英夫利西单抗生物类似药(日医工株式会社)(Infliximab(Nichi-Iko Pharmaceutical)) - 药物靶点：TNF-α_在研适应症：溃疡性结肠炎，克罗恩病，红皮病性银屑病_专利_临床

概要

基本信息

药物类型

生物类似药、单克隆抗体

别名

Infliximab biosimilar (Nichiiko Pharmaceutical/Aprogen)

+ [1]

靶点

TNF-α

作用机制

TNF-α抑制剂(肿瘤坏死因子α抑制剂)

治疗领域

免疫系统疾病感染心血管疾病+ [6]

在研适应症

溃疡性结肠炎克罗恩病红皮病性银屑病+ [6]

非在研适应症-

原研机构

Nichi-Iko Pharmaceutical Co., Ltd.

在研机构

Nichi-Iko Pharmaceutical Co., Ltd.

非在研机构-

最高研发阶段批准上市

首次获批日期

日本 (2017-09-27),

强直性脊柱炎银屑病关节炎白塞氏葡萄膜炎

最高研发阶段(中国)-

特殊审评-

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结构/序列

Sequence Code 69035L

来源: *****

Sequence Code 69038H

来源: *****

关联

3

项与英夫利西单抗生物类似药(日医工株式会社) 相关的临床试验

NCT02990806

/ Completed临床3期

A Randomized, Double-Blind, Multicenter, 3 Stage, Efficacy and Safety Study of NI-071 and US-Licensed Remicade® (Infliximab) for the Treatment of Patients With Rheumatoid Arthritis

The purpose of this study was to demonstrate similarity of NI-071 (proposed biosimilar to infliximab) to US REMICADE® (reference product) in terms of safety and efficacy in participants with rheumatoid arthritis (RA) not adequately responding to methotrexate (MTX).

开始日期2017-01-19

申办/合作机构

Nichi-Iko Pharmaceutical Co., Ltd.

NCT01931189

/ Completed临床1期

A Clinical Pharmacokinetics Study of NI-071

The purpose of this study is to assess equivalence of pharmacokinetics between NI-071 and infliximab(the comparator) in Japanese healthy volunteers

开始日期2013-08-01

申办/合作机构

Nichi-Iko Pharmaceutical Co., Ltd.

NCT01927263

/ Completed临床3期

A Phase 3 Clinical Study of NI-071 in Patients With Rheumatoid Arthritis -A Double-blind, Active Drug-controlled Study and Long-term Study-

The purpose of this study is to investigate similarity between NI-071 and infliximab(the comparator) in terms of efficacy in patients with Rheumatoid Arthritis not adequately responding to Methotrexate.

开始日期2013-07-01

申办/合作机构

Nichi-Iko Pharmaceutical Co., Ltd.

100 项与英夫利西单抗生物类似药(日医工株式会社) 相关的临床结果

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100 项与英夫利西单抗生物类似药(日医工株式会社) 相关的转化医学

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100 项与英夫利西单抗生物类似药(日医工株式会社) 相关的专利（医药）

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6

项与英夫利西单抗生物类似药(日医工株式会社) 相关的文献（医药）

2023-03-01·Zeitschrift für Rheumatologie

A network meta-analysis

Article

作者: Song, Gwan Gyu ; Lee, Young Ho

OBJECTIVETo assess the relative efficacy and safety of infliximab and its biosimilars in patients with active rheumatoid arthritis (RA) who showed an inadequate response to methotrexate (MTX).METHODSWe performed a Bayesian network meta-analysis combining direct and indirect evidence from randomized controlled trials (RCTs), comparing the efficacy and safety of infliximab biosimilars versus the originator product in patients with active RA despite receiving MTX.RESULTSOverall, 7 RCTs involving 3168 patients, including 7 biologic agents, met the inclusion criteria. The NI-071 was listed at the top left of the diagonal of the league table because it was associated with the most favorable surface under the cumulative ranking curve (SUCRA) for the American College of Rheumatology 20 (ACR20) response rate. SB2 was listed at the bottom right of the diagonal of the league table because it was associated with the least favorable results. Based on SUCRA, NI-071 had the highest probability of being the best treatment agent in terms of the ACR20 response rate (SUCRA = 0.731), followed by ABP 710, CT-P13, BCD-055, infliximab, Exemptia, PF-06438179, and SB2 (SUCRA = 0.311). Although statistically non-significant differences in safety ranking were observed for serious adverse events (SAEs) among the treatment options, ABP 710 presented the highest safety probability (SUCRA = 0.739) while BCD-055 showed the lowest safety profile (SUCRA = 0.289).CONCLUSIONNo significant difference in ACR20 response rates and SAEs were detected between infliximab biosimilars and the originator in the investigated study populations.

2019-11-02·Modern Rheumatology4区 · 医学

A randomized double-blind parallel-group phase III study to compare the efficacy and safety of NI-071 and infliximab reference product in Japanese patients with active rheumatoid arthritis refractory to methotrexate

4区 · 医学

Article

作者: Matsuno, Hiroaki ; Matsubara, Tsukasa

Objectives: This study aimed to demonstrate the equivalence of NI-071, an infliximab biosimilar (BS), and the infliximab reference product (RP) for treating Japanese patients with active rheumatoid arthritis (RA) refractory to methotrexate.Methods: In this multicenter two-period phase III study, patients were treated with BS or RP for 30 weeks (Period I) in a randomized double-blind manner and then with BS for the following 24 weeks (Period II). The efficacy and safety of BS and RP were compared.Results: The disease activity score in 28-joint count based on erythrocyte sedimentation rate or C-reactive protein and the American College of Rheumatology 20/50/70-based efficacy profiles of BS were similar to those of RP during Period I (30 weeks) including evaluations at week 14, a critical time point. BS efficacy was maintained throughout the 54-week study period. BS efficacy profile matched the RP profile until week 54 after the drug switch from RP to BS at week 30. The safety profiles of BS and RP were comparable and the long-term safety of BS was confirmed.Conclusion: BS demonstrated equivalent efficacy and safety to RP at treatment weeks 14 and 30, and long-term safety until week 54 in Japanese RA patients.

2010-05-01·Praxis

Schweizerisches Register für TNF-α-Blocker bei Kindern und Jugendlichen mit rheumatologischen Erkrankungen

Article

作者: Sauvain ; Schalm ; Hofer ; Kaiser ; Bérthet ; Bolt ; Bolz ; Saurenmann ; Cannizzaro

100 项与英夫利西单抗生物类似药(日医工株式会社) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D02598	-	L04AB02	DB00065

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
溃疡性结肠炎	日本	Nichi-Iko Pharmaceutical Co., Ltd.	2018-06-20
克罗恩病	日本	Nichi-Iko Pharmaceutical Co., Ltd.	2018-06-20
红皮病性银屑病	日本	Nichi-Iko Pharmaceutical Co., Ltd.	2018-06-20
寻常性银屑病	日本	Nichi-Iko Pharmaceutical Co., Ltd.	2018-06-20
脓疱型银屑病	日本	Nichi-Iko Pharmaceutical Co., Ltd.	2018-06-20
类风湿关节炎	日本	Nichi-Iko Pharmaceutical Co., Ltd.	2018-06-20
强直性脊柱炎	日本	Nichi-Iko Pharmaceutical Co., Ltd.	2017-09-27
银屑病关节炎	日本	Nichi-Iko Pharmaceutical Co., Ltd.	2017-09-27
白塞氏葡萄膜炎	日本	Nichi-Iko Pharmaceutical Co., Ltd.	2017-09-27

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2期	俄罗斯	Nichi-Iko Pharmaceutical Co., Ltd.	2017-01-19
类风湿关节炎	临床2期	美国	Nichi-Iko Pharmaceutical Co., Ltd.	2017-01-19
类风湿关节炎	临床2期	英国	Nichi-Iko Pharmaceutical Co., Ltd.	2017-01-19
类风湿关节炎	临床1期	波多黎各	Nichi-Iko Pharmaceutical Co., Ltd.	2017-01-19
类风湿关节炎	临床1期	波兰	Nichi-Iko Pharmaceutical Co., Ltd.	2017-01-19
类风湿关节炎	临床1期	西班牙	Nichi-Iko Pharmaceutical Co., Ltd.	2017-01-19
类风湿关节炎	临床1期	乌克兰	Nichi-Iko Pharmaceutical Co., Ltd.	2017-01-19
类风湿关节炎	临床1期	捷克	Nichi-Iko Pharmaceutical Co., Ltd.	2017-01-19

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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


NCT02990806 (CTgov)	临床3期	类风湿关节炎	683	Remicade (Stage 1: Remicade-US Group)	鏇膚積構壓網衊廠淵壓(範淵願築獵鏇壓襯構壓) = 糧願齋積鬱襯範襯膚鏇夢遞繭襯簾憲鏇鏇襯膚 (選蓋糧憲獵膚遞襯窪膚, 憲範遞範廠網壓製鑰醖 ~ 蓋鏇窪遞壓糧構鹽顧襯) 更多	-	2023-01-25
				Remicade (Stage 2 and Stage 3: Remicade US to Remicade-US Group)	廠醖醖鏇選構範醖膚範(構簾壓糧遞壓製觸願繭) = 艱鑰遞網膚願鹽繭選襯鹹窪觸網蓋選齋糧簾顧 (範廠繭窪夢夢願糧糧齋, 遞窪憲鹽築積壓範鏇鹽 ~ 鏇鑰艱遞鏇廠繭衊遞製) 更多
NCT01927263 (Pubmed \| Isr Med Assoc J) 人工标引	临床3期	类风湿关节炎	242	NI-071	艱齋鑰膚選鹽觸獵艱繭(醖夢膚艱鑰鬱醖廠襯餘) = BS demonstrated equivalent efficacy to RP at treatment weeks 14 and 30, 膚鏇遞鹹齋製膚醖艱簾 (願範鏇壓鏇繭窪艱網鹹 ) 更多	积极	2019-11-01
				Infliximab