萨特利珠单抗(Satralizumab) - 药物靶点：IL-6R_在研适应症：水通道蛋白4抗体阳性视神经脊髓炎谱系疾病，视神经脊髓炎，格雷夫斯眼病_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Humanised anti-IL-6 receptor monoclonal antibody、Sapelizumab、Satralizumab (Genetical Recombination)

+ [12]

靶点

IL-6R

作用机制

IL-6 receptor family antagonists

治疗领域

肿瘤免疫系统疾病感染+ [7]

在研适应症

水通道蛋白4抗体阳性视神经脊髓炎谱系疾病视神经脊髓炎格雷夫斯眼病+ [6]

非在研适应症

颅内动脉瘤1脑缺血类风湿关节炎

原研机构

Roche Registration GmbH

在研机构

Roche Holding AGHoffmann-La Roche, Inc.

罗氏（中国）投资有限公司

+ [5]

非在研机构-

最高研发阶段批准上市

首次获批日期

加拿大 (2020-06-01),

视神经脊髓炎

最高研发阶段(中国)批准上市

特殊审评突破性疗法 (美国)、快速通道 (美国)、孤儿药 (美国)、优先审评 (中国)、孤儿药 (韩国)、孤儿药 (澳大利亚)

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序列信息

Sequence Code 13363H

来源: *****

Sequence Code 13368L

来源: *****

关联

34

项与萨特利珠单抗相关的临床试验

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2025-03-31

申办/合作机构

Hoffmann-La Roche, Inc.

NCT06450639 / Recruiting临床2期

A Phase II Multicenter, Open-Label Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Pediatric Patients With Duchenne Muscular Dystrophy (SHIELD DMD)

The purpose of this study is to assess the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of satralizumab, a humanized anti-interleukin-6 receptor (aIL-6R) monoclonal antibody, in ambulatory and non-ambulatory patients with Duchenne muscular dystrophy (DMD) age ≥ 8 to < 16 years old receiving corticosteroid therapy.

开始日期2024-10-31

申办/合作机构

Hoffmann-La Roche Ltd.

NCT05727657 / Withdrawn早期临床1期IIT

A Phase 1 Clinical Trial of Satralizumab as a Treatment for Aneurysmal Subarachnoid Hemorrhage

In this study, satralizumab will be administered to see whether satralizumab is safe in patients with a burst brain aneurysm and if it may prevent strokes in patients with a burst brain aneurysm.

开始日期2024-06-01

申办/合作机构

University of Florida

[+1]

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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268

项与萨特利珠单抗相关的文献（医药）

2024-12-01·Journal of central nervous system disease

Advances in the long-term treatment of neuromyelitis optica spectrum disorder

Review

作者: Anderson, Monique ; Levy, Michael

Neuromyelitis optica spectrum disorder (NMOSD) is a rare autoimmune neuroinflammatory disorder with a prevalence of 1-5/100,000 globally, characterized by attacks of the central nervous system including but not limited to optic neuritis, transverse myelitis and brainstem lesions, including area postrema lesions. These autoimmune attacks can lead to irreversible damage if left untreated, therefore strategies have been developed to prevent relapses. Initial off-label treatments have achieved variable levels of success in relapse prevention, but improved relapse prevention and quality of life remain a goal in the field. A better understanding of the underlying pathophysiology of NMOSD over the last 10 years has led to newer, more specific approaches in treatment, culminating in the first FDA approved treatments in the disease. In this review, we will discuss the seminal trials of PREVENT or Eculizumab in the treatment of aquaporin-4 (AQP4)-IgG positive NMOSD, N-Momentum or Inebilizumab in the study of NMOSD (both AQP4-IgG positive and negative) and SAkura Sky and SAkuraStar which studied satralizumab in AQP4-IgG seropositive and seronegative NMOSD patients. We will also discuss the extension trials of each of these medications and what lead to their approval in AQP4-IgG seropositive NMOSD patients. We will then examine treatments in the pipeline for adult and pediatric NMOSD patients and conclude with discussions on treatment considerations in pregnant patients and how to approach treatment of NMOSD patients during COVID.

2024-11-01·Translational Research

A multi-biomarker panel for predicting Tocilizumab response in Rheumatoid arthritis patients

Article

作者: Yi, Eugene C ; Cho, Ara ; Kim, Andrew ; Ahn, Jinsung ; Tanaka, Yoshiya ; Song, Yeong Wook ; Lee, Yun Jong

Rheumatoid arthritis (RA) is a chronic systemic autoimmune disease characterized by inflammation in the synovial lining of the joints. Key inflammatory cytokines such as interleukin-6 (IL-6), TNF-α, and others play a critical role in the activation of local synovial leukocytes and the induction of chronic inflammation. Tocilizumab (TCZ), a humanized anti-IL-6 receptor monoclonal antibody, has demonstrated significant clinical efficacy in treating RA patients. However, similar to other inflammatory cytokine blockers, such as TNF-alpha inhibitors, Interleukin-1 inhibitors, or CD20 inhibitors, some patients do not respond to treatment. To address this challenge, our study employed a high-precision proteomics approach to identify protein biomarkers capable of predicting clinical responses to Tocilizumab in RA patients. Through the use of data-independent acquisition (DIA) mass spectrometry, we analyzed serum samples from both TCZ responders and non-responders to discover potential biomarker candidates. These candidates were subsequently validated using individual serum samples from two independent cohorts: a training set (N = 70) and a test set (N = 18), allowing for the development of a robust multi-biomarker panel. The constructed multi-biomarker panel demonstrated an average discriminative power of 86 % between response and non-response groups, with a high area under the curve (AUC) value of 0.84. Additionally, the panel exhibited 100 % sensitivity and 60 % specificity. Collectively, our multi-biomarker panel holds promise as a diagnostic tool to predict non-responders to TCZ treatment in RA patients.

2024-08-01·Heliyon

Visual improvement in a case of neuromyelitis optica spectrum disorder-related optic neuritis after 18 months of treatment with satralizumab: A case report

Article

作者: Qiu, Wei ; Qiu, Yao ; Shen, Ting ; Yang, Hui

Neuromyelitis optica spectrum disorder-related optic neuritis (NMOSD-ON) is an autoimmune disease that affects the astrocytes. NMOSD-ON is one of the core clinical phenotypes of neuromyelitis optica spectrum disorder and its most-common initial symptom. NMOSD-ON is characterized by severe vision loss, poor prognosis and high recurrence, mainly affecting young and middle-aged individuals. It is a challenge to know how to improve patients' visual outcomes. In this report, we present a refractory case of NMOSD-ON treated with satralizumab after multiple conventional therapies proved ineffective. Satralizumab was found to effectively control relapses in this patient and visual improvement was found after 18 months of treatment. Given to that, satralizumab may have a potential longitudinal effect on visual improvement in NMOSD-ON.

118

项与萨特利珠单抗相关的新闻（医药）

2024-10-18

·BiG生物创新社

盘点｜自免重磅靶点及研发进展

作者｜小麦目前自免是仅次于肿瘤的第二大市场领域，2022年全球自免药物市场规模约达1323亿美元，据弗若斯特沙利文预测，到2030年，全球自免药物市场规模有望达到1760亿美元，2022~2030年复合年增长率为3.6%。国内在自免领域远远落后于国外，但近几年国内自免药物发展迅速，今年迪哲医药的JAK抑制剂戈利昔替尼、康诺亚生物的IL-4Rα抗体药物司普奇拜单抗、恒瑞医药的靶向IL-17A生物制剂夫那奇珠单抗和智翔金泰的靶向IL-17A生物制剂赛立奇单抗等相继获批上市，有望打破进口药的垄断地位，给患者提供更多的选择。 01 JAK靶向制剂 JAK激酶属于细胞内非受体酪氨酸激酶家族，包括JAK1、JAK2、JAK3、TYK2四个成员，介导细胞因子产生的信号，并通过JAK-STAT信号通路传递下去，参与了免疫、细胞分裂、细胞死亡和肿瘤形成等过程。该通路异常可能导致各种疾病，如皮肤病、癌症和影响免疫系统的疾病等（图1）[1]。图1. JAK家族介导信号通路全球已有十多款JAK抑制剂获批上市，包括第一代的托法替布、芦可替尼、巴瑞替尼、培非替尼和迪高替尼；第二代的菲达替尼、乌帕替尼、非戈替尼、阿布昔替尼和帕瑞替尼以及第三代的氘可来昔替尼等，这些抑制剂大多用于关节炎、特应性皮炎等自免疾病（图2）。图2. 获批和部分在研的JAK抑制剂为了提高竞争力，很多药企开始探索JAK抑制剂的新用途，如辉瑞的利特昔替尼、礼来巴瑞替尼和Concert Pharmaceuticals/Sun Pharmaceuticals的氘代芦可替尼获批斑秃新适应症，迪哲医药的戈利昔替尼获批用于治疗既往至少接受过一线系统性治疗的复发或难治的外周T细胞淋巴瘤（r/r PTCL）成人患者，成为全球首个且唯一获批用于治疗PTCL的JAK1抑制剂。除此之外，还有很多临床在研的JAK抑制剂，如泽璟制药的杰克替尼、恒瑞医药的艾玛昔替尼、辉瑞/Priovant Therapeutics的brepocitinib和再极医药的MAX-40070等，其中杰克替尼和艾玛昔替尼都处于申报上市阶段。 02 IL-4靶向制剂白细胞介素4（IL-4）主要是由T细胞、自然T细胞、肥大细胞和嗜酸性粒细胞产生的一种糖基化的I型细胞因子。 IL-4和IL-13是2型免疫反应中的关键细胞因子，作用于1型 IL-4Rα/γ和/或2型IL-4Rα/IL-13Rα复合物引发其信号传导作用，从而激活JAK-STAT信号通路（图3）。图3. IL-4和IL-13介导的信号通路目前为止全球范围内有5款靶向IL-4R药物获批上市，分别是甲磺司特、度普利尤单抗、吡美莫司、Actimmune以及司普奇拜单抗，其中度普利尤单抗是全球首款获批的IL-4R单抗药物，司普奇拜单抗是国内首个、全球范围第二个申报并获批上市的IL-4Rα抗体药物。图4. 获批和部分在研的靶向IL-4的药物度普利尤单抗是赛诺菲的当家花旦，在自免领域尤其是特应性皮炎适应症上取得巨大成功，撑起特药板块半边天，2023年销售额达到107.15亿欧元（115.7亿美元）。今年7月和9月，度普利尤单抗相继在欧盟、美国和中国获批慢性阻塞性肺病（COPD）新适应症，扩大其适应人群。除此之外，临床上还有很多在研的IL-4/IL-4R抑制剂，如康乃德的CBP-201、康方生物的AK120以及智翔医药的GR-1802等。 03 IL-17靶向制剂白细胞介素17（IL-17）是由CD4+ T细胞分泌，能够诱导上皮细胞、内皮细胞、成纤维细胞合成分泌IL-6、IL-8、G-CSF、PGE2，促进ICAM-1的表达的促炎因子。 IL-17有 IL-17A、IL-17B、IL-17C、IL-17D、IL-17E（也被称为IL-25）和IL-17F 6个家族成员。白介素IL-17受体（IL-17R）有IL-17RA、IL-17RB、IL-17RC、IL-17RD、IL-17RE 5个家族成员（图5）[2]。图5. IL-17介导的信号通路全球范围内共上市7款靶向IL-17A/IL-17RA药物，分别是司库奇尤单抗、依奇珠单抗、尼塔奇单抗、比吉利珠单抗、布罗利尤单抗、夫那奇珠单抗和赛立奇单抗（图6）。图6. 获批和部分在研的靶向IL-17药物目前，司库奇尤单抗和依奇珠单抗是全球最畅销的两款IL-17靶向生物制剂，司库奇尤单抗是由诺华研发的首款获批上市的靶向IL-17A单抗，用于治疗银屑病、银屑病关节炎和强直性脊柱炎等自免疾病，2022年销售额达47.88亿美元，2023年销售额达49.8亿美元。依奇珠单抗是由礼来研发的靶向IL-17A单抗，是第一个在银屑病关节炎（PsA）头对头研究中疗效优于阿达木单抗的IL-17A拮抗剂，2022年销售额达到24.82亿美元，2023年销售额达到27.6亿美元。今年8月份，恒瑞医药的夫那奇珠单抗和智翔金泰的赛立奇单抗获批上市，用于治疗适合接受系统治疗或光疗的中重度斑块状银屑病成人患者，成为国产首批获批的本土自主研发重组抗IL-17A人源化单克隆抗体，将打破同类进口药物的长期垄断局面，为银屑病患者提供新的治疗选择。除此之外，还有很多临床在研的靶向IL-17的生物制剂，包括荃信生物的QX-002N，康方生物的AK-111和君实生物的JS005等。 04 IL-6靶向制剂白介素-6（IL-6）是趋化因子家族的一种细胞因子，主要由单核巨噬细胞、 Th2细胞、血管内皮细胞、成纤维细胞产生。 IL-6的受体蛋白，由特异性的IL-6结合受体蛋白（IL-6R），和被称为信号转导蛋白的gp130所组成。按照信号传导方式的差异，IL-6参与的信号途径，可以分为经典信号通路（classical signaling）和转信号通路（Trans-signaling）。在经典信号通路中，IL-6与其膜结合受体mIL-6R、可溶性受体sIL-6R结合后，招募gp130（一种跨膜蛋白，细胞因子受体）结合形成IL-6-IL-6R-gp130六聚体，触发下游JAK-STAT、RAS-RAF等信号通路转导和基因表达。在转信号通路中，IL-6-sIL-6R复合物与gp130结合，启动细胞内信号转导，促进细胞增殖、分化、氧化应激和免疫调节（图7）[3]。图7. IL-6信号转导和IL-6受体系统的模式 IL-6信号通路异常与很多疾病的发病机制有关，包括类风湿性关节炎（RA）、系统性幼年特发性关节炎(sJIA)、Castleman病、巨细胞动脉炎（GCA）、大动脉炎和细胞因子释放综合征（CRS）等。目前全球有4款药物获批上市，包括靶向IL-6R的托珠单抗、Sarilumab、和萨特利珠单抗以及靶向IL-6的司妥昔单抗，其中托珠单抗由于上市时间早应用广泛，销售额遥遥领先，受益于用于新冠治疗的获批，曾在2021年达到销售峰值39.6亿美元。图8. 部分靶向IL-6的药物除此之外，临床上还有很多在研的IL-6或IL-6R拮抗剂药物，为了提高竞争性，很多药企进行差异化布局，开发新的适应症，包括优时比的olokizumab、诺和诺德的ziltivekimab和罗氏的RG6179等（图6）。 Olokizumab最初由优时比公司研发，是一款靶向IL-6的人源化单抗。后来在2013年转让给了俄罗斯药企R-Pharm，目前正在进行RA领域的上市申请。 Ziltivekimab最初是由Corvidia Therapeutics研发的IL-6单抗药物，后于2020年6月，诺和诺德以21亿美元收购Corvidia Therapeutics，接管了其主要候选药物ziltivekimab的开发工作。 Ziltivekimab旨在阻断IL-6通路来降低全身炎症，从而降低动脉粥样硬化性心血管疾病（ASCVD）和慢性肾脏病（CKD）患者的主要心血管不良事件风险，具有延长的半衰期，可以通过每月一次皮下注射给药。 RG6179是由罗氏研发的IgG2类IL-6单抗，可阻断经典和转信号传导，用于糖尿病性黄斑水肿、自身炎症性疾病、黄斑水肿和葡萄膜性黄斑水肿。小结自免是一个很大的疾病领域，有很多疾病靶点，目前全球自身免疫病药物市场中，TNF-α和IL-12/IL-23两个自免领域老靶点抑制剂销售额仍位居前列，而JAK、IL-4R、IL-17A、IL-6、IL-5、URAT1、TSLP、MASP-2、TYK2等靶点，则吸引较多创新药企布局，本文主要介绍JAK、IL-4R、IL-17A和IL-6四个热门自免靶点及其研发进展。参考文献 1.Aikaterini Tsiogka et.al, The JAK/STAT Pathway and Its Selective Inhibition in the Treatment of Atopic Dermatitis: A Systematic Review, J. Clin. Med. 2022, 11, 4431 2.Mandy J. McGeachy, Daniel J. Cua, and Sarah L. Gaffen, The IL-17 Family of Cytokines in Health and Disease, Immunity 50, April 16, 2019 3.Masashi Narazaki and Tadamitsu Kishimoto, The Two-Faced Cytokine IL-6 in Host Defense and Diseases, Int. J. Mol. Sci. 2018, 19, 3528. BiG近期会议 10月26日，第三届生物计算大会保留栏目-第二届吐槽大会即将再度来袭！将围绕投融资、行业心态、年轻人，及AI等热门话题展开策划，通过移幕换景，大咖带新秀，一同探讨AI+Biomed的融合之道！ ▼ 10月31日，BiG联合Citeline，将于10月底，举办自免小规模私董研讨会，聚焦：TCE vs. CAR-T，自身免疫开发策略，线上同步直播，敬请期待！ ▼ 共建Biomedical创新生态圈！如何加入BiG会员？

上市批准免疫疗法细胞疗法

2024-09-10

·FierceBiotech

Viridian's drug resolves eye disease symptoms in phase 3, advancing push to topple Amgen's Tepezza

Viridian Therapeutics expects to have top-line data from a second study by the end of the year. Viridian Therapeutics’ phase 3 thyroid eye disease (TED) clinical trial has hit its primary and secondary endpoints. But with Amgen’s Tepezza already on the market, the data leave scope to question whether the biotech has done enough to differentiate its asset and unseat the incumbent.Massachusetts-based Viridian exited phase 2 with six-week data showing its anti-IGF-1R antibody looked as good or better than Tepezza on key endpoints, encouraging the biotech to advance into phase 3. The study compared the drug candidate, which is called both veligrotug and VRDN-001, to placebo. But the presence of Tepezza on the market meant Viridian would need to do more than just beat the control to secure a shot at significant market share.Here’s how the comparison to Tepezza shakes out. Viridian said 70% of recipients of veligrotug had at least a 2 mm reduction in proptosis, the medical term for bulging eyes, after receiving five infusions of the drug candidate over 15 weeks. Tepezza achieved (PDF) response rates of 71% and 83% at week 24 in its two clinical trials. The placebo-adjusted response rate in the veligrotug trial, 64%, fell between the rates seen in the Tepezza studies, 51% and 73%.The second Tepezza study reported a 2.06 mm placebo-adjusted change in proptosis after 12 weeks that increased to 2.67 mm by week 18. Viridian saw a 2.4 mm placebo-adjusted change after 15 weeks. There is a clearer separation on a secondary endpoint, with the caveat that cross-trial comparisons can be unreliable. Viridian reported the complete resolution of diplopia, the medical term for double vision, in 54% of patients on veligrotug and 12% of their peers in the placebo group. The 43% placebo-adjusted resolution rate tops the 28% figure seen across the two Tepezza studies.Safety and tolerability offer another opportunity to differentiate veligrotug. Viridian is yet to share all the data but did report a 5.5% placebo-adjusted rate of hearing impairment events. The figure is lower than the 10% seen in the Tepezza studies but the difference was driven by the rate in the placebo arm. The proportion of events in the veligrotug arm, 16%, was higher than in the Tepezza studies, 10%.Viridian expects to have top-line data from a second study by the end of the year, putting it on track to file for approval in the second half of 2025. Investors sent the biotech’s share price up 13% to above $16 in premarket trading Tuesday morning.The questions about how competitive veligrotug will be could get louder if the other companies that are gunning for Tepezza deliver strong data. Argenx is running a phase 3 trial of FcRn inhibitor efgartigimod in TED. And Roche is evaluating its anti-1L-6R satralizumab in a pair of phase 3 trials. Viridian has its own plans to improve on veligrotug, with a half-life-extended formulation now in late-phase development.

临床3期临床结果临床2期

2024-08-23

·Insight数据库

国内首个！再鼎医药「艾加莫德」皮下注射剂型启动一项 Ⅲ 期临床

8 月 22 日，中国药物临床试验登记与信息公示平台显示，再鼎医药登记了一项 Ⅲ 期临床，以评估艾加莫德皮下注射剂型治疗成人甲状腺眼病的安全性和有效性。Insight 数据库显示，这也是首个在国内启动治疗甲状腺眼病 Ⅲ 期临床的 FcRn 拮抗剂。截图来自：药物临床试验登记与信息公示平台艾加莫德是一款人 IgG1 抗体的 Fc 片段，可与新生儿 Fc 受体（FcRn）结合，旨在减少致病性免疫球蛋白 G（IgG）抗体并阻断 IgG 循环，是全球和国内首款获批的 FcRn 拮抗剂。2021 年 6 月，再鼎医药与 argenx 公司达成一项总额达 1.75 亿美元的独家授权合作，在大中华区（中国内地，香港、澳门和台湾地区）开发和商业化艾加莫德。在中国，艾加莫德静脉输注剂型（商品名：卫伟迦）于 2023 年 7 月获批，用于治疗乙酰胆碱受体抗体阳性的成人全身型重症肌无力（gMG）患者。根据再鼎医药 2024 第二季度财报，卫伟迦 Q2 销售额为 2320 万美元，该药的成功商业化也推动再鼎二季度的产品收入净额同比增长 45% 至 1.001 亿美元。不过，艾加莫德的潜力可并不止于此。静脉输注剂型之外，艾加莫德的皮下注射剂型也已在临床中取得成功。艾加莫德的皮下注射由艾加莫德皮下注射与重组人透明质酸酶 PH20 共同配制，它可在 30-90 秒内以单次皮下注射的方式给药，而静脉注射则需要约 1 小时，皮下注射无疑可大大提高给药的便捷性。目前，艾加莫德的皮下注射剂型已在美国、欧盟、日本、中国获批上市，用于治疗成人全身型重症肌无力患者。在国内，它是首个获得 NMPA 批准治疗 gMG 患者的皮下注射制剂。艾加莫德的皮下注射研究进度时光轴截图来自：Insight 数据库而在适应症方面，全身型重症肌无力之外，艾加莫德还有望治疗多种由致病性 IgG 抗体介导的严重的自身免疫性疾病的潜力。再鼎医药本次启动的就是一项艾加莫德皮下注射剂型的新适应症 Ⅲ 期临床。这是一项多中心、随机、双盲、安慰剂对照、III 期研究，旨在甲状腺眼病成人患者中评价通过预充式注射器进行艾加莫德皮下注射给药的有效性、安全性、耐受性、药代动力学、药效学和免疫原性。试验主要目的是评价在双盲治疗期的第 24 周时艾加莫德皮下注射与安慰剂 PH20 皮下注射相比，实现突眼应答率的有效性。甲状腺眼病是一种严重、进行性并可能威胁视力的罕见自身免疫性疾病。甲状腺眼病经常发生在甲状腺功能亢进症的患者中，目前这类患者急需新的治疗选择。 Insight 数据库显示，在国内，目前尚无治疗甲状腺眼病患者的创新药获批。2024 年 5 月，信达递交了 IGF1R 单抗替妥尤单抗（IBI311）的上市申请，用于治疗甲状腺眼病，Insight 数据库预测该申请有望于 2025 年第二季度获批。此外，针对这类疾病研发进度较快的药物还有罗氏的 IL6R 抗体萨特利珠单抗和再鼎的艾加莫德皮下注射剂型，目前均已进入到 Ⅲ 期临床。封面来源：企业 Logo 免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。编辑：馨药 PR 稿对接：微信 insightxb 投稿：微信 insightxb；邮箱 insight@dxy.cn 多样化功能、可溯源数据…… Insight 数据库网页版等你体验点击阅读原文，立刻解锁！

临床3期财报上市批准医药出海

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	L01XC	DB15762

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
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,

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适应症	最高研发状态	国家/地区	公司	日期
格雷夫斯眼病	临床3期	美国	Roche Holding AG	2023-10-26
格雷夫斯眼病	临床3期	日本	Roche Holding AG	2023-10-26
格雷夫斯眼病	临床3期	阿根廷	Roche Holding AG	2023-10-26
格雷夫斯眼病	临床3期	澳大利亚	Roche Holding AG	2023-10-26
格雷夫斯眼病	临床3期	德国	Roche Holding AG	2023-10-26
格雷夫斯眼病	临床3期	中国香港	Roche Holding AG	2023-10-26
格雷夫斯眼病	临床3期	意大利	Roche Holding AG	2023-10-26
格雷夫斯眼病	临床3期	新加坡	Roche Holding AG	2023-10-26
抗-N-甲基-D-天冬氨酸受体脑炎	临床3期	美国	Hoffmann-La Roche, Inc.	2022-09-27
抗-N-甲基-D-天冬氨酸受体脑炎	临床3期	中国	Hoffmann-La Roche, Inc.	2022-09-27

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临床结果

适应症

分期

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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


ACTRIMS2024	N/A	急性髓性白血病 \| 视神经脊髓炎维持 AQP4 antibodies	1	Satralizumab	鹹繭襯鹽窪獵齋齋襯網(艱憲淵簾艱積襯製鹽鹹) = 餘構範觸簾艱衊顧繭鏇獵蓋網簾衊憲鏇遞鑰鏇 (淵簾糧餘構夢鑰願壓繭 )	积极	2024-03-01
Post-Marketing Surveillance Study (ACTRIMS2024)	N/A	视神经脊髓炎 IL-6 receptor recycling antibody	570	Satralizumab	鬱製範鑰網範壓蓋膚憲(淵築鹹鏇醖鏇膚網醖築) = 鏇齋艱遞築觸淵醖網夢鹽築鑰壓膚鏇觸廠淵鑰 (鏇獵壓壓廠壓繭範壓範 ) 更多	积极	2024-03-01
NCT04660539 (SAkuraMoon, ECTRIMS2023)	临床3期	视神经脊髓炎	166	Satralizumab-treated patients in SAkuraMoon	憲壓顧網鬱構顧糧築範(選蓋鹽選齋網觸選遞製) = 願繭衊醖窪遞艱積鹽鏇鏇壓觸蓋遞廠鹹醖顧獵 (願壓壓窪夢夢衊鹹範壓, 98.77 ~ 129.00) 更多	-	2023-09-30
				Satralizumab-treated patients in post-marketing	憲壓顧網鬱構顧糧築範(選蓋鹽選齋網觸選遞製) = 蓋鬱鹹構窪憲窪壓襯廠鏇壓觸蓋遞廠鹹醖顧獵 (願壓壓窪夢夢衊鹹範壓, 87.45 ~ 101.31) 更多
NCT02028884 \| NCT02073279 (ECTRIMS2023)	临床3期	视神经脊髓炎	-	Satralizumab	製鬱膚觸齋鏇艱構顧繭(餘鬱廠鏇鑰觸顧鹹襯鏇) = 6 (4.6%) patients had relapse after the index date, while being on continuous prescription of satralizumab. All 6 patients were female and were prescribed oral glucocorticoid at the index date; 5 of these were also prescribed concomitant immunosuppressants. 憲觸餘醖鹹願膚壓遞選 (簾艱觸願艱廠齋構簾鑰 )	积极	2023-09-30
NCT04660539 (SAkuraMoon, ACTRIMS2023)	临床3期	水通道蛋白4抗体阳性视神经脊髓炎谱系疾病 AQP4-IgG+	106	Satralizumab 120mg Q4W	鬱製艱夢鑰鹽艱遞壓鏇(範築築願廠鬱膚醖觸觸) = Rates of AEs in the OST were comparable with the DBP (332.6 [316.7-349.1]/100 PY) 蓋觸範鹽鑰簾夢選糧構 (繭積糧窪憲醖積艱鑰繭 ) 更多	积极	2023-05-30
AAN2023	N/A	水通道蛋白4抗体阳性视神经脊髓炎谱系疾病 AQP4-IgG+	16	Satralizumab monotherapy	選衊觸簾鹹築鹹蓋築範(製遞顧衊積餘襯壓繭淵) = leukopenia being the most common 築鏇獵積鏇衊窪艱構鏇 (襯廠壓鹽觸糧窪餘範醖 ) 更多	积极	2023-04-25
				Satralizumab + immunosuppressants
NCT04660539 (SAkuraMoon, AAN2023)	临床3期	水通道蛋白4抗体阳性视神经脊髓炎谱系疾病 AQP4-IgG+	106	Satralizumab 120mg Q4W	鹹願構憲醖廠衊鏇淵築(齋衊鑰夢網網窪糧獵網) = 廠淵糧鹹糧襯網窪範夢簾選範糧鏇衊範願製鹹 (選艱艱鑰網鏇齋夢窪襯, 316.7 ~ 349.1) 更多	积极	2023-04-25
ASN2022	N/A	新型冠状病毒感染 inflammatory marker (CRP)	92	Hemoperfusion	襯顧築壓製築鏇鏇構廠(淵衊築鹽積醖鑰夢蓋築) = 壓窪糧衊鏇蓋獵顧製醖範鬱夢積鹹淵醖憲夢壓 (艱選壓餘範獵積範廠網 )	积极	2022-11-04
				Tocilizumab	襯顧築壓製築鏇鏇構廠(淵衊築鹽積醖鑰夢蓋築) = 夢鏇壓蓋鑰築鏇醖遞夢範鬱夢積鹹淵醖憲夢壓 (艱選壓餘範獵積範廠網 )
NCT02028884 \| NCT02073279 (SAkuraStar, ECTRIMS2021)	临床3期	视神经脊髓炎	-	Satralizumab	襯觸衊範餘艱鑰簾鏇獵(壓廠鬱憲鑰鏇鹽築鏇襯) = 膚網夢積淵糧壓觸鏇衊廠觸顧艱襯鑰鹹鏇簾襯 (壓襯廠顧糧糧鬱壓憲遞, 365.9 ~ 414.4) 更多	-	2021-10-12
				Placebo	襯觸衊範餘艱鑰簾鏇獵(壓廠鬱憲鑰鏇鹽築鏇襯) = 網糧簾鑰製壓壓蓋醖鹹廠觸顧艱襯鑰鹹鏇簾襯 (壓襯廠顧糧糧鬱壓憲遞, 379.4 ~ 427.6) 更多
NCT02028884 \| NCT02073279 (SAkuraSky \| SAkuraStar, ECTRIMS2021)	临床3期	水通道蛋白4抗体阳性视神经脊髓炎谱系疾病 AQP4-IgG+	111	Satralizumab + baseline immunosuppressants	淵選選網獵簾鹹顧鏇鏇(願淵壓衊淵艱願淵衊範) = 構選蓋齋網鑰艱構壓艱製蓋築選鹹繭顧襯範膚 (衊蓋願糧簾淵廠範淵膚 ) 更多	积极	2021-10-12
				Satralizumab monotherapy	淵選選網獵簾鹹顧鏇鏇(願淵壓衊淵艱願淵衊範) = 選壓夢獵餘餘鬱膚顧獵製蓋築選鹹繭顧襯範膚 (衊蓋願糧簾淵廠範淵膚 ) 更多