预约演示

更新于：2026-03-01

Obinutuzumab

奥妥珠单抗

更新于：2026-03-01

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

狼疮性肾炎CD20阳性B细胞慢性淋巴细胞白血病CD20阳性滤泡性淋巴瘤+ [50]

非在研适应症

攻击CD20阳性弥漫性大B细胞淋巴瘤CD20阳性血液肿瘤+ [19]

原研机构

Roche Glycart AG

在研机构

F. Hoffmann-La Roche Ltd.

AbbVie, Inc.

罗氏（中国）投资有限公司

+ [19]

非在研机构

Janssen-Cilag Ltd.Celgene International SARL

Roche Nederland BV

+ [4]

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)、优先审评 (中国)、突破性疗法 (美国)

登录后查看时间轴

结构/序列

Sequence Code 68713L

来源: *****

Sequence Code 9699891H

来源: *****

关联

336

项与奥妥珠单抗相关的临床试验

NCT07003295

/ Recruiting临床2期IIT

A Phase II Study of Glofitamab for Relapsed/Refractory Mantle Cell Lymphoma in Patients Previously Treated With CD19-Directed CAR T-Cell Therapy

This phase II trial tests the safety and side effects of glofitamab and obinutuzumab and how well they work in treating patients with mantle cell lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory) after receiving CD19-directed chimeric antigen receptor (CAR) T-cell therapy. CAR T-cell therapy is a form of immunotherapy where the immune system cell, T-cell, is changed to attack cancer cells. Glofitamab is a bispecific antibody that can bind to two different antigens at the same time. Glofitamab binds to CD3, a protein found on T cells (a type of white blood cell), and CD20 a protein found on B cells (another type of white blood cell) and some lymphoma cells. This may help the immune system kill cancer cells. Obinutuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Giving glofitamab and obinutuzumab may be safe, tolerable, and/or effective in treating patients with relapsed or refractory mantle cell lymphoma after receiving CD19-directed CAR T-cell therapy.

开始日期2026-08-14

申办/合作机构

National Cancer Institute

NCT07326371

/ Not yet recruiting临床2期IIT

A Single-Center, Prospective Study Evaluating the Efficacy and Safety of Glofitamab Combined With CAR-T Therapy in Patients With High-Risk Relapsed/Refractory Large B-Cell Lymphoma

This study is a single-center, open-label, prospective study aimed at evaluating the efficacy and safety of Glofitamab combined with CAR-T therapy in patients with high-risk relapsed/refractory large B-cell lymphoma.

开始日期2026-03-01

申办/合作机构

上海交通大学医学院附属瑞金医院

NCT07233330

/ Not yet recruiting临床2期IIT

Obinutuzumab Treatment in Frequently Relapsing and Rituximab-Dependent Idiopathic Nephrotic Syndrome in Adults: a Fully Academic, Single-arm, Open, Prospective, Intervention Trial

This is a multicenter, open-label, single-arm Phase II clinical trial designed to evaluate the safety, efficacy, and immunological effects of obinutuzumab in adult patients with multi-relapsing, rituximab-dependent steroid-sensitive NS.
Obinutuzumab is a glycoengineered, humanized type II anti-CD20 monoclonal antibody that was initially developed to overcome rituximab resistance in B-cell malignancies. Obinutuzumab induced a longer and deeper B cell depletion than rituximab being able to deplete B cells in lymphoid tissue other than peripheral blood, as shown in both animal models and patients with chronic lymphocytic leukemia or kidney transplantation. Notably, obinutuzumab was found to be more efficient than rituximab in inducing B-cell cytotoxicity in-vitro, especially on naïve (IgD+CD27-) and switched (IgD-CD27+) memory B cells. This is a clinically relevant finding, because memory B cells are known to be associated with the risk of relapse after rituximab treatment in children with nephrotic syndrome. A recent retrospective study in 41 children [median (IQR) age: 10.6 (8.5-14.29) years] with steroid-dependent or frequently relapsing nephrotic syndrome, showed that treatment with obinutuzumab achieved B-cell depletion and sustained remission in 38 (93%) and 28 (68%) children at 12 and 24 months after treatment, respectively. Treatment was safe and well tolerated. Moreover, preliminary data indicate that obinutuzumab treatment can achieve complete or partial remission of the nephrotic syndrome in the large majority of adult participants with membranous nephropathy refractory to different immunosuppressive medications including rituximab, and even the human type 1 anti-CD20 antibody ofatumumab or the anti-CD38 antibody felzartamab (NCT05050214). Notably, obinutuzumab treatment achieved B-cell depletion and proteinuria reduction in all treated participants and persistent circulating anti-PLA2R antibody depletion in all participants with PLA2R-related disease even during the recovery of circulating B cells (NCT05050214). Conceivably, obinutuzumab could achieve remission of idiopathic nephrotic syndrome by inducing profound and sustained B-cell depletion, thereby inhibiting the production of anti-podocyte autoantibodies or the production of still unknown B-cell derived nephritogenic mediators and autoantibodies.
Thus, whether obinutuzumab treatment may achieve persistent remission also in adult participants with multi-relapsing, rituximab-dependent nephrotic syndrome, as previously reported in children, and as already observed in adult participants with refractory membranous nephropathy (NCT05050214), and whether this effect is associated with delayed recovery of switched memory B cells and emergence of B cells with a naïve phenotype as well as sustained reduction or depletion of circulating anti-podocyte antibodies is worth investigating.
In parallel to the evaluation of the phenotype of repopulating B cells, we will evaluate serum levels of the B-cell activating factor (BAFF). BAFF is a cytokine that orchestrates peripheral tolerance of B cells and promotes the survival of autoreactive B cells escaping central tolerance mechanisms. In participants with autoimmune diseases, such as systemic lupus erythematosus or rheumatoid arthritis, the relapse of disease activity after rituximab treatment has been associated with compensatory elevation of the B cell-activating factor BAFF levels. Elevated BAFF levels at baseline or during the follow-up may explain the resistance or dependency to anti-CD20 depleting antibodies in participants with idiopathic nephrotic syndrome.

开始日期2026-02-01

申办/合作机构

Istituto di Ricerche Farmacologiche Mario Negri

100 项与奥妥珠单抗相关的临床结果

登录后查看更多信息

100 项与奥妥珠单抗相关的转化医学

登录后查看更多信息

100 项与奥妥珠单抗相关的专利（医药）

登录后查看更多信息

1,056

项与奥妥珠单抗相关的文献（医药）

2026-04-01·Kidney International Reports

Glucocorticoid reduction in Glomerular Diseases

Review

作者: Massicotte-Azarniouch, David ; Hesketh, Caitlin ; Fairhead, Todd ; Toal, Michael ; Canney, Mark

Glucocorticoids (GCs) remain central to the management of many glomerular diseases, providing rapid and potent antiinflammatory effects. However, their well-recognized toxicities have driven growing efforts to reduce cumulative exposure. This review synthesizes evidence from randomized and key noncontrolled studies evaluating GC-sparing strategies across diseases where these agents have historically played a central therapeutic role. In antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), large trials such as the Plasma Exchange and Glucocorticoids in Severe ANCA-Associated Vasculitis (PEXIVAS) trial and the Effect of Reduced-Dose versus High-Dose Glucocorticoids Added to Rituximab (LoVAS) trial demonstrate that reduced-dose regimens preserve efficacy while lowering infection risk. In lupus nephritis (LN), lower-dose strategies and early use of multipronged regimens incorporating targeted agents such as belimumab, calcineurin inhibitors, or obinutuzumab support faster tapering. In minimal change disease (MCD), combination approaches with calcineurin inhibitors or mycophenolate achieve remission with less steroid exposure. In IgA nephropathy (IgAN), practice is increasingly shifting away from GC use altogether, as novel immunomodulatory agents targeting disease-specific pathways are integrated into care. Although GCs will likely remain essential for induction in select inflammatory glomerulopathies, their role can increasingly be narrowed to early, time-limited use. Future studies should address key uncertainties, particularly the optimal use of i.v. methylprednisolone in rapidly progressive presentations and evaluate the safety and efficacy of even lower-dose regimens.

2026-03-01·AMERICAN JOURNAL OF KIDNEY DISEASES

“A Change Is Gonna Come” to Treatment of Lupus Nephritis: A Review

Review

作者: Gashti, Casey ; Desai, Niraj B ; Whittier, William L

Systemic lupus erythematosus (SLE) is a chronic, multiorgan autoimmune disease, with lupus nephritis (LN) affecting up to 60% of patients. Early diagnosis and treatment are critical for preserving kidney function. Advances in understanding the immunopathogenesis of LN are driving the development of personalized treatment strategies that hold promise for transforming disease management through interventions targeting distinct immunologic and histopathologic features. In this review, we discuss current and emerging therapies for proliferative and membranous LN with a focus on strategies targeting underlying mechanisms of disease in LN. Glucocorticoids with cytotoxic agents or mycophenolate mofetil (MMF) remain the standard of care, but newer therapies targeting B cells (eg, belimumab and obinutuzumab) and T cells (eg, voclosporin) have proven efficacy as add-on treatments. Novel therapies such as complement and cytokine inhibitors are being evaluated in preclinical and clinical trials. Although maintenance therapy with MMF remains the standard, the distinction between sequential induction and maintenance therapy has become increasingly blurred, and new strategies to reduce long-term disease and pharmacologic toxicity to improve remission and relapse rates are emerging.

2026-03-01·Kidney International Reports

Prospective Cohort Study of Obinutuzumab in Rituximab-Resistant Primary Membranous Nephropathy

Article

作者: Trillini, Matias ; Surdi, Livia ; Diadei, Olimpia ; Podestà, Manuel Alfredo ; Peracchi, Tobia ; Cugini, Daniela ; Carrara, Fabiola ; Fidone, Diego ; Portalupi, Valentina ; Rubis, Nadia ; Marasà, Maddalena ; Casiraghi, Federica ; Guarinoni, Chiara ; Villa, Alessandro ; Ruggenenti, Piero ; Martinetti, Davide ; Gennarini, Alessia ; Rizzo, Paola ; Remuzzi, Giuseppe ; Currado, Annachiara ; Todeschini, Marta

Introduction:

Approximately 30% of patients with primary membranous nephropathy (MN) and persistent nephrotic syndrome (NS) fail rituximab therapy through mechanisms that could be overcome by obinutuzumab.

Methods:

In this prospective, single-arm, single-center, open-label trial, 20 consenting adults with MN and rituximab-resistant NS received three 1000 mg obinutuzumab infusions at the Bergamo Nephrology Unit (Italy) between March 2022 and February 2024 and were monitored for ≤ 12 months. The primary outcome was a composite end point of normo-albuminemia and complete (proteinuria < 0.3 g/d) or partial (proteinuria < 3.5 g/d with ≥ 50% reduction from baseline) NS remission at 12-month follow-up. Twenty-four-hour proteinuria and glomerular filtration rate (GFR) were evaluated at baseline and at 3, 6, 9, 12, 18, and 24 months posttreatment.

Results:

At 12 months, 16 patients met the combined end point, 4 with complete remission. No patient relapsed after remission. Median (interquartile range) 24-h proteinuria decreased from 5.7 (4.7-8.1) to 1.3 (0.5-2.7) g/24 h. Albumin and IgG fractional clearances also decreased, whereas serum albumin increased from 2.9 ± 0.6 g/dl to 3.9 ± 0.3 g/dl (P < 0.0001 for all changes). Dyslipidemia, hypocalcemia, and hypo-gammaglobulinemia improved significantly and GFR stabilized. At 12 months, total B cells and circulating anti-phospholipase A₂ receptor (PLA₂R) antibodies were depleted. Similar findings were observed in the cohort of 10 patients who completed 24 months of follow-up. However, total B cells reemerged in the circulation without an increase in anti-PLA₂R antibodies and proteinuria, or relapses. Treatment was safe and well-tolerated.

Conclusion:

Obinutuzumab treatment is extremely effective and safe in patients with MN and rituximab-resistant NS and can achieve persistent remission in this population.

851

项与奥妥珠单抗相关的新闻（医药）

2026-02-27

·ACROBiosystems官方

药创新章｜多款重磅疗法突围，医药行业热点速递

全球医药领域创新步伐持续加快，自身免疫性疾病、代谢性疾病等核心治疗赛道成果频出，多款创新药获批上市、临床研究斩获积极数据，药企间合作授权也愈发活跃。ACROBiosystems百普赛斯提供高活性重组蛋白、功能细胞株及抑制剂筛选试剂盒等产品矩阵，打造从靶点发现与验证、候选药物筛选与开发到CMC-生产与质量控制的全流程解决方案，助力创新疗法实现从基础研究到临床转化的高效跨越。 1 自身免疫性疾病领域：多款创新药获批，临床研究成果显著奥妥珠单抗β注射液：NMOSD治疗添本土创新力量 2月14日，北京天广实生物宣布，其自主研发的创新型第三代CD20抗体药物MIL62奥妥珠单抗β注射液（商品名：倍捷欣®）获批上市，用于治疗视神经脊髓炎谱系疾病（NMOSD）。MIL62采用独特的岩藻糖全敲除技术增强抗体ADCC功能，可选择性清除异常B细胞，对正常B细胞影响较小，II/III期临床试验中72%的蛋白尿缓解率远超传统药物。临床研究数据显示，该药物可显著降低患者复发风险，或为患者带来更具可及性的治疗选择，有望重塑该疾病领域治疗格局。达尔扑拜单抗注射液：新一代CD20抗体冲刺NMOSD市场 2月24日，百奥泰生物制药宣布，其用于治疗抗水通道蛋白4（AQP4）抗体阳性NMOSD的产品达尔扑拜单抗注射液（BAT4406F）上市许可申请获国家药监局受理。BAT4406F是新一代糖基优化的全人源抗CD20抗体，具有ADCC增强功能，其关键注册II/III期临床研究于此前获独立数据监查委员会“提前结束试验”建议，并于近期完成生物制品许可申请（BLA）。奥妥珠单抗：PMN全球III 期临床取得突破性成果 2月16日，罗氏宣布，其CD20单抗奥妥珠单抗（Gazyva/Gazyvaro）在原发性膜性肾病（PMN）全球首个III期临床研究MAJESTY中取得积极结果，达到主要终点。研究显示，与活性对照相比，奥妥珠单抗治疗组患者两年时完全缓解人数显著更多，总缓解率等次要终点也表现优异，安全性与既往一致。这一突破意味着PMN患者有望迎来首个获批的特异性治疗方案，打破长期治疗选择有限的困境。 https://doi.org/10.1007/s12325-016-0451-1 奥妥珠单抗的结构与结合特性米吉珠单抗：中国炎症性肠病治疗迎来IL-23p19抑制剂 2月11日，礼来的米吉珠单抗获国家药品监督管理局批准，用于治疗成人中重度活动性克罗恩病（CD）及溃疡性结肠炎（UC）。米吉珠单抗是靶向于IL-23p19亚基的IgG4型单克隆抗体，可选择性抑制IL-23通路，2023年成为全球首个获批用于中重度UC的IL-23p19抑制剂，目前已在美、欧、日等多地获批。此次中国获批是礼来在消化免疫领域的重要突破，将惠及更多中国炎症性肠病患者。 https://doi.org/10.3390/jcm14031001 米吉珠单抗是一种人源化IgG单克隆抗体，特异性靶向IL-23的p19亚基 Rezpegaldesleukin：特应性皮炎治疗展现优越维持疗效 2月10日，Nektar Therapeutics公布了其Rezpegaldesleukin（REZPEG）全球2b期研究REZOLVE-AD的临床数据。REZPEG是选择性激活Treg型IL-2，通过直接靶向Treg表面的IL-2受体，可促进Treg增殖并增强其功能，在中重度特应性皮炎（AD）患者中，36周盲法维持期治疗取得积极结果。24μg/kg剂量下，每月与每季度给药方案分别有71%和83%的患者维持EASI-75应答。受此影响，Nektar公司股价当日暴涨51.07%，市值达11.39亿美元。 Rezpegaldesleukin及其作用机制（图源：Nektar官网） Molbreevi：自身免疫性肺泡蛋白沉积症疗法冲刺FDA 获批 2月20日，Savara Inc.宣布，美国食品药品监督管理局（FDA）已正式受理其研发的Molbreevi的BLA申报，适应症为自身免疫性肺泡蛋白沉积症（autoimmune PAP，aPAP）。FDA同步授予该申请优先审评资格，并明确处方药用户付费法案（PDUFA）目标审评日期为2026年8月22日。据悉，该药物若顺利获批，将成为美国及欧洲首款且唯一针对aPAP的疗法。Molbreevi为重组人GM-CSF，通过Savara专有大分子吸入给药在研eFlow雾化系统递送，可有效恢复肺泡巨噬细胞功能，从疾病机制层面改善患者病情，此前已获得FDA快速通道资格、突破性疗法认定与孤儿药资格。正常肺泡与 PAP 肺泡关键差异对比（图源：Savara官网） 2 代谢性疾病领域：减重新药临床数据亮眼，推进三期研究 2月24日，诺和诺德与联邦制药共同宣布，UBT251的中国减重II期研究取得积极结果，基于此，联邦制药计划启动中国超重或肥胖患者III期临床试验。UBT251是联邦生物开发的长效GLP-1R/GIPR/GCGR三重激动剂，2025年3月诺和诺德获得其海外独家权益。该II期研究纳入205例中国受试者，基线平均体重为92.2kg、BMI 33.1kg/m²，治疗24周后，UBT251组平均体重最大降幅达19.7%（-17.5kg），显著优于安慰剂组的2.0%（-1.6kg），展现出优异的减重疗效。 3 企业合作与授权：聚焦创新药研发，推动成果转化医药企业间的合作与授权成为创新研发的重要推动力，2月以来多款潜力药物达成合作。2月2日，济川药业与普祺医药签署协议，以最高1亿元对价获得普美昔替尼鼻喷雾剂在中国大陆及港澳台地区10年独家商业化权益，该药为全球首款JAK抑制剂鼻喷雾剂，针对季节性过敏性鼻炎处于III期临床，计划2026年申报上市。2月3日，药明生物与Vertex Pharmaceuticals 就一款临床前创新三特异性T细胞衔接子（TCE）达成授权协议，Vertex 获全球独家开发商业化权益，该药拟用于B细胞介导的自身免疫性疾病，药明生物将获首付款、里程碑付款及销售分成，并提供一体化研发服务。2月23日，安斯泰来与Vir Biotechnology宣布达成全球战略合作，共同开发商业化PRO-XTEN®双掩蔽PSMA/CD3 TCE VIR-5500，用于前列腺癌治疗，Vir将获得3.35亿美元的首付款及近期付款，并有资格获得高达13.7亿美元的里程碑付款，双方将分担开发成本并分享美国市场利润。 ACROBiosystems百普赛斯提供高活性重组蛋白、功能细胞株及试剂盒等产品矩阵，覆盖靶点发现验证、药物筛选开发及CMC生产质控全流程，助力创新疗法从基础研究高效迈向临床转化。验证数据全长CD20蛋白：高生物活性经Anti-CD20 CAR结合验证 2e5 of Anti-CD20 CAR-293 cells were stained with 100 μL of 3 μg/mL Biotinylated Human CD20 Full Length Protein, Flag Tag & His, Avi tag (Cat. No. CD0-H82D3) and negative control protein respectively, washed and then followed by PE-SA and analyzed with FACS (QC tested). IL-23A蛋白：高生物活性经ELISA验证 Immobilized Human IL-23A Protein, Fc Tag (Cat. No. ILA-H525h) at 1 μg/mL (100 μL/well) can bind Mirikizumab with a linear range of 0.002-0.25 μg/mL (QC tested). CD3E & CD3D蛋白：高生物活性经ELISA验证 Immobilized Human CD20 Full Length Protein, His Tag (Cat. No. CD0-H52H3) at 2 μg/mL, add increasing concentrations of Glofitamab and then add HRP-Human CD3E & CD3D Heterodimer Protein, His Tag&Tag Free (Cat. No. CDD-HR2W3) at 1 μg/mL, with sensitivity of 40.30 ng/mL (Routinely tested). IL-2RB & IL-2RA & IL-2RG蛋白：亲和力经SPR验证 Human IL-2RB&IL-2RA&IL-2RG, Fc Tag & Fc Tag (Cat. No. ILG-H5257) captured on CM5 chip via Anti-human IgG Fc antibodies surface can bind Human IL-2, Tag Free with an affinity constant of 40.6 pM as determined in a SPR assay (Biacore 8K) (Routinely tested). 相关产品推荐点击查看详情点击查看详情 >>点击图片了解ComboX，您身边的通用型研发工具参考资料 1. Colwill M, Baillie S, Clough J, et al. Role of Mirikizumab in the Treatment of Inflammatory Bowel Disease—From Bench to Bedside[J]. Journal of Clinical Medicine, 2025, 14(3): 1001. https://doi.org/10.3390/jcm14031001 2. Tobinai K, Klein C, Oya N, et al. A review of obinutuzumab (GA101), a novel type II anti-CD20 monoclonal antibody, for the treatment of patients with B-cell malignancies[J]. Advances in therapy, 2017, 34(2): 324-356. https://doi.org/10.1007/s12325-016-0451-1 3. 智慧芽研发资讯公众号 4. 药研网公众号 5. 新药说公众号 ACROBiosystems inquiry@acrobiosystems.com 15117918562 （备注：姓名+公司）

上市批准申请上市临床3期抗体药物偶联物

2026-02-26

·抗体圈

单克隆抗体 50 年：从实验室到临床的进化之旅

摘要：1975年杂交瘤技术的诞生，开启了单克隆抗体的新时代。50年间，这项技术从基础研究工具，逐步发展为全球获批212款的主流治疗手段，惠及数千万患者。从鼠源抗体的局限性突破，到人源化、双特异性抗体、抗体药物偶联物的迭代，再到生物制造与给药技术的升级，单克隆抗体的进化从未停止。如今AI赋能抗体设计，口服、中枢递送等新方向探索，让这款疗法的未来充满更多可能。一、一次实验室突破，开启50年的疗愈征程 1975年，Köhler和Milstein在实验室做出了一个改变医学的发现——杂交瘤技术。简单说，就是把小鼠免疫后的B细胞和骨髓瘤细胞融合，造出能无限分泌特异性抗体的杂交瘤细胞（图1a，来源：Nature Reviews Immunology, 2025）。这一发现直接拿下1984年诺贝尔奖，也让单克隆抗体从概念变成了可量产的科研工具。最初的鼠源单抗虽能精准结合抗原，但作为药物的短板很快显现，免疫原性强、半衰期短、效应功能弱，直到1986年首款鼠源单抗muromonab-CD3获批，才迈出临床第一步，而真正的爆发，还要等上十余年。图1 从杂交瘤技术到抗体疗法的发展路径 a为杂交瘤技术制备鼠源单克隆抗体的核心步骤；b为从杂交瘤技术诞生到抗体疗法获批的关键环节，涵盖抗体工程、生物制造、临床研究等多个阶段二、抗体的“改头换面”，突破鼠源的先天局限鼠源单抗的临床短板，逼着科研人员开始给抗体“做改造”。嵌合化是第一步，把鼠源抗体的抗原结合区嫁接到人源抗体的恒定区，降低了部分免疫原性。随后的人源化技术更精细，只保留鼠源抗体的抗原结合环，其余全部替换成人源序列，这一改造让抗体的临床兼容性大幅提升（Box1，来源：Nature Reviews Immunology, 2025）。后来全人源抗体技术出现，通过转基因小鼠、噬菌体展示等方法，直接获得全人源序列的抗体，彻底解决了免疫原性问题，2002年获批的阿达木单抗，就是首款全人源IgG抗体，也成了首款年销售额超200亿美元的抗体药。三、212款获批药的背后，是疗法格局的全面进化截至2025年5月，全球获批的抗体治疗药物已达212款，这个数字还在以每年至少18款的速度增长（图2a，来源：Nature Reviews Immunology, 2025）。这些药物不再只是单一的IgG抗体，双特异性抗体、抗体药物偶联物（ADCs）、CAR-T细胞疗法等新形式百花齐放。从疾病领域看，肿瘤占比48%，自身免疫性疾病25%，感染、神经、代谢疾病等领域也在不断拓展（图2b，来源：Nature Reviews Immunology, 2025）。给药方式也从最初的静脉输注，发展出皮下注射、玻璃体内注射等多种形式，让患者的治疗体验大幅提升（图2d，来源：Nature Reviews Immunology, 2025）。图2 全球获批抗体治疗药物的发展格局 a为不同抗体形式的累计获批数量；b为抗体疗法获批的疾病领域分布；c为不同制备技术的抗体累计获批数量；d为抗体疗法的给药途径分布；e为获批抗体药物偶联物的作用机制与数量；f为获批双特异性抗体的结构形式与数量四、精准靶向的进阶，从单一抗体到多元治疗体系抗体疗法的魅力，在于对疾病的精准靶向，而这一点在B细胞疾病和HER2+癌症的治疗中体现得淋漓尽致。针对B细胞的CD20靶点，从首款嵌合抗体利妥昔单抗，到糖基化改造的奥滨尤妥珠单抗，再到双特异性T细胞衔接器、CAR-T细胞、ADCs，形成了多代产品的治疗矩阵（图3，来源：Nature Reviews Immunology, 2025）。HER2+乳腺癌的治疗更是如此，曲妥珠单抗开启靶向时代后，帕妥珠单抗的联合、ADCs的升级、双特异性抗体的出现，让这款癌症的治疗效果不断突破，甚至能覆盖HER2低表达的患者（图4，来源：Nature Reviews Immunology, 2025）。图3 靶向B细胞的各类抗体治疗药物涵盖单克隆抗体、双特异性抗体、CAR-T细胞、抗体药物偶联物等多种形式，标注了各药物的靶点、结构改造及给药方式特点图4 靶向HER2的抗体治疗药物格局展示了单克隆抗体、双特异性抗体、抗体药物偶联物及联合制剂的靶点结合特点、结构改造和获批适应症五、给药的革新，让治疗从“医院专属”变“居家可及” 静脉输注是抗体疗法最初的给药方式，虽能保证100%的生物利用度，但每次治疗需要数小时，对患者来说既耗时又费力。皮下注射的出现改变了这一现状，给药时间缩短到10分钟内，还能实现居家给药。为了突破皮下注射的剂量和体积限制，科研人员想出了多种办法：和透明质酸酶共制剂，把给药体积从2ml提升到15ml；通过工程改造让抗体更稳定、低黏度，能制备高浓度制剂；甚至改造抗体的Fc区，延长半衰期，减少给药频率（表1，来源：Nature Reviews Immunology, 2025）。如今多款抗体药已实现皮下给药，让治疗的便捷性提升了一个台阶。表1 提升抗体皮下递送效率的核心策略涵盖增加给药体积、提高给药浓度、降低用药剂量、提升生物利用度四大方向，及各方向对应的具体技术手段六、生物制造的升级，撑起抗体药的量产底气抗体药能从实验室走向临床，生物制造的进步功不可没。最初的CHO细胞培养，抗体滴度只有1-2g/L，如今通过细胞系改造、培养基优化、灌流培养等技术，滴度能稳定在5-8g/L，部分抗体甚至能突破10g/L（Box2，来源：Nature Reviews Immunology, 2025）。生产设备也从传统的不锈钢生物反应器，发展出一次性设备，降低了污染风险，提升了生产灵活性。连续加工技术的探索，还让抗体的生产周期缩短、成本降低，让更多患者能用上这款疗法。七、未来的方向，从AI设计到全新递送的无限探索其实单克隆抗体的进化，从来没有停下脚步。现在的科研人员，已经开始用AI设计抗体了，从结构预测到多参数优化，AI能让抗体的研发效率大幅提升，甚至能设计出自然界不存在的抗体序列。除了AI，条件性抗原结合抗体、IgM/IgA等新型抗体亚型、激动性抗体的探索，都在让抗体的功能更丰富。而口服抗体、中枢神经系统递送的研究，更是试图突破抗体给药的最后壁垒，让这款疗法能覆盖更多疾病、更多患者。当然，降低高工程化抗体的免疫原性，仍是未来需要持续攻克的难题（图5，来源：Nature Reviews Immunology, 2025）。八、50年回望，抗体疗法的初心与远方从1975年杂交瘤技术的实验室发现，到如今212款药物获批、数千万患者获益，单克隆抗体的50年，是基础研究向临床转化的典范。这50年里，我们解决了鼠源抗体的局限，打造了多元的抗体形式，优化了给药和制造技术，让这款疗法从“小众工具”变成了“主流疗法”。某种程度上，抗体疗法的进化，也是人类对抗疾病的缩影——从发现到突破，从优化到创新，永远向着更精准、更便捷、更有效的方向前行。而下一个50年，随着AI、合成生物学等技术的融合，抗体疗法还会带来更多惊喜。识别微信二维码，添加抗体圈小编，符合条件者即可加入抗体微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观不本站。

2026-02-25

·Firstwordpharma

Calquence-Venclexta combo clinches FDA nod in first-line CLL

The FDA approved AstraZeneca's BTK inhibitor Calquence (acalabrutinib) in combination with AbbVie and Roche's BCL-2 inhibitor Venclexta (venetoclax) — also marketed by AbbVie as Venclyxto in the EU — for the first-line treatment of chronic lymphocytic leukaemia (CLL) in adults, establishing the first and only all-oral, fixed-duration combination therapy for previously untreated patients. Also see – Spotlight On: BTK inhibitors move towards fixed-duration combos in CLL. "The…approval expands choice and flexibility for patients and providers navigating complex treatment decisions in CLL," said Svetlana Kobina, VP of oncology global medical affairs at AbbVie. Similar to the Calquence–Venclexta pair's EU approval for the indication last year, the latest US clearance was supported by the Phase III AMPLIFY trial. Results showed the experimental duo with or without Roche's Gazyva/Gazyvaro (obinutuzumab) demonstrated a 35% reduction in the risk of disease progression or death versus chemoimmunotherapy in treatment-naïve patients, with median progression-free survival not reached in the combination arm compared with 47.6 months for chemoimmunotherapy. In a FirstWord poll of US haematologists and oncologists conducted post the AMPLIFY readout, 85% of respondents were at least somewhat impressed by the data and over half deemed the all-oral, fixed-duration regimen as highly promising. However, in a separate CLL landscape report, key opinion leaders also expressed concerns that the combination was pitted against a relatively outdated chemoimmunotherapy control arm. Meanwhile, another late-stage study, MAJIC, is evaluating the Calquence-Venclexta combination against Venclexta plus Gazyva for CLL or small lymphocytic lymphoma in the front-line setting. The content above comes from the network. if any infringement, please contact us to modify.

上市批准临床结果免疫疗法生物类似药

100 项与奥妥珠单抗相关的药物交易

登录后查看更多信息

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,

后查看更多信息

适应症	国家/地区	公司	日期
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

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
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	-	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
肿瘤溶解综合征	临床3期	希腊	AbbVie, Inc.	2024-08-05
肿瘤溶解综合征	临床3期	塞尔维亚	AbbVie, Inc.	2024-08-05
肿瘤溶解综合征	临床3期	西班牙	AbbVie, Inc.	2024-08-05
肿瘤溶解综合征	临床3期	中国台湾	AbbVie, Inc.	2024-08-05
肿瘤溶解综合征	临床3期	英国	AbbVie, Inc.	2024-08-05

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ICLL-07 (ASH2025)	临床2期	慢性淋巴细胞白血病一线	135	Ibrutinib 420 mg/day	鑰夢憲鏇鹽鬱壓襯壓製(衊夢淵窪願鹽鬱顧衊夢) = Twelve patients died, including 2 from cardiac toxicity during treatment with O+I attributable to I (M6 and M7). The ten other deaths are distributed among 4 infections (3 bacterial pneumonias at M38, M55, M50 and 1 COVID 19 at M49), 1 histiocytic sarcoma (M47), 1 myelodysplasia (MDS; M56) and 1 acute myeloid leukemia (AML; M68). Three deaths were due to progression (n=1, M103) or transformation in Richter large B-cel lymphoma (n=1; M54) or Hodgkin lymphoma (n=1; M23). 鹹憲製鏇鏇鏇餘蓋鑰範 (鑰遞襯觸窪鑰衊選淵網 ) 更多	积极	2025-12-06
NCT04608318 (CLL17, Pubmed \| N Engl J Med)	临床3期	慢性淋巴细胞白血病	909	Venetoclax-Obinutuzumab	鏇餘壓壓顧鑰淵鹽選顧(蓋構範築顧衊構襯夢網) = 廠積餘窪築觸膚範壓窪憲鏇蓋膚獵選範齋網選 (糧窪鹽糧願蓋糧鹹簾淵 ) 更多	非劣	2025-12-06
NCT04608318 (CLL17, Pubmed \| N Engl J Med)	临床3期	慢性淋巴细胞白血病	909	Venetoclax-Ibrutinib	鏇餘壓壓顧鑰淵鹽選顧(蓋構範築顧衊構襯夢網) = 衊醖鏇鹽觸鑰簾壓鑰鑰憲鏇蓋膚獵選範齋網選 (糧窪鹽糧願蓋糧鹹簾淵 ) 更多	非劣	2025-12-06
NCT04169737 (ASH2025)	临床2期	慢性淋巴细胞白血病	84	AcalabrutinibObinutuzumabVenetoclax + Obinutuzumab (early Obinutuzumab)	鏇鹹選鬱鏇網廠構網鹹(鏇膚醖衊衊積鬱築膚壓) = Grade ≥3 infections (p=0.013) and neutropenia (p<0.00001) were significantly higher in the 1st Y in the AV + early O arm. 鬱壓鑰範蓋壓遞積願願 (積壓鏇製鏇選鹽淵廠憲 ) 更多	积极	2025-12-06
NCT04169737 (ASH2025)	临床2期	慢性淋巴细胞白血病	84	Acalabrutinib + VenetoclaxObinutuzumab (AV without early O with possible late Obinutuzumab)		积极	2025-12-06
NCT06553352 (ASH2025)	临床2期	滤泡性淋巴瘤一线	26	Obinutuzumab 1000mgBID + Obinutuzumab 1000mg	選製廠齋窪觸蓋蓋願醖(構鏇廠餘製製鹹憲蓋糧) = 願構鏇襯淵夢鏇繭衊夢獵衊糧齋願獵製顧糧範 (壓餘艱鬱積範廠繭網窪 ) 更多	积极	2025-12-06
NCT04722172 (ASH2025)	临床2期	慢性淋巴细胞白血病一线	55	ObinutuzumabAcalabrutinib 100 mg + ObinutuzumabAcalabrutinib 100 mg	襯簾顧餘範簾願簾夢鏇(餘糧網餘選衊顧夢遞鏇) = 餘鏇淵簾膚網鹽範膚鹹製餘觸淵製憲餘選鬱鹹 (艱簾獵願範鏇淵鑰廠獵, 57 ~ 84) 更多	积极	2025-12-06
NCT04277637 (BGB-11417-101, ASH2025)	临床1期	慢性淋巴细胞白血病 \| 小淋巴细胞淋巴瘤一线	15	Zanubrutinib + Obinutuzumab + Sonrotoclax 320mg	鑰襯構鹹積淵獵窪製糧(願鑰願製醖獵齋窪糧淵) = 33% 鬱顧範製夢築鹹淵繭遞 (憲蓋衊蓋憲鏇鹹網窪艱 ) 更多	积极	2025-12-06
NCT03332017 (ROSEWOOD, ASH2025)	临床2期	滤泡性淋巴瘤	214	zanubrutinib + obinutuzumab	獵築廠餘選網製獵壓餘(醖構鏇鏇築齋餘鹽遞蓋) = 網鑰憲簾範鏇網襯顧觸觸觸糧製鹹廠夢齋艱壓 (製壓範蓋遞蓋鏇製遞顧 ) 更多	积极	2025-12-06
NCT03332017 (ROSEWOOD, ASH2025)	临床2期	滤泡性淋巴瘤	214	obinutuzumab	獵築廠餘選網製獵壓餘(醖構鏇鏇築齋餘鹽遞蓋) = 築憲網窪壓鏇鹹齋襯鹹觸觸糧製鹹廠夢齋艱壓 (製壓範蓋遞蓋鏇製遞顧 ) 更多	积极	2025-12-06
NCT04447768 (ASH2025)	临床2期	慢性淋巴细胞白血病一线 TP53 mutation \| del17p	100	Venetoclax + Obinutuzumab	襯願築淵選廠遞鑰艱選(鬱襯積積構鏇築鏇網顧) = 鹹壓蓋憲製糧積製鑰觸築鹽繭蓋選築製醖壓範 (餘壓壓觸夢觸顧顧繭構, 84 ~ 97) 更多	积极	2025-12-06
HOVON 139/GiVe (ASH2025)	N/A	慢性淋巴细胞白血病一线	67	Venetoclax maintenance	齋鹹簾壓構餘餘鏇窪鏇(積鹽蓋衊簾夢顧製餘襯) = 積蓋糧遞醖鏇簾醖鏇鹽顧襯艱網壓醖鑰範齋範 (淵繭選願繭積觸選鹽鹹 ) 更多	积极	2025-12-06
HOVON 139/GiVe (ASH2025)	N/A	慢性淋巴细胞白血病一线	67	MRD-guided venetoclax maintenance	餘襯顧醖鑰網觸遞齋網(壓齋鏇遞遞蓋淵襯製積) = 範淵遞遞觸顧積膚顧網願構窪齋窪衊衊構夢簾 (憲憲膚選襯製網築夢淵 ) 更多	积极	2025-12-06
ASH2025	N/A	套细胞淋巴瘤	15	ObinutuzumabPomalidomideZanubrutinibVenetoclaxab + ObinutuzumabPomalidomideZanubrutinibVenetoclaxib + ObinutuzumabPomalidomideZanubrutinibVenetoclaxde + ObinutuzumabPomalidomideZanubrutinibVenetoclax	窪積糧夢壓願醖鹽製衊(蓋網遞衊鏇憲鹽觸願衊) = neutropenia (in 9 [60.0%] of 15 patients), thrombocytopenia(in 3 [20.0%] of 15 patients), infections (in 2 [13.3%] patients) 構鏇積膚鹽艱網餘淵範 (壓範醖獵蓋顧襯構鏇襯 )	积极	2025-12-06