乐维利单抗(Levilimab) - 药物靶点：IL-6RA_在研适应症：类风湿关节炎，新型冠状病毒感染_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Ilsira

靶点

IL-6RA

作用机制

IL-6RA拮抗剂(白细胞介素-6受体α亚基拮抗剂)

治疗领域

免疫系统疾病感染呼吸系统疾病+ [1]

在研适应症

类风湿关节炎新型冠状病毒感染

非在研适应症-

原研机构

Biocad Medical, Inc.

在研机构

Biocad CJSC

非在研机构-

最高研发阶段批准上市

首次获批日期

俄罗斯 (2020-06-04),

新型冠状病毒感染

最高研发阶段(中国)-

特殊审评-

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序列信息

Sequence Code 432066943L

来源: *****

Sequence Code 432066942H

来源: *****

关联

5

项与乐维利单抗相关的临床试验

NCT05800327 / Active, not recruiting临床3期

A Two-Stage Study of the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics and Immunogenicity of Various Doses of Levilimab When Administered Intravenously and Subcutaneously to Healthy Subjects and Subjects With Active Rheumatoid Arthritis

This is a two-stage study of efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of various doses of levilimab when administered intravenously and subcutaneously to healthy subjects and subjects with active rheumatoid arthritis resistant to methotrexate monotherapy.
Aim of the Stage 1 is to study the tolerability, safety, immunogenicity, and main pharmacokinetic and pharmacodynamic parameters of levilimab after its single subcutaneous or intravenous administration at ascending doses to healthy subjects.
Aim of the Stage 2 is to confirm the efficacy and safety of levilimab 648 mg IV Q4W in combination with methotrexate and levilimab 324 mg SC Q2W in combination with methotrexate in subjects with active rheumatoid arthritis, resistant to methotrexate monotherapy.

开始日期2022-12-07

申办/合作机构

Biocad CJSC

NCT04397562 / Completed临床3期

A Multicenter, Randomized, Double-blind, Placebo-controlled, Adaptively Designed Clinical Trial of the Efficacy and Safety of Levilimab (BCD-089) in Patients With Severe COVID-19

The objective: to study the efficacy and safety of levilimab in subjects with severe COVID-19.

开始日期2020-04-29

申办/合作机构

Biocad CJSC

NCT04227366 / Completed临床3期

An International, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study of the Efficacy and Safety of BCD-089 (JSC BIOCAD, Russia) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis

BCD-089 is the original therapeutic monoclonal antibody binding the alpha subunit of the IL-6 receptor.
The aim of the study is to demonstrate the efficacy and safety of BCD-089 in combination with methotrexate in patients with active rheumatoid arthritis resistant to monotherapy with methotrexate.

开始日期2019-11-19

申办/合作机构

Biocad CJSC

100 项与乐维利单抗相关的临床结果

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100 项与乐维利单抗相关的转化医学

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100 项与乐维利单抗相关的专利（医药）

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6

项与乐维利单抗相关的文献（医药）

2023-01-01·Annals of the Rheumatic Diseases

Efficacy of synthetic and biological DMARDs: a systematic literature review informing the 2022 update of the EULAR recommendations for the management of rheumatoid arthritis

Review

作者: Edwards, Christopher John ; van der Heijde, Désirée ; de Souza, Savia ; Stamm, Tanja A ; Caporali, Roberto ; Sepriano, Alexandre ; Schoones, Jan W ; Verschueren, Patrick ; Smolen, Josef S ; Hyrich, Kimme L ; Aletaha, Daniel ; Winthrop, Kevin L ; Pope, Janet E ; Takeuchi, Tsutomu ; Kerschbaumer, Andreas ; Bergstra, Sytske Anne ; Landewé, Robert B M

ObjectivesTo update the evidence on efficacy of DMARDs (disease-modifying antirheumatic drugs) and inform the taskforce of the 2022 update of the European Alliance of Associations for Rheumatology (EULAR) recommendations for management of rheumatoid arthritis (RA).MethodsThis systematic literature review (SLR) investigated the efficacy of conventional synthetic (cs), biological (b), biosimilar and targeted synthetic (ts)DMARDs in patients with RA. Medline, EMBASE, Cochrane CENTRAL and Web of Science were used to identify all relevant articles published since the previous update in 2019 to 14 January 2022.ResultsOf 8969 search results, 169 articles were selected for detailed review and 47 were finally included. Trials investigated the efficacy of csDMARDs, bDMARDs and tsDMARDs, DMARD switching, tapering and trials investigating different treatment strategies. The compounds investigated were csDMARDs (methotrexate (MTX), leflunomide, sulfasalazine, hydroxychloroquine), bDMARDs (abatacept, adalimumab, certolizumab-pegol, denosumab, etanercept, infliximab, levilimab, olokizumab, opineracept, rituximab, sarilumab, tocilizumab) and tsDMARDs (baricitinib, filgotinib, tofacitinib, upadacitinib). The efficacy of csDMARDs+ short-term glucocorticoids in early RA was confirmed and similar to bDMARD+MTX combination therapy. Interleukin-6 pathway inhibition was effective in trials on olokizumab and levilimab. Janus kinase inhibitor (JAKi) was efficacious in different patient populations. After insufficient response to JAKi, patients could respond to TNFi treatment. Tapering of DMARDs was feasible for a proportion of patients, who were able to taper therapy while remaining in low disease activity or remission.ConclusionThe results of this SLR, together with one SLR on safety of DMARD and one on glucocorticoids, informed the taskforce of the 2022 update of the EULAR recommendations for pharmacological management of RA.

2021-12-01·Inflammation Research3区 · 医学

The efficacy and safety of levilimab in severely ill COVID-19 patients not requiring mechanical ventilation: results of a multicenter randomized double-blind placebo-controlled phase III CORONA clinical study

3区 · 医学

Article

作者: Gordeev, Ivan G ; Mazurov, Vadim I ; Pasechnik, Elena S ; Eremeeva, Anna V ; Dokukina, Ekaterina A ; Bakirov, Bulat A ; Lomakin, Nikita V ; Lutckii, Anton A ; Linkova, Yulia N ; Smolyarchuk, Elena A ; Fomina, Darya S ; Gilyarov, Mikhail Yu ; Seleznev, Anton I ; Morozova, Maria A ; Musaev, Gaziyavdibir H ; Moiseeva, Olga M ; Popov, Vladimir V ; Zinkina-Orikhan, Arina V ; Protsenko, Denis N ; Pukhtinskaia, Polina S

AbstractObjective and designThe aim of this double-blind, placebo-controlled, phase III CORONA clinical trial was to evaluate the efficacy and safety of IL-6 receptor inhibitor levilimab (LVL) in subjects with severe COVID-19.SubjectsThe study included 217 patients. The eligible were men and non-pregnant women aged 18 years or older, hospitalized for severe COVID-19 pneumonia.Treatment206 subjects were randomized (1:1) to receive single subcutaneous administration of LVL 324 mg or placebo, both in combination with standard of care (SOC). 204 patients received allocated therapy. After the LVL/placebo administration in case of deterioration of symptoms, the investigator could perform a single open-label LVL 324 mg administration as the rescue therapy.MethodsThe primary efficacy endpoint was the proportion of patients with sustained clinical improvement on the 7-category ordinal scale on Day 14. All efficacy data obtained after rescue therapy administration were considered missing. For primary efficacy analysis, all subjects with missing data were considered non-responders.Results63.1% and 42.7% of patients in the LVL and in the placebo groups, respectively, achieved sustained clinical improvement on Day 14 (P = .0017). The frequency of adverse drug reactions was comparable between the groups.ConclusionIn patients with radiologically confirmed SARS-CoV-2 pneumonia, requiring or not oxygen therapy (but not ventilation) with no signs of other active infection administration of LVL + SOC results in an increase of sustained clinical improvement rate.Trail registrationThe trial is registered at the US National Institutes of Health (ClinicalTrials.gov; NCT04397562).

2021-01-01·mAbs2区 · 医学

Antibodies to watch in 2021

2区 · 医学

Review

作者: Reichert, Janice M. ; Kaplon, Hélène

In this 12^th annual installment of the Antibodies to Watch article series, we discuss key events in antibody therapeutics development that occurred in 2020 and forecast events that might occur in 2021. The coronavirus disease 2019 (COVID-19) pandemic posed an array of challenges and opportunities to the healthcare system in 2020, and it will continue to do so in 2021. Remarkably, by late November 2020, two anti-SARS-CoV antibody products, bamlanivimab and the casirivimab and imdevimab cocktail, were authorized for emergency use by the US Food and Drug Administration (FDA) and the repurposed antibodies levilimab and itolizumab had been registered for emergency use as treatments for COVID-19 in Russia and India, respectively. Despite the pandemic, 10 antibody therapeutics had been granted the first approval in the US or EU in 2020, as of November, and 2 more (tanezumab and margetuximab) may be granted approvals in December 2020.* In addition, prolgolimab and olokizumab had been granted first approvals in Russia and cetuximab saratolacan sodium was first approved in Japan. The number of approvals in 2021 may set a record, as marketing applications for 16 investigational antibody therapeutics are already undergoing regulatory review by either the FDA or the European Medicines Agency. Of these 16 mAbs, 11 are possible treatments for non-cancer indications and 5 are potential treatments for cancer. Based on the information publicly available as of November 2020, 44 antibody therapeutics are in late-stage clinical studies for non-cancer indications, including 6 for COVID-19, and marketing applications for at least 6 (leronlimab, tezepelumab, faricimab, ligelizumab, garetosmab, and fasinumab) are planned in 2021. In addition, 44 antibody therapeutics are in late-stage clinical studies for cancer indications. Of these 44, marketing application submissions for 13 may be submitted by the end of 2021. *Note added in proof on key events announced during December 1-21, 2020: margetuximab-cmkb and ansuvimab-zykl were approved by FDA on December 16 and 21, 2020, respectively; biologics license applications were submitted for ublituximab and amivantamab.

1

项与乐维利单抗相关的新闻（医药）

2024-01-29

·BioBAY

资本市场丨艾视雅：完成千万级Pre A轮融资

近日，BioBAY园内企业艾视雅成功完成Pre A轮融资，本轮融资由国内知名的风险投资机构聚明创投领投。艾视雅成立于2021年6月, 是一家聚焦眼科领域多产品布局的创新型医疗器械公司。截至2023.12.31累计提交42个专利，其中已授权10个，2023年新增申请9个, 2024年拟新增申请23个，获得商标及著作权18件，艾视雅公司产品获第四届中国医疗器械创新创业大赛获二等奖, 公司创始人姜皓天获评第十七届苏州工业园区领军人才。姜皓天毕业于美国罗切斯特大学光学工程专业，已在眼视光及眼科器械研发领域深耕7年，2020年起与资深医疗器械研发专家、公司共同创始人于林一起构建了艾视雅强大的多管线研发团队, 与多名眼科专家及医疗机构合作，持续加大研发投入陆续推出近视防控、视力保护、干眼症治疗等系列智能化眼科电子产品及医疗器械，针对目前大医院采购流程长回款慢的现状，艾视雅主推量大面广的智能型基层医疗机构产品及患者家用产品，并努力打造研产销用数据服务一体化平台，特别是艾视雅推出的近视防控及干眼症治疗产品前期体验及测试深受患者和医疗机构好评，本轮融资将进一步推动艾视雅持续在眼科领域创新发展。艾视雅管理层表示融资的资金将主要用于开发新产品，进一步完善核心技术并进行产品迭代，同时着手提升市场营销能力和品牌影响力。艾视雅将加强与合作伙伴的合作，进一步优化产品和服务为广大客户提供更优质、更可靠的产品，力争成为眼视光及眼科器械领域提供专业化患者服务方案的头部企业。艾视雅研发副总于林透露，目前公司有多款在研新品，其中部分产品即将获得国家医疗器械注册，预计2024年即将在各大眼科展会上亮相。此次融资的领投方聚明创投代表对于艾视雅的发展前景表示乐观。聚明创投认为，艾视雅在核心技术领域具有深厚的积累和领先优势，针对患者家用和基层医疗机构推出产品能够使产品较快进入市场，避免大医院集采及流程长付款慢等影响，使企业在激烈的市场竞争中保持领先地位，聚明创投看好艾视雅在未来的发展并将继续提供支持。▌文章来源：艾视雅责编：何文正审核：任旭推荐阅读资本市场丨超7亿美元！康宁杰瑞恩沃利单抗注射液达成海外授权许可协议资本市场丨纽伦捷生物：完成数千万元pre-A轮融资，深耕神经原位转分化创新基因疗法资本市场丨麦锐克生物：完成数千万天使轮融资，加速microRNA核心技术平台搭建

基因疗法引进/卖出

100 项与乐维利单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16387

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
类风湿关节炎	俄罗斯	Biocad CJSC	2021-06-08
新型冠状病毒感染	俄罗斯	Biocad CJSC	2020-06-04

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
类风湿关节炎	临床3期	-	Biocad CJSC	2019-11-19
新型冠状病毒感染	药物发现	-	Biocad CJSC	2020-04-29

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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


NCT03103438 (CTgov)	临床1期	-	19	BCD-089 (Cohort 1)	觸簾衊艱顧鹽積獵艱醖(構齋窪鏇壓蓋築餘蓋簾) = 獵構鏇築壓製鹹糧餘築網淵夢鏇餘襯膚廠夢醖 (製糧艱網選艱簾廠願夢, 廠製簾壓鹹齋衊鹹網夢 ~ 衊遞壓窪鹽艱願繭鏇鏇) 更多	-	2021-02-26
				BCD-089 (Cohort 2)	觸簾衊艱顧鹽積獵艱醖(構齋窪鏇壓蓋築餘蓋簾) = 憲夢鬱艱鹽遞鹹顧夢鏇網淵夢鏇餘襯膚廠夢醖 (製糧艱網選艱簾廠願夢, 窪遞鹹繭積簾遞選衊餘 ~ 壓鏇網廠願衊膚繭壓壓) 更多
NCT04397562 (SOLAR, EULAR2022)	临床3期	类风湿关节炎	154	Levilimab 162 mg, SC + MTX	醖鹽糧繭淵衊鏇觸膚網(遞網顧衊淵簾鹹簾醖蓋) = 繭觸簾蓋膚醖鹹醖遞製鹹艱構製淵鬱醖鏇積鑰 (鹹膚構鏇憲窪襯獵選構 ) 更多	积极	2022-06-01
NCT03455842 (EULAR2020)	临床2期	类风湿关节炎	105	Levilimab + Methotrexate (QW)	(鬱製夢鬱願餘襯齋遞鬱) = 製顧廠蓋鹽憲衊窪憲憲廠壓膚選製鏇壓願窪憲 (艱廠襯鏇壓構齋構遞窪 ) 更多	-	2020-06-03
				Levilimab + Methotrexate (Q2W)	(鬱製夢鬱願餘襯齋遞鬱) = 繭網繭選膚獵繭膚觸製廠壓膚選製鏇壓願窪憲 (艱廠襯鏇壓構齋構遞窪 ) 更多
NCT04397562 (CORONA, Pubmed) 人工标引	临床3期	新型冠状病毒感染	217	SOC+levilimab	(夢糧觸窪醖顧鬱淵憲顧) = 廠窪顧鹽艱繭鏇衊鑰襯選範襯憲範鏇夢顧選淵 (遞構淵鏇觸顧憲網鏇鹽 )	积极	2021-12-01
				Placebo+SOC	(夢糧觸窪醖顧鬱淵憲顧) = 製鑰艱蓋蓋艱壓積鏇願選範襯憲範鏇夢顧選淵 (遞構淵鏇觸顧憲網鏇鹽 )
NCT04397562 (CORONA, EULAR2021)	临床3期	新型冠状病毒感染 Erythrocyte sedimentation rate (ESR) \| C-reactive protein (CRP) \| IL-6	217	Levilimab	(製鬱夢艱構憲醖範憲觸) = 艱憲選蓋選衊醖憲選獵鹹鹹構衊鹹顧衊膚襯壓 (鏇觸製鹹網艱糧繭築鹽 ) 更多	积极	2021-06-02
				Placebo	(製鬱夢艱構憲醖範憲觸) = 製餘襯繭衊獵壓繭顧衊鹹鹹構衊鹹顧衊膚襯壓 (鏇觸製鹹網艱糧繭築鹽 ) 更多
NCT03455842 (AURORA, EULAR2019)	临床2期	类风湿关节炎	105	BCD-089 QW+MTX	(蓋繭襯繭壓鹽壓網鹹醖) = 餘艱衊鹹繭願觸築餘膚艱製憲餘鹽觸構壓顧衊 (憲觸鹹構齋獵衊鏇願範 ) 更多	积极	2019-06-12
				BCD-089 Q2W+MTX	(蓋繭襯繭壓鹽壓網鹹醖) = 鹽壓廠憲淵製夢鑰夢艱艱製憲餘鹽觸構壓顧衊 (憲觸鹹構齋獵衊鏇願範 ) 更多
NCT04397562 (SOLAR, EULAR2021)	临床3期	类风湿关节炎	154	Levilimab + MTX	(願窪艱糧蓋遞遞夢淵窪) = 憲選鏇鏇製顧簾範鏇醖鑰獵衊憲積憲築襯繭淵 (窪襯鬱遞淵築憲鹽鬱鏇 ) 更多	积极	2021-06-02
				Placebo + MTX	(願窪艱糧蓋遞遞夢淵窪) = 齋憲壓觸範蓋構網積壓鑰獵衊憲積憲築襯繭淵 (窪襯鬱遞淵築憲鹽鬱鏇 ) 更多