A Phase I/II Study of Natalizumab as a Single Agent in Children, Adolescents and Young Adults With Recurrent, Refractory or Progressive Pulmonary Metastatic Osteosarcoma

The purpose of this study is to evaluate the safety and tolerability of Natalizumab in children, adolescent and young adult patients with pulmonary metastatic osteosarcoma (pOS) and to assess clinical response associated with this treatment as well as overall survival.

开始日期2024-12-01

申办/合作机构

The Case Comprehensive Cancer Center

NCT05658497

/ RecruitingN/A

Vumerity (Diroximel Fumarate) Prospective MS Pregnancy Exposure Registry

The primary objectives of the study are to estimate the risk of major congenital malformations (MCMs) in infants born to women with multiple sclerosis (MS) who were exposed to diroximel fumarate (DRF) at any time from 2 weeks after the first day of their last menstrual period (LMP) up through the first trimester of pregnancy and to comparatively evaluate pregnancy outcomes with MCMs in women with MS who were exposed to DRF at any time from 2 weeks after the first day of their LMP through the first trimester of pregnancy with the following: i) women with MS who were unexposed to disease modifying therapies (DMTs) and, ii) women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries).
The secondary objective of the study is to evaluate pregnancy outcomes in women with DRF exposure at any time from 2 weeks after the first day of their LMP through the end of pregnancy compared with the following: i) women with MS who were unexposed to DMTs, ii) women with dimethyl fumarate (DMF) exposure, iii) women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries), and iv) women without MS (e.g., women from external, general population comparators).

开始日期2023-10-27

申办/合作机构

Biogen, Inc.

NCT05618301

/ Completed临床1期IIT

A Pilot Safety and Feasibility Study to Evaluate Motixafortide (CXCR4/SDF-1 Inhibition) and Natalizumab (VLA-4/VCAM-1 Inhibition) as a Novel Regimen to Mobilize CD34+ Hematopoietic Stem Cells for Gene Therapies in Sickle Cell Disease (SCD)

Hematopoietic stem cell (HSC)-based gene therapies now offer curative potential for patients with sickle cell disease (SCD), with decreased toxicity compared to allogeneic hematopoietic cell transplantation. However, effective HSC-based gene therapy depends on collecting sufficient HSCs to generate the therapeutic product, and currently available mobilization regimens carry unacceptable risk for patients with SCD or do not reliably yield optimal numbers of HSCs for gene therapy.
The investigators hypothesize that HSC mobilization with motixafortide (CXCR4i) alone and the combination of motixafortide plus natalizumab (VLA-4i) will be safe and tolerable in SCD patients. In addition, the investigators hypothesize that combined CXCR4 and VLA-4 blockade with motixafortide plus natalizumab will result in a rapid, robust, and synergistic increase in HSC mobilization to peripheral blood (PB) in patients with SCD, when compared to motixafortide alone.

开始日期2023-07-07

申办/合作机构

Washington University School of Medicine

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100 项与那他珠单抗相关的临床结果

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100 项与那他珠单抗相关的转化医学

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100 项与那他珠单抗相关的专利（医药）

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2,526

项与那他珠单抗相关的文献（医药）

2026-02-01·Multiple Sclerosis and Related Disorders

Relapse activity during pregnancy and the postpartum year is associated with accelerated disability progression in multiple sclerosis

Article

作者: Walter, Lea I ; Nierobisch, Nathalie ; Kana, Veronika ; Roth, Patrick ; Herwerth, Marina ; Weller, Michael ; Hösli, Sarah

Management of multiple sclerosis (MS) presents unique challenges during pregnancy, particularly regarding disease-modifying therapies (DMT) and the risk of postpartum relapses. We investigated DMT exposure and further clinical and radiological parameters to identify predictors of relapse and disability progression during pregnancy and the postpartum year. We identified 112 pregnancies in 70 women with MS followed between 2010 and 2023. After excluding pregnancies lasting <22 weeks, 96 pregnancies in 66 women, primarily with relapsing-remitting MS (RRMS), were included in the analysis. 77 pregnancies (80.2 %) developed during DMT exposure, with natalizumab, injectables, and fumarates being the most common. Relapse during pregnancy or the postpartum year occurred in 33 pregnancies, with 39.5 % happening during pregnancy and 60.5 % in the postpartum year, peaking in the first postpartum trimester. Women with pregnancies complicated by relapses during pregnancy or the postpartum year had lower rates of DMT exposure (66.7 % vs. 87.3 %, p = 0.016) and a non-significant trend toward higher baseline disability at conception. Disability progression within the first postpartum year was more frequent in the relapse group (25.8 % vs. 5.5 %, p = 0.010), with sustained differences in EDSS at two years postpartum. Postpartum MRI showed higher lesion load and more contrast-enhancing lesions in the relapse group. Spinal lesions at diagnosis and prior to conception were associated with significant higher risk of relapse during pregnancy and the postpartum year. Subgroup analysis of pregnant women treated with natalizumab indicated a lower relapse risk when natalizumab was continued into the third trimester. Pregnancy outcomes were mostly favorable, with 95.4 % term births and no significant differences in delivery mode or neonatal outcomes between women with versus without relapses during pregnancy. Our findings emphasize the importance of DMT management, particularly the potential benefits of sustained natalizumab therapy for high-risk pregnancies. These results highlight the need for tailored treatment strategies to minimize postpartum relapses and long-term disability progression for women with MS.

2026-01-01·Multiple Sclerosis Journal

Managing reactivation of multiple sclerosis during treatment with natalizumab

Article

作者: Patti, Francesco ; Khoury, Samia J ; Roos, Izanne ; Lizak, Nathaniel ; Hodgkinson, Suzanne ; Cartechini, Elisabetta ; Kalincik, Tomas ; Ozakbas, Serkan ; Boz, Cavit ; Alroughani, Raed ; Kuhle, Jens ; Aguera-Morales, Eduardo ; Laureys, Guy ; John, Nevin ; Skibina, Olga ; Amato, Maria Pia ; van der Walt, Anneke ; Butzkueven, Helmut ; Gouider, Riadh ; Yamout, Bassem ; Lechner-Scott, Jeannette ; Prat, Alexandre ; Mrabet, Saloua ; Gerlach, Oliver ; Duquette, Pierre ; Havrdova, Eva Kubala ; Grand’Maison, Francois ; Terzi, Murat ; Sharmin, Sifat ; Csepany, Tunde ; Sá, Maria José ; Al-Asmi, Abdullah ; Horáková, Dana ; Buzzard, Katherine ; Girard, Marc ; Grammond, Pierre ; Eichau, Sara

Background::

Following natalizumab failure, it is unknown whether switching to alternative high-efficacy therapies offers superior effectiveness over continuing natalizumab.

Objective::

To compare different treatment strategies following natalizumab failure.

Methods::

Patients suffering a relapse during natalizumab treatment with adequate follow-up were identified from the MSBase registry. Following natalizumab failure, natalizumab continuation was compared to switching to anti-CD20 therapies/alemtuzumab/lower-efficacy therapies and treatment discontinuation. The primary outcome was the risk of further relapses. Secondary outcomes included risk of subsequent magnetic resonance imaging (MRI) activity, confirmed disability worsening and disease-activity-free survival. Multivariable proportional hazards models compared outcomes during time-varying therapy exposures. Four sensitivity analyses were conducted with varied inclusion criteria and treatment failure definitions.

Results::

Of 1553 patients experiencing a relapse during natalizumab treatment, 1037 met the inclusion criteria. Following natalizumab failure, switch to anti-CD20 therapy was associated with a lower relapse risk (heart rate (HR) = 0.48, 95% confidence interval (CI) = 0.27–0.84) compared to continuing natalizumab; no differences were observed in MRI or disability outcomes. Treatment de-escalation or cessation was associated with increased relapse risk (HR = 1.46, 95% CI = 1.15–1.85; HR = 2.08, 95% CI = 1.22–3.55, respectively). We did not find evidence of a difference for switching to alemtuzumab. Sensitivity analyses replicated primary findings.

Conclusion::

This exploratory study indicates that switching to anti-CD20 therapies following natalizumab failure is associated with a >50% reduction in relapse risk. No differences were seen in secondary outcomes, despite consistent trends. Clinicians may consider anti-CD20 therapies following natalizumab failure, noting further research is needed to confirm differences in MRI and disability outcomes.

2026-01-01·Multiple Sclerosis and Related Disorders

Real-world evaluation of subcutaneous natalizumab in patients with highly active relapsing-remitting multiple sclerosis

Article

作者: Al-Araji, Sarmad ; Arun, Tarunya ; Pye, Eleanor ; Shehu, Abdullah

BACKGROUND:

Natalizumab is a highly effective therapy for highly active relapsing-remitting multiple sclerosis (RRMS), traditionally administered intravenously (IV). A subcutaneous (SC) formulation offers a more convenient alternative, but real-world data comparing its efficacy to the IV route are limited. This study aimed to evaluate the real-world outcomes of SC natalizumab in patients with highly active RRMS at a single UK center.

METHODS:

A retrospective, observational cohort study was conducted on 63 patients receiving 300 mg SC natalizumab between November 2021 and January 2024. We analyzed clinical outcomes including annualized relapse rate (ARR), Expanded Disability Status Scale (EDSS) scores, and new magnetic resonance imaging (MRI) lesion activity.

RESULTS:

In the 55 patients with at least 12 months of follow-up, the mean ARR was 0.03. Ninety-four percent of these patients remained relapse-free, and 85 % had stable or improved EDSS scores at the 12-month follow-up. No new MRI lesions were observed across the entire cohort (n = 55) after initiating SC natalizumab, and no significant adverse safety events were reported. Efficacy was comparable between treatment-naïve patients and those who switched from the IV formulation.

CONCLUSIONS:

This real-world analysis demonstrates that SC natalizumab is a highly effective and safe treatment for patients with highly active RRMS. The observed clinical and radiological stability supports the use of SC natalizumab as a viable and convenient alternative to IV administration, aligning with outcomes from pivotal clinical trials.

297

项与那他珠单抗相关的新闻（医药）

2026-01-07

·今日头条

罗尚伟：全球医疗专利到期潮，投资机遇与重点上市公司深度分析

只谈个人看法，不做投资指导。本文内容仅供参考，不构成任何投资建议。股市有风险，投资需谨慎。投资者应根据自身风险承受能力和投资目标，独立做出投资决策。一、全球医疗专利到期概况 2025-2030年将迎来史无前例的"专利悬崖" ，未来几年将有近200种药物失去专利保护，其中包括至少69种年销售额超10亿美元的重磅炸弹药物，累计损失销售额超 3000亿美元。 1. 核心到期药物领域分布治疗领域主要到期药物到期时间年销售额肿瘤免疫 Keytruda(帕博利珠单抗)、Opdivo(纳武利尤单抗)、Ibrance(帕博西尼) 2028-2030年 338亿美元(2026预测)、100+亿美元、50+亿美元代谢疾病 Trulicity(度拉糖肽)、Ozempic(司美格鲁肽)、Eliquis(阿哌沙班) 2026-2028年 100+亿美元、100+亿美元、100+亿美元心血管 Entresto(沙库巴曲缬沙坦)、Xarelto(利伐沙班) 2025-2027年 78.22亿美元(2024)、100+亿美元自身免疫 Humira(阿达木单抗)、Skyrizi(瑞莎珠单抗)、Rinvoq(乌帕替尼) 2023-2030年 200+亿美元、50+亿美元、50+亿美元骨科 Prolia/Xgeva(地舒单抗) 2025年 50+亿美元 2. 专利到期对产业链影响原研药企：面临收入大幅下滑(如辉瑞预计损失170-180亿美元/年)，被迫加速创新与并购仿制药/生物类似药企业：获得抢占市场的黄金机会，价格通常为原研药的20-80% 原料药/中间体企业：需求激增，尤其是特色原料药供应商 CDMO企业：承接仿制药企业的生产订单，多肽、生物药CDMO需求增长显著二、值得投资的主要上市公司分类与分析 1. 全球仿制药龙头企业 (1) Teva Pharmaceutical Industries Ltd ([Teva.US](TEVA.US)) - 全球最大仿制药企业核心优势：产品组合覆盖3000+种药物，美国ANDA获批数量领先，拥有Austedo等品牌药支撑利润受益点：布局Keytruda、Eliquis等重磅药物仿制药，2026-2028年将迎来集中上市期股价分析：当前价：32.11美元(2026/1/6)，市值约150亿美元估值：PE约12倍，低于行业平均目标价：24.71-30美元(分析师共识)，上涨空间33.86% 风险：债务负担较重，美国市场竞争激烈 (2) Sandoz Group AG (SDZ.SIX) - 诺华分拆的全球第二大仿制药企业核心优势：生物类似药管线强劲，已获批Humira、Tysabri等类似药，欧洲市场领导者受益点：Eylea(阿柏西普)生物类似药即将获批，抢占50+亿美元市场股价分析：当前价：约25瑞士法郎，市值约150亿美元估值：PE约10倍，具备价值洼地特征目标价：28-32瑞士法郎，上涨空间15-25% 风险：分拆后整合压力，研发投入不足 (3) 华海药业 ([600521.SH](600521.SH)) - 中国制剂出口龙头核心优势："原料药+制剂"一体化，美国ANDA获批80+个，首仿药经验丰富受益点：布局沙班、列汀、列净等下一轮到期品种，2026年迎来收获期股价分析：当前价：17.89元(2026/1/6)，市值267.86亿元估值：PE约57倍，高于行业平均，反映创新药预期目标价：22-25元，上涨空间23-40% 风险：FDA合规风险，创新药研发不及预期 2. 生物类似药龙头企业核心优势：已获批5款生物类似药(包括利妥昔单抗、贝伐珠单抗等)，管线覆盖肿瘤、自身免疫等领域受益点：司美格鲁肽生物类似药即将进入临床III期，抢占100+亿美元市场股价分析：当前价：84.50港元(2026/1/6)，市值1454.08亿港元估值：PE约117倍，反映高成长性目标价：112港元(大和证券)，上涨空间32.5% 风险：研发投入大，盈利周期长核心优势：已获批4款生物类似药，HLX04-OD(长效GLP-1)完成III期临床受益点：地舒单抗生物类似药已在美获批，抢占安进市场份额股价分析：当前价：约40港元，市值约200亿港元估值：PE约50倍，低于行业平均目标价：95港元(花旗)，上涨空间137.5% 风险：产品商业化进度慢，竞争激烈 (3) Amgen ([AMGN.US](AMGN.US)) - 原研+生物类似药双布局核心优势：自身拥有生物类似药管线，同时通过收购扩大布局受益点：利用自身研发优势开发类似药，对冲Prolia/Xgeva专利到期损失股价分析：当前价：约280美元，市值1777.90亿美元估值：PE约15倍，低于行业平均目标价：320-350美元，上涨空间14-25% 风险：创新药管线不及预期，生物类似药竞争激烈 3. 原料药与CDMO受益企业 (1) 诺泰生物 ([688076.SH](688076.SH)) - GLP-1原料药龙头核心优势：司美格鲁肽、替尔泊肽原料药规模化生产，与国际药企签十年期供应协议受益点：司美格鲁肽专利2026年到期，全球仿制药需求爆发，2025年前三季度净利润增长26.92% 股价分析：当前价：约80元，市值约200亿元估值：PE约45倍，反映高成长性目标价：95-110元，上涨空间19-37.5% 风险：产品价格下行压力，扩产不及预期 (2) 药明康德 ([603259.SH/02359.HK)](603259.SH/02359.HK)) - 全球CRDMO龙头核心优势：一体化研发生产服务，覆盖小分子、生物药、多肽等领域，客户包括全球Top20药企受益点：承接仿制药企业的研发生产订单，多肽CDMO需求增长显著股价分析：当前价：98.51元(A股，2026/1/7)，市值2939.30亿元估值：PE约19.6倍，处于历史低位(33.43%分位) 目标价：120-150元，上涨空间22-52% 风险：美国《生物安全法案》影响，汇率波动 4. 中国特色仿制药企业 (1) 恒瑞医药 ([600276.SH](600276.SH)) - 创新+仿制双轮驱动核心优势：仿制药业务提供现金流，创新药管线丰富(2025-2027年预计上市47个产品) 受益点：布局多个重磅药物仿制药，同时创新药收入占比提升对冲风险股价分析：当前价：63.06元(2026/1/6)，市值4185.42亿元估值：PE约66倍，高于行业平均目标价：80元(大和证券)，上涨空间26.9% 风险：医保谈判降价压力，创新药研发失败风险 (2) 复星医药 ([600196.SH](600196.SH)) - 全球化布局的综合药企核心优势：仿制药业务稳健，生物类似药管线丰富，同时布局创新药和医疗服务受益点：长效GLP-1类似物HLX04-OD完成III期临床，2026年上市，抢占减肥市场股价分析：当前价：27.35元(2026/1/6)，市值730.36亿元估值：PE约30倍，合理区间目标价：35-40元，上涨空间28-46.2% 风险：海外业务整合不及预期，研发投入大三、投资策略与风险提示 1. 核心投资逻辑投资标的投资周期预期收益率核心催化因素仿制药龙头(Teva、Sandoz) 1-2年 20-30% 重磅药物仿制药获批上市，市场份额提升生物类似药龙头(信达、复宏汉霖) 2-3年 30-50% 生物类似药获批，定价优势显现原料药/CDMO(诺泰、药明康德) 1-2年 20-40% 仿制药需求爆发，订单增长综合药企(恒瑞、复星) 3-5年 25-40% 创新药与仿制药双轮驱动，业绩稳定增长 2. 重点风险提示政策风险：各国药品监管政策变化，如集采、价格管控，可能影响仿制药定价与利润竞争风险：同一药物可能有数十家企业同时申报仿制药，导致价格战和利润压缩研发风险：生物类似药研发难度大，审批周期长，可能面临临床试验失败或审批延迟专利挑战风险：原研药企可能通过专利诉讼延长市场独占期，如诺华对Entresto的专利保护供应链风险：原料药供应短缺、质量问题可能影响仿制药生产与上市 3. 推荐投资组合核心配置(60%) ：仿制药龙头(Teva、华海药业)+ CDMO龙头(药明康德)，收益稳定，风险较低成长配置(30%) ：生物类似药龙头(信达生物、复宏汉霖)，高成长性，风险中等弹性配置(10%) ：原料药龙头(诺泰生物)，受益于仿制药需求爆发，弹性大，风险较高

生物类似药专利到期一致性评价

2026-01-05

·Pharmaceutical Technology

Biogen’s Tysabri to be used on England’s NHS for highly active MS

An estimated 43,000 people have RRMS at any one time and thousands of these people will have highly active RRMS. Vink Fan via Shutterstock.com. The National Institute for Health and Care Excellence (NICE) has recommended natalizumab as an option for adults with highly active multiple sclerosis (MS), a move that expands the drug’s use in patients with the chronic autoimmune disease. Two versions of natalizumab are set for use on the NHS following the decision – Biogen’s Tysabri and biosimilar Tyruko, the latter made by Sandoz. Tysabri is given as an injection, while Tyruko is administered as an infusion. NICE’s recommendation is that the drug be used for patients with highly active relapsing-remitting (RR) MS – an aggressive form of the central nervous system (CNS) disease. Eligible patients are those whose MS remains highly active after a full course of at least one disease-modifying therapy (DMT), and for whom Mavenclad (cladribine) is not suitable. MS is a lifelong condition affecting around 123,000 people and is around three times more common in women than men. An estimated 43,000 people have RRMS at any one time and thousands of these people will have highly active RRMS. Tysabri is already recommended in England for people with rapidly evolving severe RRMS. Tysabri and Tyruko work by preventing immune cells from attacking myelin – the protective sheath that wraps neurons. There is already a range of targeted treatments available on the NHS for RRMS patients. A prominent therapy is Roche’s Ocrevus (ocrelizumab), given as twice-yearly infusions or twice-yearly injections. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence According to Ceri Smith, head of policy at the MS Society, natalizumab’s availability will particularly benefit pregnant women with the disease. “Natalizumab is a highly effective treatment, and we’re really pleased that people with highly active relapsing MS who haven’t responded to previous DMTs will now have the option to take it. Our decision will particularly benefit people who want to start a family, as natalizumab can be taken during pregnancy, unlike other highly effective DMTs,” Smith commented. NICE’s director of medicines evaluation, Helen Knight, said: “This recommendation means people living with highly active RRMS now have a meaningful additional treatment option. Having choice matters enormously to people managing a lifelong condition — it allows individuals and their clinicians to select the treatment that best fits their personal circumstances.” Tysabri is one of Biogen’s top-selling drugs, generating $415.4m in revenue in 2024. The treatment saw peak sales of around $2bn in 2021, with revenue decreasing since due to competition from biosimilars. Pharmaceutical Technology Excellence Awards - Nominations Closed Nominations are now closed for the Pharmaceutical Technology Excellence Awards . A big thanks to all the organisations that entered – your response has been outstanding, showcasing exceptional innovation, leadership, and impact. Excellence in Action Awarded the 2025 Pharmaceutical Technology Excellence Award for Business Expansion in Integrated Manufacturing , Upperton Pharma Solutions is rapidly expanding its UK GMP and sterile manufacturing footprint. Find out how Upperton’s integrated CDMO model helps pharma companies move from early development to clinical and niche commercial supply with fewer handovers and faster timelines. Discover the Impact

上市批准

2026-01-04

·百度百家

CD49d 靶向免疫迁移阻断：那他珠单抗的自身免疫病治疗与科研价值

CD49d（α4 整合素亚基，ITGA4）是整合素家族关键成员，与 β1 亚基（CD29）形成功能性 VLA-4（极迟抗原 - 4），主要表达于 T 细胞、B 细胞、单核细胞等免疫细胞表面。其核心功能是通过与血管内皮细胞表面的配体 VCAM-1（血管细胞黏附分子 - 1）结合，介导免疫细胞跨血管内皮迁移至炎症部位，同时参与免疫细胞活化与信号传导，是自身免疫病中炎症浸润的关键 “分子桥梁”。在病理场景中，CD49d 介导的异常免疫细胞浸润会引发中枢神经系统、肠道等组织的慢性炎症损伤，成为多发性硬化症（MS）、克罗恩病（CD）等疾病的核心致病机制。那他珠单抗（Natalizumab，商品名 Tysabri）是一款高特异性靶向 CD49d 的人源化 IgG4 单克隆抗体，核心优势在于精准阻断免疫迁移关键通路—— 通过与 CD49d 的胞外功能域特异性结合，竞争性抑制 VLA-4 与 VCAM-1 的相互作用，从源头阻止致病性免疫细胞穿越血管壁浸润靶器官，减少组织炎症损伤。与传统免疫抑制剂相比，其不直接杀伤免疫细胞或广泛抑制免疫功能，而是选择性调控免疫细胞的迁移能力，在控制炎症的同时保留机体抗感染免疫，安全性更具优势；但需注意，长期用药可能因免疫细胞迁移受限增加机会性感染风险。作为 CD49d 靶向治疗的标杆药物，那他珠单抗的临床应用聚焦于难治性自身免疫病。2004 年，该药获美国 FDA 批准上市，用于治疗复发型多发性硬化症（RMS），临床数据显示其能显著降低年复发率，减少脑部病灶数量，延缓疾病进展；2008 年，适应症拓展至中重度克罗恩病，为对 TNF-α 抑制剂应答不佳的患者提供了新的治疗选择。尽管上市初期曾因罕见的进行性多灶性白质脑病（PML）风险暂停销售，但后续通过建立患者筛查与风险监测体系，重新获批并规范临床使用，成为自身免疫病精准治疗的重要药物。近年来，CD49d 介导的免疫迁移通路研究持续深化，那他珠单抗的科研价值被进一步挖掘。在联合治疗策略中，科研人员发现其与 B 细胞靶向药物联用，可通过 “阻断免疫迁移 + 清除异常 B 细胞” 的协同效应，提升难治性 MS 患者的疗效；与 JAK 抑制剂联用，能更全面地调控炎症通路，为克罗恩病的阶梯式治疗提供新思路。在机制研究领域，通过那他珠单抗验证发现，CD49d 不仅参与免疫细胞迁移，还可调控 T 细胞极化，为自身免疫病的致病机制研究提供了关键依据。在药物创新层面，那他珠单抗的研发经验推动了新一代 CD49d 靶向药物的优化。科研人员通过抗体结构改造（如降低 Fc 段效应、提升组织穿透性）、开发局部给药制剂等方式，进一步降低系统性安全风险；同时，基于其结合表位设计的双特异性抗体，在临床前研究中展现出更强的炎症部位特异性免疫调控效果。在科研领域，科研级那他珠单抗凭借高纯度（≥95%）、高特异性及稳定的生物学活性，成为核心研究工具。其广泛应用于CD49d-VCAM-1 结合机制验证、免疫细胞跨内皮迁移实验、MS 与克罗恩病动物模型构建、新型免疫调控药物筛选等场景。例如，在 MS 动物模型中，通过那他珠单抗阻断 CD49d，可明确免疫细胞浸润与神经髓鞘损伤的关联；在药物研发中，其可作为阳性对照，验证候选药物的免疫迁移抑制活性。随着自身免疫病精准治疗技术的迭代，CD49d 靶点的临床价值与科研潜力持续释放。泰克生物依托成熟的重组抗体研发平台与丰富的免疫调控药物研究经验，推出科研级那他珠单抗（TKYR1032），产品严格遵循科研标准，精准匹配 CD49d 相关科研需求，助力科研工作者在自身免疫病机制研究、新型靶向疗法研发中高效突破。

免疫疗法上市批准细胞疗法

100 项与那他珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D06886	那他珠单抗	L04AA23	DB00108

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
克罗恩病	美国	Biogen, Inc.	2008-01-14
复发-缓解型多发性硬化	欧盟	BIOGEN NETHERLANDS BV	2006-06-27
复发-缓解型多发性硬化	冰岛	BIOGEN NETHERLANDS BV	2006-06-27
复发-缓解型多发性硬化	列支敦士登	BIOGEN NETHERLANDS BV	2006-06-27
复发-缓解型多发性硬化	挪威	BIOGEN NETHERLANDS BV	2006-06-27
多发性硬化症	美国	Biogen, Inc.	2004-11-23

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
继发进展型多发性硬化	临床3期	美国	Biogen, Inc.	2011-09-13
继发进展型多发性硬化	临床3期	比利时	Biogen, Inc.	2011-09-13
继发进展型多发性硬化	临床3期	加拿大	Biogen, Inc.	2011-09-13
继发进展型多发性硬化	临床3期	捷克	Biogen, Inc.	2011-09-13
继发进展型多发性硬化	临床3期	丹麦	Biogen, Inc.	2011-09-13
继发进展型多发性硬化	临床3期	芬兰	Biogen, Inc.	2011-09-13
继发进展型多发性硬化	临床3期	法国	Biogen, Inc.	2011-09-13
继发进展型多发性硬化	临床3期	德国	Biogen, Inc.	2011-09-13
继发进展型多发性硬化	临床3期	爱尔兰	Biogen, Inc.	2011-09-13
继发进展型多发性硬化	临床3期	以色列	Biogen, Inc.	2011-09-13

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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


NCT05265728 (CTgov)	临床3期	复发-缓解型多发性硬化	21	Natalizumab	憲製廠選鹽願築糧憲鬱(艱衊鑰廠糧壓鹽醖製夢) = 膚範選選艱積廠網願範築衊醖遞鏇簾糧製蓋鹹 (選衊鏇襯窪淵願遞繭醖, 0.60) 更多	-	2025-11-25
P8-1.016 (AAN2025)	N/A	多发性硬化症 anti-CD20s \| natalizumab	188	Anti-CD20 therapy (Ocrelizumab)	糧範遞齋鏇願鹽憲構襯(膚獵獵餘觸範觸糧獵積): rate ratio = 0.81 (95% CI, 0.48 ~ 1.36), P-Value = 0.42 更多	积极	2025-04-07
				Natalizumab (TYSABRI)
NCT03689972 (NOVA, Pubmed \| Neurol Neuroimmunol Neuroinflamm)	临床3期	复发-缓解型多发性硬化 trough serum natalizumab concentration \| α4-integrin saturation	486	Natalizumab Q6W dosing	糧齋製鑰簾夢衊鏇淵壓(鏇淵範鑰壓範鏇鑰築齋) = 網鏇淵壓簾鬱醖蓋鏇製鹹壓蓋選鏇淵鏇廠蓋醖 (夢壓鹹鏇蓋繭鏇衊願淵 )	积极	2024-11-01
				Natalizumab Q4W dosing	糧齋製鑰簾夢衊鏇淵壓(鏇淵範鑰壓範鏇鑰築齋) = 糧鬱糧膚構鬱蓋選壓膚鹹壓蓋選鏇淵鏇廠蓋醖 (夢壓鹹鏇蓋繭鏇衊願淵 )
NCT03689972 (NOVA, CTgov)	临床3期	复发-缓解型多发性硬化	585	Natalizumab (Part 1: IV Q4W)	艱齋蓋艱顧網糧鹹膚蓋(鏇製鹽蓋積構簾簾夢範) = 壓糧觸築鬱製餘艱觸鏇選積夢繭願壓齋鬱繭鏇 (獵簾醖艱構獵鑰淵鏇衊, 壓襯築鹽觸簾願衊艱餘 ~ 鑰鹽衊構壓餘淵膚鬱襯) 更多	-	2024-06-12
				Natalizumab (Part 1: IV Q6W)	艱齋蓋艱顧網糧鹹膚蓋(鏇製鹽蓋積構簾簾夢範) = 醖築鏇憲齋餘餘獵壓憲選積夢繭願壓齋鬱繭鏇 (獵簾醖艱構獵鑰淵鏇衊, 淵鏇夢餘廠繭網選鏇餘 ~ 遞觸鬱繭壓鏇鬱鹹衊蓋) 更多
S31.010 (AAN2024)	N/A	多发性硬化症	930	Fingolimod	網壓蓋餘艱壓淵齋獵醖(窪鬱餘鹽餘製遞積醖鏇) = 製膚衊廠鬱觸膚憲獵醖鏇鏇顧窪淵齋艱艱夢夢 (鹽簾淵襯簾顧蓋簾簾鑰 )	不佳	2024-04-09
				Natalizumab	網壓蓋餘艱壓淵齋獵醖(窪鬱餘鹽餘製遞積醖鏇) = 網積膚簾鏇餘網選醖廠鏇鏇顧窪淵齋艱艱夢夢 (鹽簾淵襯簾顧蓋簾簾鑰 )
NCT00027300 (AFFIRM, Pubmed \| Mult Scler) 人工标引	临床3期	复发-缓解型多发性硬化	-	Natalizumab	襯醖遞簾壓蓋網艱壓艱(糧窪範衊鹹築製願簾膚) = 衊鹽憲築淵製襯構壓醖觸襯醖壓顧範鏇選鹹願 (窪築膚襯夢醖觸窪蓋選 ) 更多	积极	2024-03-12
				placebo	-
ACTRIMS2024	N/A	复发性多发性硬化	69	Natalizumab	壓窪壓齋醖積齋艱製壓(選製糧築壓鏇醖構願簾) = 糧鬱襯遞鑰廠蓋糧獵壓鹹繭願壓廠鏇鏇壓網艱 (願壓憲網鹽鑰壓願鏇簾 ) 更多	积极	2024-03-01
				Ocrelizumab	壓窪壓齋醖積齋艱製壓(選製糧築壓鏇醖構願簾) = 醖廠窪淵遞襯蓋餘顧觸鹹繭願壓廠鏇鏇壓網艱 (願壓憲網鹽鑰壓願鏇簾 ) 更多
NCT05304520 (SISTER, Pubmed \| Ther Adv Neurol Disord) 人工标引	N/A	复发-缓解型多发性硬化	262	Subcutaneous natalizumab	簾獵憲網淵選願獵蓋廠(餘壓醖鹽積窪遞觸製簾) = 窪餘廠簾範網膚範糧積鬱衊鬱製廠艱窪製餘觸 (膚製製齋鏇憲鬱顧艱壓 )	积极	2024-01-01
				Intravenous natalizumab	簾獵憲網淵選願獵蓋廠(餘壓醖鹽積窪遞觸製簾) = 顧鹽窪蓋構遞壓蓋積醖鬱衊鬱製廠艱窪製餘觸 (膚製製齋鏇憲鬱顧艱壓 ) 更多
NCT04225312 (NEXT-MS, Pubmed \| J Neurol Neurosurg Psychiatry)	临床4期	复发-缓解型多发性硬化 neurofilament light levels	376	Personalised EID with target drug trough concentration of 10 µg/mL (EID10)	餘鬱鬱鬱艱鏇夢憲廠鏇(範齋糧繭廠鹹壓糧艱餘) = 顧鏇壓鑰夢憲觸蓋鹹積壓艱積簾繭餘襯鏇構構 (艱膚觸鏇蓋願簾鹹積簾 )	积极	2023-11-14
				Personalised EID with target drug trough concentration of 5 µg/mL (EID5)	餘鬱鬱鬱艱鏇夢憲廠鏇(範齋糧繭廠鹹壓糧艱餘) = 製壓網獵網獵網淵鏇廠壓艱積簾繭餘襯鏇構構 (艱膚觸鏇蓋願簾鹹積簾 )
ECTRIMS2023	N/A	复发-缓解型多发性硬化	141	Natalizumab	餘觸積餘鹹夢繭鬱鬱願(廠繭網鹹窪齋窪壓鏇構) = 衊窪鹽網遞獵觸憲築艱鹹網構窪襯鹹範蓋憲願 (夢餘觸蓋鏇製淵鏇獵鏇, 77.7 ~ 93.0)	-	2023-09-30
				Ocrelizumab	餘觸積餘鹹夢繭鬱鬱願(廠繭網鹹窪齋窪壓鏇構) = 壓夢壓醖襯壓衊衊夢鏇鹹網構窪襯鹹範蓋憲願 (夢餘觸蓋鏇製淵鏇獵鏇, 55.4 ~ 84.1)