罗泽利昔单抗(Rozanolixizumab) - 药物靶点：FcRn_在研适应症：血小板减少症，重症肌无力，髓鞘少突胶质细胞糖蛋白抗体相关疾病_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Rozanolixizumab-noli、洛利昔珠单抗、罗扎诺利珠单抗

+ [11]

靶点

FcRn

作用方式

拮抗剂、调节剂

作用机制

FcRn拮抗剂(IgG受体FcRn大亚基p51拮抗剂)、免疫调节剂

治疗领域

肿瘤免疫系统疾病神经系统疾病+ [5]

在研适应症

血小板减少症重症肌无力髓鞘少突胶质细胞糖蛋白抗体相关疾病+ [4]

非在研适应症

慢性血小板减少症慢性炎症性脱髓鞘性多发性神经病原发性血小板减少症+ [1]

原研机构

在研机构

+ [6]

非在研机构

UCB Pharma SA

Nova Laboratories Ltd.UCB Celltech

权益机构-

最高研发阶段批准上市

首次获批日期

美国 (2023-06-26),

重症肌无力

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 (日本)、孤儿药 (韩国)、优先审评 (美国)、优先审评 (日本)

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结构/序列

Sequence Code 9474006L

来源: *****

Sequence Code 9474023H

来源: *****

关联

21

项与罗泽利昔单抗相关的临床试验

NCT07246564

/ Recruiting临床4期

An Open-label, Prospective, Single-arm Study Assessing the Efficacy and Safety of Rozanolixizumab in Adult Chinese Participants With Generalized Myasthenia Gravis

The purpose of the study is to assess the clinical efficacy of rozanolixizumab in adult Chinese participants with generalized myasthenia gravis (gMG) in the first Treatment Cycle.

开始日期2025-12-01

申办/合作机构

UCB Biopharma SRL

NCT06720714

/ Completed临床1期

An Open-Label, Single-Dose Study to Assess the Concentration of Rozanolixizumab in the Breast Milk of Healthy Lactating Women

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

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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66

项与罗泽利昔单抗相关的文献（医药）

2026-01-01·ANNALS OF THE RHEUMATIC DISEASES

Blocking the neonatal Fc receptor as a novel approach to prevent cardiac neonatal lupus: a proof-of-concept study

Article

作者: Clancy, Robert ; Carlucci, Philip M ; Cuneo, Bettina F ; Izmirly, Peter ; Donofrio, Mary T ; Masson, Mala ; Fraser, Nicola ; Brandt, Justin S ; Buyon, Jill P ; Worthing, Angus B ; Sachan, Nalani

OBJECTIVES:

Novel biologic agents targeting the neonatal Fc receptor (FcRn) offer a promising strategy to prevent cardiac neonatal lupus (cardiac-NL) in pregnant patients with high-titre anti-SSA/Ro52 kD or 60 kD autoantibodies via dual effects: reducing serum immunoglobin G (IgG) levels and inhibiting placental transfer. This study was initiated to assess the feasibility of FcRn blockade as prophylactic therapy for recurrent cardiac-NL.

METHODS:

A 34-year-old pregnant patient with systemic lupus erythematosus and 3 prior consecutive pregnancies complicated by neonatal lupus (1 cutaneous, 1 fatal cardiac-NL at 20 weeks, 1 cardiac-NL delivered at 32 weeks and neonatal cutaneous NL), each despite hydroxychloroquine 400 mg daily, was treated with weekly subcutaneous infusions of 560 mg rozanolixizumab (humanised IgG4 monoclonal antibody against FcRn) from gestational weeks 14 to 28 (to cover the vulnerable period of fetal cardiac injury) through a compassionate use designation. The patient performed home fetal heart rhythm monitoring thrice daily with weekly echocardiograms.

RESULTS:

Maternal anti-SSA/Ro52 kD and 60 kD autoantibodies, total IgG, and subclasses IgG1, 2, 3 decreased by about 65% at gestational week 22, with a return to near baseline levels by week 34. The pregnancy was uncomplicated, resulting in a spontaneous vaginal delivery of a healthy neonate at 37 weeks. At delivery, cord blood and maternal IgG levels were normal, obviating the need for rescue intravenous immune globulin. The neonate had a normal echocardiogram and electrocardiogram but developed a rash consistent with neonatal lupus at 5 weeks of life. There were no serious adverse events.

CONCLUSIONS:

The successful application of FcRn blockade to prevent recurrent cardiac-NL sets a precedent for a multicentre study.

2025-12-31·JOURNAL OF MEDICAL ECONOMICS

Body weight distribution of US patients with myasthenia gravis

Article

作者: Menon, Rohit R. ; Qi, Cynthia Z. ; Du, Mandy ; Sato, Mai ; Yang, Hongbo ; Tse, Kevin

OBJECTIVE:

Several novel therapies have been approved for treatment of generalized myasthenia gravis (gMG). The dosing requirements of certain therapies (efgartigimod intravenous, nipocalimab, ravulizumab, rozanolixizumab, zilucoplan) are based on patient's body weight. To determine costs of weight-based gMG treatments to payers, accurate assessment of the body weight distribution of patients with MG is required. However, little is known about these patients' weight profile. The current study aims to provide robust weight data in multiple cohorts of patients with MG and elucidate the cost of gMG therapies based on weight.

METHODS:

Body weight distribution of patients with MG was analyzed using Optum's de-identified Market Clarity Data and data from the efgartigimod patient support program (PSP). Adult patients with MG with available body weight were included. Additionally, a literature review of clinical trials of gMG therapies that reported patient body weight was conducted. An analysis of the annual cost of weight-based dosing was also performed.

RESULTS:

Patients from the Optum database (N = 5,033) had mean body weight = 86.6 kg (standard deviation [SD] = 23.1 kg) and median weight = 83.7 kg (interquartile range [IQR] 70.3-99.9 kg). Patients from the PSP (N = 4,539) had mean weight = 92.1 kg (SD = 25.6 kg) and median weight = 89.0 kg (IQR = 74.0-106.1 kg). In each cohort, most patients weighed ≥80 kg (58.0% Optum, 66.2% PSP). Across clinical trials of patients with gMG, mean body weights ranged from 79.1-91.2 kg and median weights from 74.4-90.0 kg. The annual cost of health-care-provider-administered treatment for patients with gMG was estimated at $223,272-$648,960 depending on drug and body weight; annual cost was highest for patients who weighed >80 kg (up to $648,960 versus up to $467,044 for patients who weighed <80 kg).

CONCLUSION:

Our findings demonstrate that patients with MG may be heavier on average than previously assumed, which may influence the cost-effectiveness of gMG therapies with weight-based dosing.

2025-12-31·Human Vaccines & Immunotherapeutics

Pharmacovigilance analysis of FcRn antagonists in the treatment of myasthenia gravis: A disproportionality analysis based on the FAERS database

Article

作者: Zhang, Wenchao ; Liu, Boyi ; Chen, Danna ; Han, Ao ; Chen, Yuxin

This study aimed to evaluate the safety profiles of FcRn antagonists, efgartigimod alfa and rozanolixizumab, in the treatment of myasthenia gravis using real-world adverse event data from the FAERS database. A disproportionality analysis was conducted employing Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR) methods on reports from Q1 2022 to Q2 2025. The most frequently reported adverse events for efgartigimod alfa included falls, urinary tract infections, and symptom recurrence, with signals also detected for atrial fibrillation, peripheral neuropathy, and prostate cancer. For rozanolixizumab, common events were headache, diarrhea, and vomiting, with potential signals such as meningitis, hypersomnia, and feeding disorder. Subgroup analysis revealed gender-specific differences in adverse reactions. Most events occurred within 30 days of treatment initiation, though efgartigimod alfa showed a sustained risk beyond 180 days. The study identifies novel safety signals and highlights clinically relevant risk patterns, supporting enhanced monitoring in clinical use. It is crucial to emphasize that this disproportionality analysis is exploratory in nature and identifies potential associations, which do not establish causality and require confirmation through further dedicated studies.

200

项与罗泽利昔单抗相关的新闻（医药）

2026-02-01

·腾讯网

首款儿童重症肌无力靶向药获批！告别大剂量激素，孩子有了精准新选择

对于患有重症肌无力（gMG）的孩子和家庭来说，这不仅是一个新药获批的消息，更是一次治疗逻辑的革新。1 月 26 日，国家药监局（NMPA）正式批准依库珠单抗注射液适应症扩展，用于 6 岁及以上抗乙酰胆碱受体（AChR）抗体阳性的难治性全身型重症肌无力（gMG）儿童患者。这意味着，针对儿童的“精准治疗”大门终于被推开了。01为什么要精准重症肌无力的核心问题，在于免疫系统“敌我不分”，错误地攻击了神经肌肉接头。在 AChR 抗体阳性的患者中，这种攻击具有双重破坏性：抗体不仅阻断了受体，还会激活体内的补体系统，形成一种“膜攻击复合物”，直接破坏神经与肌肉连接的突触结构。这种微观层面的破坏，对正处于生长发育阶段的儿童和青少年来说，意味着更持久、更沉重的功能负担。依库珠单抗的作用点，正是这条被过度激活的补体通路。它通过阻断补体 C5，抑制终末补体级联反应，从机制源头上减少神经肌肉接头的持续破坏[1] 。02起效快，改善明显此次获批的直接证据，来自一项在难治性 gMG 儿童和青少年中开展的 III 期研究（ECU-MG-303）[2] 。数据展示了非常积极的治疗信号：症状评分显著下降：在量化重症肌无力评分（QMG）上，基线到第 26 周平均下降了 5.8 分；在反映日常功能的 MG-ADL 评分上，平均下降了 2.3 分。第 26 周时（A）QMG 和（B）MG-ADL 总分降低幅度的患者比例临床意义明确：这两个变化幅度均超过了临床意义的阈值，且改善在治疗早期就已出现，并在后续随访中持续存在。安全性可控：整个研究过程中，未观察到新的安全性信号，治疗相关不良事件以轻中度为主。03给孩子带来的改变这些冷冰冰的数字背后，是孩子们生活质量的实实在在的改变。过去，儿童患者的治疗往往依赖大剂量激素、免疫抑制剂，或者反复进行静丙输注和血浆置换。这种“全面压制免疫”的策略虽然有效，但疗效不稳定，且长期用药会叠加生长发育迟缓、骨密度下降和感染风险等副作用。依库珠单抗提供了一条不同的路径：在不进一步压低整体免疫力的前提下，针对关键致病环节持续抑制。这让症状控制变得更可预测，也减少了反复进行抢救性治疗的需求。04生物疗法爆发近年来，一批新兴生物疗法正在彻底改变这一疾病的治疗版图。除了依库珠单抗，我们还看到了更多选择：补体通路抑制剂：包括长效 C5 抑制剂 ravulizumab，以及靶向 C5/C5b 的小分子肽 zilucoplan 。FcRn抑制剂：通过加速致病抗体清除来起效，如 efgartigimod、rozanolixizumab 等。B细胞/浆细胞策略：如抗 CD20、抗 CD19 单抗等。重症肌无力的现代治疗药物这些药物在起效速度、给药方式上各有千秋，它们不是互相替代的关系，而是共同构成了一个精细的“工具箱”，让医生能为孩子制定更个性化的方案。参考资料 [1] Gerischer L, et al. New and Emerging Biological Therapies for Myasthenia Gravis: A Focussed Review for Clinical Decision-Making. BioDrugs. 2025;39(2):185-213. [2] Brandsema JF, et al. Eculizumab in Adolescent Patients With Refractory Generalized Myasthenia Gravis: A Phase 3, Open-Label, Multicenter Study. Pediatr Neurol. 2024;156:198-207.#新药速递

临床3期临床结果

2026-02-01

·今日头条

首款儿童重症肌无力靶向药获批：告别激素依赖，精准治疗时代来临

对于患有重症肌无力（gMG）的孩子和家庭来说，这不仅是一个新药获批的消息，更是一次治疗逻辑的革新。 1 月 26 日，国家药监局（NMPA）正式批准依库珠单抗注射液适应症扩展，用于 6 岁及以上抗乙酰胆碱受体（AChR）抗体阳性的难治性全身型重症肌无力（gMG）儿童患者。这意味着，针对儿童的“精准治疗”大门终于被推开了。 1. 为什么要“精准”？解决最核心的破坏重症肌无力的核心问题，在于免疫系统“敌我不分”，错误地攻击了神经肌肉接头。在 AChR 抗体阳性的患者中，这种攻击具有双重破坏性：抗体不仅阻断了受体，还会激活体内的补体系统，形成一种“膜攻击复合物”，直接破坏神经与肌肉连接的突触结构。这种微观层面的破坏，对正处于生长发育阶段的儿童和青少年来说，意味着更持久、更沉重的功能负担。依库珠单抗的作用点，正是这条被过度激活的补体通路。它通过阻断补体 C5，抑制终末补体级联反应，从机制源头上减少神经肌肉接头的持续破坏[1] 。 2. 临床数据：起效快，改善明显此次获批的直接证据，来自一项在难治性 gMG 儿童和青少年中开展的 III 期研究（ECU-MG-303）[2]。数据展示了非常积极的治疗信号：症状评分显著下降：在量化重症肌无力评分（QMG）上，基线到第 26 周平均下降了 5.8 分；在反映日常功能的 MG-ADL 评分上，平均下降了 2.3 分。第 26 周时（A）QMG 和（B）MG-ADL 总分降低幅度的患者比例临床意义明确：这两个变化幅度均超过了临床意义的阈值，且改善在治疗早期就已出现，并在后续随访中持续存在。安全性可控：整个研究过程中，未观察到新的安全性信号，治疗相关不良事件以轻中度为主。 3. 给孩子带来的改变：减少“代价” 这些冷冰冰的数字背后，是孩子们生活质量的实实在在的改变。过去，儿童患者的治疗往往依赖大剂量激素、免疫抑制剂，或者反复进行静丙输注和血浆置换。这种“全面压制免疫”的策略虽然有效，但疗效不稳定，且长期用药会叠加生长发育迟缓、骨密度下降和感染风险等副作用。依库珠单抗提供了一条不同的路径：在不进一步压低整体免疫力的前提下，针对关键致病环节持续抑制。这让症状控制变得更可预测，也减少了反复进行抢救性治疗的需求。 4. 未来的工具箱：生物疗法爆发近年来，一批新兴生物疗法正在彻底改变这一疾病的治疗版图。除了依库珠单抗，我们还看到了更多选择：补体通路抑制剂：包括长效 C5 抑制剂 ravulizumab，以及靶向 C5/C5b 的小分子肽 zilucoplan 。 FcRn 抑制剂：通过加速致病抗体清除来起效，如 efgartigimod、rozanolixizumab 等。 B 细胞/浆细胞策略：如抗 CD20、抗 CD19 单抗等。重症肌无力的现代治疗药物这些药物在起效速度、给药方式上各有千秋，它们不是互相替代的关系，而是共同构成了一个精细的“工具箱”，让医生能为孩子制定更个性化的方案。参考资料 [1] Gerischer L, et al. New and Emerging Biological Therapies for Myasthenia Gravis: A Focussed Review for Clinical Decision-Making. BioDrugs. 2025;39(2):185-213. [2] Brandsema JF, et al. Eculizumab in Adolescent Patients With Refractory Generalized Myasthenia Gravis: A Phase 3, Open-Label, Multicenter Study. Pediatr Neurol. 2024;156:198-207.

临床3期申请上市临床结果免疫疗法

2026-01-30

·BioSpace

KORU Medical Systems Receives FDA 510(k) Clearance for Delivery of RYSTIGGO® (rozanolixizumab-noli), Expanding Label for FreedomEDGE® Infusion System

MAHWAH, N.J.--(BUSINESS WIRE)-- KORU Medical Systems, Inc. (NASDAQ: KRMD) (“KORU Medical” or the “Company”), a leading medical technology company focused on the development, manufacturing, and commercialization of innovative and patient-centric large volume subcutaneous infusion solutions, today announced that the Company received U.S. Food and Drug Administration (FDA) clearance for use of the KORU Medical FreedomEDGE® infusion system to deliver RYSTIGGO® (rozanolixizumab-noli), a therapy commercialized globally by UCB, Brussels, Belgium ( ). The clearance for the FreedomEDGE® label includes indicated administration by a healthcare professional, increasing flexibility and access for patients living with generalized myasthenia (gMG). RYSTIGGO® is a novel biologic approved to treat adults with generalized myasthenia gravis (gMG), a rare, chronic autoimmune disorder that affects communication between nerves and muscles.¹ RYSTIGGO® is administered as a weekly infusion of 3mL-6mL of drug over 15-30 minutes for 6 weeks, with subsequent treatment cycles based on clinical evaluation.¹ “With this new FDA clearance, we are proud to further our leadership in the rapidly growing large-volume subcutaneous infusion market, with our ninth subcutaneous drug clearance," said Linda Tharby, KORU Medical’s President and CEO. "Expanding from home administration into clinic-based care highlights the versatility of our Freedom Infusion System to deliver life-changing therapies wherever patients are treated. This clearance aligns with our strategy to extend the Freedom platform to more drug therapies, more settings, and more patients.” KORU Medical’s Freedom Infusion System enables, simplifies, and enhances the delivery of large-volume subcutaneous drugs. Supporting drug products with various requirements for viscosity, flow rate, and delivered drug volume from 5mL-50mL+, the Freedom System is market proven with: 15+ years of patient self-administration in the home 45,000+ patients and over 2M infusions annually 2 97% adherence rate 3 and 9 on-label subcutaneous drugs distributed across 30+ countries About KORU Medical Systems KORU Medical Systems develops, manufactures, and commercializes innovative and patient-centric large volume subcutaneous infusion solutions that improve quality of life for patients around the world. The Freedom Syringe Infusion System (the “Freedom System”) currently includes the Freedom60® and FreedomEDGE® Syringe Infusion Drivers, Precision Flow Rate Tubing™ and HigH-Flo Subcutaneous Safety Needle Sets™. The Freedom System, which received its first FDA clearance in 1994, is used for self-administration in the home by the patient and/or delivery in an ambulatory infusion center by a healthcare professional. Through its Pharma Service and Clinical Trials business, KORU Medical provides products for use by biopharmaceutical companies in feasibility/clinical trials during the drug development process and, as needed, is capable of customizing the Freedom System for clinical and commercial use across multiple drug categories. For more information, please visit . Trademark Statement RYSTIGGO® is a registered trademark of the UCB Group of Companies. References U.S. Prescribing Information: UCB, Inc. RYSTIGGO® (rozanolixizumab-noli) injection, for subcutaneous use – Prescribing Information . UCB, Inc.; Revised June 2023. Available at: . Accessed July 28, 2025. KORU Medical Estimates and Third-Party Data on File Rutland B, Bosshard J, Southworth C. Enhancing Drug Adherence and Patient Outcomes: The Role of SCIG Pump Selection in Subcutaneous Immunoglobulin Therapy for Primary Immunodeficiency Disease. Poster presented at: National Home Infusion Association Annual Conference; March 23-27, 2024; Austin TX. Contacts Investor Contact: Louisa Smith investor@korumedical.com

上市批准免疫疗法

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

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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	希腊	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

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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


NCT03971422 (MycarinG, Pubmed \| J Neurol)	临床3期	重症肌无力	200	Rozanolixizumab 7 mg/kg	餘醖鏇獵鹽窪憲構範夢(淵鬱觸齋積齋餘繭淵顧) = 築蓋簾遞鹽餘積憲齋齋鏇範衊選艱網繭餘膚醖 (選簾淵衊壓鹹願壓衊選 ) 更多	积极	2025-12-01
				Rozanolixizumab 10 mg/kg	餘醖鏇獵鹽窪憲構範夢(淵鬱觸齋積齋餘繭淵顧) = 糧構鏇襯製製衊膚簾廠鏇範衊選艱網繭餘膚醖 (選簾淵衊壓鹹願壓衊選 ) 更多
NCT05681715 (MG0020, Pubmed \| J Neurol)	临床3期	重症肌无力	55	Rozanolixizumab	網鏇築築構構衊壓餘衊(糧蓋壓糧範憲鑰願蓋築) = 齋廠簾餘鑰願顧窪蓋艱糧觸網餘網鹽觸築觸築 (齋衊簾齋網襯鹹構獵襯 ) 更多	积极	2025-10-01
NCT03971422 (MycarinG, Pubmed \| Eur J Neurol)	临床3期	重症肌无力	164	Rozanolixizumab 7 mg/kg	淵壓憲鹽艱壓範鑰蓋觸(繭簾壓醖餘壓鏇築鹽膚) = 範遞餘顧積獵觸製鏇遞壓築構獵築鏇選鏇構鹽 (衊蓋膚襯構膚構築鏇蓋 ) 更多	积极	2025-08-01
				Rozanolixizumab 10 mg/kg	淵壓憲鹽艱壓範鑰蓋觸(繭簾壓醖餘壓鏇築鹽膚) = 網顧選糧鏇觸淵蓋鹽觸壓築構獵築鏇選鏇構鹽 (衊蓋膚襯構膚構築鏇蓋 ) 更多
NCT04875975 (CTgov)	临床2期	桥本脑炎	12	Placebo	夢築壓獵膚觸範窪憲壓 = 鑰醖蓋壓顧醖顧獵憲築艱願窪顧獵製獵鬱糧壓 (鹹鏇顧繭鹽壓憲鬱鹹選, 鏇鹹製廠餘願觸膚願鏇 ~ 鑰顧窪膚範選窪鑰鏇鬱) 更多	-	2025-05-31
NCT05681715 (MG0020, CTgov)	临床3期	重症肌无力	62	RLZ SRD (Period 1: RLZ SRD)	憲願製構簾鏇構願夢遞 = 壓糧齋鬱繭範觸醖顧繭製選觸襯淵獵鹽蓋選淵 (鏇淵壓鹽憲鑰構鑰願鏇, 鹽蓋淵鏇齋積襯夢願糧 ~ 構廠築窪簾觸遞築遞淵) 更多	-	2025-05-07
				RLZ (Period 1: RLZ MP)	憲願製構簾鏇構願夢遞 = 衊繭鹹繭積觸憲鑰築鹽製選觸襯淵獵鹽蓋選淵 (鏇淵壓鹽憲鑰構鑰願鏇, 積艱鹹艱鏇夢範觸襯艱 ~ 積構齋窪窪積廠齋衊繭) 更多
NCT04650854 (CTgov)	临床3期	重症肌无力	165	Rozanolixizumab (Rozanolixizumab ~7 mg/kg)	鑰觸齋簾網艱蓋顧餘齋 = 鏇膚廠蓋製網顧齋鏇壓醖醖鏇窪繭鏇鏇齋積壓 (憲淵膚鏇築選鹽廠壓獵, 獵鏇醖積獵繭憲範餘願 ~ 鏇網鏇齋製鏇餘繭餘鹹) 更多	-	2025-04-18
				Rozanolixizumab (Rozanolixizumab ~10 mg/kg)	鑰觸齋簾網艱蓋顧餘齋 = 憲選糧淵願夢簾膚築夢醖醖鏇窪繭鏇鏇齋積壓 (憲淵膚鏇築選鹽廠壓獵, 製觸壓製鬱構鹹憲範製 ~ 遞觸選壓壓鬱遞廠鏇構) 更多
NCT04124965 \| NCT04650854 (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	膚膚淵廠鬱窪醖遞窪繭(衊鹽齋糧淵選簾鏇鬱淵) = 11/70 [15.7%] 艱築鬱鬱夢網網選獵醖 (觸選衊觸廠廠艱憲遞鑰 ) 更多	积极	2025-04-01
				Rozanolixizumab 10mg/kg
NCT04124965 (MG0004, MDA2025)	临床3期	重症肌无力	70	Rozanolixizumab 7mg/kg	餘鏇觸衊襯齋範繭鑰鑰(築網獵壓廠醖網憲襯衊) = 艱網糧構構膚淵築鏇構遞築糧觸鹽簾積鹹製糧 (蓋獵獵衊遞窪願餘鏇遞 ) 更多	积极	2025-03-16
				Rozanolixizumab 10mg/kg	餘鏇觸衊襯齋範繭鑰鑰(築網獵壓廠醖網憲襯衊) = 構製觸選齋糧壓糧製繭遞築糧觸鹽簾積鹹製糧 (蓋獵獵衊遞窪願餘鏇遞 ) 更多
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	願夢鑰衊壓窪鹹壓壓獵(齋醖夢網窪遞糧憲鬱餘) = 選選艱獵願簾範繭齋襯襯獵糧觸齋衊遞顧壓選 (憲鹹廠襯鏇獵觸廠淵鑰, 3.2) 更多	积极	2024-05-10
				Placebo	願夢鑰衊壓窪鹹壓壓獵(齋醖夢網窪遞糧憲鬱餘) = 繭範選淵廠廠選積製廠襯獵糧觸齋衊遞顧壓選 (憲鹹廠襯鏇獵觸廠淵鑰, 2.6) 更多
NCT03971422 (MycarinG, AAN2024)	临床3期	重症肌无力	127	Rozanolixizumab 7mg/kg	窪簾網齋鏇醖簾觸鬱衊(廠膚醖醖蓋憲夢範淵鑰) = 鏇窪網鬱鏇衊蓋襯鑰網夢網齋廠淵夢製鏇襯築 (構窪醖衊願蓋衊獵襯製 ) 更多	积极	2024-04-09
				Rozanolixizumab 10mg/kg	窪簾網齋鏇醖簾觸鬱衊(廠膚醖醖蓋憲夢範淵鑰) = 憲齋鏇齋構壓淵艱鑰壓夢網齋廠淵夢製鏇襯築 (構窪醖衊願蓋衊獵襯製 ) 更多