The purpose of the study is to assess the concentration of rozanolixizumab in mature breast milk of healthy study participants following administration of a single dose of rozanolixizumab

开始日期2024-12-03

申办/合作机构

UCB Biopharma SRL

NCT06540144

/ Enrolling by invitation临床3期

An Open-label Extension Study to Evaluate Rozanolixizumab in Pediatric Study Participants With Generalized Myasthenia Gravis

The purpose of the study is to assess the long term safety and tolerability of additional 6-week treatment cycles with rozanolixizumab in pediatric participants with generalized Myasthenia Gravis (gMG) aged ≥2 at the time of the Screening Visit of MG0006.

开始日期2024-10-08

申办/合作机构

UCB Biopharma SRL

NCT06149559

/ Recruiting临床2/3期

An Open-label, Single-arm Study Evaluating the Activity, Safety, and Pharmacokinetics of Rozanolixizumab in Pediatric Study Participants With Moderate to Severe Generalized Myasthenia Gravis

The purpose of the study is to assess the safety and tolerability of subcutaneous (sc) administration of rozanolixizumab in pediatric participants aged ≥2 to <18 years with generalized Myasthenia Gravis (gMG).

开始日期2024-06-14

申办/合作机构

UCB Biopharma SRL

100 项与罗泽利昔单抗相关的临床结果

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100 项与罗泽利昔单抗相关的转化医学

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100 项与罗泽利昔单抗相关的专利（医药）

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项与罗泽利昔单抗相关的文献（医药）

2025-04-01·JOURNAL OF NEUROLOGY

Safety and efficacy of chronic weekly rozanolixizumab in generalized myasthenia gravis: the randomized open-label extension MG0004 study

Article

Abstract:

Background:

In the Phase 3 MycarinG study (NCT03971422), six once-weekly subcutaneous infusions of rozanolixizumab significantly improved myasthenia gravis (MG)-specific outcomes versus placebo in patients with acetylcholine receptor or muscle-specific tyrosine kinase autoantibody-positive generalized MG (gMG). Following completion of MycarinG, patients could enroll in the open-label extension MG0004 study (NCT04124965) to receive chronic weekly rozanolixizumab.

Methods:

Patients were re-randomized 1:1 to once-weekly rozanolixizumab 7 or 10 mg/kg for up to 52 infusions. The primary endpoints were the occurrence of treatment-emergent adverse events (TEAEs) and TEAEs leading to rozanolixizumab discontinuation. After ≥6 visits/infusions patients could switch to the MG0007 study (NCT04650854) to receive cyclic rozanolixizumab treatment.

Results:

In MG0004, 70 patients received rozanolixizumab 7 mg/kg (n = 35) or 10 mg/kg (n = 35). Mean treatment duration was 22.9 and 23.7 weeks, respectively, due to rollover into MG0007. TEAEs were reported in 60/70 (85.7%) patients; most were mild/moderate. The most frequently reported TEAEs were headache (25/70 [35.7%]), diarrhea (13/70 [18.6%]) and decreased blood immunoglobulin G (11/70 [15.7%]). There were no opportunistic, serious or severe infections, serious or severe hypersensitivity or injection-site reactions, any anaphylactic reactions or albumin or lipid abnormalities. Maximum mean reduction from baseline in MG Activities of Daily Living score was 3.1 in the 7 mg/kg group and 4.1 in the 10 mg/kg group.

Conclusion:

Chronic weekly rozanolixizumab for up to 52 infusions was generally well tolerated, and clinically relevant improvements across MG-specific outcomes were maintained, supporting the long-term use of rozanolixizumab in patients with gMG.

Trial registration:

NCT04124965 (registered October 11, 2019).

2025-03-01·REPRODUCTIVE TOXICOLOGY

Evaluation of the effect of rozanolixizumab on pregnancy outcomes and pre- and postnatal development in cynomolgus monkeys

Article

作者: Cauvin, Annick ; Cavagnaro, Joy ; Luetjens, C Marc ; Brady, Kevin

Rozanolixizumab, a humanised immunoglobulin (Ig) G4 monoclonal antibody that selectively inhibits binding of IgG to the neonatal Fc receptor (FcRn), was evaluated in an embryo-foetal enhanced pre- and postnatal development (ePPND) study. Pregnant female cynomolgus monkeys (19 per group) received subcutaneous rozanolixizumab 50 mg/kg or 150 mg/kg or vehicle every 3 days from gestation day 20 until delivery. The proportion of pregnancy losses was 15.8%, 21.1% and 5.3% in the rozanolixizumab 50 mg/kg, 150 mg/kg and control groups, respectively. Based on eNormograms for groups of 18 or 20 animals, these results were considered to be within the range of spontaneous prenatal losses naturally observed in cynomolgus monkeys. Foetal examinations revealed no treatment-related effects. All infants had normal postnatal development, although higher mortality was observed in female infants from the control group during the first 3 weeks. All infants were able to mount a normal immune response to keyhole limpet haemocyanin when vaccinated at the age of 4 months. Offspring from 150 mg/kg-treated mothers had very low IgG levels at birth, indicating blockade of maternal IgG transfer; infants from mothers who received 50 mg/kg had variable IgG levels at birth, with mothers who had developed significant anti-drug antibodies conferring maternal IgG transfer to varying degrees. Rates of infection in infants were similar across treatment groups. IgG levels in infants from rozanolixizumab-treated groups normalised within 2 months. Treatment of pregnant cynomolgus monkeys with the FcRn inhibitor rozanolixizumab had no adverse effects on pre- or postnatal development of offspring, including immune system development.

2025-02-01·BRITISH JOURNAL OF HAEMATOLOGY

Inhibition of FcRn with rozanolixizumab in adults with immune thrombocytopenia: Two randomised, double‐blind, placebo‐controlled phase 3 studies and their open‐label extension

Article

作者: Snipes, Rose ; Miyakawa, Yoshitaka ; Lledó García, Rocío ; Cooper, Nichola ; Singh, Puneet ; Haier, Birgit ; Lavrov, Andreea ; Bussel, James B. ; Kaźmierczak, Maciej ; Kuter, David J. ; Cluck, Sarah

Summary:

Primary immune thrombocytopenia (ITP) is an antiplatelet‐antibody‐mediated disorder with accelerated platelet clearance and decreased platelet production. Rozanolixizumab, a monoclonal IgG4 anti‐FcRn antibody, blocks IgG recycling and decreases IgG levels. We report efficacy and safety of rozanolixizumab in adults with persistent/chronic ITP in 24‐week phase 3 studies (TP0003; TP0006), and their 52‐week open‐label extension (OLE). Primary end‐point was durable clinically meaningful platelet response (DCMPR) of ≥50 × 109/L for 8/12 weeks during Weeks 13–25 in the double‐blind studies. Operational delays and evolving ITP treatment landscape led the sponsor to terminate these studies early; thus, only 21 and 12 (TP0003) and 20 and 10 (TP0006) patients were randomised to rozanolixizumab or placebo. Forty‐three patients enrolled in the OLE: 42 started on every 2‐week dosing; 21 later switched to weekly dosing. More rozanolixizumab‐treated than placebo‐treated patients achieved DCMPR: 4/21 versus 0 (TP0003) and 1/20 versus 0 (TP0006). Platelet increases to ≥50 × 109/L were observed on Day 8 in 52.4% (TP0003; 2/12 placebo) and 45.0% (TP0006; 1/10 placebo) of rozanolixizumab‐treated patients. OLE platelet increases were maintained while on weekly dosing. The most frequent treatment‐emergent adverse events overall were headache, pyrexia and nausea, as seen previously. Weekly dosing appears more efficacious than every 2‐week dosing.

136

项与罗泽利昔单抗相关的新闻（医药）

2025-04-23

·药事纵横

强生FcRn抗体1类新药尼卡利单抗在中国申报上市！

4月23日，强生公司（Johnson & Johnson）的尼卡利单抗（nipocalimab）在中国的上市申请获国家药监局药品审评中心（CDE）受理。其靶向新生儿Fc受体（FcRn）的单克隆抗体疗法被Evaluate列为2025年十大潜在重磅疗法之一，尼卡利单抗的核心机制是通过阻断FcRn介导的IgG抗体再循环，降低血液中的致病性IgG抗体水平，从而缓解自身免疫性疾病的症状。在针对全身性重症肌无力（gMG）的临床试验中，这一机制显示出显著效果。根据3期Vivacity-MG3研究数据，尼卡利单抗联合标准治疗（SOC）可使患者的总IgG水平降低最多达75%，同时致病性抗体（如抗AChR、抗MuSK）水平也显著下降。这一效果不仅体现在生物标志物上，还转化为患者生活质量的改善：治疗组在MG-ADL（日常生活活动评分）上的平均改善为4.70分，显著优于安慰剂组的3.25分（P=0.002）。对于患者而言，1-2分的差异可能意味着从正常进食到吞咽困难、甚至需要呼吸机支持的巨大变化。尼卡利单抗的临床试验设计覆盖了广泛的gMG患者群体，包括抗AChR、抗MuSK和抗LRP4抗体阳性患者（约占gMG患者的95%），而现有竞品如Vyvgart和Rystiggo主要针对特定抗体亚型。强生的研究还纳入了青少年患者（12-17岁），这在同类药物中较为罕见。在安全性方面，尼卡利单抗的不良事件发生率与安慰剂组相当，且未观察到IgE、IgA和IgM水平的显著变化，提示其选择性降低致病性IgG的同时保留了保护性免疫功能。目前，gMG治疗领域已有两款FcRn抑制剂获批：argenx的Vyvgart（efgartigimod）和优时比的Rystiggo（rozanolixizumab）。Vyvgart于2021年获批，主要针对抗AChR抗体阳性成人患者，而Rystiggo在2023年扩展至抗AChR和抗MuSK双阳性人群，这两款药物凭借先发优势占据了一定市场份额，仅2024年上半年，Vyvgart的净销售额就达4.78亿美元。不过尼卡利单抗也可能打破这一格局。首先，其适应症覆盖更广，包括抗LRP4抗体阳性患者，且同时涵盖成人和青少年群体，这在当前市场中是独一无二的。其次，疗效的持续性是强生强调的关键优势。Vivacity-MG3研究显示，尼卡利单抗在持续用药6个月期间实现了疾病控制的稳定性，而此前的FcRn抑制剂研究多聚焦于短期疗效。此外，尼卡利单抗还在探索其他适应症，如干燥综合征（SjD）和胎儿新生儿溶血病（HDFN），其中干燥综合征的2期试验已获FDA突破性疗法认定，未来可能形成多疾病领域的协同效应。市场竞争方面，优时比在推广Rystiggo时强调其对疲劳症状的改善，而疲劳是gMG患者最困扰的问题之一；argenx则凭借皮下注射剂型（Vyvgart Hytrulo）在给药便利性上占优。相比之下，尼卡利单抗目前为静脉输注，可能限制部分患者的依从性。强生若想后来居上，需在临床数据差异化、定价策略及后续剂型优化上持续发力。尼卡利单抗在美国的PDUFA日期定于2025年4月29日，已获得优先审评资格，欧洲的上市申请也于2024年9月提交。若获批，它将成为首个覆盖三大抗体类型（AChR、MuSK、LRP4）的gMG疗法。而在中国，CDE的受理意味着该药有望填补国内FcRn靶向治疗的空白，目前中国尚未批准任何同类药物，且gMG患者对新型疗法的需求迫切，全球约70万患者中，中国占比不低。强生早在2020年以65亿美元收购Momenta Pharmaceuticals获得尼卡利单抗，并持续加码其在自身免疫领域的布局，公司预计该药的峰值销售额可能超过50亿美元，这一目标若能实现，将显著改变gMG市场的竞争格局，并对argenx和优时比形成压力。尼卡利单抗的价值不仅限于gMG。其在干燥综合征的2期试验中，15 mg/kg剂量组患者疾病活动度改善超过70%，而针对HDFN、温抗体型自身免疫性溶血性贫血（wAIHA）等适应症的开发也在推进中。这种“一药多病”的策略不仅降低了研发风险，还扩大了潜在市场空间。例如，干燥综合征全球患者约数百万，且目前治疗选择有限，尼卡利单抗若获批将成为该领域的首个FcRn靶向药物。此外，强生通过收购和合作，如收购Intra-Cellular加强神经科学管线，正在构建涵盖自身免疫、神经疾病等多领域的治疗生态。尼卡利单抗作为其中的核心资产，其成功与否将影响强生未来十年的市场地位。尼卡利单抗的上市进程折射出自身免疫疾病治疗领域的激烈竞争与创新活力。凭借广泛的适应症覆盖、持久的疗效数据及多疾病拓展潜力，它有望在gMG市场占据一席之地，并成为强生巩固其在生物制药领域领导地位的关键棋子。面对已有竞品的先发优势和患者对给药方式的偏好，强生仍需在商业化策略上精准布局，同时加速其在其他适应症中的临床推进，以最大化这款药物的价值。信息来源：［1］Insight Database. (2025, April 23). Nipocalimab submitted for marketing approval in China [Article]. Retrieved from https://mp.weixin.qq.com/s?__biz=Mzg3OTE3NjA4Nw==&idx=1&mid=2247616109&sn=703fb01cb35386c100c2ab4d5755b2f3［2］Johnson & Johnson. (2025, March 18). Nipocalimab receives FDA Fast Track designation for moderate-to-severe Sjögren's disease [Press release]. Retrieved from https://www.raredisease.cn/News/Info/23925药事纵横投稿须知：稿费已上调，欢迎投稿

临床3期突破性疗法临床2期申请上市

2025-04-18

·BiG生物创新社

豪掷超17亿美元！深度拆解TL1A/FcRn的破局潜力

4月17日，赛诺菲一口气拿下Earendil Labs两款“同类首创双抗”全球独家权：HXN-1002（α4β7和TL1A）和HXN-1003（TL1A和IL23），Earendil Labs将获得1.25亿美元预付款，以及总额高达17.2亿美元的里程碑付款等。自免，无疑是2025年的热门词汇！早在3月21日，BiG联合上海浦东生命科学产业发展有限公司举办了BiG Moment｜TL1A/FcRn靶点能否成为自免市场的又一个“爆点”？本文将带您深度拆解TL1A/FcRn的破局潜力！相关阅读：TL1A靶点：两全其美的自免炎症通路放大器能否通过成药性考验？一文了解新生儿Fc受体（FcRn） 01 TL1A/FcRn靶点是否具备“爆点基因”？1.1 TL1A靶点：通路放大器与抗纤维化双重作用TL1A（TNF-like ligand 1A）如同炎症通路的"智能放大器"，通过与其唯一配体死亡受体3（DR3）的结合激活一系列炎症信号通路。包括调节Th17细胞分化、上调促炎细胞因子（如IL-17A、IL-6）的表达，并影响成纤维细胞的活性。从临床路径来看，TL1A既是炎症通路的放大器，也是抗纤维化的解决方案。在炎症性肠病（IBD）中，TL1A在溃疡性结肠炎（UC）和克罗恩病（CD）患者的肠黏膜中广泛上调，这使其成为精准治疗的关键靶点。此外，研究显示，中和TL1A可逆转结肠纤维化进程，限制促纤维化因子如TGF-β1等的表达，这为早期干预IBD相关性纤维化提供了理论依据。图1.TL1A和DR3在免疫应答中的角色1.2 FcRn靶点：IgG代谢调控的精准干预点与TL1A针对炎症通路不同，FcRn（新生儿Fc受体）则扮演着抗体代谢的"智能管家"。它能通过pH值依赖的循环机制，将IgG抗体从溶酶体降解途径中抢救回来。但在自身免疫疾病中，这个生理机制反而延长了致病抗体的寿命。通过阻断FcRn（开发FcRn的抑制剂），可以实现对多种自身抗体的"无差别清除"，堪称自身免疫领域的"万能钥匙"。应用广泛，涵盖重症肌无力（MG）、特发性血小板减少性紫癜（ITP）等疾病。图2.FcRn抑制剂作用机制 02 临床需求：自免赛道的痛点与机会2.1 炎症性肠病未满足的治疗需求炎症性肠病（IBD）是一种导致消化道长期炎症的疾病，主要包括溃疡性结肠炎（UC）和克罗恩病（CD）。目前，现有抗TNF药物尽管疗效突出，但全球范围内约有40%的IBD患者对抗TNF生物制剂治疗呈现原发性或继发性失应答。此外，长期炎症带来的肠纤维化问题普遍存在，超过50%的IBD患者在五年以上病程中合并纤维化并发症，而现有靶向疗法对纤维化干预的效果有限。前面已经提到，TL1A既是炎症通路的放大器，也是抗纤维化的解决方案。抑制TL1A不仅可以减少成纤维细胞数量，还能逆转纤维化相关指标。2.2 FcRn靶点适应症扩展潜力FcRn靶点体现了“一药多治”的潜力。除了在MG和ITP中的有效应用，其进一步扩展至系统性红斑狼疮（SLE）、视网膜病变等疾病。不仅如此，其与现有免疫调节剂的联合治疗方案也受到业界极大的关注。 03 商业化路径：从靶点到市场的转化逻辑3.1 TL1A靶点药物临床表现全球范围内尚无靶向TL1A的药物获批上市，正在临床阶段的同靶点候选药物均由国外药企研发。目前至少有十余款TL1A靶点药物在研，包括单抗和双抗，6项临床试验正在进行，其中进展最快的是tulisokibart，3期适应症为溃疡性结肠炎（UC）、克罗恩病（CD）和系统性硬化症相关的间质性肺部疾病（SSc-ILD）。表1.MNC现有主要TL1A管线布局随着前三条管线（duvakitug、RG6631和tulisokibart）陆续披露临床数据，TL1A靶点潜力被进一步释放。✔ TL1A靶点有较好的临床治疗效果：在UC患者中，duvakitug、RG6631和tulisokibart临床缓解率分别为47.8%、29%、26.5%；在CD患者中，duvakitug、RG6631和tulisokibart内镜响应率分别为47.8%、26%、26%。 ✔ TL1A靶点有可控的安全性和耐受性：duvakitug、RG6631和tulisokibart均显示出良好的耐受性和安全性，没有报告严重的不良事件。三条管线比较下来，疗效上duvakitug具有优势，但是到底谁是best-in-class药物，还需要看更大规模的3期临床数据表现。前面也提到，4月17日，赛诺菲获得了Earendil Labs自主研发的两款潜在同类首创双特异性抗体HXN-1002（α4β7和TL1A）和HXN-1003（TL1A和IL23）的全球独家权利，Earendil Labs将获得1.25亿美元预付款，以及总额高达17.2亿美元的开发和商业化里程碑付款，以及产品销售的分层特许权使用费。图3.Earendil Labs与赛诺菲达成了一项全球独家许可协议值得一提的是，三生国健的重组抗TL1A单抗SSGJ-627成为国内首个进入IND阶段的TL1A单抗，临床前研究显示，SSGJ-627 与 TL1A 具有高亲和力及特异性的结合，在不同动物模型中展示出显著的药效。同时，SSGJ-627 具备良好、可接受的安全性。图4.三生国健SSGJ-627进入IND3.2 FcRn抑制剂市场的表现阻断FcRn通路的药物包括靶向FcRn单克隆抗体药物和体外重组的Fc片段蛋白，相关领域的药物产品包括：Fc重组蛋白药物Efgartigimod 、单抗 Rozanolixizumab、M281和 SYNT001等。图5.FcRn抑制剂研究布局① Efgartigimod（艾加莫德，Argenx公司），作为全球首款获批的FcRn抑制剂，其在重症肌无力患者中的疗效不俗，真实世界证据显示治疗方案的应答率达70%以上。其商业化潜力也得到验证，2024年海外年销售额已经突破20亿美元，同比增长84%。Efgartigimod是人源IgG1的Fc结构的体外重组蛋白片段。该产品利用Argenx的专有的点突变技术分别在5个位点对Fc片段的序列进行了突变，突变后的Fc蛋白和FcRn的结合力在中性和酸性的条件下得到了显著增强。2020年5月底Argenx公司宣布，Efgartigimod在治疗抗乙酰胆碱受体（AChR）抗体阳性全身性重症肌无力（gMG）患者的关键性3期临床试验中，达到了主要研究终点。2021年12月，Efgartigimod作为全球首款FcRn拮抗剂获美国食品药品监督管理局(FDA)批准。2021年1月再鼎医药与Argenx达成独家授权合作，负责Efgartigimod在大中华区的开发和商业化工作。图6.首个周期输注完成后的疗效② Nipocalimab(M281)是美国生物医药公司Momenta的核心产品管线。其分子本质是去糖基化的全人源IgG1抗体，靶向FcRn，去掉了抗体的Fc功能。Nipocalimab在预防胎儿和新生儿溶血性疾病方面获得了孤儿药认定和罕见儿科疾病认定。目前已经处于临床 III 期研究阶段。2020年 8 月，强生宣布以 65 亿美元收购Momenta，从而将该产品纳入到旗下。③ Rozanolixizumab(UCB-7665)是来自布鲁塞尔生物技术公司UCB Biopharma的一种皮下给药的人源化IgG4抗体，能特异性结合人FcRn，阻断FcRn与IgG的相互作用，抑制循环中的IgG，诱导致病性IgG自身抗体的清除。II 期临床研究显示，其总IgG和抗-AChR抗体滴度平均降低68%，目前正处于 III 期研究中。④ Batoclimab(RVT1401)是来自和铂医药的一种完整的人源单克隆抗体，与FcRn结合，阻断FcRn-IgG相互作用以加速自身抗体的降解，治疗各种致病性IgG介导的自身免疫疾病。该产品曾在中国被纳入突破性治疗品种，目前正在开展多种适应症的临床研究。 04 MNC的商业布局与竞赛多家跨国公司（MNC）已完成针对TL1A或FcRn的巨额交易：● 默沙东2023年以108亿美元收购Prometheus Biosciences，将tulisokibart列为核心管线。● 罗氏同年以71亿美元收购Telavant，重点开发RG6631。● 赛诺菲同年与梯瓦（Teva Pharmaceuticals）达成合作协议，以15亿美元投入Duvakitug研发。● 2021年1月，再鼎医药与Argenx达成独家授权合作，负责Efgartigimod在大中华区的开发和商业化工作。● 2020年 8 月，强生宣布以 65 亿美元收购Momenta，从而将Nipocalimab(M281)纳入旗下。FcRn赛道已有产品上市，并且强生、argenx等多家大型药企布局。TL1A领域则因全球尚无获批产品而呈现高度开放的市场环境，默沙东、罗氏、赛诺菲等MNC已先后启动研发并取得关键进展，这些交易不仅代表了MNC对该靶点机制的认可，也再次说明其百亿美元市场潜力。 05 TL1A/FcRn靶点下一步开发趋势如何？5.1 临床设计的创新：个性化与联合终点多终点设计：TL1A在IBD治疗中可结合内镜改善、生物标志物动态变化等复合终点，以更全面评估疗效。这一设计可显著提高新药通过III期试验的概率。分层治疗：FcRn抑制剂可基于循环IgG水平、生物标志物特征制定个体化给药方案，提高疗效稳定性。5.2 靶点联合开发：从单一疗法到组合拳新靶点间的协同效应成为创新热点。例如：TL1A靶点可尝试与IL-23抑制剂或JAK抑制剂联合构成“炎症双阻断”，并与抗纤维化药物联合治疗IBD并发症；FcRn抑制剂亦可与免疫抑制剂或肿瘤免疫药物形成联合方案。写在最后当TL1A遇见FcRn，这不仅是两个靶点的邂逅，更是免疫治疗范式革命的序章。在这个百亿美元级的竞技场上，中国药企正奋勇直追。虽然前路仍有科学迷雾（如TL1A的肠外效应、FcRn的免疫稳态平衡），但敢于在"无人区"探索的勇者，终将收获创新的馈赠。让我们共同期待，这些"免疫调节器"如何改写人类对抗自免疾病的史诗！参考资料[1] Earendil Labs Announces Worldwide Exclusive License Agreement with Sanofi for Next-Generation Bispecific Antibodies for Autoimmune and Inflammatory Bowel Diseases[2] 国家药品监督管理局药品审评中心，信息公开[3] TL1A靶点：两全其美的自免炎症通路放大器能否通过成药性考验？BiG生物医药创新社[4] 一文了解新生儿Fc受体（FcRn）。小药说药共建Biomedical创新生态圈！如何加入BiG会员？

引进/卖出

2025-04-08

·FierceBiotech

J&J links FcRn blocker to sustained benefits as FDA ruling on potential blockbuster nears

J&J acquired nipocalimab in its $6.5 billion takeover of Momenta. \n Johnson & Johnson has reinforced a key plank of its plan to build nipocalimab into a $5 billion medicine, reporting that the benefits seen earlier in a phase 3 autoimmune trial persisted through Week 60 of the open-label extension.The FDA is reviewing a request for approval of FcRn blocker nipocalimab in generalized myasthenia gravis (gMG). J&J is late to the party, with argenx and UCB already selling rival FcRn blockers, but has bet big in the belief nipocalimab has advantages over the competition. Ongoing dosing with argenx’s Vyvgart and UCB’s Rystiggo is based on clinical evaluation. J&J has studied consistent dosing of nipocalimab.The Big Pharma previously reported a 5.73-point reduction on a gMG symptom scale after 24 weeks of the open-label extension. The reduction hit 5.97 points at Week 48. Tuesday, J&J published the latest cut of data from the ongoing extension trial, reporting a reduction of 5.64 points after 60 weeks.The average symptom score fell 6.01 points in people who switched to nipocalimab from placebo after the trial’s double-blind period. Forty-five percent of antibody-positive patients reduced or discontinued steroids. The mean dose of the steroid prednisone decreased from 23 mg to 10 mg a day. If the FDA approves nipocalimab, the long-term data could form part of J&J’s pitch for the gMG market. The labels for argenx’s Vyvgart, in its intravenous and subcutaneous forms, state the safety of delivering ongoing doses less than 50 days apart hasn’t been established. The figure for UCB’s Rystiggo is 63 days.J&J, which acquired nipocalimab in its $6.5 billion takeover of Momenta Pharmaceuticals, has made the case that its FcRn blocker should be safer than rival molecules because it is highly specific to the IgG binding site without overlap on the albumin binding site. Consistent nipocalimab dosing could support sustained disease control, strengthening J&J’s play for the gMG market and other indications.However, the company will face a well-established rival in gMG. Argenx won approval in 2021 and later launched a subcutaneous version. The biotech has pointed to the established safety profile of Vyvgart as a factor that could help it hold off competition.

临床结果临床3期上市批准并购上市后研究

100 项与罗泽利昔单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB14919

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
血小板减少症	加拿大	UCB SA	2025-03-01
重症肌无力	美国	UCB, Inc.	2023-06-26

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
髓鞘少突胶质细胞糖蛋白抗体相关疾病	临床3期	美国	UCB Biopharma SRL	2022-02-02
髓鞘少突胶质细胞糖蛋白抗体相关疾病	临床3期	日本	UCB Biopharma SRL	2022-02-02
髓鞘少突胶质细胞糖蛋白抗体相关疾病	临床3期	澳大利亚	UCB Biopharma SRL	2022-02-02
髓鞘少突胶质细胞糖蛋白抗体相关疾病	临床3期	比利时	UCB Biopharma SRL	2022-02-02
髓鞘少突胶质细胞糖蛋白抗体相关疾病	临床3期	巴西	UCB Biopharma SRL	2022-02-02
髓鞘少突胶质细胞糖蛋白抗体相关疾病	临床3期	捷克	UCB Biopharma SRL	2022-02-02
髓鞘少突胶质细胞糖蛋白抗体相关疾病	临床3期	法国	UCB Biopharma SRL	2022-02-02
髓鞘少突胶质细胞糖蛋白抗体相关疾病	临床3期	德国	UCB Biopharma SRL	2022-02-02
髓鞘少突胶质细胞糖蛋白抗体相关疾病	临床3期	意大利	UCB Biopharma SRL	2022-02-02
髓鞘少突胶质细胞糖蛋白抗体相关疾病	临床3期	墨西哥	UCB Biopharma SRL	2022-02-02

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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


NCT04650854 (CTgov)	临床3期	重症肌无力	165	Rozanolixizumab (Rozanolixizumab ~7 mg/kg)	範廠醖餘蓋鹽襯製餘齋 = 繭醖鑰醖獵鏇鑰範築鑰願鏇廠網糧壓構壓顧廠 (蓋鬱憲繭蓋憲積製鏇願, 構網窪製繭觸鏇鑰選鬱 ~ 積遞簾繭網膚鹹膚積鹹) 更多	-	2025-04-18
				Rozanolixizumab (Rozanolixizumab ~10 mg/kg)	範廠醖餘蓋鹽襯製餘齋 = 鹽製蓋膚膚簾繭夢簾壓願鏇廠網糧壓構壓顧廠 (蓋鬱憲繭蓋憲積製鏇願, 鹽壓淵鏇簾艱齋鑰鬱艱 ~ 遞糧願壓廠衊網鏇艱窪) 更多
NCT04124965 (MG0004, Pubmed \| J Neurol)	临床3期	重症肌无力 acetylcholine receptor \| muscle-specific tyrosine kinase autoantibody-positive	70	Rozanolixizumab 7mg/kg	憲窪鏇糧鑰淵廠製艱醖(顧簾選廠構壓齋築顧構) = 11/70 [15.7%] 築廠蓋膚選糧範鹽鹽鹹 (齋醖繭繭醖蓋壓鏇衊築 ) 更多	积极	2025-04-01
				Rozanolixizumab 10mg/kg
NCT04051944 \| NCT03861481 (CIDP04, Pubmed) 人工标引	临床2期	慢性炎症性脱髓鞘性多发性神经病维持	34	Rozanolixizumab 10 mg/kg	淵蓋艱壓淵鏇蓋醖製壓(糧顧蓋築範顧餘獵觸醖) = 簾願鏇蓋壓襯鬱積製淵遞觸製鏇鑰餘襯遞鏇夢 (鬱鬱淵願顧範艱遞構築, 3.2) 更多	积极	2024-05-10
				Placebo	淵蓋艱壓淵鏇蓋醖製壓(糧顧蓋築範顧餘獵觸醖) = 構膚鹹糧選鑰壓獵蓋鏇遞觸製鏇鑰餘襯遞鏇夢 (鬱鬱淵願顧範艱遞構築, 2.6) 更多
NCT03971422 (MycarinG, AAN2024)	临床3期	重症肌无力	127	Rozanolixizumab 7mg/kg	襯鑰蓋艱築夢淵糧襯積(糧選齋鹽憲壓鏇壓鑰鹹) = 繭齋製獵遞膚構夢遞範鹽齋獵繭觸壓獵製膚選 (製顧鹹壓選襯衊網鹽顧 ) 更多	积极	2024-04-09
				Rozanolixizumab 10mg/kg	襯鑰蓋艱築夢淵糧襯積(糧選齋鹽憲壓鏇壓鑰鹹) = 衊選積糧顧蓋鹽蓋遞繭鹽齋獵繭觸壓獵製膚選 (製顧鹹壓選襯衊網鹽顧 ) 更多
AAN2024	N/A	重症肌无力	-	Rozanolixizumab	鹹顧廠糧製鹹壓鏇壓齋(獵積鹽構獵蓋鏇艱鹽糧) = 蓋襯衊艱廠構網鬱網糧鹽餘選選製顧顧憲鏇蓋 (積製齋廠憲鹽獵鬱製膚, 3.5) 更多	-	2024-04-09
AAN2024	N/A	重症肌无力	-	Rozanolixizumab 7mg/kg	鑰襯艱鬱遞鑰襯鏇鏇遞(鹹網顧襯艱鹽襯鹹鹽遞) = mean reduction from baseline between Weeks 7–33 ranged from -2.6 to -5.4 (7mg/kg) and -4.2 to -6.2 points (10mg/kg) 願選壓鏇構觸觸壓獵構 (蓋蓋願窪選餘衊衊構壓 ) 更多	-	2024-04-09
				Rozanolixizumab 10mg/kg
AAN2024	N/A	睑板腺功能障碍	-	Rozanolixizumab 7mg/kg	簾網獵襯範壓簾積蓋願(顧餘廠窪襯鏇築鏇選觸) = 艱範願鹹醖壓糧憲願繭簾鬱齋憲憲憲艱願蓋鹹 (鬱簾遞選構衊憲蓋鑰積 ) 更多	-	2024-04-09
				Rozanolixizumab 10mg/kg	簾網獵襯範壓簾積蓋願(顧餘廠窪襯鏇築鏇選觸) = 願選獵襯繭鹹壓壓繭蓋簾鬱齋憲憲憲艱願蓋鹹 (鬱簾遞選構衊憲蓋鑰積 ) 更多
NCT04828343 (CTgov)	临床1期	-	32	RLZ (Cohort 1: Syringe Driver- RLZ Dose 1 (>=35 kg to <50 kg))	淵餘築鹹襯醖夢廠網齋 = 鑰願夢鹹醖鹹憲餘齋襯鬱艱夢鏇願齋襯網積選 (壓鏇窪獵窪淵齋蓋簾膚, 襯淵夢淵壓築願艱鏇窪 ~ 廠願遞製築製鬱憲遞鑰) 更多	-	2024-03-07
				placebo (PBO) (Cohort 1: Syringe Driver- PBO (>=35 kg to <50 kg))	淵餘築鹹襯醖夢廠網齋 = 網齋蓋遞襯構觸鬱積繭鬱艱夢鏇願齋襯網積選 (壓鏇窪獵窪淵齋蓋簾膚, 願襯簾壓鏇獵齋壓獵艱 ~ 壓衊廠蓋艱餘鑰鏇襯鬱) 更多
NCT03971422 (MG0003, MDA2024) 人工标引	临床3期	重症肌无力	188	Rozanolixizumab 7mg/kg	築築艱顧構鑰鑰齋艱製(築艱願廠構蓋餘膚齋憲) = 顧衊壓鬱醖簾選積築繭襯襯窪膚鬱蓋構製憲壓 (鑰獵齋蓋衊膚鹽製繭網 ) 更多	积极	2024-03-03
				Rozanolixizumab 10mg/kg	築築艱顧構鑰鑰齋艱製(夢齋醖繭蓋夢艱觸糧齋) = 窪簾齋鹽積積鹹膚鑰鹹壓艱夢鹽顧襯餘衊積鹽 (願顧繭膚築衊築選範簾 ) 更多
NCT04596995 (myOpportunITy3, CTgov)	临床3期	免疫性血小板减少症	43	Rozanolixizumab	壓鹽蓋鬱願範糧顧鏇獵 = 壓遞膚襯膚艱築顧壓淵築簾襯築築憲繭餘鏇選 (構鹽齋繭顧觸遞鑰顧窪, 繭壓糧範鏇鹹鏇鬱襯積 ~ 簾獵築鏇簾壓齋築觸壓) 更多	-	2024-02-05