖的细胞毒作用)、CD20定向的溶细胞作用

治疗领域

肿瘤免疫系统疾病血液及淋巴系统疾病+ [6]

在研适应症

肾病综合征狼疮性肾炎CD20阳性B细胞慢性淋巴细胞白血病+ [47]

非在研适应症

CD20阳性弥漫性大B细胞淋巴瘤CD20阳性血液肿瘤肉芽肿伴多血管炎+ [17]

原研机构

Roche Glycart AG

在研机构

Roche Pharma (Schweiz) AG

F. Hoffmann-La Roche Ltd.

罗氏（中国）投资有限公司

+ [18]

非在研机构

Janssen-Cilag Ltd.

Roche Nederland BVJanssen-Cilag GmbH

权益机构

Biogen, Inc.

Nippon Shinyaku Co., Ltd.

Genentech, Inc.

+ [1]

最高研发阶段批准上市

首次获批日期

美国 (2013-11-01),

慢性淋巴细胞白血病

最高研发阶段(中国)批准上市

特殊审评孤儿药 (美国)、孤儿药 (欧盟)、孤儿药 (澳大利亚)、优先审评 (美国)、优先审评 (中国)、突破性疗法 (美国)

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结构/序列

Sequence Code 68713L

来源: *****

Sequence Code 9699891H

来源: *****

关联

373

项与奥妥珠单抗相关的临床试验

NCT07847957

/ Not yet recruiting临床1/2期IIT

A Phase 1b and 2 Study of Roginolisib (IOA-244) Combined With Obinutuzumab Followed by Venetoclax in Patients With Refractory/Relapsed Chronic Lymphocytic Leukemia (CLL) After Progression on Prior Bruton Tyrosine Kinase (BTK) Inhibitors

This is a Phase 1b and 2, open-label, single-arm study evaluating the safety, tolerability, and efficacy of roginolisib (IOA-244) in combination with obinutuzumab followed by venetoclax in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) who have progressed after prior Bruton Tyrosine Kinase (BTK) inhibitor therapy. The study aims to determine the maximum tolerated dose of roginolisib in combination with obinutuzumab, and to assess the rate of undetectable minimal residual disease (uMRD) after sequential therapy with roginolisib, obinutuzumab, and venetoclax.

开始日期2027-01-13

申办/合作机构

Dana-Farber Cancer Institute, Inc.

[+1]

NCT07674810

/ Not yet recruiting临床2期

A Phase 2 Trial Of The Combination Of Zanubrutinib, Sonrotoclax, And Obinutuzumab For Patients With Treatment-Naïve Chronic Lymphocytic Leukemia

The goal of this clinical research study is to learn if the combination of zanubrutinib, sonrotoclax, and obinutuzumab can help to control previously untreated CLL/SLL.

开始日期2026-12-31

申办/合作机构

M.D. Anderson International España SA

[+1]

NCT07634289

/ Not yet recruiting临床2期IIT

Radiotherapy in Combination With Glofitamab in Relapsed/Refractory Diffuse Large B Cell Lymphoma: The Phase II Radio-GLO Study

The goal of this clinical trial is to see if a new combination of standard of care radiotherapy treatment prior to administering the study drugs obinutuzumab and glofitamab in relapsed/refractory Diffuse Large B Cell Lymphoma patients is effective. The main question it aims to answer is:
If you are able to tolerate the study treatments, and whether your cancer responds to the study treatment, compared with other reported studies of standard care treatments.
Participants will have three parts they need to complete over a 5 year period.
* Screening period over a 28 day period
* Treatment period - Radiotherapy followed by 12 treatment cycles every three weeks (total time approx. 37 weeks)
* Follow up, up to 4 years. Additional PET imaging studies will be performed in a cohort of patients (up to 6) who are willing to undergo infusions of 89Zr-Df-Crefmirlimab and 18F-Granzyme B for evaluation of the impact of radiotherapy plus glofitamab with relapsed diffuse large B-cell lymphoma.

开始日期2026-12-01

申办/合作机构

Olivia Newton-John Cancer Research Institute

[+5]

100 项与奥妥珠单抗相关的临床结果

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100 项与奥妥珠单抗相关的转化医学

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100 项与奥妥珠单抗相关的专利（医药）

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1,158

项与奥妥珠单抗相关的文献（医药）

2026-12-31·mAbs

Impact of afucosylation strategy on antibody function: a comparative study of glycoengineered anti-CD20 antibodies Obinutuzumab and Obinutuzumab beta

Article

作者: Sun, Mingze ; Huang, Shuo ; Shuang, Qing ; Sun, Jicui ; Jiang, Lingling ; Shen, Qunfang ; Li, Feng ; Yang, Lijing ; Zhang, Lunfeng ; Li, Jiangmei ; Chen, Hong ; Lin, Guangzhong

Enhancing antibody-dependent cellular cytotoxicity (ADCC) via N-glycan afucosylation of Asn-297 is a validated strategy to improve the clinical efficacy of therapeutic antibodies. However, the impact of distinct glycoengineering approaches on the function of antibodies has not been systematically elucidated. Here, we experimentally compared two type II anti-CD20 antibodies, Obinutuzumab (Gazyva®) and Obinutuzumab beta (MIL62, Bejescin®), which share identical amino acid sequences but exhibit divergent glycosylation profiles. MIL62 was engineered with complete core afucosylation (fucose < 0.1%) lacking bisecting N-acetylglucosamine (GlcNAc) via knockout of the GDP-fucose transporter (GFT) in Chinese hamster ovary (CHO) cells used to produce the antibody. Conversely, Gazyva was produced in CHO cells that overexpress β-1,4-N-acetylglucosaminyltransferase III (GnT-III) and α-mannosidase II (α-ManII), resulting in ~50% fucose content and >80% bisecting GlcNAc occupancy. These distinct glycoengineering strategies led to disparate functional outcomes: afucosylated MIL62 showed improved FcγRIIIA binding and ADCC potency, while Gazyva with bisecting GlcNAc modifications exhibited higher glycoform heterogeneity and reduced thermal stability. Both antibodies displayed comparable FcRn binding, mannosylation, sialylation, and murine pharmacodynamics, mediating complete depletion of B cells in blood, lymph nodes, and spleen. Upon antigen rechallenge, MIL62 suppressed specific antibody titers, indicating memory B-cell eradication and profound potential to prevent autoimmune relapse. This study demonstrates that distinct glycoengineering strategies fundamentally reshape the antibody glycan profile beyond merely reducing fucose. These structural differences not only fine-tune ADCC potency, but also impact antibody stability. Particularly, complete afucosylation of MIL62 led to optimized ADCC potency and effectively suppressed pathogenic B cells repopulation in a delta-like ligand 3 (DLL3) re-challenge model, providing a critical framework for designing next-generation antibodies with superior therapeutic efficacy.

2026-11-01·Blood neoplasia

Low lymphoma macrophage infiltration predicts poor outcomes for R-CHOP– but not Pola-R-CHP–treated patients with DLBCL

Article

作者: Yan, Mark ; Jiang, Yanwen ; Herrera, Alex F ; Izutsu, Koji ; Staber, Philipp B ; Bolen, Christopher R ; Tucci, Alessandra ; Lenz, Georg ; Harris, Will ; Jardin, Fabrice ; Lu, Kai ; Hou, Jing-Zhou ; Hirata, Jamie ; Morschhauser, Franck ; Belada, David ; Hatzi, Katerina ; Hawkes, Eliza A ; Burke, John M ; Le Gouill, Steven ; Flowers, Christopher R ; Trněný, Marek ; Lee, Calvin

The influence of the tumor immune microenvironment (TME) on therapeutic efficacy remains unclear in diffuse large B-cell lymphoma, particularly for regimens incorporating antibody-drug conjugates (ADCs). We aimed to define the key lymphoma microenvironment factors associated with clinical outcomes in patients treated with anti-CD20 (rituximab or obinutuzumab) plus CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone; anti-CD20 + CHOP) and to understand how treatment with a modified, ADC-containing chemoimmunotherapy regimen alters the influence of the pretreatment immune landscape on clinical outcome. We evaluated associations between TME composition and clinical outcomes in a harmonized data set of 1279 patients treated with either anti-CD20 + CHOP or a modified regimen of anti-CD20 + CHOP containing polatuzumab vedotin (Pola-R-CHP) across 3 clinical studies. We found that low enrichment of M1-like macrophages was consistently associated with inferior overall and progression-free survival in anti-CD20 + CHOP-treated patients, suggesting that these macrophages may facilitate antibody-mediated efficacy. In contrast, outcomes in polatuzumab vedotin-treated patients were independent of macrophage levels, supporting a mechanism of action driven primarily by ADC payload cytotoxicity. Other immune signatures that predicted outcome with anti-CD20 + CHOP treatment were also not prognostic with Pola-R-CHP treatment. Our results indicate that ADCs may provide therapeutic benefit to patients with unfavorable immune microenvironments. These trials were registered at www.clinicaltrials.gov as #NCT01287741, #NCT00486759, and #NCT03274492.

2026-11-01·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Consensus-based ranking of determinants for frontline therapy selection in chronic lymphocytic leukemia: A conjoint analysis

Review

作者: Tedeschi, Alessandra ; Zinzani, Pier Luigi ; Coscia, Marta ; Ghia, Paolo ; Sportoletti, Paolo ; Marchetti, Monia ; Laurenti, Luca ; Gaidano, Gianluca

Recent updates in Chronic Lymphocytic Leukemia (CLL) management guidelines emphasize three determinants for first-line treatment choice: patient age, clinical fitness, and key molecular features (IGHV and TP53/17p status). However, multiple therapeutic options are suggested within each clinical scenario, often without clear prioritization. We aimed to transparently rank host, disease and therapy-related determinants influencing frontline therapy selection in CLL, to enhance personalized prescription and clinical decision-making. To achieve this aim, a national expert panel of seven Italian key opinion leaders in Hematology participated in a structured consensus using conjoint analysis methodology. Five major treatment goals and fourteen host or disease-related determinants were selected based on literature and panelists expertise expert input. Conjoint analysis estimated determinant weights for each treatment goal: Time-to-Next-Treatment (TTNT), Rapidity of Disease Control, Infective Safety, Cardiovascular Safety, and Quality of Life. Furthermore, five commonly used regimens (ibrutinib, acalabrutinib, zanubrutinib, ibrutinib-venetoclax, venetoclax-obinutuzumab) were comparatively ranked according to their ability to accomplish each goal. Host/disease-related determinants with the highest impact on TTNT included life expectancy, cytopenias, and complex karyotype. Infective safety was mostly influenced by TP53 disruption and severe comorbidity burden, while cardiovascular safety was primarily affected by comorbidity type and frailty. Among therapies, zanubrutinib and ibrutinib-venetoclax achieved the most balanced profiles across goals. This national consensus provides a transparent, goal-oriented framework for CLL frontline therapy selection. Integrating conjoint analysis enables quantitative weighting of determinants and prioritization of treatment options beyond conventional categorical algorithms. The model supports evidence-based, individualized treatment strategies for CLL in clinical practice.

1,428

项与奥妥珠单抗相关的新闻（医药）

2026-10-02

·药研苑

FDA批准罗氏CD20单抗奥妥珠用于≥2岁患者特发性肾病

药品营销避坑”试读：药品导入期管理视频课（试听）药品生命周期管理（案例）药品立项需要注意什么（案例） 2026年9月25日罗氏成员企业基因泰克Genentech宣布，奥妥珠单抗（Gazyva）已获得美国食品药品监督管理局（FDA），用于降低2岁及以上儿童和成人频繁发作型或激素依赖型儿童起病特发性肾病综合征患者完全缓解期的复发风险。本次获批基于开放标准，随机对照3期临床试验INShore的研究结果。INShore研究共纳入85名2-25岁处于完全缓解期的频繁发作型或激素依赖型儿童起病特发性肾病综合征（INS）患者。入组患者按1:1比例随机接受奥妥珠单抗或吗替麦考酚酯（Mycophenolate Mofetil）。至第52周，奥妥珠单抗组和吗替麦考酚酯组，达到持续完全缓解的比例分别为95.5%和73.2%（差值23.36%; P=0.0031）。奥妥珠单抗组与吗替麦考酚酯组相比降低75%的复发或死亡风险（HR 0.25; P=0.0074）。奥妥珠单抗组与吗替麦考酚酯组相比体重调整糖皮质激素用量降低8.86 mg/kg（P=0.0391）。在安全性方面，奥妥珠单抗组和吗替麦考酚酯组不良事件的发生率分别为95.5%和82.9%，≥3级不良事件的发生率分别为25.0%和7.3%。奥妥珠单抗组大多数不良事件与输液反应有关（36.4%）。奥妥珠单抗组和吗替麦考酚酯组上呼吸道感染的发生率分别为29.5%和36.6%。奥妥珠单抗组和吗替麦考酚酯组分别有1例患者由于不良事件导致中止治疗。奥妥珠单抗组和吗替麦考酚酯均未发现新的安全性信号（Julien Hogan., 2026）。奥妥珠单抗（Obinutuzumab，佳罗华Gazyva）是糖基化结构改造的抗CD20单克隆抗体。通过抗体依赖性细胞毒性耗竭表达CD20的B细胞。其采用糖基化结构改造技术，能够增强细胞毒性。奥妥珠单抗在国内获批的适应症为：与化疗联合，用于初治的Ⅱ期伴有巨大肿块、Ⅲ期或Ⅳ期滤泡性淋巴瘤成人患者，达到至少部分缓解的患者随后用奥妥珠单抗维持治疗。推荐指数：★★★ 推荐原因：在降低INS复发风险方面，奥妥珠单抗的持续完全缓解率高达95.5%。个人观点，仅限参考。相关阅读：歌礼小分子IL-17A抑制剂ASC50一期试验取得积极结果印度太阳制药晟华药业申请IL-23单抗替瑞奇珠地产化更方便，默沙东帕博利珠单抗注射液（皮下注射）获批赛沃替尼+奥希替尼EGFR耐药MET+晚期NSCLC申请美国上市正大天晴/成都倍特降脂药佩玛贝特片同日首仿获批匹妥布替尼获批全线慢性淋巴细胞白血病/小淋巴细胞淋巴瘤默沙东新靶点Remigromig糖尿病黄斑水肿2b/3期试验达到终点 FDA批准默沙东贝组替凡+仑伐替尼用于经治晚期肾透明细胞癌翰森制药B7-H3 ADC瑞康立伏妥塔单抗申请上市用于骨肉瘤 FDA批准礼来周基础胰岛素Efsitora Alfa用于2型糖尿病华东医药小分子GLP-1卡维列隆减重3期试验取得极顶结果 FDA批准礼来非选择性JAK抑制剂巴瑞替尼治疗青少年严重斑秃安进CD40L靶向Dazodalibep干燥综合征3期试验取得积极结果珠海联邦申请德谷胰岛素利拉鲁肽注射液首仿上市大冢Ulefnersen用于FUS突变相关ALS三期试验取得积极结果相关内容只作为药物研发的参信息。不构成任何与用药咨询有关的建议。如需发稿，您可通过在药研苑公众号下以发送信息的方式将官网或官方公众号的稿件链接和标题发送给我们。我们将择优确定是否发布。

2026-10-02

·AI4BioSci

罗氏免疫学研发全景-2026罗氏免疫产品业务战略

罗氏免疫学研发的核心，不是简单地增加候选药物数量，而是围绕疾病机制重新组织研发体系：在肾脏免疫疾病中追求更深的B细胞清除和更持久的缓解，在IgA肾病中精准抑制补体，在炎症性肠病中通过TL1A及多特异性抗体突破现有疗法的疗效上限。本文根据视频讲解，并结合罗氏 Pharma Day 2026 相关幻灯片，梳理这条研发主线。免疫学研发重点：优化通路、联合治疗、患者分型、长期缓解和端到端投入一免疫学研发从单一靶点走向系统性设计视频开篇介绍了罗氏在免疫学领域的五个研发重点。第一是优化已知机制并寻找新的疾病靶点，例如增强B细胞清除、调节TL1A通路和抑制补体通路。第二是联合多个通路，用互补机制提高疗效并争取更深的缓解。第三是识别不同患者的疾病内型，通过生物标志物判断谁更可能从治疗中获益。第四是把长期缓解甚至治愈作为研发目标。第五是在炎症性肠病和慢性阻塞性肺疾病等重点领域进行从早期发现、临床开发到商业化的端到端投入。这套框架反映出免疫学治疗正在从“找到一个靶点”转向“理解疾病网络”。对于同一种临床疾病，患者可能由不同的炎症通路驱动，治疗也因此需要更精细的分层和更有针对性的组合。免疫学管线覆盖肾脏和风湿免疫疾病、胃肠道疾病、呼吸与过敏疾病等多个方向二肾脏免疫疾病是近期最清晰的价值主线罗氏把免疫介导的肾脏疾病放在了免疫学战略的中心位置。系统性红斑狼疮、狼疮肾炎、IgA肾病和膜性肾病不仅会造成长期器官损伤，也可能最终进展到终末期肾病，需要透析或肾移植。视频中强调，现有治疗仍无法阻止相当一部分患者持续失去肾功能，因此研发目标不应只停留在短期改善症状，而应转向降低疾病活动、延缓肾功能下降和维持长期缓解。免疫介导肾病与慢性肾病进展之间的关系，以及罗氏的开发项目三 Gazyva 通过更深的B细胞清除扩大治疗边界 Gazyva（obinutuzumab）是视频中最重要的项目。 B细胞参与抗体产生、抗原呈递和多种免疫炎症过程，因此在狼疮肾炎、系统性红斑狼疮及其他免疫介导肾病中，B细胞是具有病理意义的治疗节点。 Gazyva的II型抗CD20机制及其相较Rituxan的B细胞清除特点与早期抗CD20抗体相比，Gazyva通过II型抗CD20结合方式增强B细胞直接死亡，并减少抗体内吞；同时，糖基工程化Fc区域提高FcγR亲和力，增强抗体依赖的细胞介导细胞毒作用和吞噬作用。视频将这一点概括为“更深的B细胞清除”，并进一步提出，深度清除可能带来更强的临床反应和更持久的免疫重置。在系统性红斑狼疮的ALLEGORY III期研究中，Gazyva达到SRI-4主要终点，并在DORIS缓解、疾病活动度和激素控制等次要指标上表现出一致获益。罗氏据此将其定位为可能改变狼疮标准治疗的B细胞清除药物。 Gazyva在膜性肾病和儿童起病特发性肾病中的临床结果 Gazyva的价值并不局限于狼疮。膜性肾病研究中，Gazyva相较他克莫司提高了完全缓解率；儿童起病特发性肾病研究中，Gazyva相较吗替麦考酚酯也达到了完全缓解终点。对于儿童患者，视频特别强调了减少激素依赖、维持缓解和改善长期治疗体验的潜在意义。四 Sefaxersen 将补体抑制推进到IgA肾病 IgA肾病的核心问题，是异常IgA引发免疫反应，继而激活补体系统并造成肾脏炎症。 Sefaxersen是一种靶向补体因子B的反义寡核苷酸，通过抑制CFB信使RNA翻译，降低替代补体途径的活性。它代表了另一种不同于B细胞清除的疾病干预思路：不是广泛重塑免疫系统，而是选择性压低与肾脏炎症相关的补体信号。 Sefaxersen的补体因子B机制及IMAgINATION III期研究设计 IMAgINATION III期研究的中期结果显示，Sefaxersen在第37周显著降低蛋白尿。蛋白尿是IgA肾病早期评估治疗反应的重要指标，但研究还将继续观察至第105周，以确认eGFR下降是否减慢。视频因此把Sefaxersen的临床意义概括为：在降低蛋白尿的基础上，进一步证明其能否延缓真实的肾功能恶化。 IgA肾病的疾病负担、现有治疗范式和Sefaxersen的潜在定位 IgA肾病患者中，仍有相当比例在现有治疗下控制不充分。 Sefaxersen每月一次皮下注射的给药方式，也可能改善依从性和生活质量。罗氏希望将其用于具有持续活动性炎症或现有一线治疗控制不足的高风险患者。五 Afimkibart 从TL1A切入炎症性肠病在胃肠道免疫疾病中，罗氏的核心资产是Afimkibart。TL1A位于多个炎症和组织重塑通路的上游，能够放大免疫反应，并与慢性炎症及纤维化过程有关。基于这一机制，Afimkibart的开发范围覆盖溃疡性结肠炎、克罗恩病、类风湿关节炎、特应性皮炎和MASH。 Afimkibart围绕TL1A展开的多疾病开发计划视频强调，TL1A的价值在于它可能不是一个局限于单一器官的靶点，而是一个具有泛免疫学潜力的炎症放大器。罗氏希望通过在多个疾病中的临床验证，建立一个可以跨疾病扩展的研发平台。 IBD的疾病特征、现有疗法的疗效上限和持续未满足需求六 IBD的关键问题是疗效上限和反复换药炎症性肠病包括溃疡性结肠炎和克罗恩病，具有反复发作和缓解的特点。现有治疗虽然覆盖TNF、整合素、IL-12/23、JAK和S1P等多个通路，但不同类别普遍存在疗效上限，许多患者无法在一年内获得稳定缓解。患者因此可能在多种生物制剂之间反复切换，疾病负担和生活质量问题仍然突出。 Afimkibart的开发重点，是在诱导期和维持期都探索皮下注射，并通过生物标志物寻找更可能获益的患者。 AMETRINE-1和AMETRINE-2 III期研究已经完成入组，结果预计在2027年公布。 Afimkibart在溃疡性结肠炎中的AMETRINE研究和皮下注射方案七多特异性抗体试图突破单通路疗法的天花板罗氏并没有把IBD战略完全押在单一TL1A药物上。 p40×TL1A双抗同时针对IL-12/IL-23和TL1A：前者是推动肠道炎症的重要细胞因子轴，后者则是炎症放大器。理论上，同时抑制两条相互补充的通路，可能获得比单一靶点更深的缓解。 p40×TL1A双抗及罗氏IBD多特异性研发管线这一思路代表罗氏免疫学研发的最终方向：从单一机制优化，逐步走向疾病网络层面的联合干预。 SUNCREST研究正在进行，预计2027年获得数据。若疗效和安全性得到验证，多特异性抗体有机会成为突破IBD疗效上限的重要工具。结语从Gazyva的深度B细胞清除，到Sefaxersen的补体因子B抑制，再到Afimkibart和p40×TL1A双抗，罗氏免疫学研发呈现出一条清晰的升级路径：更精准地找到疾病驱动机制，更深入地改变免疫反应，并以长期器官保护和持久缓解作为临床终点。需要注意的是，文中涉及的研发阶段、监管状态和未来数据时间点均以罗氏Pharma Day 2026材料为准，部分项目仍处于临床开发或监管审评阶段，不能等同于最终获批结论。本文为基于公开材料的视频内容整理，不构成医疗建议或投资建议加入AI药研交流群或获取PPT，加我V：myt030489，备注：姓名_研究方向_公司

2026-09-30

·泰博士

文献解读｜从安全性看SLE治疗：B细胞靶向生物制剂带来哪些新选择？

点击蓝字关注我们 // 跟着泰博士学文献系统性红斑狼疮（SLE）是一种慢性自身免疫性疾病，由于免疫系统长期处于异常激活状态，患者在疾病进展和治疗过程中可能面临多种安全性事件，其中感染风险尤为突出。研究显示，SLE患者总体严重感染风险约为普通人群的2.96倍，肺炎、带状疱疹和结核感染发生率均显著升高；目前，感染已经成为我国SLE患者死亡的首位原因1-3。因此，在控制疾病活动的同时，如何减少长期治疗带来的安全风险，成为SLE管理的重要目标。图1 SLE患者感染风险远高于普通人群（普通人群风险=1.0 （参照基线））安心之选：B细胞靶向生物制剂可使严重感染风险降低22% 糖皮质激素及免疫抑制剂通过广泛抑制免疫反应控制SLE疾病活动，但同时也会影响机体正常的免疫防御功能。研究显示，SLE患者感染风险与激素使用相关，且随激素剂量的升高而增加4。同样，使用免疫抑制剂治疗的患者感染风险为未使用者的2.24倍5。面对这一困境，SLE逐步迈入靶向治疗时代，随着生物制剂陆续获批应用于临床，也给患者带来了更多新的治疗选择。通过靶向调节B细胞及其相关免疫通路，生物制剂作用更加精准，可使患者严重感染风险降低21%，因严重感染住院风险降低27%6。目前，用于SLE治疗的生物制剂按作用机制大致可分为三类：一类是以泰它西普、贝利尤单抗为代表的间接靶向B细胞药物，整体安全性较好；第二类是直接靶向B细胞的耗竭类药物，如利妥昔单抗、奥妥珠单抗等，感染风险相对较高；第三类是作用于I型干扰素通路的生物制剂，如阿尼鲁单抗，长期应用可能增加带状疱疹、呼吸道感染等风险。 🔹 泰它西普SAE 7.2%，严重感染患者比例仅为1.2% 泰它西普III期临床研究纳入335例活动性SLE患者，在标准治疗基础上随机接受泰它西普160 mg或安慰剂治疗52周。研究结果显示：泰它西普组严重不良事件发生率为7.2%，低于安慰剂组的14.3%；其中严重感染事件患者比例仅为1.2%；未观察到治疗相关死亡事件7。这一结果说明，在标准治疗基础上加入泰它西普，并未明显增加严重感染风险，整体安全性表现良好。此外，一项中国SLE患者长期真实世界研究显示，泰它西普随访36个月，整体不良事件发生率为34.0%，研究期间未发生严重感染、严重不良事件或死亡，进一步支持其长期应用的安全性8。 SAE：严重不良事件；AE：不良事件表1泰它西普与安慰剂两组患者治疗期间不良事件发生情况 🔹 贝利尤单抗SAE 15.0%，感染相关严重不良事件比例为5.4% 贝利尤单抗安全性数据主要来源于一项事后汇总分析，该研究整合了1项II期和5项III期随机、安慰剂对照临床研究数据，共纳入4170例成人SLE患者，在标准治疗基础上随机接受贝利尤单抗或安慰剂治疗。总体来看，贝利尤单抗联合标准治疗具有良好的安全性特征，其严重不良事件及感染相关严重不良事件发生率均处于较低水平9。表2贝利尤单抗与安慰剂两组患者治疗期间不良事件发生情况虽然泰它西普和贝利尤单抗均表现出良好的安全性特征，但两者的作用机制并不完全相同。贝利尤单抗是一种单克隆抗体，通过靶向B淋巴细胞刺激因子（BLyS），抑制B细胞存活与成熟；泰它西普则同时靶向BLyS和增殖诱导配体（APRIL），阻断两条B细胞生存信号通路，更全面地调节B细胞及浆细胞相关免疫反应10。从机制上推测，融合蛋白的抗原结合区域与Fc区域相对独立，理论上可能减少ADA对功能性结合的影响。研究显示泰它西普ADA阳性率仅为5.6%11，提示其免疫原性风险较低。图2 贝利尤单抗与泰它西普分子结构及ADA结合位点示意图 B细胞耗竭剂及干扰素抑制剂：需警惕感染相关安全性风险在其它靶向生物制剂中，抗CD20单抗（如利妥昔单抗、奥妥珠单抗）通过直接耗竭B细胞发挥免疫抑制作用，可能导致B细胞持续减少，增加患者的感染风险。EXPLORER研究数据显示，接受利妥昔单抗治疗的SLE患者严重不良事件发生率为37.9%，高于安慰剂的36.4%，感染相关严重不良事件发生率为9.5%12；奥妥珠单抗ALLEGORY III期研究结果表明，在活动性SLE患者中，治疗52周时总体感染发生率为68.2%，感染相关严重不良事件发生率为8.6%，均高于安慰剂组的54.3%和4.6%13。除抗CD20单抗之外，阿尼鲁单抗通过长期抑制IFN信号传导，也可能让患者面临更高的感染风险。TULIP III期及长期扩展研究汇总显示，使用阿尼鲁单抗治疗严重不良事件发生率为26.3%，而安慰剂组为25.3%，感染相关严重不良事件发生率为9.8%，特别是带状疱疹发生风险高14。表3 利妥昔单抗、奥妥珠单抗及阿尼鲁单抗与安慰剂治疗不良事件发生情况以上结果提示，此类生物制剂的感染相关安全性仍值得关注，因此在控制疾病活动的同时，如何在保证疗效的基础上降低感染风险，是SLE长期治疗需要重点考虑的问题。总结 🔹 SLE患者本身感染风险较高，长期治疗不仅要控制疾病活动，还需关注感染及治疗相关不良事件； 🔹 真实世界研究数据显示，泰它西普整体安全性表现良好，治疗期间严重感染事件患者比例仅为1.2%；且长期随访中未观察到严重不良事件，为其长期规范应用提供了证据支持。参考文献： 1. 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Comparative risks of infection with belimumab versus oral immunosuppressants in patients with nonrenal systemic lupus erythematosus. Arthritis Rheumatol. 2023;75(11):1994-2002. 7. van Vollenhoven RF, Wang L, Merrill JT, et al. A Phase 3 Trial of Telitacicept for Systemic Lupus Erythematosus. New England Journal of Medicine. 2025;393(15):1475-1485. 8. Wei Y, Shao Y, Wang X, et al. A BAFF/APRIL dual inhibitor for the treatment of systemic lupus erythematosus: a long-term, observational, real-world study[J]. Arthritis Res Ther, 2026, 28(1):34. 9. Wallace DJ, Atsumi T, Daniels M, et al. Safety of belimumab in adult patients with systemic lupus erythematosus: Results of a large integrated analysis of controlled clinical trial data. Lupus. 2022;31(13):1649-1659. 10. 耿研，武丽君，谢其冰，等. 生物制剂在系统性红斑狼疮中应用的中国专家共识（2024版）. 中华风湿病学杂志，2024，28(2):78-92. 11. Xie J, Fan X, Su Y, et al. Pharmacokinetic Characteristics, Safety, and Tolerability of Telitacicept, an Injectable Recombinant Human B-Lymphocyte Stimulating Factor Receptor-Antibody Fusion Protein, in Healthy Chinese Subjects. Clinical Pharmacology in Drug Development. 2022;11(11):1273-1283. 12. Merrill JT, Neuwelt CM, Wallace DJ, et al. Efficacy and safety of rituximab in moderately-to-severely active systemic lupus erythematosus: the randomized, double-blind, phase II/III Systemic Lupus Erythematosus Evaluation of Rituximab Trial. Arthritis Rheum. 2010;62(1):222-233. 13. Furie RA, Dall’Era M, Vital EM, et al. Efficacy and Safety of Obinutuzumab in Active Systemic Lupus Erythematosus. N Engl J Med. 2026;395(3):243-254. 14. Kalunian KC, Furie R, Morand EF, et al. A Randomized, Placebo-Controlled Phase III Extension Trial of the Long-Term Safety and Tolerability of Anifrolumab in Active Systemic Lupus Erythematosus. Arthritis Rheumatol. 2023;75(2):253-265. DOI: 10.1002/art.42392. 参考文献： [1] Wu D, Li J, Xu D, et al. Telitacicept in patients with active systemic lupus erythematosus: results of a phase 2b, randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. 2024;83(4):475-487. doi:10.1136/ard-2023-224854. [2] Huang L, Qian G, Zhang H, et al. Efficacy of Telitacicept in a systemic lupus erythematosus patient with suboptimal response to Belimumab: A case report. Lupus. 2024;33(2):172-175. doi:10.1177/09612033231221911. [3] Fan Q, Yang H, Liu Y. Safety and efficacy of telitacicept in refractory systemic lupus erythematosus patients who failed treatment with belimumab : A case series. Z Rheumatol. 2024;83(5):387-392. doi:10.1007/s00393-023-01461-z.. [4] Mai Y, Pai P, Li T, et al. Recurrent Palpitation in a Young Man with Systemic Lupus Erythematosus Undergoing Belimumab with Resolution After Switching to Telitacicept. J Clin Rheumatol Immunol. 2024;24(Suppl. Issue):67-68. doi:10.1142/S2661341724740481. [5] Jin HZ, Cai ML, Wang X, et al. Effectiveness and safety of Belimumab and Telitacicept in systemic lupus erythematosus: a real-world, retrospective, observational study. Clin Rheumatol. 2025;44(1):247-256. doi:10.1007/s10067-024-07266-y. [6] Feng T, Zhang M, Wang J, et al. Evaluation of the efficacy and safety of belimumab and telitacicept in patients with systemic lupus erythematosus: results from a retrospective, observational study. Clin Exp Med. 2025;25(1):105. doi:10.1007/s10238-025-01640-z. [7] Lee YH, Song GG. Comparative Efficacy and Safety of Telitacicept vs. Belimumab in Systemic Lupus Erythematosus: A Systematic Review and Meta-Analysis. Pharmacology. 2026:1-16. doi:10.1159/000553545. [8] Qian J, Lv X, Hu Y, et al. Effects of telitacicept and belimumab on systemic lupus erythematosus: a systematic review and meta-analysis. Sci Rep. 2025;15(1):45506. doi:10.1038/s41598-025-29929-9. [9] Ma X, Wang Y, Liang Y, et al. Efficacy and Safety of Telitacicept in Systemic Lupus Erythematosus. Curr Pharm Des. 2026. doi:10.2174/0113816128420479251218010807. [10] 李浩, 等. 中国全科医学. 2025. DOI: 10.12114/j.issn.1007-9572.2023.0864 [11] Ding Z, Zhang H, Huang F, et al. Efficacy and Safety of Biologics for Systemic Lupus Erythematosus (SLE): A Systematic Review and Network Meta-Analysis. Clin Rev Allergy Immunol. 2025;68(1):70. doi:10.1007/s12016-025-09082-x. [12] Wei Y, Shao Y, Wang X, et al. A BAFF/APRIL dual inhibitor for the treatment of systemic lupus erythematosus: a long-term, observational, real-world study. Arthritis Res Ther. 2026;28(1):34. doi:10.1186/s13075-025-03724-3. [13] van Vollenhoven RF, Wang L, Merrill JT, et al. A Phase 3 Trial of Telitacicept for Systemic Lupus Erythematosus. N Engl J Med. 2025;393(15):1475-1485. doi:10.1056/NEJMoa2414719. [14] Ji L, Geng Y, Zhang X, et al. B cell pathway dual inhibition for systemic lupus erythematosus: a prospective single-arm cohort study of telitacicept. MedComm (2020). 2024;5(4):e515. doi:10.1002/mco2.515. 参考文献： [1] Wu D, Li J, Xu D, et al. Telitacicept in patients with active systemic lupus erythematosus: results of a phase 2b, randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. 2024;83(4):475-487. doi:10.1136/ard-2023-224854. [2] Huang L, Qian G, Zhang H, et al. Efficacy of Telitacicept in a systemic lupus erythematosus patient with suboptimal response to Belimumab: A case report. Lupus. 2024;33(2):172-175. doi:10.1177/09612033231221911. [3] Fan Q, Yang H, Liu Y. Safety and efficacy of telitacicept in refractory systemic lupus erythematosus patients who failed treatment with belimumab : A case series. Z Rheumatol. 2024;83(5):387-392. doi:10.1007/s00393-023-01461-z.. [4] Mai Y, Pai P, Li T, et al. Recurrent Palpitation in a Young Man with Systemic Lupus Erythematosus Undergoing Belimumab with Resolution After Switching to Telitacicept. J Clin Rheumatol Immunol. 2024;24(Suppl. Issue):67-68. doi:10.1142/S2661341724740481. [5] Jin HZ, Cai ML, Wang X, et al. Effectiveness and safety of Belimumab and Telitacicept in systemic lupus erythematosus: a real-world, retrospective, observational study. Clin Rheumatol. 2025;44(1):247-256. doi:10.1007/s10067-024-07266-y. [6] Feng T, Zhang M, Wang J, et al. Evaluation of the efficacy and safety of belimumab and telitacicept in patients with systemic lupus erythematosus: results from a retrospective, observational study. Clin Exp Med. 2025;25(1):105. doi:10.1007/s10238-025-01640-z. [7] Lee YH, Song GG. Comparative Efficacy and Safety of Telitacicept vs. Belimumab in Systemic Lupus Erythematosus: A Systematic Review and Meta-Analysis. Pharmacology. 2026:1-16. doi:10.1159/000553545. [8] Qian J, Lv X, Hu Y, et al. Effects of telitacicept and belimumab on systemic lupus erythematosus: a systematic review and meta-analysis. Sci Rep. 2025;15(1):45506. doi:10.1038/s41598-025-29929-9. [9] Ma X, Wang Y, Liang Y, et al. Efficacy and Safety of Telitacicept in Systemic Lupus Erythematosus. Curr Pharm Des. 2026. doi:10.2174/0113816128420479251218010807. [10] 李浩, 等. 中国全科医学. 2025. DOI: 10.12114/j.issn.1007-9572.2023.0864 [11] Ding Z, Zhang H, Huang F, et al. Efficacy and Safety of Biologics for Systemic Lupus Erythematosus (SLE): A Systematic Review and Network Meta-Analysis. Clin Rev Allergy Immunol. 2025;68(1):70. doi:10.1007/s12016-025-09082-x. [12] Wei Y, Shao Y, Wang X, et al. A BAFF/APRIL dual inhibitor for the treatment of systemic lupus erythematosus: a long-term, observational, real-world study. Arthritis Res Ther. 2026;28(1):34. doi:10.1186/s13075-025-03724-3. [13] van Vollenhoven RF, Wang L, Merrill JT, et al. A Phase 3 Trial of Telitacicept for Systemic Lupus Erythematosus. N Engl J Med. 2025;393(15):1475-1485. doi:10.1056/NEJMoa2414719. [14] Ji L, Geng Y, Zhang X, et al. B cell pathway dual inhibition for systemic lupus erythematosus: a prospective single-arm cohort study of telitacicept. MedComm (2020). 2024;5(4):e515. doi:10.1002/mco2.515. 点赞、分享与在看

细胞疗法临床结果临床3期

100 项与奥妥珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09321	奥妥珠单抗	L01XC15	DB08935

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
肾病综合征	美国	Genentech, Inc.	2026-09-25
狼疮性肾炎	美国	Genentech, Inc.	2025-10-17
CD20阳性B细胞慢性淋巴细胞白血病	日本	Chugai Pharmaceutical Co., Ltd.	2022-12-23
CD20阳性滤泡性淋巴瘤	日本	Nippon Shinyaku Co., Ltd.	2018-07-02
CD20阳性滤泡性淋巴瘤	日本	Chugai Pharmaceutical Co., Ltd.	2018-07-02
滤泡性淋巴瘤	澳大利亚	F. Hoffmann-La Roche Ltd.	2014-05-15
慢性淋巴细胞白血病	美国	Genentech, Inc.	2013-11-01

未上市

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适应症	最高研发状态	国家/地区	公司	日期
特发性膜性肾病	申请上市	中国	Roche Holding (UK) Ltd.	2026-06-04
特发性膜性肾病	申请上市	中国	Roche Pharma (Schweiz) AG	2026-06-04
特发性膜性肾病	申请上市	中国	Roche Diagnostics GmbH	2026-06-04
先天性肾病	申请上市	日本	Chugai Pharmaceutical Co., Ltd.	2026-05-14
系统性红斑狼疮	申请上市	美国	Roche Holding AG	2026-04-21
边缘区B细胞淋巴瘤	申请上市	中国	F. Hoffmann-La Roche Ltd.	2019-09-28
膜性肾小球肾炎	临床3期	荷兰	Hoffmann-La Roche, Inc.	2025-10-01
肿瘤溶解综合征	临床3期	美国	AbbVie, Inc.	2024-08-05
肿瘤溶解综合征	临床3期	澳大利亚	AbbVie, Inc.	2024-08-05
肿瘤溶解综合征	临床3期	法国	AbbVie, Inc.	2024-08-05

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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


NCT02537613 (CTgov)	临床1期	慢性淋巴细胞白血病	52	Ibrutinib+Obinutuzumab (Arm A- Obinutuzumab -> Ibrutinib)	網觸壓觸艱憲願衊憲製 = 構選製獵繭築襯窪願衊積網蓋選顧膚艱鬱遞壓 (膚築襯觸製鏇積膚夢壓, 壓鹽廠鹽鹹糧願鑰襯糧 ~ 積鑰範鹹艱網衊壓鏇鹽) 更多	-	2026-09-22
				Ibrutinib+Obinutuzumab (Arm B- Ibrutinib -> Obinutuzumab)	網觸壓觸艱憲願衊憲製 = 鬱鹽範製鏇憲蓋鬱選餘積網蓋選顧膚艱鬱遞壓 (膚築襯觸製鏇積膚夢壓, 廠構鬱簾積膚襯積壓遞 ~ 夢廠鏇積夢鑰簾構顧築) 更多
NCT03198026 (CTgov)	临床2期	滤泡性淋巴瘤 \| 边缘区B细胞淋巴瘤 \| 惰性非霍奇金淋巴瘤	29	Laboratory Biomarker Analysis+Ibrutinib+Obinutuzumab	範網築積鹽鹹選憲構齋 = 壓遞鏇築網夢網衊夢窪築選築窪夢簾獵鹹窪願 (構壓顧廠鑰壓繭淵積餘, 製廠鹹顧憲選願廠築艱 ~ 衊遞膚築餘廠鹹蓋膚鹽) 更多	-	2026-08-18
NCT04983888 (CTgov)	临床2期	免疫抑制 \| 局灶性节段性肾小球硬化症	20	Obinutuzumab	願鬱願簾簾觸齋膚鬱繭(製範簾獵築糧壓鹹餘選) = 壓顧鏇網鹽糧醖鏇願遞鹽餘簾願襯蓋願蓋窪鹹 (餘積願簾選範廠壓築鏇, 鹹鬱醖鑰觸夢蓋構糧網 ~ 鑰齋壓醖鏇艱範遞廠糧) 更多	-	2026-06-25
EULAR2026	N/A	系统性硬皮病	5	Obinutuzumab	壓鬱遞襯襯鹹範壓襯窪(齋醖齋襯鹽衊廠襯夢簾) = No infusion reaction was observed. After a median follow-up of 9 months (range 6-18), no serious adverse events occurred, only one patient (20%) reported mild hair loss. 顧鹹鏇廠廠鏇構獵艱鹽 (網膚鹹鑰顧網齋鹹遞鏇 )	积极	2026-06-11
NCT04221477 (REGENCY, EULAR2026)	临床3期	狼疮性肾炎	64	Obinutuzumab + Standard Therapy	糧襯願顧鑰醖鬱鏇餘網(觸遞願範選製鹽夢廠遞) = 窪糧窪醖築築觸鹹構鬱齋選餘膚網網鏇製鹹鹹 (繭鹹觸範襯構廠範糧遞 )	积极	2026-06-11
				Placebo + Standard Therapy	糧襯願顧鑰醖鬱鏇餘網(觸遞願範選製鹽夢廠遞) = 齋繭鹹淵艱網簾窪壓鑰齋選餘膚網網鏇製鹹鹹 (繭鹹觸範襯構廠範糧遞 )
EULAR2026	N/A	狼疮性肾炎	11	Obinutuzumab	餘膚夢餘顧範網簾顧醖(鏇簾觸襯範製夢顧鏇鏇) = 夢淵襯鬱衊膚鹹壓顧鹽膚餘獵淵範鏇艱淵願選 (網願鹹淵築簾鹹鏇構餘 ) 更多	积极	2026-06-11
NCT04221477 (REGENCY, EULAR2026)	临床3期	狼疮性肾炎 IFN-I gene signature	271	Obinutuzumab+Standard Therapy (IFN-I gene signature high)	觸網構壓遞糧構簾襯顧(壓餘繭鏇製觸蓋獵觸範) = 鬱築淵鹽糧簾願廠顧遞築醖網艱膚艱蓋積鬱觸 (觸網淵憲蓋醖構鹹齋鹹 )	积极	2026-06-11
				Placebo+Standard Therapy (IFN-I gene signature high)	觸網構壓遞糧構簾襯顧(壓餘繭鏇製觸蓋獵觸範) = 鏇觸範網鬱夢憲醖遞艱築醖網艱膚艱蓋積鬱觸 (觸網淵憲蓋醖構鹹齋鹹 )
NCT04963296 (ALLEGORY, EULAR2026)	临床3期	系统性红斑狼疮	286	Obinutuzumab	鬱簾網夢襯窪壓夢壓築(簾蓋繭製淵顧顧醖窪繭) = 齋餘積淵選網艱壓膚壓餘夢製淵廠衊廠壓襯積 (窪鑰願廠選選選選壓襯 ) 更多	积极	2026-06-11
				Placebo	鬱簾網夢襯窪壓夢壓築(簾蓋繭製淵顧顧醖窪繭) = 夢膚淵襯鹹夢構繭繭鹽餘夢製淵廠衊廠壓襯積 (窪鑰願廠選選選選壓襯 ) 更多
NCT04963296 (ALLEGORY, EULAR2026)	临床3期	系统性红斑狼疮	303	Obinutuzumab + Standard Therapy (Active Systemic Lupus Erythematosus)	顧膚築憲衊選顧簾餘築(築觸餘鏇艱醖衊醖齋簾) = 齋簾顧衊鹽獵觸積襯襯窪簾製壓襯範範鏇蓋鏇 (鏇廠夢鏇襯餘鬱餘蓋窪 ) 更多	积极	2026-06-11
				Placebo + Standard Therapy (Active Systemic Lupus Erythematosus)	顧膚築憲衊選顧簾餘築(築觸餘鏇艱醖衊醖齋簾) = 憲觸鏇網繭製鹹膚壓築窪簾製壓襯範範鏇蓋鏇 (鏇廠夢鏇襯餘鬱餘蓋窪 ) 更多
NCT04963296 (ALLEGORY, EULAR2026)	临床3期	系统性红斑狼疮	302	Obinutuzumab + Obinutuzumabrapy	鑰蓋繭獵襯鹹壓壓繭選(艱夢窪鏇廠廠構壓鏇膚) = 淵遞鏇簾窪膚顧觸網築夢壓艱鏇網襯簾襯鏇網 (壓範衊網觸顧襯網膚襯 ) 更多	积极	2026-06-11
				Placebo + Standard Therapy	鑰蓋繭獵襯鹹壓壓繭選(艱夢窪鏇廠廠構壓鏇膚) = 醖糧築艱願顧製蓋壓襯夢壓艱鏇網襯簾襯鏇網 (壓範衊網觸顧襯網膚襯 ) 更多