促红素β生物类似药(Cinnagen)(Epoetin beta biosimilar(Cinnagen)) - 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

Beta erythropoietin、CinnaPoietin、Epoetin beta biosimilar

+ [2]

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

在研适应症

非在研适应症

原研机构

在研机构

非在研机构-

最高研发阶段批准上市

首次获批日期

印度 (2013-01-01),

贫血

最高研发阶段(中国)-

特殊审评-

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结构/序列

Sequence Code 8988

当前序列信息引自: *****

关联

2

项与促红素β生物类似药(Cinnagen) 相关的临床试验

IRCT2013080812685N2

/ Completed临床2期IIT

Clinical trial for comparative study of PDpoietin and Cinnapoietin on anemia in End Stage Renal Disease(ESRD ) patients under hemodialysis.

开始日期2016-07-22

申办/合作机构-

NCT03408639

/ Completed临床3期

A Phase III, Randomized, Two Armed, Parallel, Double Blind (Patient and Assessor Blinded), Active Controlled Non Inferiority Clinical Trial to Determine the Non Inferior Therapeutic Efficacy and Safety Between CinnaPoietin® (Beta Erythropoietin) and Eprex® (Epoetin Alpha) on the Treatment of Anemia in ESRD Hemodialysis Patients

This Phase III, randomized, two-armed, parallel, double-blind, active-controlled clinical trial is designed to compare efficacy and safety of CinnaPoietin® (Beta erythropoietin) and Eprex® (epoetin alpha) on the treatment of anemia in 156 End-Stage Renal Disease hemodialysis patients. 156 patients have been planned to randomize and assign to receive CinnaPoietin® or Eprex® for a 26-week period. Administration dose for patients who are treated with erythropoietin is the similar dose of the previously administered amount (IV or SC without any change). After then, dose adjustment will be made based on patients' response. The primary objective of this study is to compare the efficacy of CinnaPoietin® with Eprex®. The secondary objectives of this study are further comparison and evaluation of efficacy along with safety between CinnaPoietin® and Eprex®.

开始日期2016-06-22

申办/合作机构

CinnaGen Co.

100 项与促红素β生物类似药(Cinnagen) 相关的临床结果

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100 项与促红素β生物类似药(Cinnagen) 相关的转化医学

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100 项与促红素β生物类似药(Cinnagen) 相关的专利（医药）

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13

项与促红素β生物类似药(Cinnagen) 相关的文献（医药）

2023-11-07·Advances in Pharmacological and Pharmaceutical Sciences

Drug Utilization Evaluation of Erythropoietin at a Referral Teaching Hospital in Iran

Article

作者: Rasekh, Hanieh ; Karimian, Ava ; Vazin, Afsaneh ; Shabani-Borujeni, Mojtaba ; Karimzadeh, Iman

Objectives. Drug utilization evaluation (DUE) studies aim to survey the appropriateness of drug use. DUE is an executive approach used to improve the use of medications as well as reduce the cost of treatment, ensure drug adequacy, and improve patient safety. The aim of this study was to evaluate the pattern of erythropoietin use, according to standard guidelines, in patients admitted to Namazi Hospital in Shiraz, Iran. Methods. In this descriptive, retrospective study, 230 patients were assessed. All patients who were hospitalized in different wards of Namazi Hospital, affiliated to Shiraz University of Medical Sciences, and received at least three doses of erythropoietin from September 2019 to March 2020 participated in this study. The following standard indicators of erythropoietin use were evaluated through reviewing medical charts of the cohort: drug dose, dosing intervals, route of administration, indication, monitoring of laboratory parameters, drug dose adjustment based on the response rate as well as target hemoglobin ≥12 g/dl, attention to major drug interactions, and administration of injectable or oral iron supplementation during treatment. Results. Most (65.2%) of the participants were male. The mean ± SD age of the patients was 47.55 ± 22.71 years. More than half (51.3%) of the included subjects were hospitalized in the nephrology ward. PDpoetin® and Cinnapoietin® were given to 52.6% and 47.4% of the study participants, respectively. Treatment of anemia due to chronic kidney disease was the most frequent indication of erythropoietin. The time interval of erythropoietin administration was three times a week for 68.3% of the patients. The most frequently administered weekly dose of erythropoietin was 12,000 units. The weekly dose, dose interval, and route of administration of erythropoietin were appropriate in 52.6%, 77.4%, and 100% of the patients, respectively. Dose adjustment based on the response rate, attention to major drug interactions as well as absolute-relative contraindications, and attention to the target hemoglobin ≥12 g/dl to decide whether or not to continue treatment were based on standard guideline in 98.1%, 98.7%, and 93% of the patients, respectively. The sum indexes of erythropoietin use were in line with standard guidelines in 75.84% of the cases. Conclusion. According to our results, in the setting of erythropoietin use in hospitals, physicians need more attention and education in areas such as selecting the proper dose of medication, correct indication of the drug, temporal arrangement of monitoring laboratory items, and the patient’s need for iron supplements.

2018-01-01·American Journal of Nephrology3区 · 医学

Comparing Therapeutic Efficacy and Safety of Epoetin Beta and Epoetin Alfa in the Treatment of Anemia in End-Stage Renal Disease Hemodialysis Patients

3区 · 医学

Article

作者: Nasiri, Amir Ahmad ; Pourfarziani, Vahid ; Ezzatzadegan Jahromi, Shahrokh ; Ossareh, Shahrzad ; Amini, Somayeh ; Sanadgol, Hooshang ; Abbasi, Mohammad Reza ; Shahvaroughi Farahani, Arshia ; Azmandian, Jalal

Background: Anemia is one of the most prevalent complications in patients with chronic kidney disease, which is believed to be caused by the insufficient synthesis of erythropoietin by the kidney. This phase III study aimed to compare the efficacy and safety of CinnaPoietin® (epoetin beta, CinnaGen) with Eprex® (epoetin alfa, Janssen Cilag) in the treatment of anemia in ESRD hemodialysis patients. Methods: In this randomized, active-controlled, double-blind, parallel, and non-inferiority trial, patients were randomized to receive either CinnaPoietin® or Eprex® for a 26-week period. The primary endpoints of this study were to assess the mean hemoglobin (Hb) change during the last 4 weeks of treatment from baseline along with the evaluation of the mean weekly epoetin dosage per kilogram of body weight that was necessary to maintain the Hb level within 10–12 g/dL during the last 4 weeks of treatment. As the secondary objective, safety was assessed along with other efficacy endpoints. Results: A total of 156 patients were included in this clinical trial. There was no statistically significant difference between treatment groups regarding the mean Hb change (p = 0.21). In addition, the mean weekly epoetin dosage per kg of body weight for maintaining the Hb level within 10–12 g/dL showed no statistically significant difference between treatment arms (p = 0.63). Moreover, both products had comparable safety profiles. However, the incidence of Hb levels above 13 g/dL was significantly lower in the CinnaPoietin® group. Conclusion: CinnaPoietin® was proved to be non-inferior to Eprex® in the treatment of anemia in ESRD hemodialysis patients. The trial was registered in Clinicaltrials.gov (NCT03408639).

2016-04-01·Leukemia1区 · 医学

Lenalidomide with or without erythropoietin in transfusion-dependent erythropoiesis-stimulating agent-refractory lower-risk MDS without 5q deletion

1区 · 医学

Article

作者: Stamatoullas, A ; Lejeune, J ; Nimuboma, S ; Guilhot, F ; Bouabdallah, K ; Gyan, E ; Delaunay, J ; Taksin, A L ; Rose, C ; Laribi, K ; Cony-Makhoul, P ; Sardnal, V ; Beyne-Rauzy, O ; Chouffi, B ; Fenaux, P ; Guerci-Bresler, A ; Maloum, K ; Banos, A ; De Renzis, B ; Legros, L ; Soussain, C ; Gardin, C ; Cheze, S ; Preudhomme, C ; Fontenay, M ; Petit, R ; Slama, B ; Renneville, A ; Sanhes, L ; Gruson, B ; Kosmider, O ; Wattel, E ; Chevret, S ; Bordessoule, D ; Tertian, G ; Caillot, D ; Toma, A ; Isnard, F ; Wickenhauser, S ; Dreyfus, F ; Benramdane, R ; Salanoubat, C

After failure of erythropoiesis-stimulating agents (ESAs), lenalidomide (LEN) yields red blood cell (RBC) transfusion independence (TI) in 20-30% of lower-risk non-del5q myelodysplastic syndrome (MDS). Several observations suggest an additive effect of ESA and LEN in this situation. We performed a randomized phase III study in 131 RBC transfusion-dependent (TD, median transfusion requirement six RBC units per 8 weeks) lower-risk ESA-refractory non-del5q MDS. Patients received LEN alone, 10 mg per day, 21 days per 4 weeks (L arm) or LEN (same schedule) + erythropoietin (EPO) beta, 60,000 U per week (LE arm). In an intent-to-treat (ITT) analysis, erythroid response (HI-E, IWG 2006 criteria) after four treatment cycles (primary end point) was 23.1% (95% CI 13.5-35.2) in the L arm and 39.4% (95% CI 27.6-52.2) in the LE arm (P=0.044), while RBC-TI was reached in 13.8 and 24.2% of the patients in the L and LE arms, respectively (P=0.13). Median response duration was 18.1 and 15.1 months in the L and LE arms, respectively (P=0.47). Side effects were moderate and similar in the two arms. Low baseline serum EPO level and a G polymorphism of CRBN gene predicted HI-E. Combining LEN and EPO significantly improves erythroid response over LEN alone in lower-risk non-del5q MDS patients with anemia resistant to ESA.

100 项与促红素β生物类似药(Cinnagen) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	B03XA01	-

研发状态

批准上市

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适应症	国家/地区	公司	日期
贫血	印度	CinnaGen Co.	2013-01-01

未上市

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适应症	最高研发状态	国家/地区	公司	日期
伴随慢性肾病的贫血	临床1期	伊朗	CinnaGen Co.	2016-06-22
终末期肾脏病	临床1期	伊朗	CinnaGen Co.	2016-06-22

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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


NCT03408639 (CTgov)	临床3期	终末期肾脏病 \| 伴随慢性肾病的贫血	156	Nephrovit+Vitamin B12 Injection+CinnaPoietin® (CinnaPoietin®)	淵觸鏇窪鏇壓遞壓壓糧(艱築憲繭壓艱壓蓋鏇淵) = 繭蓋夢網齋鑰膚積簾構蓋繭糧襯鑰遞構蓋鏇願 (鬱簾觸齋簾艱廠鹹觸製, 範艱淵鏇衊糧選構觸製 ~ 廠鏇製糧構繭糧壓窪選) 更多	-	2019-11-06
NCT03408639 (CTgov)	临床3期	终末期肾脏病 \| 伴随慢性肾病的贫血	156	Nephrovit+Vitamin B12 Injection+Eprex® (Eprex®)	淵觸鏇窪鏇壓遞壓壓糧(艱築憲繭壓艱壓蓋鏇淵) = 範築窪簾蓋網艱選壓簾蓋繭糧襯鑰遞構蓋鏇願 (鬱簾觸齋簾艱廠鹹觸製, 廠衊鬱獵憲廠鏇願鹹襯 ~ 餘齋鏇鹽艱夢範鹽壓艱) 更多	-	2019-11-06
Pananemia 2008 (ASCO2009)	N/A	肿瘤	591	Erythropoietin beta	(鹽廠餘襯鹹獵蓋繭網衊) = 繭鬱壓選鏇餘選鑰顧觸鏇蓋醖糧網糧繭製顧鬱 (淵壓觸窪鑰顧夢觸鬱積 )	-	2009-05-20