干扰素α-2b生物类似药(Center For Genetic Engineering And Biotechnology)(Interferon alfa-2b biosimilar(Center For Genetic Engineering And Biotechnology))

概要

基本信息

药物类型

干扰素、生物类似药

别名

Heberon Alfa R、Inrec

靶点

IFNAR

作用方式

激动剂、刺激剂、诱导剂

作用机制

IFNAR激动剂(干扰素α/β受体复合体激动剂)、免疫刺激剂、先天性抗病毒免疫应答诱导剂

治疗领域

感染

在研适应症

病毒感染

非在研适应症-

原研机构

Centro de Ingenieria Genetica y Biotecnologia

在研机构

Heber Biotec SA

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

古巴 (2000-12-01),

病毒感染

最高研发阶段(中国)-

特殊审评-

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结构/序列

Sequence Code 26333714

当前序列信息引自: *****

关联

15

项与干扰素α-2b生物类似药(Center For Genetic Engineering And Biotechnology) 相关的临床试验

NCT04093323

/ Recruiting临床2期IIT

A Phase II Study of Type-1 Polarized Dendritic Cell (aDC1) -Based Treatment in Combination With Tumor-Selective Chemokine Modulation (CKM: Interferon Alpha 2b, Rintatolimod and Celecoxib) in Melanoma Patients With Primary PD-1/PD-L1 Resistance

This phase II trial studies how well polarized dendritic cell (aDC1) based therapy, interferon alpha-2, rintatolimod, and celecoxib work together in treating patients with HLA-A2 positive (+) melanoma that has not responded to previous treatment (refractory). The aDC1 cell-based treatment contains white blood cells (dendritic cells or DCs) that stimulates the immune system. Interferon alpha-2 can improve the body's natural response to infections and other diseases. It can also interfere with the division of cancer cells and slow tumor growth. Rintalolimid may stimulate the immune system. Celecoxib is a drug that reduces pain. This study is being done to find out if the combination of the study cell-based treatment (aDC1 dendritic cells) and interferon alpha-2, rintatolimod, and celecoxib can prevent the growth and/or progression of melanoma.

开始日期2024-11-13

申办/合作机构

Roswell Park Comprehensive Cancer Center

[+1]

RPCEC00000412

/ Suspended临床2/3期

Evaluation of intranasal recombinant human interferon alfa-2b in the treatment of acute respiratory viral infections with mild clinical classification. Dose study. NASIRA studio. Phase II-III trial - IFNARI

开始日期2023-02-01

申办/合作机构

Centro de Ingenieria Genetica y Biotecnologia

RPCEC00000407

/ Suspended临床2/3期

Evaluation of intranasal recombinant human interferon alfa-2b in the treatment of acute respiratory viral infections with mild clinical classification. Dose and frequency study. INDIRA study. Phase II-III trial - NASALFERON-ARI

开始日期2022-09-01

申办/合作机构

Centro de Ingenieria Genetica y Biotecnologia

100 项与干扰素α-2b生物类似药(Center For Genetic Engineering And Biotechnology) 相关的临床结果

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100 项与干扰素α-2b生物类似药(Center For Genetic Engineering And Biotechnology) 相关的转化医学

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100 项与干扰素α-2b生物类似药(Center For Genetic Engineering And Biotechnology) 相关的专利（医药）

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2

项与干扰素α-2b生物类似药(Center For Genetic Engineering And Biotechnology) 相关的文献（医药）

2004-01-01·Drugs in R & D4区 · 医学

Bioequivalence of Two Recombinant Interferon ??-2b Liquid Formulations in Healthy Male Volunteers

4区 · 医学

ArticleOA

作者: Armando Correa-Fernandez ; Jorge Ducongé ; Idrian Garcia-Garcia ; Lourdes Olivera-Ruano ; Francisco Hernandez-Bernal ; Carmen Valenzuela-Silva ; Majel Cervantes-Llano ; Joel Ferrero-Bibilonia ; Carlos Alberto Gonzalez-Delgado ; Pedro Lopez-Saura ; Ramon Soto-Hernandez

OBJECTIVEInterferon (IFN) alpha-2b is a protein with antiviral, antiproliferative and immunoregulatory properties that is approved for several clinical indications. A new liquid, albumin-free, IFNalpha-2b formulation has recently been developed. This study aimed to evaluate the equivalence of the pharmacokinetic, pharmacodynamic and safety properties of the new formulation with a reference one in healthy male volunteers.METHODSA randomised, crossover, double-blind study with a 3-week washout period was performed in which Heberon Alfa R (formulation A) and Viraferon (formulation B) were compared. A single 20 x 10(6) IU IFNalpha-2b dose was administered subcutaneously to 14 apparently healthy male subjects. Serum IFN level was measured over 48 hours by enzyme immunoassay (EIA) and by antiviral activity titration. Clinical and laboratory variables were determined, as were pharmacodynamic and safety criteria.RESULTSGroups were homogeneous with regard to all demographic and baseline variables. Pharmacokinetic comparison by EIA did not show differences between the formulations: area under the curve (AUC) 2572 versus 2561 ng x h/L, maximum plasma concentration (Cmax) 318 versus 354 ng/L, time to Cmax (tmax) 8.2 versus 8.5 h, elimination half-life (t(1/2)) 5.87 versus 6.08 h, terminal elimination rate (lambda) 0.122 versus 0.118 h(-1), and mean residence time (MRT) 10.9 versus 12.0 h for formulations A and B, respectively. The differences never reached 20%, which is the clinically significant threshold. The 90% confidence interval of the ratio between them was in all cases within the 0.8, 1.25 range. The two formulations were clinically equivalent with regard to serum IFN antiviral activity titration (0.8, 1.25 criterion) regarding their pharmacokinetic parameters. There were no significant differences with respect to the pharmacodynamic variables: serum beta2-microglobulin and temperature increase. Heart rate and blood pressure changes did not differ either. Both products provoked similar haematological count decreases and had similar safety profiles. The most frequent adverse reactions were fever, tachycardia, headache and arthralgias.CONCLUSIONThe overall analysis strongly suggests the bioequivalence of these two products.

G.E.N

Estudio a largo plazo del tratamiento con interferon recombinante alfa 2b en la hepatitis crónica activa por virus b en niños y adolescentes.

Article

作者: Borbolla Bousquets, E ; García Bacallao, E ; Escobar Capote, M D ; Castañeda Guillot, C

To assess the efficacy of recombinant alfa 2b-interferon treatment "Heberon alfa R" in children with chronic active hepatitis (CAH) B virus, we conducted a long-term study (three years) in 22 children infected with hepatitis B virus (17 males and 5 females), age range 3 to 15 years. Diagnostic criteria included the clinical picture, laboratory tests, virus markers (HBeAg, HBsAg), laparoscopy and liver biopsy. Children under 12 years received 3 million IU of interferon per day whereas those older than 12 years received 6 million IU of interferon per day by intramuscular injection, three times per week for four months. Alanine aminotransferase (ALT) levels had been elevated for six months in all patients and hepatitis B viral infection was replicative. A variance analysis was made to evaluate ALT response to interferon administration and the Mc Nemar test was used to analyze HBeAg/anti-HBe behavior. Seventeen (77%) out of 22 patients responded to treatment (clearance of HBeAg and ALT levels returned to normal. HBeAg seroconversion (anti-HBe) occurred in 36% of patients during the first year (p < 0.01) and it increased to 50% by the third year follow-up. ALAT levels also decreased and the difference was statistically significant (p < 0.01). This occurred during and after treatment with a steady and increasing tendency to return to normal levels within the first and third year. Side effects were scarce, transient and tolerable and they only appeared during the initial phase of treatment; symptoms were mainly influenza-like and they disappeared very soon. There were no late side effects such as medullar depression, renal toxicity and glycemia alterations.(ABSTRACT TRUNCATED AT 250 WORDS)

100 项与干扰素α-2b生物类似药(Center For Genetic Engineering And Biotechnology) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L03AB05	-

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
病毒感染	古巴	-	2000-12-01

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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


NCT03403634 (CTgov)	临床2期	肝转移 \| 复发性结直肠癌 \| 结直肠癌	19	Laboratory Biomarker Analysis+Intron A+Heberon Alfa+Urifron+Rintatolimod+Celecoxib	壓艱餘網範築構繭顧憲(觸淵鑰膚鏇糧衊襯衊齋) = 糧繭網製憲艱網夢淵鑰廠膚構築襯蓋繭鹽觸餘 (網範鏇憲顧顧廠製艱繭, 壓選憲範憲繭製淵網夢 ~ 壓醖壓獵獵醖積壓繭齋) 更多	-	2022-03-02
NCT01460875 (CTgov)	N/A	皮肤黑色素瘤	34	laboratory biomarker analysis+Intron A+Heberon Alfa	繭齋鏇製廠遞糧鹽遞獵(齋網顧觸艱範衊艱積淵) = 糧簾鏇膚襯鏇壓蓋憲獵夢製鬱衊簾淵鏇夢簾構 (窪膚鏇淵糧鑰夢鹽獵窪, 窪艱餘憲鑰窪廠遞鹹願 ~ 襯願觸顧醖選鬱鬱製夢) 更多	-	2018-11-02
NCT00126594 (CTgov)	临床2期	转移性肾细胞癌	80	Laboratory Biomarker Analysis+Sorafenib Tosylate (Sorafenib Tosylate)	網憲蓋網淵廠糧鑰鏇壓(窪廠憲廠鑰壓鬱繭窪鑰) = 鏇鑰選鹽蓋鹽繭夢廠遞鏇觸窪憲鹹鬱鏇顧鹽構 (觸鬱衊膚簾網襯網蓋繭, 構窪鏇繭艱襯製夢膚廠 ~ 選膚願襯簾鏇鏇鹽鑰廠) 更多	-	2016-09-16
NCT00126594 (CTgov)	临床2期	转移性肾细胞癌	80	Laboratory Biomarker Analysis+Sch 30500+Heberon Alfa+Urifron+Sorafenib Tosylate (Sorafenib Tosylate, Recombinant Interferon Alfa-2b)	網憲蓋網淵廠糧鑰鏇壓(窪廠憲廠鑰壓鬱繭窪鑰) = 衊壓淵醖衊範夢齋憲鏇鏇觸窪憲鹹鬱鏇顧鹽構 (觸鬱衊膚簾網襯網蓋繭, 選簾鏇膚顧糧艱壓餘壓 ~ 繭鑰積製積願襯顧餘壓) 更多	-	2016-09-16