阿法依伯汀生物类似药(LG Life Sciences Ltd.)(Epoetin alfa biosimilar (LG Life Sciences)) - 药物靶点：EPO receptor_在研适应症：贫血_专利_临床

概要

基本信息

药物类型

生物类似药、集落刺激因子

别名

EPO、Recombinant Human Erythropoietin Injection(CHO Cell) (LG Life Sciences)、Espogen

+ [1]

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

LG Life Sciences Ltd.

在研机构

LG Life Sciences Ltd.

非在研机构-

权益机构-

最高研发阶段批准上市

首次获批日期

中国 (2009-05-31),

贫血

最高研发阶段(中国)批准上市

特殊审评-

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结构/序列

Sequence Code 9003

当前序列信息引自: *****

关联

2

项与阿法依伯汀生物类似药(LG Life Sciences Ltd.) 相关的临床试验

ChiCTR1900024947

/ Recruiting临床4期IIT

A randomized, open, parallel controlled, single-center clinical trial for recombinant human erythropoietin injection (CHO cells) in the treatment of anemia caused by chemotherapy in non-bone marrow malignant tumors at different times

开始日期2019-08-01

申办/合作机构-

ChiCTR1800014265

/ Suspended临床4期IIT

A Randomized, controlled, open multicenter clinical trial of Recombinant Human Erythropoietin Injection (CHO cells) comparing for single and two to three times weekly administration of renal anemia in maintenance hemodialysis

开始日期2018-01-19

申办/合作机构-

100 项与阿法依伯汀生物类似药(LG Life Sciences Ltd.) 相关的临床结果

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100 项与阿法依伯汀生物类似药(LG Life Sciences Ltd.) 相关的转化医学

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100 项与阿法依伯汀生物类似药(LG Life Sciences Ltd.) 相关的专利（医药）

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2

项与阿法依伯汀生物类似药(LG Life Sciences Ltd.) 相关的文献（医药）

2009-05-01·Clinical Therapeutics4区 · 医学

Pharmacokinetic, tolerability, and bioequivalence comparison of three different intravenous formulations of recombinant human erythropoietin in healthy Korean adult male volunteers: An open-label, randomized-sequence, three-treatment, three-way crossover study

4区 · 医学

Article

作者: Jong Lyul Ghim ; Jin Ah Jung ; Un Jib Kim ; Kyun Seop Bae ; Sang Heon Cho ; Sangmin Choe ; Hyeong Seok Lim

BACKGROUNDExisting formulations of recombinant human erythropoietin (rhEPO) in Korea contain human serum albumin. To avoid the potential risk of infection by human serum albumin, a new albumin-free rhEPO has been developed.OBJECTIVEThis study was conducted to characterize and compare the pharmacokinetic and safety profiles and the bioequivalence of a newly developed albumin-free rhEPO (Aropotin [TS Corporation, Seoul, South Korea]) with 2 existing rhEPO formulations (Espogen [LG Life Sciences, Seoul, South Korea]; Recormon [Roche, Basel, Switzerland]) with albumin in healthy Korean subjects.METHODSThis was an open-label, randomized-sequence, 3-treatment, 3-way crossover study in which healthy, nonobese (+/-20% of ideal weight), male volunteers between the ages of 19 and 50 years were assigned to 1 of 2 dose levels (50 IU/kg or 100 IU/kg) of 3 formulations. Blood was collected over 32 hours and plasma rhEPO concentrations were determined using a validated enzyme immunoassay. There was a 14-day washout between periods. The pharmacokinetic parameters of the 3 formulations were compared using the bioequivalence criteria of the US Food and Drug Administration, which requires that the 90% CIs of the geometric mean ratios for AUC(0-t), AUC(0-infinity), and C(max) fall within 0.80 to 1.25. Tolerability was evaluated by physical examination with measurements of vital signs, clinical laboratory tests, and electrocardiogram. Subjects were followed up for 2 weeks after the last administration of study drug.RESULTSTwelve Korean male volunteers were enrolled and completed the study. Six subjects (mean [SD] age, 22.0 [1.7] years; weight, 63.3 [6.2] kg; height, 172.3 [3.5] cm) received a single 50 IU/kg IV bolus dose of study drug and the remaining 6 subjects (mean [SD] age, 23.7 [1.5] years; weight, 66.3 [4.8] kg; height, 174 [4.7] cm) received 100 IU/kg. After a single 50 IU/kg dose, the geometric mean ratio (90% CI) for Aropotin/Espogen was 1.04 (0.91-1.19) IU/L/h for AUC(0-t) and 1.02 (0.89-1.17) IU/L for C(max). The geometric mean ratio (90% CI) for Aropotin/Recormon was 1.01 (0.88-1.15) IU/L/h for AUC(0-t) and 1.01 (0.89-1.16) IU/L for C(max). After a single 100-IU/kg dose, the geometric mean ratio (90% CI) for Aropotin/ Espogen was 0.98 (0.86-1.13) IU/L/h for AUC(0-t) and 0.99 (0.87-1.13) IU/L for C(max). The geometric mean ratio (90% CI) for Aropotin/Recormon was 0.99 (0.861.14) IU/L/h for AUC(0-t) and 0.96 (0.84-1.10) IU/L for C(max). The most frequent adverse events (AEs) were 3 occurrences of elevated serum creatine phosphokinase and serum lactate dehydrogenase levels in the Recormon 100-IU/kg group (n = 3), 3 events of elevated serum lactate dehydrogenase levels in the Espogen 100-IU/kg group (n = 3), and 4 events of elevated serum total bilirubin levels in the Aropotin 100-IU/kg group (n = 3). All formulations were well tolerated with no serious AEs.CONCLUSIONThe new formulation of rhEPO met the regulatory criteria for bioequivalence in these healthy Korean adult male volunteers. All formulations were generally well tolerated.

2007-04-01·Journal of the Medical Association of Thailand = Chotmaihet thangphaet

12-week clinical effects of erythropoietin espogen in end stage renal patients undergoing hemodialysis.

Article

作者: Thitiarchakul, Supachai ; Tasanarong, Adis

BACKGROUNDAnemia is one of most common complications in end stage renal disease (ESRD) patients. Erythropoietin has been recommended for treatment of anemia in these patients.OBJECTIVESTo evaluate the clinical efficacy, safety and usefulness of newly imported erythropoietin, called Espogen, usage in ESRD undergoing hemodialysis.MATERIAL AND METHODAn open, non-comparative, prospective study of administered Espogen was conducted in 30 ESRD patients undergoing hemodialysis for a 12 week period. Eligible criteria included hemoglobin of less than 8 g%, hematocrit of less than 25% for at least three consecutive months with a serum ferritin of more than 100 ng%. Initial dose of drug was 150 units/kg/week subcutaneously, two or three times a week and dosage was adjusted to maintain the Hb at 10-12g%.RESULTSIn 28 patients, hemoglobin and hematocrit were increased significantly from 7.1 +/- 1.14 g/dl and 22.1 +/- 3.24% at baseline to 10.1 +/- 1.49 g/dl and 31.7 +/- 4.01% at the end of the study period respectively (p < 0.05). Mean weekly of Espogen dosage was 8390 +/- 2452.7 IU/week, which was 152.1 IU/kg/week. Some patients could reduce the dose at week 10. Reticulocyte increased significantly from 0.69 +/- 0.58% at baseline to highest value, 1.41 +/- 0.74 at 2 week and 1.30 +/- 0.66 at the end of the present study. Serum vitamin B12, serum folate, and red blood cell folate were not significantly changed. However serum ferritin decreased significantly from 840.6 +/- 948.95 to 582.7 +/- 990.70 ng/ml (p < 0.05). General condition including SF-36 score and tiredness were improved. There were no significant adverse events except mean arterial blood pressure of pre dialysis value which was statistically significant increased at the end of the present study (from 101.0 +/- 17.65 at week 0 and 110.4 +/- 16.8 mmHg at week 12, p = 0.0223).CONCLUSIONThis clinical study showed that Espogen has proven effective and safe for treatment of anemia in hemodialysis patients. No serious adverse events occurred during the study period.

100 项与阿法依伯汀生物类似药(LG Life Sciences Ltd.) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	B03XA01	-

研发状态

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	中国	LG Life Sciences Ltd.	2009-05-31

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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


EHA2015	N/A	骨髓增生异常综合征	107	ERYTHROPOIETIN (No support)	(窪顧築夢壓壓製網廠鏇) = 窪鬱鏇鏇鹽艱築範範齋網糧齋選憲壓鹹鏇糧夢 (齋餘醖遞壓選構鬱鬱繭 ) 更多	-	2015-05-21
				Epo support	(窪顧築夢壓壓製網廠鏇) = 鏇繭醖夢構廠選夢憲膚網糧齋選憲壓鹹鏇糧夢 (齋餘醖遞壓選構鬱鬱繭 ) 更多
AUO-AP/33/02 (ASCO2015)	临床2期	转移性去势抵抗性前列腺癌	139	DOC + EMP + EPO	(餘醖遞廠鑰艱鏇淵築壓) = 簾齋餘顧範鬱獵選衊壓繭選襯齋鹽鑰壓鹽夢製 (鏇獵鹹製憲鑰膚顧鏇繭 ) 更多	-	2015-05-20
				DOC + EMP	(餘醖遞廠鑰艱鏇淵築壓) = 艱衊襯繭蓋觸獵鏇艱蓋繭選襯齋鹽鑰壓鹽夢製 (鏇獵鹹製憲鑰膚顧鏇繭 ) 更多
ASCO2008	N/A	贫血 \| 骨髓增生异常综合征	-	EPO Monotherapy	鹹製蓋齋積憲獵膚窪鹹(膚壓鹹餘齋顧鑰鹽鏇鏇) = 鹹願夢製膚夢鹽構餘鏇襯夢顧鹽鹹憲膚築壓繭 (蓋廠觸網膚鑰廠廠簾鏇, 49 ~ 57) 更多	-	2008-05-20
				EPO+G/GM-CSF	鹹製蓋齋積憲獵膚窪鹹(膚壓鹹餘齋顧鑰鹽鏇鏇) = 襯鹽膚醖築繭繭製構夢襯夢顧鹽鹹憲膚築壓繭 (蓋廠觸網膚鑰廠廠簾鏇, 43 ~ 59) 更多
ASCO2005	临床2期	转移性实体瘤	34	EPO+Dexa	積蓋顧鬱膚艱蓋構遞蓋(夢獵鑰齋網鏇願鏇憲醖) = 艱餘顧範繭廠襯願網鏇壓齋淵衊廠窪夢壓憲膚 (遞獵窪顧鹽網廠製廠構 ) 更多	-	2005-06-01
ASCO2005	N/A	心肌疾病	-	EPO	遞醖製艱鏇淵顧築鏇餘(範鏇襯鹽餘廠壓鬱範醖) = 鹽構積選餘夢衊網襯鬱鏇艱蓋鏇壓襯鹹廠鏇艱 (憲遞餘鹽廠鏇衊夢憲夢 ) 更多	-	2005-06-01
Study N02C2 (ASCO2005)	临床3期	贫血 \| 肿瘤	365	40,000U EPO SC every week	繭襯憲獵鹹網顧鬱積艱(憲夢構窪築鹽淵願遞選) = There was a slight trend towards superior survival in the 120K arm 鏇鏇繭網艱構鑰鬱鏇鹽 (網網鏇夢膚遞製餘蓋艱 )	积极	2005-06-01
				120,000U EPO SC every 3 weeks
ASCO2004	临床2期	转移性肾细胞癌	25	Thalidomide	繭觸鑰鏇鑰築遞築夢廠(範齋廠範憲壓鏇廠簾鑰) = 積製衊憲積選壓遞艱鹽鏇襯築襯蓋獵襯繭製鏇 (蓋齋憲鹽遞製醖顧鬱襯 ) 更多	-	2004-07-15
				Thalidomide + EPO	繭觸鑰鏇鑰築遞築夢廠(範齋廠範憲壓鏇廠簾鑰) = 襯窪網餘鹹膚網夢齋簾鏇襯築襯蓋獵襯繭製鏇 (蓋齋憲鹽遞製醖顧鬱襯 ) 更多