依那西普生物类似药(Hanwha Chemical (Thailand) Co. Ltd.)(Etanercept biosimilar(Hanwha Chemical (Thailand) Co. Ltd.)) - 药物靶点：LTα x TNF-α_在研适应症：强直性脊柱炎，银屑病关节炎，银屑病_专利_临床

概要

基本信息

药物类型

生物类似药、融合蛋白

别名

Davictrel、Etanercept biosimilar

+ [2]

靶点

LTα x TNF-α

作用机制

LTα抑制剂(肿瘤坏死因子β抑制剂)、TNF-α抑制剂(肿瘤坏死因子α抑制剂)

治疗领域

免疫系统疾病感染皮肤和肌肉骨骼疾病

在研适应症

强直性脊柱炎银屑病关节炎银屑病+ [1]

非在研适应症-

原研机构

Hanwha Chemical (Thailand) Co., Ltd.

在研机构

HANWHA SOLUTIONS CORP.

非在研机构

Hanwha Chemical (Thailand) Co., Ltd.

最高研发阶段批准上市

首次获批日期

(2014-11-11),

强直性脊柱炎银屑病关节炎银屑病+ [1]

最高研发阶段(中国)-

特殊审评-

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结构/序列

Sequence Code 38320

当前序列信息引自: *****

关联

4

项与依那西普生物类似药(Hanwha Chemical (Thailand) Co. Ltd.) 相关的临床试验

NCT01894412

/ Completed临床1期

A Randomized, Double-blind, Single-dosing, Crossover Study to Compare the Safety and Pharmacokinetic Characteristics of HD203 25 mg With Those of Enbrel® Injection 25 mg After Subcutaneous Injection in Healthy Male Volunteers

The purpose of this study is to compare the safety and pharmacokinetic characteristics of HD203 liquid with those of etanercept (enbrel) prefilled injection after subcutaneous injection

开始日期2013-07-01

申办/合作机构

Hanwha Chemical (Thailand) Co., Ltd.

NCT01431404

/ Completed临床1期

Randomized,Double-blind,Single-dosing,Crossover Study to Compare the Safety and Pharmacokinetic Characteristics of HD203 With Active Comparator

The purpose of this study is compare the safety and pharmacokinetic characteristics of HD203 liquid with those of etanercept (enbrel) prefilled injection after subcutaneous injection.

开始日期2011-08-01

申办/合作机构

Hanwha Chemical (Thailand) Co., Ltd.

NCT01270997

/ Completed临床3期

A Multicenter Randomized Double-blind Active-controlled Parallel Group Phase Ⅲ Trial to Evaluate the Equivalence in Efficacy and Safety of HD203 and Enbrel in Combination With Methotrexate in Patients With Rheumatoid Arthritis

The objective is to prove the equivalence in efficacy and safety of HD203 and Enbrel® in combination with Methotrexate in patients with rheumatoid arthritis.

开始日期2010-12-01

申办/合作机构

Hanwha Chemical (Thailand) Co., Ltd.

100 项与依那西普生物类似药(Hanwha Chemical (Thailand) Co. Ltd.) 相关的临床结果

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100 项与依那西普生物类似药(Hanwha Chemical (Thailand) Co. Ltd.) 相关的转化医学

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100 项与依那西普生物类似药(Hanwha Chemical (Thailand) Co. Ltd.) 相关的专利（医药）

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7

项与依那西普生物类似药(Hanwha Chemical (Thailand) Co. Ltd.) 相关的文献（医药）

2021-12-01·Int. Journal of Clinical Pharmacology and Therapeutics4区 · 医学

Comparative efficacy and safety of etanercept biosimilars in comparison with etanercept in patients with rheumatoid arthritis who have insufficient response to methotrexate: A network meta-analysis

4区 · 医学

Article

作者: Lee, Young Ho ; Song, Gwan Gyu

OBJECTIVEWe aimed to assess the relative efficacy and safety of etanercept biosimilars and etanercept originators in patients with active rheumatoid arthritis (RA) who showed an inadequate response to methotrexate (MTX).MATERIALS AND METHODSWe performed a Bayesian network meta-analysis to combine direct and indirect evidence from randomized controlled trials (RCTs) examining the efficacy and safety of etanercept biosimilars vs. etanercept originators in patients with active RA despite treatment with MTX.RESULTSThree RCTs involving 1,200 patients, including 4 types of biologics, were included. Ranking probability based on the surface under the cumulative ranking curve (SUCRA) indicated that LBEC0101 had a high probability of being the better treatment in terms of the American College of Rheumatology 20 (ACR20) response rate (SUCRA = 0.744), followed by HD203 (SUCRA = 0.457), SB4 (SUCRA = 0.446), and etanercept (SUCRA = 0.352), although no difference in the ACR20 response rate between the biosimilars and etanercept groups was found. Although not statistically significant, there was a difference in the ranking probability of safety based on serious adverse events (SAEs) among interventions. Ranking probability based on SUCRA values indicated that LBEC0101 had the highest probability of being the safest treatment (SUCRA = 0.638), followed by SB4 (SUCRA = 0.495) and HD203 (SUCRA = 0.475), while etanercept had the lowest probability of being the safest treatment (SUCRA = 0.393).CONCLUSIONNo significant difference was found between etanercept biosimilars and etanercept originators in patients with active RA despite treatment with MTX in terms of the ACR20 response rate and SAEs.

2017-01-01·Annals of the Rheumatic Diseases1区 · 医学

A phase III, multicentre, randomised, double-blind, active-controlled, parallel-group trial comparing safety and efficacy of HD203, with innovator etanercept, in combination with methotrexate, in patients with rheumatoid arthritis: the HERA study

1区 · 医学

Article

作者: Shim, Seung-Cheol ; Park, HanYu ; Lee, Sang-Heon ; Ahn, Yongho ; Park, Yong-Beom ; Choe, Jung-Yoon ; Park, Won ; Choi, Chan-Bum ; Kim, Jinseok ; Lee, Shin-Seok ; Lee, So-Ra ; Sung, Yoon-Kyoung ; Bae, Sang-Cheol

ObjectivesTo evaluate equivalence in efficacy for rheumatoid arthritis (RA) and compare the safety of the biosimilar HD203 with innovator etanercept (ETN) plus methotrexate (MTX) (ClinicalTrials.govNCT01270997).MethodsPatients with active RA received 25 mg HD203 or ETN subcutaneously twice-weekly with MTX for 48 weeks in a phase III, multicentre, randomised, double-blind, parallel-group design. The primary end point was the proportion of patients achieving the American College of Rheumatology 20% response (ACR20) at week 24 for per-protocol study completer set (PPS). Secondary end points included ACR response criteria, ACRn, European League against Rheumatism (EULAR) response, change in Disease Activity Score 28 (DAS28), patient-reported outcomes, safety and immunogenicity.ResultsOf the 294 randomised patients (HD203, n=147; ETN, n=147), 233 comprised the 24-week PPS (n=115 and 118, respectively). ACR20 at week 24 was achieved by 83.48% and 81.36% of PPS patients, respectively, demonstrating equivalent efficacy within predefined margins of ±20% (treatment difference 2.12%, 95% CI −7.65% to 11.89%). Outcomes for secondary end points were consistent with the primary efficacy findings. Groups were comparable for overall incidences of treatment-emergent (all-causality) adverse events (AEs) (HD203 113 (76.9%) vs ETN 114 (78.1%) (p=0.804)), adverse drug reactions, serious AEs and discontinuations due to AEs. Few patients (HD203, n=8; ETN, n=3) tested positive for anti-drug antibodies.ConclusionThe study met the primary objective of demonstrating equivalent efficacy of HD203 and ETN. HD203 was well tolerated, with safety comparable with ETN in this population of patients with RA.Trial registration numberNCT01270997; Results.

2017-01-01·Annals of the Rheumatic Diseases

Clinical trials of biosimilars should become more similar

Communications

作者: Isaacs, John D ; Kay, Jonathan

Since the approval of the infliximab biosimilar, CT-P13, by the Korean Ministry of Food & Drug Safety (MFDS) on 23 July 2012,1 biosimilars to treat inflammatory diseases have become available to patients in many countries around the world.2 The European Commission (EC) approved CT-P13 on 10 September 2013,3 and, subsequently, it has been granted marketing authorisation by regulatory agencies in many other countries, including the USA. CT-P13 is now marketed in >70 countries worldwide as Remsima, Inflectra and Flammegis.4 Several other biosimilars of tumour necrosis factor (TNF) inhibitors have also received regulatory approval and are commercially available. HD203 was the first etanercept biosimilar granted marketing authorisation by the Korean MFDS on 11 November 2014 and was marketed as Davictrel in South Korea.5 However, because the facility where it was manufactured was sold, its licence could not be retained and it was withdrawn from the market upon the request of its manufacturer on 30 September 2015. Another etanercept biosimilar, SB4, which received approval by the Korean MFDS on 8 September 2015 and by the EC on 14 January 2016, is marketed as Brenzys in South Korea and as Benepali in the European Union (EU) and in the European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein.5 ,6 SB2, another infliximab biosimilar, was granted marketing authorisation by the Korean MFDS on 4 December 2015 and by the EC on 26 May 2016, and is sold as Renflexis in South Korea and as Flixabi in the EU and EEA member states.5 ,7 In this issue, Bae et al 8 report the results of the phase III clinical trial of HD203 (etanercept biosimilar), Emery and colleagues report the results of the phase III clinical trial of SB4 (etanercept biosimilar)9 and Choe et …

100 项与依那西普生物类似药(Hanwha Chemical (Thailand) Co. Ltd.) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L04AB01	-

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
强直性脊柱炎	-	HANWHA SOLUTIONS CORP.	2014-11-11
银屑病关节炎	-	HANWHA SOLUTIONS CORP.	2014-11-11
银屑病	-	HANWHA SOLUTIONS CORP.	2014-11-11
类风湿关节炎	-	HANWHA SOLUTIONS CORP.	2014-11-11

未上市

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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	药物发现	韩国	Hanwha Chemical (Thailand) Co., Ltd.	2010-12-01

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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


NCT01270997 (HERA, Pubmed \| Arthritis Rheumatol \| Ann Rheum Dis) 人工标引	临床3期	类风湿关节炎	294	methotrexate+HD203	(鏇蓋鬱醖窪夢選願夢齋) = 構構範鹽淵膚選願鑰餘遞廠獵襯鹹衊糧糧遞蓋 (築簾願衊鏇選築觸醖簾 ) 更多	相似	2017-01-01
				methotrexate+etanercept	(鏇蓋鬱醖窪夢選願夢齋) = 糧製遞選糧夢簾艱衊鏇遞廠獵襯鹹衊糧糧遞蓋 (築簾願衊鏇選築觸醖簾 ) 更多
NCT01270997 (EULAR2014)	临床3期	类风湿关节炎	294	HD203	(鹹鏇醖壓蓋遞顧衊醖淵) = 簾顧鬱獵糧遞簾顧積鑰鑰築衊範獵積衊蓋築淵 (積餘鏇製廠鏇淵衊簾築 ) 更多	积极	2014-06-11
				Enbrel	(鹹鏇醖壓蓋遞顧衊醖淵) = 遞糧選夢製糧製構積鹽鑰築衊範獵積衊蓋築淵 (積餘鏇製廠鏇淵衊簾築 ) 更多