依库珠单抗(Eculizumab) - 药物靶点：C5_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，非典型溶血性尿毒症综合征，重症肌无力_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Anti-C5 monoclonal antibody 5G1-1、Eculizumab (Genetical Recombination)、Eculizumab (genetical recombination) (JAN)

+ [16]

靶点

C5

作用方式

抑制剂

作用机制

C5抑制剂(补体C5抑制剂)

治疗领域

肿瘤免疫系统疾病感染+ [5]

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非典型溶血性尿毒症综合征重症肌无力+ [2]

非在研适应症

原研机构

Alexion Pharmaceuticals, Inc.

在研机构

Alexion Europe SAS

Alexion Pharmaceuticals, Inc.阿斯利康全球研发（中国）有限公司

+ [3]

非在研机构-

权益机构

Alexion Pharmaceuticals, Inc.

AstraZeneca PLC

最高研发阶段批准上市

首次获批日期

美国 (2007-03-16),

阵发性睡眠性血红蛋白尿症

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)、优先审评 (中国)、孤儿药 (韩国)、孤儿药 (澳大利亚)、孤儿药 (日本)

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结构/序列

Sequence Code 66437L

来源: *****

Sequence Code 66453H

来源: *****

关联

61

项与依库珠单抗相关的临床试验

NCT05646563

/ Not yet recruiting临床2期

A Phase II, Open-Label Study of NM8074 in Soliris®-Treated Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)

This is a Phase II, open-label study designed to evaluate the safety, efficacy, and immunogenicity of NM8074 in PNH patients undergoing complement-inhibitor therapy with Soliris.

开始日期2026-01-01

申办/合作机构

NovelMed Therapeutics, Inc.

NCT07010302

/ Not yet recruiting临床4期IIT

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2025-11-01

申办/合作机构

The Massachusetts General Hospital

[+1]

NCT06724809

/ Recruiting临床3期

An Open-label, Single-arm, Multi-Center, Interventional Study to Evaluate the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Eculizumab in Chinese Adult Participants With Anti-Aquaporin-4 Antibody Positive Neuromyelitis Optica Spectrum Disorders (NMOSD)

The primary objective of this study is to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of Eculizumab in Chinese Adults with Neuromyelitis Optica Spectrum Disorders (NMOSD).

开始日期2025-01-16

申办/合作机构

Alexion Pharmaceuticals, Inc.

[+1]

100 项与依库珠单抗相关的临床结果

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100 项与依库珠单抗相关的转化医学

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100 项与依库珠单抗相关的专利（医药）

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2,793

项与依库珠单抗相关的文献（医药）

2025-12-31·Hematology

Eculizumab treatment for Chinese patients with hemolytic paroxysmal nocturnal hemoglobinuria (PNH): efficacy and safety – a single-center study

Article

作者: Yang, Chen ; Chen, Miao ; Han, Bing ; Liu, Ziwei ; Wang, Leyu

OBJECTIVE:

To evaluate the short-term efficacy and safety of eculizumab for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) in China.

METHOD:

Data were retrospectively collected from patients with PNH who received at least 3 months of full-dose eculizumab. Changes in clinical and laboratory indicators after 1, 3, and 6 months of eculizumab therapy and at the end of follow-up were documented. The incidence rates of breakthrough hemolysis (BTH), extravascular hemolysis (EVH), and adverse events were recorded.

RESULT:

A total of 48 patients, including 27 males, with a median age of 46 (12-78) years were included. Twenty-four (50%) patients had classic PNH and 24 (50%) had bone marrow failure (BMF)/PNH. Eighteen (37.5%) patients required blood transfusion. The median duration of follow-up was 6 (3-15) months. During the follow-up period, Lactate Dehydrogenase (LDH) levels were lower than those at baseline (<0.05) at all observation points. The patients showed a significant reduction in creatinine levels from baseline (P = 0.022 and P = 0.039, respectively) at 1 and 3 months. At the end of the follow-up, fifteen (83.3%) became transfusion-independent. No new thrombotic events were observed. The FACIT-Fatigue score significantly improved (P < 0.05). No significant differences were observed in the changes in hemoglobin or LDH levels between patients with classic PNH and those with BMF/PNH. BTH was observed in 17.4% of patients and EVH in 10.4%. Mild adverse events occurred in 22.9% of patients. No deaths or clonal evolution was observed.

CONCLUSION:

Eculizumab can effectively control the hemolytic symptoms of PNH with good tolerance for Chinese patients.

2025-09-01·JOURNAL OF INFECTION AND CHEMOTHERAPY

Disseminated gonococcal infection developing two days after initial eculizumab administration in a patient with neuromyelitis optica spectrum disorder: A case report and literature review

Review

作者: Kawamura, Mayuko ; Ono, Daisuke ; Ebihara, Yasuhiro ; Ebata, Eiyu ; Nishida, Yusuke ; Koyama, Sachie ; Mimura, Kazuyuki ; Fukaura, Hikoaki ; Kawamura, Takayuki ; Oka, Hideaki

Disseminated gonococcal infection (DGI) is a rare complication of Neisseria gonorrhoeae infection. Eculizumab, a complement C5 inhibitor used in conditions such as paroxysmal nocturnal hemoglobinuria, increases the risk of invasive Neisseria spp. infections. Although previous reports have described DGI in eculizumab-treated patients, evidence involving individuals with neuromyelitis optica spectrum disorder (NMOSD) is limited, and all cases occurred weeks to months after treatment initiation. In the present case, the patient received a quadrivalent meningococcal vaccine before receiving eculizumab. Two days after the first dose, the patient presented with fever, chills, and headache. Laboratory findings revealed leukocytosis and mildly elevated C-reactive protein levels, with unremarkable urinalysis and cerebrospinal fluid results. Blood cultures revealed the presence of N. gonorrhoeae, confirming DGI. A blood test on day 5 revealed a CH50 level of 6.0 U/mL. Screening for other sexually transmitted infections was negative. Antimicrobial susceptibility testing revealed elevated minimum inhibitory concentrations (MICs) for penicillin G, ciprofloxacin, azithromycin, and minocycline, whereas the MIC for ceftriaxone remained low. The patient received intravenous ceftriaxone for 14 days. Following the patient's refusal to continue eculizumab therapy, the patient has chosen inebilizumab, resulting in stable management of NMOSD symptoms. The patient has been attending outpatient appointments approximately every two months, and no recurrence of gonococcal infection has been observed for at least 2 years. This is a case of DGI in a patient with NMOSD, and the earliest reported onset of DGI following eculizumab initiation. Clinicians should remain vigilant for invasive gonococcal infections, even shortly after initiating complement-inhibiting therapy.

2025-09-01·CLINICAL TRANSPLANTATION

Effectiveness and Safety of Switching to Ravulizumab From Eculizumab in Kidney Transplant Recipients With Atypical Hemolytic Uremic Syndrome: A Global aHUS Registry Analysis

Article

作者: Isbel, Nicole ; Eygenraam, Margriet ; Saval, Nuria ; Dieperink, Hans Herman ; Gaeckler, Anja ; Greenbaum, Larry A. ; Al‐Dakkak, Imad ; Walle, Johan Vande

ABSTRACT:

Introduction:

Atypical hemolytic uremic syndrome (aHUS) is a disease of complement dysregulation that may lead to kidney failure. Ravulizumab and eculizumab are complement C5 inhibitors approved for the treatment of aHUS. This study assessed the real‐world effectiveness and safety of switching to ravulizumab from eculizumab in kidney transplant recipients with aHUS.

Methods:

The Global aHUS Registry is a multicenter study enrolling patients with aHUS since 2012. Effectiveness and safety outcomes were assessed in kidney transplant recipients with aHUS who switched to ravulizumab from eculizumab up to September 2, 2024.

Results:

Overall, 38 patients received a kidney transplant before ravulizumab initiation; 27 patients with ≥3 months of ravulizumab treatment were included in the patient characteristics and effectiveness analyses. Median (range) time on eculizumab and ravulizumab treatment was 66.1 (3.7, 158.3) and 24.1 (4.2, 49.3) months, respectively (n = 27); time from last kidney transplantation to ravulizumab initiation was 65.9 (3.7, 184.0) months. Following ravulizumab initiation, laboratory parameters remained stable, and no kidney transplant rejections/graft failures were reported. In the safety analysis (n = 38), 23 adverse events were reported in 19 patients (50.0%) at or after ravulizumab initiation, and none were considered treatment‐related. No new events of thrombotic microangiopathy or kidney impairment and no meningococcal infections or deaths were reported.

Conclusion:

This analysis from the Global aHUS Registry provides real‐world evidence to demonstrate that the transition to ravulizumab from eculizumab in kidney transplant recipients with aHUS is successful, with stable graft function with no treatment‐related safety concerns.

Trial Registration:

ClinicalTrials.gov identifier: NCT01522183

502

项与依库珠单抗相关的新闻（医药）

2025-09-09

·ETPharma

AstraZeneca launches rare blood, kidney disease drug Eculizumab in India

New Delhi: UK Pharma major AstraZeneca India arm has announced the launch of its C-5 inhibitor, Eculizumab in India The drug is approved by the CDSCO for the treatment of rare, life-threatening disease Paroxysmal Nocturnal Hemoglobinuria (PNH) and atypical Hemolytic Uremic Syndrome (aHUS) in both adults and children. In India the pharma giant India arm has secured approval for the import, sale, and distribution of the product. Eculizumab, a novel monoclonal antibody developed by Alexion Pharmaceuticals, Inc, later became part of the UK major portfolio following its acquisition of Alexion for around $39 billion in 2021. The drug is designed to block the C5 protein which damages blood cells and kidney tissues in conditions like PNH, aHUS. “The launch of Eculizumab as India’s first approved anti-complement therapy demonstrates our dedication to delivering innovative medicines at the earliest opportunity, especially where there is significant unmet medical need,” said Praveen Akkinepally, Country President and Managing Director, AstraZeneca India. In the US the drug is marketed under the brand name ‘ Soliris ’ and has been accused of evergreening the patent with minor increments in the country. The therapy compositions are set to lose their patent protection by 2027. According to AstraZeneca 2024 annual sales, Soliris (Eculizumab) is the company’s second leading rare disease asset with net world wide sales of $2.58 billion (~around Rs 22,000 crore). By Online Bureau ,

上市批准并购专利到期

2025-09-08

·FierceBiotech

Dianthus\' gMG prospect blooms, with phase 2 win setting up pivotal plans

Dosing is central to Dianthus Therapeutics\' plans to differentiate its candidate in a competitive market. \n Dianthus Therapeutics is advancing its challenge for the increasingly competitive generalized myasthenia gravis (gMG) market, outlining plans to move into phase 3 on the back of hits in a midphase study.The phase 2 trial compared two doses of claseprubart, an antibody engineered to selectively target the classical pathway, to placebo in 65 adults with AChR-positive gMG. Patients received claseprubart every two weeks via subcutaneous injection. While the primary endpoint looked at safety and tolerability, the secondary endpoint data provided a glimpse of the efficacy of the drug candidate. At the low dose, Dianthus reported a 4.6-point improvement on MG-ADL, a scale that measures the impact of gMG on daily functions. The improvement rose to 5.4 points on the high dose. Adjusted for placebo, the improvements on the low and high doses were 1.8 points and 2.6 points, respectively.Dianthus shared the results alongside data on QMG, a physician\'s score of disease severity. QMG scores improved 4.4 points and 4.5 points, respectively, on the low and high doses. Scores improved by two points in the placebo arm. Dianthus also reported statistically significant improvements on other measures of gMG. The biotech shared cross-trial comparisons to show how claseprubart performed against AstraZeneca’s Soliris and Ultomiris and UCB’s Zilbrysq. Claseprubart outperformed the competition in the data shared by Dianthus, with the caveat that such cross-trial comparisons can be unreliable. The company found the drug candidate was generally well tolerated, giving it a data set to inform talks with the FDA and preparations for phase 3. Dianthus plans to test two regimens of the low dose in phase 3, with patients receiving the study drug every two or four weeks. Dianthus didn’t test four-week dosing in the phase 2 study, but the lack of statistical difference between the low and high doses, coupled with evidence such as half-life data, led it to speculate that a less-frequent regimen could work. The two-week dose is Dianthus’ target product profile, but CEO Marino Garcia sees an opportunity to go beyond the base case.“Why not go further? Why not push that differentiation? I don\'t see much of a downside to be honest,” Garcia said on a call with investors to discuss the data. Dosing is central to Dianthus’ plans to differentiate its candidate in a competitive market. The company said more than 80% of patients with AChR-positive gMG have yet to switch to a biologic, despite the availability of C5 inhibitors such as Ultomiris and FcRn drugs, including argenx’s Vyvgart. Dianthus has identified intravenous and high-volume subcutaneous dosing as a barrier to uptake of rival drugs.That thinking led Dianthus to develop an autoinjector. The overarching goal is to combine the efficacy of C5 inhibitors such as Ultomiris with the safety of C1 blockers such as Enjaymo and the convenience of Dupixent. Analysts at Evercore ISI said in a note to clients that: “Both doses clearly met all the bull case efficacy bars” the firm had discussed in preview ahead these data. They added that the biotech “convincingly” matched the C5s. It didn’t see a dose response, thus “opening the door to a longer Q4W dosing interval.”

$Dianthus\' gMG prospect blooms, with phase 2 win setting up pivotal plans$

临床结果临床2期临床3期

2025-09-08

·BiG生物创新社

阿斯利康走出阴霾

▼ 9月26-29日，BiG将召开以「创新出海云起潮升」为主题的第十一届IMPACT年会，9月27日下午分论坛四：全球视角，MNC与顶级VC的战略布局上，我们邀请了五家MNC高管，一起聊一聊跨国药企的中国棋局：BD热点的寻猎、Biotech价值的反哺与未来生态！作者｜momo 阿斯利康曾凭借明星药物风光无限，却也在专利悬崖袭来时跌入谷底，一度陷入至暗时刻。然而，通过果断的战略重组、聚焦肿瘤与自免领域，阿斯利康成功走出阴霾，重回行业前沿。 01 风暴降临阿斯利康在21世纪初曾是全球制药行业中最耀眼的企业之一。其营收从2000年的142.28亿美元跃升至2010年的332.69亿美元，增幅高达134%。这一爆发式增长主要倚仗降脂药Crestor、抗精神分裂药物Seroquel和抑酸药Nexium这三款核心药物。这三款药物总销售额从2003年的49.18亿美元攀升至2010年的159.69亿美元，占总营收比重从26%提高到48%，这一期间阿斯利康的业绩增长严重依赖单一产品组合。然而，专利悬崖成为悬在阿斯利康头顶的达摩克利斯之剑。2012年至2017年间，三大核心药物专利相继到期，仿制药迅速侵蚀市场。这一连串打击使公司营收从2011年的335.91亿美元萎缩至2017年的201.52亿美元。与此同时，阿斯利康也面临内部创新乏力问题。2009至2014年间推出的多款新产品中，除降糖药Farxiga外均未达预期，无法填补核心药物衰退留下的空洞，公司陷入至暗时刻。为应对危机，阿斯利康开启深度重组。通过整合研发体系、控制用人成本，并大幅增加肿瘤领域投入以及通过并购拓展业务边界成功获得显著成效，2020年以390亿美元收购Alexion，进军罕见病和自免领域，形成“肿瘤+自免”双轮驱动的格局。值得注意的是，在中国市场的表现成为阿斯利康渡过难关的重要支撑。在阿斯利康全球营收低迷期，中国区业绩持续增长，占比一度超过20%，成为其全球第二大市场。然而，高增长背后隐藏着合规隐患。2021年4月起，阿斯利康在中国多地爆发“骗保窝案”，员工通过伪造基因检测报告、虚构处方等方式骗取医保基金，涉案人员从基层代表蔓延至高层管理者，数十人被判重刑。这起近年最大规模的药企骗保案，对阿斯利康声誉造成严重损害，2024年年末，阿斯利康股价下跌超过18%，直接丢掉了英国市值最高药企的宝座，阿斯利康再次陷入风暴中心。 02 深耕乳腺癌陷入阴霾的阿斯利康，试图重塑了其在全球制药行业的领导地位，在此背景下，乳腺癌领域逐渐成为其战略布局的重中之重，通过自研、合作与并购，阿斯利康正逐渐构建起覆盖乳腺癌全周期的产品矩阵（表1）。表1.阿斯利康乳腺癌核心产品布局数据来源：公开资料整理 2025年上半年业绩数据显示，阿斯利康肿瘤业务营收达120亿美元，占总营收的43%，同比增长16%，成为公司增长的核心动力。其中乳腺癌药物表现尤为突出，Enhertu（德曲妥珠单抗）收入12.62亿美元，同比增长38%，已成为全球乳腺癌治疗领域的标杆产品，进一步巩固其在肿瘤领域的领导地位。上世纪70年代，阿斯利康推出的全球首个雌激素受体靶向药物他莫昔芬（Nolvadex）。此后数十年间，阿斯利康以内分泌治疗为基石，陆续开发了阿那曲唑（Arimidex）、氟维司群（Faslodex）和戈舍瑞林（Zoladex）等药物，形成了针对HR+乳腺癌的全面解决方案。后续随着研发重点向精准治疗拓展，阿斯利康通过自研与合作，快速丰富了乳腺癌产品管线。表2.阿斯利康乳腺癌领域合作与收购数据来源：公开资料整理 2018年，PARP抑制剂奥拉帕利（Lynparza）获批用于BRCA突变HER2阴性乳腺癌，通过“合成致死”机制为特定遗传背景患者提供精准治疗，应用场景也从晚期拓展至早期辅助治疗； 2019年，阿斯利康通过与第一三共的合作获得了HER2靶向ADC药物Enhertu。该药物将适用人群从传统HER2阳性患者扩展至HER2低表达及超低表达群体，重新定义了乳腺癌分子分型标准。 2025年ASCO大会公布的DESTINY-Breast09 III期研究结果进一步巩固了Enhertu的领导地位。研究结果显示：Enhertu联合帕妥珠单抗一线治疗HER2阳性转移性乳腺癌，中位无进展生存期超过36个月，创下该领域新纪录。基于这一数据，美国FDA于2025年7月授予该组合突破性疗法认定。与此同时，阿斯利康后续相继推出AKT抑制剂Truqap（Capivasertib）和TROP2 ADC药物Datroway，形成战略互补。Datroway凭借独特的“旁观者效应”在异质性肿瘤治疗中展现优势，目前已在美国、日本以及中国获批用于HR+/HER2-乳腺癌治疗，并正探索三阴性乳腺癌（TNBC）领域的应用潜力。在内部研发取得突破的同时，阿斯利康通过一系列高价值合作持续强化乳腺癌领域布局。2019年以69亿美元获得Enhertu全球权益（除日本外），不仅解决了HER2领域产品空白，更获得了DXd ADC技术平台； 2023年与中国康诺亚合作开发Claudin 18.2 ADC（CMG901），加码胃癌及乳腺癌潜力靶点； 2025年3月，公司与和铂医药达成45.75亿美元合作，利用其全人源抗体平台开发多特异性抗体疗法。 2025年，阿斯利康将目光投向2030年后的技术竞争，通过收购布局下一代治疗平台。收购EsoBiotec获得体内CART技术ENaBL平台；与韩国Alteogen合作开发皮下注射剂型。 03 自免新突破在自免领域，阿斯利康同样展现出强劲市场竞争力。近年来，其自免管线涵盖补体通路抑制、细胞因子调控、多特异性抗体技术等多个前沿方向，不断取得重要进展。瑞利珠单抗（Ultomiris）作为第二代长效C5补体抑制剂，通过精准抑制末端补体级联反应中的C5蛋白，实现即时、完全且持续的免疫调控，其能够显著延长给药间隔，提高患者依从性，并有效替代第一代产品依库珠单抗（Soliris）。目前该药已在美国、欧盟和日本获批用于治疗视神经脊髓炎谱系疾病（NMOSD）、阵发性睡眠性血红蛋白尿症（PNH）、非典型溶血尿毒综合征（aHUS）及重症肌无力（gMG）。2025年上半年，瑞利珠单抗全球销售额达22.28亿美元，同比增长24%（图1），其中新兴市场增长高达82%，美国与欧洲市场分别增长23%和21%，体现其迭代优势。图1.阿斯利康2025上半年自免相关产品收入与此同时，特泽利尤单抗（Tezspire）作为全球首款靶向胸腺基质淋巴生成素（TSLP）的单抗药物，于2021年12月获FDA批准用于重症哮喘的附加维持治疗，2024年全球销售额突破10亿美元，2025年上半年达4.83亿美元，同比增长73%（图1）。目前，其适应症正拓展至慢性鼻窦炎伴鼻息肉（CRSwNP）、慢性阻塞性肺病（COPD）和嗜酸性食管炎（EoE）等领域。在系统性红斑狼疮（SLE）领域，阿伏利尤单抗（Saphnelo）作为全球首个靶向I型干扰素通路的生物制剂，通过阻断多种干扰素亚型的作用，直接调控SLE的核心发病机制。自2021年获批以来，其销售额持续增长，2024年达4.74亿美元，2025年上半年为3.04亿美元，同比增长49%（图1）。另外，AZD5492作为全球首款CD20/TCR/CD8三特异性抗体，最初针对B细胞恶性肿瘤开发，2025年4月已在国内获批临床用于系统性红斑狼疮和特发性炎症性肌病，实现了从肿瘤到自免领域的机制迁移。体现出阿斯利康跨界拓展能力。另一亮点是本瑞利珠单抗（Fasenra），其通过精准靶向嗜酸性粒细胞（EOS）通路，已获批用于重度嗜酸粒细胞性哮喘和嗜酸性肉芽肿性多血管炎（EGPA）。2025年上半年该药销售额达9.2亿美元，同比增长18%，凸显其在嗜酸粒细胞相关疾病中的核心地位。此外，固定剂量三联疗法Breztri Aerosphere（布地奈德/格隆溴铵/福莫特罗）在哮喘治疗中取得重大进展。2025年5月公布的III期KALOS和LOGOS研究显示，与标准ICS/LABA疗法相比，Breztri在改善肺功能方面具有统计学和临床意义的优势，且未出现新的安全性信号。该药已在全球多国获批用于COPD，其哮喘适应症的拓展将有望惠及更广泛的哮喘患者群体。结语从风暴中走出的阿斯利康，凭借其在乳腺癌领域的精准布局与自免领域的创新突破，实现了业绩的强势回升，展现出MNC在危机中转型的战略韧性。参考资料 [1]https://mp.weixin.qq.com/s/ElLIESUlqkU50TagYfU8Kw [2]https://www.astrazeneca.com/content/dam/az/Investor_Relations/events/ASCO2025-Presentation-20250602b.pdf [3]https://dailynews.ascopubs.org/do/destiny-breast09-trastuzumab-deruxtecan-plus-pertuzumab-sets-new-first-line-benchmark [4]https://www.astrazeneca.com/ [5]https://www.sciencedirect.com/science/article/pii/S1535610820301495?via%3Dihub [6]https://www.astrazeneca.com/content/dam/az/PDF/2025/h1q2/H1-and-Q2-2025-results-announcement.pdf 近期活动 9月26-29日，BiG将召开以「创新出海云起潮升」为主题的第十一届IMPACT年会，届时上海杭州双城联动，向全球化，再出发！ ▼ 时间及地点： 9月26-27日上海-张江希尔顿；规模：600-800人 9月29日杭州-西湖大学；规模：100人（需单独注册）报名入口会议门票：审核制(免费)；含主论坛+分论坛，不含餐；优先Biotech/Pharma、临床、院校科学家、投资机构付费门票：详见上二维码，注册内信息 1v1资本对接会路演项目征集可扫码填写项目信息现场开放1v1咨询台，与各大头部VC面对面 ▼ 电脑端链接：https://event.mymova.com/spa4/#/?eventname=11bigvc 共建Biomedical创新生态圈！如何加入BiG会员？

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100 项与依库珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D03940	依库珠单抗	L04AA25	DB01257

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	Alexion Pharmaceuticals, Inc.	2009-03-20
非典型溶血性尿毒症综合征	欧盟	Alexion Europe SAS	2007-06-20
非典型溶血性尿毒症综合征	冰岛	Alexion Europe SAS	2007-06-20
非典型溶血性尿毒症综合征	列支敦士登	Alexion Europe SAS	2007-06-20
非典型溶血性尿毒症综合征	挪威	Alexion Europe SAS	2007-06-20
重症肌无力	欧盟	Alexion Europe SAS	2007-06-20
重症肌无力	冰岛	Alexion Europe SAS	2007-06-20
重症肌无力	列支敦士登	Alexion Europe SAS	2007-06-20
重症肌无力	挪威	Alexion Europe SAS	2007-06-20
视神经脊髓炎	欧盟	Alexion Europe SAS	2007-06-20
视神经脊髓炎	冰岛	Alexion Europe SAS	2007-06-20
视神经脊髓炎	列支敦士登	Alexion Europe SAS	2007-06-20
视神经脊髓炎	挪威	Alexion Europe SAS	2007-06-20
阵发性睡眠性血红蛋白尿症	美国	Alexion Pharmaceuticals, Inc.	2007-03-16

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
移植物功能延迟恢复	临床3期	美国	Alexion Pharmaceuticals, Inc.	2014-08-21
移植物功能延迟恢复	临床3期	澳大利亚	Alexion Pharmaceuticals, Inc.	2014-08-21
移植物功能延迟恢复	临床3期	巴西	Alexion Pharmaceuticals, Inc.	2014-08-21
移植物功能延迟恢复	临床3期	加拿大	Alexion Pharmaceuticals, Inc.	2014-08-21
移植物功能延迟恢复	临床3期	捷克	Alexion Pharmaceuticals, Inc.	2014-08-21
移植物功能延迟恢复	临床3期	法国	Alexion Pharmaceuticals, Inc.	2014-08-21
移植物功能延迟恢复	临床3期	德国	Alexion Pharmaceuticals, Inc.	2014-08-21
移植物功能延迟恢复	临床3期	意大利	Alexion Pharmaceuticals, Inc.	2014-08-21
移植物功能延迟恢复	临床3期	西班牙	Alexion Pharmaceuticals, Inc.	2014-08-21
水通道蛋白4抗体阳性视神经炎	临床3期	美国	Alexion Pharmaceuticals, Inc.	2014-04-11

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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


PB2827 (EHA2025)	N/A	阵发性睡眠性血红蛋白尿症	52	Eculizumab	膚艱觸壓襯願獵鹽醖夢(醖積繭遞窪憲鏇築觸夢) = occurred in 30.8% 範鹽獵範淵醖衊繭鏇憲 (鹹蓋獵選衊齋艱構積顧 ) 更多	-	2025-05-14
S34.006 (AAN2025)	N/A	重症肌无力 anti-acetylcholine receptor antibody-positive (AChR-Ab+)	254	Eculizumab	憲選餘鏇糧顧襯壓蓋窪(鏇醖齋鹽夢範艱網鑰鑰) = 40.5% experienced adverse drug reactions (ADRs) 蓋淵鹹觸廠遞鹽鏇獵鹹 (憲構鑰選衊願鏇獵衊夢 ) 更多	积极	2025-04-07
SOHO2024	N/A	阵发性睡眠性血红蛋白尿症	-	Eculizumab	壓廠顧淵醖窪網網鹽觸(膚網淵鹹壓膚範夢積鑰) = 廠醖構鏇襯遞鑰鏇積鏇膚築淵艱構鬱願獵網鏇 (夢鹹鏇簾顧築淵簾築窪 ) 更多	-	2024-09-04
				Ravulizumab	壓廠顧淵醖窪網網鹽觸(膚網淵鹹壓膚範夢積鑰) = 顧範襯醖窪醖膚願鏇繭膚築淵艱構鬱願獵網鏇 (夢鹹鏇簾顧築淵簾築窪 ) 更多
NCT04320602 (CTgov)	临床4期	阵发性睡眠性血红蛋白尿症	18	Eculizumab+Ravulizumab	積鹹鏇網觸鹽淵壓憲襯 = 選齋醖艱鹽獵觸夢窪積觸窪鹽範膚網範鏇築顧 (艱選鹹顧夢遞構製艱齋, 網鹹鬱鬱鹽築淵構網網 ~ 製簾餘廠獵鏇繭繭觸積) 更多	-	2024-08-12
NCT01770951 (C09-001r, FDA_CDER) 人工标引	N/A	非典型溶血性尿毒症综合征	19	Eculizumab (<2 yrs)	觸鹹繭觸夢鹹蓋範鏇簾(網糧簾築衊窪遞廠艱積) = 顧築鹹齋衊夢憲鹹窪餘遞膚夢鏇鬱鹹獵製遞簾 (繭膚膚艱獵蓋膚鹽夢夢 ) 更多	积极	2024-07-19
				Eculizumab (2 to <12 yrs)	觸鹹繭觸夢鹹蓋範鏇簾(網糧簾築衊窪遞廠艱積) = 觸壓憲憲夢鏇壓夢簾顧遞膚夢鏇鬱鹹獵製遞簾 (繭膚膚艱獵蓋膚鹽夢夢 ) 更多
NCT01194973 (C10-004, FDA_CDER) 人工标引	临床2期	非典型溶血性尿毒症综合征	41	Eculizumab	糧蓋範醖餘顧憲蓋糧積(蓋選鏇積淵獵選憲齋簾) = 範襯積鹽夢簾鏇廠範觸壓願襯壓醖衊獵蓋淵簾 (網憲醖艱鬱鏇夢蓋願夢, 40 ~ 72) 更多	积极	2024-07-19
NCT00844844 \| NCT00844545 (C08-002B, FDA_CDER) 人工标引	临床2期	非典型溶血性尿毒症综合征	17	Eculizumab (at 26 wks)	壓鏇遞製鑰鹽繭網襯簾(蓋夢夢壓醖遞鏇壓網廠) = 鏇齋窪顧淵鹽網鏇廠選獵餘襯糧鬱構願夢蓋襯 (願鹽鏇選蓋憲膚選蓋糧 ) 更多	积极	2024-07-19
				Eculizumab (at 2 yrs)	壓鏇遞製鑰鹽繭網襯簾(蓋夢夢壓醖遞鏇壓網廠) = 衊餘夢廠餘願鹹襯蓋齋獵餘襯糧鬱構願夢蓋襯 (願鹽鏇選蓋憲膚選蓋糧 ) 更多
NCT01193348 (C10-003, FDA_CDER) 人工标引	临床2期	非典型溶血性尿毒症综合征	22	Eculizumab (Patients 1 month to <12 years)	衊蓋觸積衊糧鹹壓襯選(齋鹽膚積製壓觸遞願蓋) = 鏇構糧窪網範鹹齋廠憲積糧製鏇糧願簾築壓艱 (構淵艱製窪顧衊製選廠, 36 ~ 83) 更多	积极	2024-07-19
				Eculizumab (All Patients)	衊蓋觸積衊糧鹹壓襯選(齋鹽膚積製壓觸遞願蓋) = 觸製鏇鬱獵衊膚選醖壓積糧製鏇糧願簾築壓艱 (構淵艱製窪顧衊製選廠, 41 ~ 83) 更多
NCT00844428 \| NCT00838513 (C08-003B, FDA_CDER) 人工标引	临床2期	非典型溶血性尿毒症综合征	20	Eculizumab (at 26 wks)	網鏇鹹範窪遞壓繭遞製(選壓憲淵願範製顧積鹽) = 鬱襯醖窪範簾鹹壓襯膚淵廠鬱選繭鹹遞簾製鏇 (製鏇淵糧築糧壓糧鑰觸 ) 更多	积极	2024-07-19
				Eculizumab (at 2 yrs)	網鏇鹹範窪遞壓繭遞製(選壓憲淵願範製顧積鹽) = 遞觸壓蓋齋製獵糧製鬱淵廠鬱選繭鹹遞簾製鏇 (製鏇淵糧築糧壓糧鑰觸 ) 更多
NCT00122330 (FDA_CDER) 人工标引	临床3期	阵发性睡眠性血红蛋白尿症	87	Placebo	衊衊範壓壓遞憲願簾憲(淵窪淵鑰觸顧餘顧願膚) = 鏇獵簾顧製繭繭鹹窪齋壓製觸壓鏇積醖廠膚鹹 (鹽觸製願餘簾壓醖夢壓 ) 更多	积极	2024-07-19
				Eculizumab	衊衊範壓壓遞憲願簾憲(淵窪淵鑰觸顧餘顧願膚) = 鑰廠憲積範衊獵顧鹹糧壓製觸壓鏇積醖廠膚鹹 (鹽觸製願餘簾壓醖夢壓 ) 更多