依库珠单抗生物类似药(Ibc Generium)(Eculizumab biosimilar(Ibc Generium)) - 药物靶点：C5_在研适应症：非典型溶血性尿毒症综合征，阵发性睡眠性血红蛋白尿症_专利_临床

概要

基本信息

药物类型

生物类似药、单克隆抗体

别名

Eculizumab biosimilar、Elizaria

靶点

C5

作用机制

C5抑制剂(补体C5抑制剂)

治疗领域

血液及淋巴系统疾病泌尿生殖系统疾病其他疾病

在研适应症

非典型溶血性尿毒症综合征阵发性睡眠性血红蛋白尿症

非在研适应症-

原研机构

International Biotech Center Generium

在研机构

International Biotech Center Generium

非在研机构-

最高研发阶段临床3期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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序列信息

Sequence Code 66453H

当前序列信息引自: *****

Sequence Code 66437L

当前序列信息引自: *****

关联

3

项与依库珠单抗生物类似药(Ibc Generium) 相关的临床试验

NCT04749810 / CompletedN/A

Prospective Observational Study of Long-term Pathogenic Treatment of Elizaria® in Patients With Atypical Hemolytic Uremic Syndrome

It is a multicenter observational non-comparative study of the efficacy and safety of long-term pathogenetic Elizaria® therapy in patients with atypical Hemolytic Uremic Syndrome

开始日期2019-12-19

申办/合作机构

Generium ZAO

NCT04671810 / CompletedN/A

Prospective Observational Study of Long-term Pathogenic Treatment of Elizaria® in Patients With Paroxysmal Nocturnal Hemoglobinuria.

This is prospective observational study of long-term pathogenic treatment of Elizaria® in patients with paroxysmal nocturnal hemoglobinuria.

开始日期2019-06-13

申办/合作机构

Generium ZAO

NCT04463056 / Completed临床3期

A Multicenter, Open Label, Randomized, Parallel-group Study of Efficacy and Safety of Eculizumab (JSC GENERIUM, Russia) vs. Soliris® (Alexion Pharma GmbH, Switzerland) in Patients With Paroxysmal Nocturnal Hemoglobinuria

It is a multicenter, open-label, randomized, parallel-group study of the efficacy and safety of Elizaria® (eculizumab, GENERIUM JSC, Russia) versus Soliris® (Alexion Pharma GmbH, Switzerland) in patients with paroxysmal nocturnal hemoglobinuria.

开始日期2017-11-29

申办/合作机构

Generium ZAO

100 项与依库珠单抗生物类似药(Ibc Generium) 相关的临床结果

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100 项与依库珠单抗生物类似药(Ibc Generium) 相关的转化医学

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100 项与依库珠单抗生物类似药(Ibc Generium) 相关的专利（医药）

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4

项与依库珠单抗生物类似药(Ibc Generium) 相关的文献（医药）

2023-09-01·Hematology reports

The Features of COVID-19's Course and the Efficacy of the Gam-COVID-Vac Vaccine in Patients with Paroxysmal Nocturnal Hemoglobinuria.

Article

作者: Nikitin, Eugene ; Arshanskaya, Evgeniya ; Vinogradova, Olga ; Kudlay, Dmitry ; Ptushkin, Vadim

COVID-19 and other infectious diseases can exacerbate the course of paroxysmal nocturnal hemoglobinuria (PNH). The efficacy and safety of the Gam-COVID-Vac vaccine in patients with PNH has not been adequately studied. A retrospective, observational, cohort, non-comparative study was performed to assess the course of COVID-19 as well as the safety and efficacy of the Gam-COVID-Vac (Sputnik V) vaccine in patients with paroxysmal nocturnal hemoglobinuria (PNH). The study included data from 52 patients with PNH aged 18 to 75 years, 38 of whom received background therapy with eculizumab (Elizaria^®) between March 2020 and January 2022. COVID-19 was diagnosed according to the results of PCR testing. The patients were divided into two groups for comparison of the incidence of COVID-19. Group 1 included non-vaccinated patients with PNH, and Group 2 included patients vaccinated prior to the onset of COVID-19. According to vaccination, patients were subdivided into non-vaccinated and vaccinated groups without signs of previous COVID-19 at the beginning of the analyzed period, and patients vaccinated half a year or more after recovery from COVID-19. Testing for anti-SARS-CoV-2 IgG levels was carried out in patients with PNH in the year after their COVID-19. Tests for anti-SARS-CoV-2 RBD IgG levels were performed on vaccinated patients. In total, 28 (53.8%) of the enrolled patients had COVID-19, including asymptomatic forms in 7 (25%) and mild forms in 16 (57%) patients. A total of 22 (42.3%) patients were fully vaccinated with Gam-COVID-Vac, of which 13 (25%) patients were vaccinated without the signs of previous SARS-CoV-2infection, and 9 (17.3%) patients were vaccinated after COVID-19. The number of patients who had COVID-19 was about two times higher in Group 1 (non-vaccinated; 24) (61.5%), whereas in Group 2 (vaccinated), the number of patients with COVID-19 was only 4 (30.8%). The proportion and number of patients who did not have COVID-19 was higher in the group of vaccinated patients (9; 69.2%) than in the group of non-vaccinated patients (15; 38.5%) (p = 0.054). In patients who had been infected with COVID-19, maximum concentrations of anti-SARS-CoV-2 IgG were observed 2-3 months after the acute infection phase, followed by a gradual decline by month 9-10. The mean RBD IgG concentration was higher in the group of patients who had been infected by COVID-19 than in the group of patients without COVID-19 (p = 0.047). Therapy type, including eculizumab, did not have a significant impact on RBD IgG titers (p > 0.05). Hospitalization was required in five (18%) patients, all of whom had breakthrough hemolysis and severe lung damage on CT scans. After the first dose, adverse events (AEs) were reported in 41% of the patients (body temperature increased in 18%; headache in 13.6%; and pain in joints in 4.5%; colitis exacerbation was observed in 4.5%). After the second dose, no AEs were reported. The performed study suggests the possible efficacy and demonstrates the safety of Gam-COVID-Vac (Sputnik V) for the prophylaxis of COVID-19 in patients with PNH who experience immunosuppression due to target therapy.

2022-10-01·Journal of Pharmaceutical and Biomedical Analysis

Analytical and functional similarity of biosimilar Elizaria® with eculizumab reference product

Article

作者: Taran, Sergey ; Lyagoskin, Ivan ; Shukurov, Rahim ; Simonov, Vladimir ; Gusarova, Valentina ; Degterev, Maxim ; Smolov, Maxim

A recombinant humanized monoclonal antibody (mAb) Eculizumab, C5-complement cascade inhibitor, is an important treatment of complement-based diseases recommended by international guidelines. Elizaria® Drug Product (DP), developed by IBC Generium, Russia, is the world's first registered biosimilar of eculizumab (Soliris®, Alexion Pharmaceuticals). Using sensitive state-of-the-art analytical techniques extensive similarity assessment has been conducted to demonstrate the structural and functional similarity of original Soliris® (Eculizumab Reference Product, RP) and the biosimilar Elizaria®, focusing on the physicochemical and biological quality attributes, including those known to affect the mechanisms of action. A multitude of analyses revealed that amino acid sequence is identical, the higher order structures, post-translational modifications, purity, and product variants are highly similar between Elizaria® DP and Eculizumab RP, except for minor differences in the relative abundance of the charge variants and glycan moieties considered not clinically significant. The results demonstrate that Elizaria® is highly analytically similar to Eculizumab RP in terms of physicochemical properties and biological activities.

2021-11-01·Annals of Hematology3区 · 医学

Randomized multicenter noninferiority phase III clinical trial of the first biosimilar of eculizumab

3区 · 医学

Article

作者: Shamrai, Vladimir S ; Lukina, Elena A ; Korobkin, Alexander V ; Kulagin, Alexander D ; Zuev, Evgeny V ; Kudlay, Dmitry A ; Konstantinova, Tatyana S ; Davydkin, Igor L ; Mitina, Tatyana A ; Ksenzova, Tatyana I ; Markova, Oksana A ; Gapchenko, Elena V ; Kaporskaya, Tatyana S ; Ptushkin, Vadim V

AbstractCurrently, eculizumab is the main effective treatment for paroxysmal nocturnal hemoglobinuria (PNH). The aim of this randomized multicenter noninferiority study was to evaluate the efficacy and safety of the Biosimilar (Elizaria) in comparison with the Originator (Soliris) in patients with PNH. Biosimilar and Originator were administered at a dose of 600 mg weekly for 4 weeks at the initial stage in naive patients, as well as for maintenance therapy at a dose of 900 mg every 2 weeks in all patients. The primary endpoint was a comparative assessment of hemolytic activity based on the area under the lactate dehydrogenase (LDH) concentration–time curve during the maintenance therapy. Thirty-two (32) patients were randomized for therapy with Biosimilar (n = 16) or Originator (n = 16). The mean values of LDH concentration–time curve were similar in both treatment groups without statistically significant differences (p > 0.05). Evaluation of secondary endpoints has shown no statistically significant differences between the groups. Safety values were comparable in both treatment groups. The data obtained confirm that the Biosimilar is not inferior to the Originator in terms of the main efficacy parameter, and is also comparable with it in terms of safety and additional efficacy parameters. Clinicaltrials.gov identifier: NCT04463056

100 项与依库珠单抗生物类似药(Ibc Generium) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L04AA25	DB01257

研发状态

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
非典型溶血性尿毒症综合征	临床3期	-	International Biotech Center Generium	-
阵发性睡眠性血红蛋白尿症	临床3期	-	International Biotech Center Generium	-