A Comparative Clinical Effectiveness Trial of Rituximab Versus Ravulizumab, Inebilizumab, Satralizumab and Eculizumab To Prevent Relapses in Neuromyelitis Optica Spectrum Disorder

Neuromyelitis Optica Spectrum Disorder (NMOSD) is a rare autoimmune condition that mainly affects the eyes and spinal cord, causing serious symptoms such as vision loss, paralysis, and severe pain. This trial compares the effectiveness and safety of five medications commonly used to prevent NMOSD relapses: rituximab, ravulizumab, inebilizumab, satralizumab, and eculizumab.
In this study, 160 adults with NMOSD who test positive for a specific antibody (AQP4-IgG) will participate. They will be randomly assigned to receive either rituximab or one of the four other FDA-approved medications. The main goal is to find out which treatment best prevents relapses and has fewer serious side effects. The trial will also measure disability, patient satisfaction, quality of life, and biomarkers that help track disease activity.
Participants will have regular assessments, including medical exams, surveys, and tests for vision, walking ability, and brain function. They will report any side effects or health issues experienced during the study. The trial will last from one to four years for each participant.
This research aims to help patients and doctors make better-informed treatment decisions by providing clear evidence about the best available therapies for NMOSD.

开始日期2026-09-01

申办/合作机构

The Massachusetts General Hospital

[+1]

NCT07762872

/ RecruitingN/AIIT

Real-World Effectiveness and Safety of Satralizumab in the Early Treatment of Attacks in Neuromyelitis Optica Spectrum Disorder: A Multicenter Prospective Cohort Study

This study is a multicenter, prospective cohort study designed to enroll 50 NMOSD patients who receive Satralizumab treatment during the early phase of an NMOSD attack. Follow-up visits will be conducted at baseline, 3 months, and 6 months to record and assess EDSS scores, modified Rankin Scale (mRS) scores, EQ-5D scores, Activities of Daily Living (ADL) scores, relapse events, safety data, and exploratory endpoints (e.g., blood inflammatory markers and visual function), with the aim of evaluating the efficacy and safety of Satralizumab in the early treatment of NMOSD-thereby providing patients with more effective therapeutic options and further optimizing the clinical management of NMOSD.

开始日期2026-07-20

申办/合作机构

首都医科大学宣武医院

[+3]

NCT05199688

/ Recruiting临床3期

A Phase III, Multicenter, Open-Label, Uncontrolled Study to Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, and Pharmacodynamics of Satralizumab in Pediatric Patients With AQP4 Antibody Positive Neuromyelitis Optica Spectrum Disorder (NMOSD)

This study will primarily evaluate the pharmacokinetics of satralizumab in pediatric patients aged 2-11 years with anti-aquaporin-4 (AQP4) antibody seropositive neuromyelitis optica spectrum disorder (NMOSD). Efficacy, safety, tolerability, and pharmacodynamics will be evaluated in a descriptive manner, given the small number of patients who will be enrolled in this study.

开始日期2026-05-06

申办/合作机构

Hoffmann-La Roche, Inc.

100 项与萨特利珠单抗相关的临床结果

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100 项与萨特利珠单抗相关的转化医学

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100 项与萨特利珠单抗相关的专利（医药）

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211

项与萨特利珠单抗相关的文献（医药）

2026-10-01·Neurology and Therapy

Comparative Evaluation of Rituximab Versus Approved Therapies in Aquaporin-4-IgG-Positive Neuromyelitis Optica Spectrum Disorder: A Systematic Review and Network Meta-analysis

Review

作者: Samadzadeh, Sara ; Altintas, Ayse ; Berthele, Achim ; Papp, Viktoria ; Barzegar, Mahdi ; Collongues, Nicolas ; Ringelstein, Marius ; Cortese, Rosa ; Illes, Zsolt ; Arrambide, Georgina ; Palace, Jacqueline ; Audoin, Bertrand ; Asgari, Nasrin ; Paulus, Rommer ; Laakso, Sini ; Paul, Friedemann ; Geraldes, Ruth ; Lefter, Antonia ; Möller, Sören ; Messina, Silvia ; Mariotto, Sara ; Hacohen, Yael ; Afshari-Safavi, Alireza ; Huda, Saif ; Willekens, Barbara ; Jahani, Shima ; Siva, Aksel ; Wokke, Beatrijs ; Zappe, Clarissa ; Cobo-Calvo, Álvaro ; Marignier, Romain

INTRODUCTION:

Neuromyelitis optica spectrum disorder (NMOSD) is a rare antibody-mediated neuro-autoimmune disease. Monoclonal antibodies targeting B cell antigens CD19 and CD20, the interleukin-6 receptor, or the complement cascade are used as preventive therapies to reduce relapse rates. We conducted a network meta-analysis (NMA) to compare the effect of rituximab on time to first relapse with ravulizumab, eculizumab, inebilizumab, and satralizumab in patients with NMOSD who are aquaporin-4 (AQP4)-IgG-positive.

METHODS:

A systematic search was conducted in PubMed, Scopus, CINAHL, EMBASE, Web of Science, the Cochrane Library, and gray literature sources up to October 31, 2024, and updated on November 1, 2025, following PRISMA guidelines. A network meta-analysis of randomized and open-label trials was conducted to compare time to first relapse between rituximab and other monoclonal antibody therapies.

RESULTS:

From 6337 records, 3825 duplicates were removed; 2512 were screened, 2327 excluded, leaving eight trials. The prior treatment, relapse history, and definitions and adjudication of relapse varied across studies. Rituximab showed higher hazard ratio (HR) point estimates for time to first relapse compared with ravulizumab with or without immunosuppressive therapies (IST) (HR 5.00, 95% CI 0.25, 101.01) and eculizumab ± IST (HR 1.17, 95% CI 0.12, 10.89), but were lower compared with satralizumab ± IST (HR 0.29, 95% CI 0.04, 2.23). In patients not receiving IST, rituximab showed numerically higher HR compared with ravulizumab (HR 3.33, 95% CI 0.13, 83.16) and eculizumab (HR 1.59, 95% CI 0.05, 50.17), but lower point estimates compared with inebilizumab (HR 0.31, 95% CI 0.04, 2.31) and satralizumab (HR 0.27, 95% CI 0.03, 2.21).

CONCLUSION:

This NMA showed hazard ratio point estimates favoring eculizumab and ravulizumab over rituximab. However, wide, overlapping confidence intervals and between-study heterogeneity indicate substantial uncertainty. Head-to-head trials or registry-based studies are needed to determine the most effective treatment for AQP4-IgG-positive NMOSD.

2026-10-01·Neurology and Therapy

AQP4-IgG Dynamics and Exploratory Assessment of SERA-3 in Neuromyelitis Optica Spectrum Disorder Treated with Satralizumab

Article

作者: Li, Xiang ; He, Yang ; Wang, Renbin ; Peng, Dantao ; Jiao, Jinsong ; Cui, Lei ; Zhang, Yeqiong ; Zhang, Weihe ; Yu, Miaoxin ; Jiao, Yujuan ; Sun, Qing

INTRODUCTION:

Neuromyelitis optica spectrum disorder (NMOSD) is an autoimmune condition driven by aquaporin-4 immunoglobulin G (AQP4-IgG). The current treatment paradigm focuses on mitigating clinical relapses and disability accumulation, leaving the underlying serological activity unaddressed. This study evaluated the capacity of satralizumab to achieve a comprehensive remission, as defined by the Serological, Relapse, and Accumulated-disability Remission (SERA-3) target.

METHODS:

In this multicenter, real-world cohort study, patients with NMOSD from three tertiary centers in China initiating satralizumab were enrolled. AQP4-IgG levels were measured at baseline, 6, and 12 months. Clinical efficacy [annualized relapse rate (ARR), Expanded Disability Status Scale (EDSS)] and safety were evaluated. Heterogeneity in antibody response was analyzed, and baseline characteristics potentially associated with titer reduction were explored.

RESULTS:

Of the 19 patients who were AQP4-IgG seropositive at baseline, 7 (36.84%) met the strict definition of SERA-3 Complete. Of these, 4 patients achieved seroconversion at month 6 and remained seronegative through month 12, whereas 3 first achieved seroconversion at month 12. An additional 5 (26.32%) showed a reduction in AQP4-IgG titers. Satralizumab treatment was associated with marked clinical benefit. Among 33 patients included in the clinical efficacy analysis, 27 (81.82%) remained relapse-free during follow-up, median ARR decreased from 0.92 (IQR 0.56-1.59) to 0 (IQR 0-0), and EDSS scores remained stable in most patients. Exploratory analyses suggested that patients achieving serological response were older at disease onset (57.42 ± 17.82 versus 42 ± 14.24 years, p = 0.039) and had experienced fewer pre-treatment relapses (median 2 versus 5, p = 0.049). Satralizumab was generally well tolerated, including in older patients.

CONCLUSIONS:

Our findings support SERA-3 as a potential treatment framework for NMOSD. Satralizumab was associated with attainment of serological, relapse, and disability remission in a substantial proportion of patients, supporting further prospective evaluation of SERA-3 as a hypothesis-generating outcome framework.

2026-10-01·JOURNAL OF NEUROIMMUNOLOGY

Intitiation of satralizumab during pregnancy for successful childbirth in neuromyelitis optica spectrum disorder: A case report and literature review

Review

作者: Hasegawa, Tomoya ; Tsuda, Hiroyuki ; Ando, Takashi ; Sekikawa, Hiroshi ; Watanabe, Hazuki ; Goto, Yoji

Neuromyelitis optica spectrum disorder (NMOSD) predominantly affects women of reproductive age, posing significant risks for pregnancy-associated relapses and adverse perinatal outcomes. While biologic agents such as satralizumab are established therapies for NMOSD, data regarding their safety and efficacy when initiated during pregnancy remain scarce. Here we report the case of a 32-year-old woman with a history of NMOSD (diagnosed at age 24), taking oral low-dose prednisolone before conception. To mitigate the risk of relapse, satralizumab was first injected at 28 + 3 weeks of gestation. She delivered vaginally at 40 + 1 weeks of gestation without peripartum complications or disease relapse. Notably, while transplacental transfer of satralizumab was demonstrated, the drug was undetectable in breast milk and the neonate developed normally. To our knowledge, this is the first reported case of satralizumab initiation during pregnancy for relapse prevention in a patient with NMOSD. Our findings suggest that satralizumab may represent a viable therapeutic option for NMOSD management even when pregnancy is already established.

410

项与萨特利珠单抗相关的新闻（医药）

2026-10-29

·信狐药迅

2款1类国产新药：君赛诺吉仑赛、智翔金泰泰利奇拜单抗提交上市申请|新受理（10.22-10.29）

本周药品注册受理数据，分门别类呈现，一目了然。(10.22-10.29）新药上市申请药品名称企业注册分类受理号注射用瑞康曲妥珠单抗苏州盛迪亚生物医药有限公司 2.2 CXSS2600174 特瑞普利单抗注射液(皮下注射) 上海君实生物医药科技股份有限公司 2.1 CXSS2600173 注射用芦康沙妥珠单抗四川科伦博泰生物医药股份有限公司 2.2 CXSS2600172 注射用芦康沙妥珠单抗四川科伦博泰生物医药股份有限公司 2.2 CXSS2600171 信迪利单抗注射液信达生物制药(苏州)有限公司 2.2 CXSS2600170 诺吉仑赛注射液上海君赛生物药业有限公司 1 CXSS2600169 泰利奇拜单抗注射液(皮下注射) 重庆智翔金泰生物制药股份有限公司 1 CXSS2600167 注射用伦康依隆妥单抗成都百利多特生物药业有限责任公司 2.2 CXSS2600168新药临床申请药品名称企业注册分类受理号 JZ-603鼻用粉剂江之生物医药科技(上海)有限公司 1 CXSL2601178 JZ-603鼻用粉剂江之生物医药科技(上海)有限公司 1 CXSL2601177 注射用ZG006 苏州泽璟生物制药股份有限公司 1 CXSL2601176 BSD2502 江苏百奥信康医药科技有限公司 2.2 CXHL2601323 SKB118注射液四川科伦博泰生物医药股份有限公司 1 CXSL2601179 Argo-3004 阿格纳生物制药有限公司 1.2 CXSL2601182 CG001注射液上海康景生物医药科技有限公司 1 CXSL2601184 CG001注射液上海康景生物医药科技有限公司 1 CXSL2601183 SSS68注射液沈阳三生制药有限责任公司 1 CXSL2601181 注射用SKB315 四川科伦博泰生物医药股份有限公司 1 CXSL2601180 注射用GFS784 劲方医药科技(上海)股份有限公司 1 CXSL2601185 NRT6003注射液成都纽瑞特医疗科技股份有限公司 1 CXHL2601324 注射用重组A型肉毒毒素(Sf9细胞,150 kD天然氨基酸序列) 苏州若弋生物科技有限公司 2.4 CXSL2601173 RO7840734 罗氏(中国)投资有限公司 1 CXHL2601322 RO7840734 罗氏(中国)投资有限公司 1 CXHL2601321 KYS2302注射液江苏康缘药业股份有限公司 1 CXSL2601174 注射用LY4052031 礼来苏州制药有限公司 1 CXSL2601175 SSGJ-706注射液沈阳三生制药有限责任公司 1 CXSL2601170 CM398注射液康诺亚生物医药科技有限公司 1 CXSL2601172 SPGL008注射液深圳赛保尔生物药业有限公司 1 CXSL2601171 注射用HLX403 上海复宏瑞霖生物技术有限公司 1 CXSL2601166 TQC3721吸入粉雾剂正大天晴药业集团股份有限公司 1 CXHL2601320 TQC3721吸入粉雾剂正大天晴药业集团股份有限公司 1 CXHL2601319 OV329胶囊缔脉生物医药科技(上海)有限公司 1 CXHL2601318 OV329胶囊缔脉生物医药科技(上海)有限公司 1 CXHL2601317 IMM092注射液北京免疫方舟医药科技有限公司 1 CXSL2601168 KN060注射液苏州康宁杰瑞生物科技有限公司 1 CXSL2601167 IMM040811注射液北京免疫方舟医药科技有限公司 1 CXSL2601169 人脐带间充质干细胞注射液天津和创生物技术有限公司 1 CXSL2601162 CG-0416片上海柯君医药科技有限公司 1 CXHL2601316 CG-0416片上海柯君医药科技有限公司 1 CXHL2601315 JK06注射液深圳信立泰药业股份有限公司 1 CXSL2601163 NK010(冻存制剂)细胞注射液上海恩凯细胞技术有限公司 1 CXSL2601164 冻干人用狂犬病疫苗(Vero细胞) 广州白云山生物制品股份有限公司 2.5 CXSL2601165仿制药申请药品名称企业注册分类受理号磷酸奥司他韦胶囊新天地药业股份有限公司 4 CYHS2602633 磷酸奥司他韦胶囊新天地药业股份有限公司 4 CYHS2602632 磷酸奥司他韦胶囊新天地药业股份有限公司 4 CYHS2602631 环孢素滴眼液(III) 南京海纳医药科技股份有限公司 4 CYHS2602635 注射用磷酸左奥硝唑酯二钠安徽美来药业股份有限公司 4 CYHS2602634 枸橼酸铋钾片福建海西新药创制股份有限公司 4 CYHS2602640 利奈唑胺葡萄糖注射液鲁南贝特制药有限公司 4 CYHS2602637 盐酸氮䓬斯汀滴眼液宁夏康亚药业股份有限公司 4 CYHS2602636 复方电解质维持液南京恩泰医药科技有限公司 3 CYHS2602639 复方电解质维持液南京恩泰医药科技有限公司 3 CYHS2602638 比拉斯汀口服溶液南京海纳制药有限公司 3 CYHS2602628 注射用多种维生素(12) 山东齐都药业有限公司 4 CYHS2602629 贝派度酸依折麦布片成都诺和晟鸿生物制药有限公司 3 CYHL2600125 磷酸芦可替尼片湖南科伦制药有限公司 4 CYHS2602630 苏沃雷生片广东豪瑞恩制药有限公司 3 CYHL2600124 苏沃雷生片广东豪瑞恩制药有限公司 3 CYHL2600123 苏沃雷生片广东豪瑞恩制药有限公司 3 CYHL2600122 注射用醋酸西曲瑞克南京海纳制药有限公司 4 CYHS2602620 苯磺酸美洛加巴林口崩片天方药业有限公司 3 CYHS2602617 苯磺酸美洛加巴林口崩片天方药业有限公司 3 CYHS2602616 磷酸芦可替尼片湖北民康制药有限公司 4 CYHS2602615 磷酸芦可替尼片湖北民康制药有限公司 4 CYHS2602614 磷酸芦可替尼片湖北民康制药有限公司 4 CYHS2602613 甲泼尼龙片天津信谊津津药业有限公司 4 CYHS2602621 复方托吡卡胺滴眼液武汉五景药业有限公司 4 CYHS2602626 亚硒酸钠注射液仁合益康汇泽药业河北有限公司 3 CYHS2602625 西诺氨酯片宜昌东阳光长江药业股份有限公司 4 CYHS2602624 西诺氨酯片宜昌东阳光长江药业股份有限公司 4 CYHS2602623 乌帕替尼缓释片黑龙江福和制药集团股份有限公司 4 CYHS2602622 利那洛肽胶囊佑华医药科技有限公司 4 CYHS2602627 达肝素钠注射液苏州二叶制药有限公司 4 CYHS2602619 达肝素钠注射液苏州二叶制药有限公司 4 CYHS2602618 蒙脱石散西安安健药业有限公司 4 CYHS2602605 氟比洛芬凝胶贴膏湖北民康药业集团有限公司 4 CYHS2602604 玻璃酸钠滴眼液广州白云山天心制药股份有限公司 4 CYHS2602603 玻璃酸钠滴眼液广州白云山天心制药股份有限公司 4 CYHS2602602 盐酸倍他司汀片卡文迪许(泰州)药业有限公司 3 CYHS2602608 亚甲蓝注射液成都瑞尔医药科技有限公司 4 CYHS2602607 枸橼酸钠血滤置换液华仁药业股份有限公司 4 CYHS2602606 格拉司琼透皮贴片宜昌人福药业有限责任公司 4 CYHS2602612 硫酸氨基葡萄糖胶囊湖南欧拉医药科技有限公司 4 CYHS2602609 双氯芬酸依泊胺凝胶贴膏杭州端本医药科技有限公司 3 CYHL2600121 氧(液态) 南京杭氧气体有限公司 4 CYHS2602611 利丙双卡因乳膏哈药集团生物工程有限公司 4 CYHS2602610 阿卡波糖片天地恒一制药股份有限公司 4 CYHS2602591 葡萄糖酸钙注射液哈尔滨三联药业股份有限公司 3 CYHS2602590 注射用美罗培南海南全星制药有限公司 4 CYHS2602589 醋酸地非法林注射液苏州天马医药集团天吉生物制药有限公司 4 CYHS2602593 艾地骨化醇片南京海融制药有限公司 3 CYHS2602592 硝苯地平控释片山东宜岛康制药有限公司 4 CYHS2602595 依折麦布片国药集团致君(深圳)制药有限公司 4 CYHS2602594 劳拉西泮注射液四川科瑞德制药股份有限公司 3 CYHL2600120 溴莫尼定噻吗洛尔滴眼液鲁南贝特制药有限公司 4 CYHS2602601 阿仑膦酸钠口服溶液西洲医药科技(浙江)有限公司 3 CYHS2602600 糠酸莫米松乳膏浙江昂利康制药股份有限公司 4 CYHS2602599 多替诺雷片安徽省先锋制药有限公司 4 CYHS2602598 多替诺雷片安徽省先锋制药有限公司 4 CYHS2602597 西罗莫司片杭州中美华东制药江东有限公司 4 CYHS2602596进口申请药品名称企业注册分类受理号 AZD0486 AstraZeneca AB 1 JXSL2600288 AZD0486 AstraZeneca AB 1 JXSL2600287 AZD4512 AstraZeneca AB 1 JXSL2600286 ABBV-706注射用冻干粉 AbbVie Inc. 1 JXSL2600289 帕博利珠单抗注射液 MSD International Business GmbH 2.2 JXSS2600099 Giredestrant胶囊 F. Hoffmann-La Roche Ltd. 1 JXHL2600465 Giredestrant胶囊 F. Hoffmann-La Roche Ltd. 1 JXHL2600464 Azenosertib片 K-Group Beta, Inc. 1 JXHL2600463 Azenosertib片 K-Group Beta, Inc. 1 JXHL2600462 ABBV-901注射用粉末 AbbVie Inc. 1 JXSL2600285 注射用WCK 5222 Wockhardt Bio AG 2.4 JXHL2600461 萨特利珠单抗注射液 Roche Pharma (Schweiz) AG 2.2 JXSS2600098 注射用ABBV-969 AbbVie Inc. 1 JXSL2600282 579 - 痤疮 mRNA 注射液 Sanofi Vaccines US Inc. 1 JXSL2600281 甲苯磺酸利特昔替尼胶囊 Pfizer Inc. 2.4 JXHS2600132 甲苯磺酸利特昔替尼胶囊 Pfizer Inc. 2.4 JXHS2600131 AZD0486 AstraZeneca AB 1 JXSL2600284 AZD0486 AstraZeneca AB 1 JXSL2600283中药相关申请药品名称企业注册分类受理号欣力康颗粒贵阳新天药业股份有限公司 2.3 CXZL2600110 金叶败毒颗粒国药集团中联药业有限公司 2.3 CXZL2600109 黄葵胶囊苏中药业集团股份有限公司 2.3 CXZL2600108 逍遥静音颗粒北京欣瑞元医药科技有限公司 1.1 CXZL2600107 注：绿色字体部分为潜在首仿品种；橙色字体部分结论为不批准或收到通知件；不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。

申请上市

2026-10-27

·chugai-pharm.co.jp

Chugai Announces 2026 3rd Quarter Results

TOKYO, October 27, 2026 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced its financial results for the third quarter of fiscal year 2026. Core revenue of ¥1,068.1 billion (+17.2%), core operating profit of ¥536.1 billion (+19.0%), and core net income of ¥384.7 billion (+20.2%) were achieved, resulting in increased revenue and profit year-on-year. Full-year results are expected to exceed the forecast Sales increased, driven by increased exports of NEMLUVIO® and Alecensa®, as well as growth in mainstay products and new products in Japan. Domestic sales also increased due to front-loaded shipments associated with the transition to the next-generation enterprise resource planning (ERP) system. Other revenue increased due to royalty income from Hemlibra® and NEMLUVIO, as well as one-time income R&D activities progressed steadily across both early- and late-stage development, including Chugai-originated projects Enspryng®, created using Chugai’s proprietary antibody engineering technologies, was approved by the U.S. FDA for thyroid eye disease (TED) For Hemlibra, a treatment for hemophilia A whose discovery was led by Chugai researchers who received the prestigious Lasker-DeBakey Clinical Medical Research Award, an autoinjector formulation aimed at further reducing the treatment burden is targeted for launch in Japan and overseas in 2027 The license for emugrobart is planned to be returned to Chugai by Roche. In addition, preparations have begun to resume Chugai-led development for spinal muscular atrophy (SMA), including the possibility of out-licensing to a third party In Phase III studies of Lunsumio® for relapsed or refractory follicular lymphoma and sefaxersen for IgA nephropathy, both studies met their primary endpoints at interim analysis Biological PoC results from the Phase Ia/b and Phase Ic studies of Chugai-originated project DONQ52 in celiac disease are scheduled to be presented at ICDS 2026 (International Celiac Disease Symposium) in November Enspryng®, created using Chugai’s proprietary antibody engineering technologies, was approved by the U.S. FDA for thyroid eye disease (TED) For Hemlibra, a treatment for hemophilia A whose discovery was led by Chugai researchers who received the prestigious Lasker-DeBakey Clinical Medical Research Award, an autoinjector formulation aimed at further reducing the treatment burden is targeted for launch in Japan and overseas in 2027 The license for emugrobart is planned to be returned to Chugai by Roche. In addition, preparations have begun to resume Chugai-led development for spinal muscular atrophy (SMA), including the possibility of out-licensing to a third party In Phase III studies of Lunsumio® for relapsed or refractory follicular lymphoma and sefaxersen for IgA nephropathy, both studies met their primary endpoints at interim analysis Biological PoC results from the Phase Ia/b and Phase Ic studies of Chugai-originated project DONQ52 in celiac disease are scheduled to be presented at ICDS 2026 (International Celiac Disease Symposium) in November Refer to the information below for details on the financial results: Quarterly Reports / Finance Reports https://www.chugai-pharm.co.jp/english/ir/reports_downloads/tanshin.html Presentation Materials In addition to Chugai’s business and financial performance, these materials provide updates on our research and development pipeline. Videos and transcripts (including Q&A) will be made available at a later date. https://www.chugai-pharm.co.jp/english/media/conference.html [2026 Third Quarter Results] 2026 Jan-Sep 2025 Jan-Sep Revenue 1,068.1 [PDF 140KB] Contact: For Media Chugai Pharmaceutical Co., Ltd. Media Relations Group, Corporate Communications Dept., Naoki Kouzai Tel: +81-3-3273-0881 E-mail: pr@chugai-pharm.co.jp For Investors Chugai Pharmaceutical Co., Ltd. Investor Relations Group, Corporate Communications Dept., Takayuki Sakurai Tel: +81-3-3273-0554 E-mail: ir@chugai-pharm.co.jp Back

临床3期临床结果上市批准财报临床1期

2026-10-26

·猪猪爱宝贝

美国FDA批准罗氏萨特利珠单抗，甲亢突眼眼病可居家皮下注射

甲状腺相关眼病，也就是大家常说的突眼眼病，属于自身免疫引发的眼眶炎症。很多甲亢的患者会伴随这类问题，眼球往外突出、眼皮肿胀、看东西重影，严重的时候还会压迫视神经，威胁视力安全。以往主流的靶向药物都需要到医院静脉输液，要来回跑医院，长期治疗很不方便。罗氏的萨特利珠单抗获得美国FDA批准，成为首款支持居家皮下注射的甲状腺眼病治疗药物，给长期患病的人群带来不一样的给药选择。甲状腺眼病发病，是身体免疫系统出现紊乱，持续释放炎症因子，刺激眼眶里面的软组织增生水肿，把眼球向外顶出。不少患者经过激素治疗之后，容易反复，输液类靶向药虽然有效，但每次都要到医疗机构输注，耗费时间，对于需要长期维持治疗的人来说负担不小。这款药物靶向IL-6受体，阻断炎症信号传导，从根源上抑制眼眶持续的免疫炎症反应，和现有的几款突眼治疗药物作用通路不一样，属于新的治疗方向。给药方案分为负荷期和维持期，前期第0、2、4周各打一针，完成诱导之后，后续每四周注射一次。患者或者家属经过医护正规培训，掌握操作方法之后，在家就可以完成皮下注射，不用频繁往返医院输液。三期临床数据显示，一部分活动性突眼患者用药之后，眼球突出程度减轻，重影症状得到改善，眼部红肿发炎的情况逐步缓解。同时也需要清楚它的适用边界，不是所有突眼都适合。它针对的是成人活动性甲状腺眼病，如果已经到后期组织纤维化稳定阶段，眼球突出定型，药物改善效果有限。用药前还要筛查结核、乙肝、肝功能，有活动性感染的人群不能使用，用药期间也需要监测相关指标，留意感染、肝功能异常这类潜在风险。它属于处方免疫药物，不是甲亢常规用药，必须由内分泌或者眼整形专科医生评估病情之后，才能够启动治疗。国内目前还没有获批这个适应症，暂时还不能在国内直接用于突眼治疗，只能作为海外新治疗方向来了解。对于饱受甲状腺眼病困扰、长期反复炎症的患者来说，居家给药的模式，是这项新药最大的亮点，也给后续同类药物研发提供了新的思路。本文仅为前沿科研资讯科普，不构成任何诊疗建议，眼部疾病请前往正规医疗机构就诊。如果你喜欢这类前沿眼科资讯，欢迎点赞、转发，分享给身边有需要的朋友。《手术还要拆线？北京同仁研究这款透光生物胶，探索眼科无缝线的可能》美国甲亢眼病新药三期临床效果亮眼，预计明年引入国内开展试验深圳智视创新：TAG‑W1衣领式离线AI助盲模组首次亮相太

100 项与萨特利珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11079	萨特利珠单抗	L04AC19 L04AG L01XC	DB15762

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
格雷夫斯眼病	美国	Roche Holding AG	2026-10-16
水通道蛋白4抗体阳性视神经脊髓炎谱系疾病	澳大利亚	Roche Holding AG	2020-11-17
视神经脊髓炎	加拿大	Hoffmann-La Roche Ltd.	2020-06-01

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
自身免疫性脑炎	临床3期	美国	罗氏（中国）投资有限公司	2023-04-24
自身免疫性脑炎	临床3期	美国	F. Hoffmann-La Roche Ltd.	2023-04-24
自身免疫性脑炎	临床3期	中国	罗氏（中国）投资有限公司	2023-04-24
自身免疫性脑炎	临床3期	中国	F. Hoffmann-La Roche Ltd.	2023-04-24
自身免疫性脑炎	临床3期	日本	F. Hoffmann-La Roche Ltd.	2023-04-24
自身免疫性脑炎	临床3期	日本	罗氏（中国）投资有限公司	2023-04-24
自身免疫性脑炎	临床3期	阿根廷	罗氏（中国）投资有限公司	2023-04-24
自身免疫性脑炎	临床3期	阿根廷	F. Hoffmann-La Roche Ltd.	2023-04-24
自身免疫性脑炎	临床3期	澳大利亚	F. Hoffmann-La Roche Ltd.	2023-04-24
自身免疫性脑炎	临床3期	澳大利亚	罗氏（中国）投资有限公司	2023-04-24

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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


NCT06106828 (SatraGO-2, CTgov)	临床3期	格雷夫斯眼病	127	Satralizumab (Part I: Satralizumab)	觸構膚鑰遞廠淵選鬱襯 = 壓憲觸獵壓鑰網築憲淵繭壓鏇夢鏇獵窪簾遞築 (鏇範蓋壓構繭鑰窪構襯, 糧遞築積襯夢製鏇繭鏇 ~ 觸網網廠築積襯網鹹鏇) 更多	-	2026-08-12
				placebo+satralizumab (Part I: Placebo)	觸構膚鑰遞廠淵選鬱襯 = 鬱築觸簾憲範築廠醖淵繭壓鏇夢鏇獵窪簾遞築 (鏇範蓋壓構繭鑰窪構襯, 壓築夢窪製廠網衊醖蓋 ~ 鏇膚齋鏇選選齋獵窪窪) 更多
NCT05987423 (SatraGO-1, CTgov)	临床3期	格雷夫斯眼病	131	Satralizumab (Part I: Satralizumab)	窪壓鹹鹹鹹餘簾觸齋選 = 廠餘簾網齋鹹糧顧鑰鬱襯醖網鏇製齋淵膚選願 (鏇夢艱繭鹽選膚鏇膚鏇, 網鏇構簾選鹹蓋襯鏇鏇 ~ 積鏇憲願鏇窪蓋鑰範餘) 更多	-	2026-07-31
				placebo+satralizumab (Part I: Placebo)	窪壓鹹鹹鹹餘簾觸齋選 = 衊製餘衊艱淵膚衊衊製襯醖網鏇製齋淵膚選願 (鏇夢艱繭鹽選膚鏇膚鏇, 艱夢艱範醖醖齋艱願齋 ~ 築顧願蓋壓淵襯鏇襯積) 更多
AAN2026	N/A	视神经脊髓炎 AQP4-IgG+	422	Rituximab	鹽繭遞鑰遞窪壓鹹製襯(網齋廠選獵餘齋醖醖齋) = 夢繭淵遞鑰簾鬱蓋觸艱壓繭膚網鹹夢膚艱憲壓 (製簾鏇範艱襯衊鹽衊淵 ) 更多	积极	2026-04-25
				Eculizumab	鹽繭遞鑰遞窪壓鹹製襯(網齋廠選獵餘齋醖醖齋) = 艱築簾醖獵膚鏇夢鑰繭壓繭膚網鹹夢膚艱憲壓 (製簾鏇範艱襯衊鹽衊淵 ) 更多
AAN2026	N/A	髓鞘少突胶质细胞糖蛋白抗体相关疾病	25	TocilizumabSatralizumab + TocilizumabSatralizumab	積衊繭鬱廠簾餘築憲築(鹹壓夢鹹膚鏇鏇鏇襯憲) = 壓壓壓積鹽淵獵艱蓋壓鏇窪簾餘鬱壓淵醖壓簾 (廠鏇製構襯襯壓範壓鏇 ) 更多	积极	2026-04-25
AAN2026	N/A	视神经脊髓炎	361	Tocilizumab (8 mg/kg weekly)	鬱襯範築醖願鏇衊衊積(製鏇蓋鑰鬱鹹鏇壓範築): MD = -2.26 (95.0% CI, -3.4 ~ -1.12), P-Value = 0.0001 更多	积极	2026-04-25
				Satralizumab (120 mg q4w)
ECTRIMS2025	N/A	视神经脊髓炎	78	Azathioprine	齋艱淵憲鏇範憲簾製衊(觸夢構築鏇齋鹹鹽築夢) = 範壓鏇鏇積廠顧艱鏇選構遞築壓夢築窪構製襯 (蓋簾壓憲遞壓膚鏇願鹹 ) 更多	积极	2025-09-24
ECTRIMS2025	N/A	视神经脊髓炎 AQP4 antibody positive	8	Satralizumab	顧積顧鏇築願憲構網鏇(衊襯鏇膚網獵窪壓鏇鹽) = The only adverse events were transient liver enzymes increase, mild neutropenia, mild-moderate infections 醖積艱鬱襯衊膚築築憲 (鬱選鑰糧糧襯膚遞構網 )	积极	2025-09-24
ECTRIMS2025	临床1期	-	188	satralizumab (Autoinjector + Abdomen injection)	選廠鬱壓觸鏇網鏇鹹鬱(糧鏇積顧築壓艱觸壓衊) = 104.9% (97.2-113.3%) 鏇蓋夢選鹹齋襯繭壓簾 (鑰網壓製鹽構糧顧獵構 ) 更多	积极	2025-09-24
				satralizumab (Autoinjector + Thigh injection)
ECTRIMS2025	N/A	视神经脊髓炎 aquaporin-4 antibodies (AQP4-IgG+)	422	Rituximab	鏇鬱襯構顧簾遞淵憲獵(積鏇艱鏇壓壓繭憲衊壓) = 構餘糧範構築顧簾鬱襯膚糧淵範觸遞積窪積鬱 (顧製願糧衊構膚鏇糧艱 )	积极	2025-09-24
				Eculizumab	鏇鬱襯構顧簾遞淵憲獵(積鏇艱鏇壓壓繭憲衊壓) = 範衊觸鏇範範醖醖餘簾膚糧淵範觸遞積窪積鬱 (顧製願糧衊構膚鏇糧艱 )
ECTRIMS2025	N/A	水通道蛋白4抗体阳性视神经脊髓炎谱系疾病 aquaporin-4-IgG+	54	Satralizumab	鬱獵鬱繭製遞構蓋鹹糧(蓋窪範憲構糧選鑰顧鬱) = After starting satralizumab, safety data revealed mild to moderate liver enzyme elevations in 31 %, serum lipid elevations in 38 %, and cytopenia in 18 % of patients. Infections occurred in 14 % and injection site reactions in 6 % of patients. 鑰糧齋獵夢襯壓製廠積 (糧範鑰築淵築簾夢窪繭 ) 更多	积极	2025-09-24