阿法达贝泊汀生物类似药(Dong-A Pharmaceutical Co., Ltd.)(Darbepoetin alfa biosimilar(Dong-A Pharmaceutical Co., Ltd.))

概要

基本信息

药物类型

生物类似药、集落刺激因子

别名

Darbepoetin alfa biosimilar、Darbepoetin alpha biosimilar、Darbepoetin α biosimilar

+ [2]

靶点

EPO receptor

作用方式

激动剂

作用机制

EPO receptor激动剂(促红细胞生成素受体激动剂)

治疗领域

血液及淋巴系统疾病

在研适应症

贫血

非在研适应症-

原研机构

Dong-A Pharmaceutical Co., Ltd.

在研机构

Sanwa Kagaku Kenkyusho Co., Ltd.

非在研机构

Dong-A ST Co., Ltd.

最高研发阶段批准上市

首次获批日期

日本 (2019-09-20),

贫血

最高研发阶段(中国)-

特殊审评孤儿药 (美国)

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结构/序列

Sequence Code 54492

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关联

1

项与阿法达贝泊汀生物类似药(Dong-A Pharmaceutical Co., Ltd.) 相关的临床试验

NCT02241200

/ Completed临床1期

A Randomized, 2 Part, 4-treatment, 2-way Cross-over Study in Healthy Volunteers to Compare the Pharmacokinetic and Pharmacodynamic Profiles of 1ug/kg of DA-3880 and EU Sourced ARANESP® (Amgen) After Single Intravenous or Subcutaneous Administration

The main purpose of the study is to determine whether the test product and the reference product are bioequivalent based on the pharmacokinetics after administration of ug/kg as a single intravenous dose and as a single subcutaneous dose of each of the formulations. The study is consisted of randomization, 2 parts, 4 treatments, 2 way cross over.

开始日期2014-08-18

申办/合作机构

Dong-A ST Co., Ltd.

100 项与阿法达贝泊汀生物类似药(Dong-A Pharmaceutical Co., Ltd.) 相关的临床结果

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100 项与阿法达贝泊汀生物类似药(Dong-A Pharmaceutical Co., Ltd.) 相关的转化医学

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100 项与阿法达贝泊汀生物类似药(Dong-A Pharmaceutical Co., Ltd.) 相关的专利（医药）

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35

项与阿法达贝泊汀生物类似药(Dong-A Pharmaceutical Co., Ltd.) 相关的文献（医药）

2014-05-01·Acta Neurochirurgica3区 · 医学

The comparative effects of recombinant human erythropoietin and darbepoetin-alpha on cerebral vasospasm following experimental subarachnoid hemorrhage in the rabbit

3区 · 医学

Article

作者: Erdal Resit Yilmaz ; Mehmet Ali Kanat ; Ata Türker Arikok ; Berrin Imge Ergüder ; Zeki Sekerci ; Bora Gürer ; Hayri Kertmen

BACKGROUNDDarbepoetin alpha is a hypersialylated analogue of erythropoietin effective for activating erythropoietin-receptors. This study investigated the vasodilator and neuroprotective effects of darbepoetin alpha on an experimental subarachnoid hemorrhage model and compared it with erythropoietin.METHODSForty adult male New Zealand white rabbits were randomly divided into four groups of ten rabbits each: group 1 (control), group 2 (subarachnoid hemorrhage), group 3 (erythropoietin), and group 4 (darbepoetin alpha). Recombinant human erythropoietin was administered at a dose of 1,000 U/kg intraperitoneally after the induction of subarachnoid hemorrhage and continued every 8 h up to 72 h. Darbepoetin alpha was administered at a single intraperitoneal dose of 30 μg/kg. Animals were killed 72 h after subarachnoid hemorrhage. Basilar artery cross-sectional areas, arterial wall thicknesses, hippocampal degeneration scores and biochemical analyses were measured in all groups.RESULTSBoth erythropoietin and darbepoetin alpha treatments were found to attenuate cerebral vasospasm and provide neuroprotection after subarachnoid hemorrhage in rabbits. Darbepoetin alpha revealed better morphometric and histopathological results than erythropoietin among experimental subarachnoid hemorrhage-induced vasospasm.CONCLUSIONSOur findings, for the first time, showed that darbepoetin alpha can prevent vasospasm and provides neuroprotection following experimental subarachnoid hemorrhage. Moreover, darbepoetin alpha showed better results when compared with erythropoietin.

2013-06-01·Current Therapeutic Research

A Safe and Easy Introduction of Darbepoetin-Alpha in Patients Receiving Maintenance Hemodialysis and Epoetin Monotherapy: A “Half-and-Half” Combination Therapy

Article

作者: Shimamatsu, Kazumasa ; Inamasu, Hiroko

BACKGROUNDIn hemodialysis (HD) patients requiring anemia management, the 3-fold longer terminal half-life (25.3 hours) of darbepoetin-alpha (DA) results in reduced dose frequency when compared with recombinant human erythropoietin (EPO) -alpha or -beta by intravenous administration (8.5 hours). However, this might become a disadvantage in the face of rapid withdrawal of the drug against hemoglobin (Hb) overshoot and/or cycling.OBJECTIVEA "half-and-half" combination therapy of DA and EPO was used to avoid a possible Hb overshoot due to the full conversion from EPO to DA.METHODSThirty-two stable patients receiving HD (13 men, 19 women) and EPO monotherapy were enrolled and prospectively followed for 9 months. The mean (SD) patient age was 63.2 (11.3) years. The HD duration was 10.7 (8.2) years. The DA doses (in micrograms) of 1/200 of halves of previous weekly EPO doses (in international units) were given intravenously on the second HD day of a week. The remaining half doses of previous weekly EPO doses were dividedly administered intravenously on the first and the third HD days of the week. The target Hb was 11 g/dL.RESULTSThe "half-and-half" combination with DA and EPO resulted in no episodes of Hb overshoot. The Hb values did not exceed 13 g/dL throughout the follow-up period. The mean (SD) dose of 3984 (2175) IU/wk EPO was converted to a combination of 1688 (894) IU/wk EPO and 13.4 (7.9) μg/wk DA at baseline. Thereafter, the mean (SD) doses became 304 (656) IU/wk EPO and 16.0 (8.4) μg/wk DA at 3 months, and 532 (912) IU/wk and 15.8 (9.0) μg/wk, respectively, at 9 months. The total combination doses of DA/EPO (as EPO equivalents) were significantly reduced to 80% to 84% of the original EPO doses after 2 months of introduction of the DA/EPO combination.CONCLUSIONSA "half-and-half" combination therapy may be a safe and easy method to merge DA into EPO monotherapy without Hb overshoot or dramatic cycling.

2013-03-01·Archives of Cardiovascular Diseases4区 · 医学

Intracoronary administration of darbepoetin-alpha at onset of reperfusion in acute myocardial infarction: Results of the randomized Intra-Co-EpoMI trial

4区 · 医学

Article

作者: Stéphane Cade ; Séverine Thibaut ; Franck Raczka ; Florence Leclercq ; Stéphanie Barrère-Lemaire ; Laurent Bonello ; Nathalie Lesavre ; François Roubille ; Samir Berboucha ; Guillaume Cayla ; Franck Paganelli ; Richard Gervasoni ; Hélène Vernhet Kovacsik ; Géraud Souteyrand ; Christophe Piot ; Thien-Tri Cung ; François Klein ; Frédéric Cransac ; Pascal Mottref ; Jean-Christophe Macia ; Michel Ovize ; Catherine Sportouch-Dukhan ; Stéphane Combes ; Antoine Micheau

BACKGROUNDSeveral trials investigating erythropoietin as a novel cytoprotective agent in myocardial infarction (MI) failed to translate promising preclinical results into the clinical setting. These trials could have missed crucial events occurring in the first few minutes of reperfusion. Our study differs by earlier intracoronary administration of a longer-acting erythropoietin analogue at the onset of reperfusion.AIMTo evaluate the ability of intracoronary administration of darbepoetin-alpha (DA) at the very onset of the reperfusion, to decrease infarct size (IS).METHODSWe randomly assigned 56 patients with acute ST-segment elevation MI to receive an intracoronary bolus of DA 150 μg (DA group) or normal saline (control group) at the onset of reflow obtained by primary percutaneous coronary intervention (PCI). IS and area at risk (AAR) were evaluated by biomarkers, cardiac magnetic resonance (CMR) and validated angiographical scores.RESULTSThere was no difference between groups regarding duration of ischemia, Thrombolysis in Myocardial Infarction flow grade at admission and after PCI, AAR size and extent of the collateral circulation, which are the main determinants of IS. The release of creatine kinase was not significantly different between the two groups even when adjusted to AAR size. Between 3-7 days and at 3 months, the area of hyperenhancement on CMR expressed as a percentage of the left ventricular myocardium was not significantly reduced in the DA group even when adjusted to AAR size.CONCLUSIONEarly intracoronary administration of a longer-acting erythropoietin analogue in patients with acute MI at the time of reperfusion does not significantly reduce IS.

1

项与阿法达贝泊汀生物类似药(Dong-A Pharmaceutical Co., Ltd.) 相关的新闻（医药）

2022-11-09

·BioSpace

Dong-A ST Signs License-out Deal with Polifarma of Türkiye for NESP® Biosimilar DA-3880

- Dong-A building a foundation for expanding its biosimilar business through license-out and supply agreements to Türkiye, Brazil and Mexico - Creating a synergy effect with STgen Bio, an affiliated Bio CDMO of Dong-A Socio Holdings SEOUL, South Korea--(BUSINESS WIRE)-- Dong-A ST (Min Young Kim, President and CEO) (KRX: 170900) announced that they signed an exclusive license-out and supply agreement on November 4, 2022, with Polifarma (Mehmet Asri, CEO) for NESP® biosimilar DA-3880. According to the agreement, Dong-A ST will license out the exclusive rights for the development and commercialization of DA-3880 in Türkiye, Brazil, and Mexico to Polifarma. Dong-A ST will receive upfront and developmental/commercial milestone payments and will exclusively supply the finished product through STgen Bio, an affiliated Bio CDMO of Dong-A Socio Holdings. Meanwhile, Polifarma will be responsible for the development and commercialization in Türkiye, Brazil, and Mexico. The details of the upfront, milestone payments, and supply profit structure remain undisclosed as per the consensus between both parties. “DA-3880” is an ARANESP®/NESP® biosimilar for the treatment of anemic patients with chronic renal failure or those undergoing chemotherapy. Dong-A ST signed a license-out agreement with Sanwa Kagaku Kenkyusho in 2014 for the development and commercialization of DA-3880 in Japan. After regulatory approval from PMDA (Pharmaceuticals and Medical Devices Agency, Japan) in 2019, DA-3880 has been successfully commercialized in the Japanese market, making it one of the bestsellers among darbepoetin alfa biosimilar products. Polifarma is a Türkiye pharmaceutical company with 100% domestic capital and 36 years of experience. It has established actual export records of 586 drugs to over 70 countries, including the US, Europe, Brazil, and Mexico. As the most well-known, and most preferred, hospital products brand in Türkiye, Polifarma’s goal is to maintain its lead in the Türkiye market and become one of the biggest global leaders by sustaining its quality and technological superiority. Jae Hong Park (President and CSO of Dong-A ST) said, “This agreement provides an opportunity for Dong-A ST to introduce DA-3880 beyond the Japanese market and into the global biosimilar market including Türkiye and South & Central America. Dong-A ST will commit to expanding its global market presence by showcasing our biosimilar R&D and overseas business capabilities.”

合作生物类似药引进/卖出

100 项与阿法达贝泊汀生物类似药(Dong-A Pharmaceutical Co., Ltd.) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	B03XA02	-

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
贫血	日本	Sanwa Kagaku Kenkyusho Co., Ltd.	2019-09-20

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
贫血	临床前	荷兰	Dong-A ST Co., Ltd.	2014-08-18

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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


ASN2012	N/A	TAFI \| CRP \| MPV	-	Darbepoetin-alpha	(齋觸齋築遞繭廠遞蓋鬱) = 鹹製範蓋醖製壓遞鬱網艱構餘衊願襯膚築繭廠 (遞鏇膚製壓遞淵鹽製艱, 1.87)	积极	2012-10-30
				Epoetin alfa	(齋觸齋築遞繭廠遞蓋鬱) = 顧獵壓夢鏇積糧範醖鏇艱構餘衊願襯膚築繭廠 (遞鏇膚製壓遞淵鹽製艱, 2.06)
ASN2010	N/A	-	-	CERA	(鹹襯構蓋膚蓋遞夢鬱淵) = 鏇鬱獵鏇齋觸選醖壓願製選憲積醖構淵鏇鑰製 (餘簾製蓋憲憲鹹憲遞壓 ) 更多	-	2010-11-16
				Darbepoetin-alpha	(鹹襯構蓋膚蓋遞夢鬱淵) = 淵構糧願鹽夢夢齋鏇鏇製選憲積醖構淵鏇鑰製 (餘簾製蓋憲憲鹹憲遞壓 ) 更多
ASN2010	N/A	-	281	Darbepoetin alpha 1 µg	(餘膚製廠艱廠壓窪鬱遞) = 遞觸選夢衊網獵鹽獵遞窪積鹽膚窪憲齋衊簾構 (餘簾憲觸夢積窪繭觸選, 2.7)	积极	2010-11-16
				Epoetin beta 3000 IU	(餘膚製廠艱廠壓窪鬱遞) = 觸製衊蓋築艱淵製糧衊窪積鹽膚窪憲齋衊簾構 (餘簾憲觸夢積窪繭觸選, 3.1)