阿法达贝泊汀生物类似药(JCR Pharmaceuticals Co., Ltd.)(Darbepoetin alfa biosimilar(JCR Pharmaceuticals 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

ダルベポエチンアルファ

靶点

EPO receptor

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

肾性贫血

非在研适应症

慢性肾病

原研机构

JCR Pharmaceuticals Co., Ltd.

在研机构

JCR Pharmaceuticals Co., Ltd.

非在研机构

Kissei Pharmaceutical Co., Ltd.

最高研发阶段批准上市

首次获批日期

日本 (2019-09-20),

肾性贫血

最高研发阶段(中国)-

特殊审评-

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结构/序列

Sequence Code 54492

当前序列信息引自: *****

关联

2

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

NCT02912494

/ Completed临床3期

A Phase III Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD)

The purpose of this study is to investigate the equivalence of JR-131 to Darbepoetin alfa and evaluate the safety of JR-131 in renal anemia patients with chronic kidney disease (CKD).

开始日期2016-09-01

申办/合作机构

Kissei Pharmaceutical Co., Ltd.

[+1]

NCT02912533

/ Completed临床3期

A Long-term Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD)

The purpose of this study is to investigate the safety and efficacy for 52-week dosing of JR-131 in renal anemia patients with chronic kidney disease (CKD).

开始日期2016-09-01

申办/合作机构

Kissei Pharmaceutical Co., Ltd.

[+1]

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

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3

项与阿法达贝泊汀生物类似药(JCR Pharmaceuticals Co., Ltd.) 相关的文献（医药）

2020-04-01·Therapeutic Apheresis and Dialysis4区 · 医学

JR‐131, a Biosimilar of Darbepoetin Alfa, for the Treatment of Hemodialysis Patients With Renal Anemia: A Randomized, Double‐Blinded, Parallel‐Group Phase 3 Study

4区 · 医学

Article

作者: Masakane, Ikuto ; Nakamoto, Hidetomo ; Nishi, Shinichi ; Yamada, Masayuki ; Tsuruya, Kazuhiko

AbstractThe aim of this study was to compare the efficacy and safety of intravenous JR‐131, a darbepoetin alfa biosimilar, to darbepoetin alfa in hemodialysis patients with renal anemia. In this 24‐week, multicenter, randomized, double‐blinded, parallel‐group phase 3 study, 334 hemodialysis patients with renal anemia who had been receiving darbepoetin alfa were randomized to either JR‐131 or darbepoetin alfa group. The initial dose was set based on the darbepoetin alfa dose during the observation period. The primary endpoint was change in hemoglobin level from baseline to end of treatment. The 95% confidence interval of the difference in the change in hemoglobin level between the groups was −0.19 to −0.20 g/dL, within the equivalent margin of −0.5 to 0.5 g/dL. No notable treatment‐emergent adverse events were observed in either group. JR‐131 was therapeutically equivalent to darbepoetin alfa, and the safety profile of JR‐131 was similar to that of darbepoetin alfa.

2020-04-01·Therapeutic Apheresis and Dialysis

Long‐Term Safety and Efficacy of JR‐131, a Biosimilar of Darbepoetin Alfa, in Japanese Patients With Renal Anemia Undergoing Hemodialysis: Phase 3 Prospective Study

Article

作者: Masakane, Ikuto ; Nakamoto, Hidetomo ; Nishi, Shinichi ; Yamada, Masayuki ; Tsuruya, Kazuhiko

AbstractThe objective of this study was to evaluate the safety and efficacy of JR‐131, a biosimilar of darbepoetin alfa, for long‐term treatment of renal anemia patients undergoing hemodialysis. In this multicenter, single‐arm, phase 3 study, 159 patients with renal anemia who had been receiving darbepoetin alfa or recombinant human erythropoietins were treated with intravenous JR‐131 for 52 weeks. In patients receiving darbepoetin alfa, JR‐131 was administered at the same dose, while in patients receiving recombinant human erythropoietin the dose was determined based on the 1:200 conversion ratio following the Japanese darbepoetin alfa package insert. No notable adverse drug reactions were reported, and no anti‐JR‐131 antibodies were detected. The hemoglobin levels were maintained in the range of 10.0–12.0 g/dL throughout the study. JR‐131 proved to be a useful and lower‐cost alternative to darbepoetin alfa in the management of renal anemia in patients undergoing hemodialysis.

PLOS ONE3区 · 综合性期刊

Physicochemical and biological evaluation of JR-131 as a biosimilar to a long-acting erythropoiesis-stimulating agent darbepoetin alfa

3区 · 综合性期刊

ArticleOA

作者: Yamakami, Makoto ; Sugimura, Atsushi ; Tatemichi, Satoshi ; Mihara, Kazutoshi ; Hatano, Yukichi ; Minami, Kohtaro ; Kakimoto, Shinji ; Ito, Yae ; Hirato, Tohru ; Kotani, Ayaka ; Fukui, Tsuyoshi ; Yamamoto, Ryuji ; Tani, Junya ; Tanaka, Noboru ; Takahashi, Kenichi

Renal anemia is predominantly caused by a relative deficiency in erythropoietin (EPO). Conventional treatment for renal anemia includes the use of recombinant human EPO (rhEPO) or a long-acting erythropoiesis-activating agent named darbepoetin alfa, which is a modified rhEPO with a carbohydrate chain structure that differs from native hEPO. We have developed a biosimilar to darbepoetin alfa designated JR-131. Here, we comprehensively compare the physicochemical and biological characteristics of JR-131 to darbepoetin alfa. JR-131 demonstrated similar protein structure to the originator, darbepoetin alfa, by peptide mapping and circular dichroism spectroscopy. Additionally, mass spectroscopic analyses and capillary zone electrophoresis revealed similar glycosylation patterns between the two products. Human bone marrow-derived erythroblasts differentiated and proliferated to form colonies with JR-131 to a similar degree as darbepoetin alfa. Finally, JR-131 stimulated erythropoiesis and improved anemia in rats similarly to darbepoetin alfa. Our data show the similarity in physicochemical and biological properties of JR-131 to those of darbepoetin alfa, and JR-131 therefore represents a biosimilar for use in the treatment of renal anemia.

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

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	B03XA02	DB00012

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
肾性贫血	日本	JCR Pharmaceuticals 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
肾性贫血	药物发现	日本	Kissei Pharmaceutical Co., Ltd.	2016-09-01
慢性肾病	药物发现	日本	JCR Pharmaceuticals Co., Ltd.	2016-09-01
慢性肾病	药物发现	日本	Kissei Pharmaceutical Co., Ltd.	2016-09-01

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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


NCT02912533 (Pubmed) 人工标引	临床3期	肾性贫血	159	JR-131	(廠蓋憲醖獵齋淵選窪築) = no notable AE 鏇齋衊鑰鹽構鏇夢鏇願 (鏇築繭壓獵壓蓋廠範憲 )	积极	2020-04-01
NCT02912494 (Pubmed \| Ther Apher Dial) 人工标引	临床3期	贫血	334	JR-131	(衊衊餘糧積選壓夢齋壓) = 觸窪夢選襯繭醖積鏇襯範願鹽淵膚範製夢願願 (繭選製鏇衊膚鑰廠範醖, 0.73 ) 更多	相似	2020-04-01
NCT02912494 (Pubmed \| Ther Apher Dial) 人工标引	临床3期	贫血	334	darbepoetin alfa	(衊衊餘糧積選壓夢齋壓) = 膚衊鬱壓觸淵願積襯遞範願鹽淵膚範製夢願願 (繭選製鏇衊膚鑰廠範醖, 0.77) 更多	相似	2020-04-01