Delving into the Latest Updates on Rituximab biosimilar (Shanghai Institute of Biological Products) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Monoclonal antibody

Synonyms

Recombinant chimeric anti-CD20 antibody(Shanghai Institute of Biological Products), 重组人鼠嵌合抗CD20单克隆抗体 (上海生物制品研究所)

+ [3]

Target

CD20

Mechanism

CD20 inhibitors(B-lymphocyte antigen CD20 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), CD20-directed cytolytic effects

+ [1]

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases

Active Indication

CD20 positive Diffuse Large B-Cell LymphomaChronic Lymphocytic LeukemiaFollicular Lymphoma+ [1]

Inactive Indication-

Originator Organization

Shanghai Institute of Biological Products Co., Ltd.

Active Organization

Shanghai Institute of Biological Products Co., Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

CN (19 Mar 2024),

CD20 positive Diffuse Large B-Cell LymphomaChronic Lymphocytic LeukemiaFollicular Lymphoma

Regulation-

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Gene Sequence

Sequence Code 83181H

The sequence is quoted from: *****

Sequence Code 27145L

The sequence is quoted from: *****

比较重组人鼠嵌合抗CD20单克隆抗体注射液联合CHOP化疗方案与美罗华®联合CHOP化疗方案治疗CD20阳性弥漫性大B细胞淋巴瘤初治患者的有效性。比较重组人鼠嵌合抗CD20单克隆抗体注射液联合CHOP化疗方案与美罗华®联合CHOP化疗方案治疗CD20阳性弥漫性大B细胞淋巴瘤初治患者的免疫原性,安全性,静脉滴注给药后的药效动力学参数。

[Translation]

To compare the efficacy of recombinant human-mouse chimeric anti-CD20 monoclonal antibody injection combined with CHOP chemotherapy and Rituxan® combined with CHOP chemotherapy in the treatment of CD20-positive diffuse large B-cell lymphoma in patients with untreated disease. To compare the immunogenicity, safety, and pharmacodynamic parameters of recombinant human-mouse chimeric anti-CD20 monoclonal antibody injection combined with CHOP chemotherapy and Rituxan® combined with CHOP chemotherapy in the treatment of CD20-positive diffuse large B-cell lymphoma in patients with untreated disease.

Start Date25 Jul 2019

Sponsor / Collaborator

Shanghai Institute of Biological Products Co., Ltd.

CTR20181068 / Active, not recruitingPhase 1

重组人鼠嵌合抗CD20单克隆抗体注射液和美罗华的药代动力学、药效动力学及安全性的比对研究

[Translation] Comparative study on the pharmacokinetics, pharmacodynamics and safety of recombinant human-mouse chimeric anti-CD20 monoclonal antibody injection and rituximab

比较重组人鼠嵌合抗CD20单克隆抗体注射液和利妥昔单克隆抗体注射液（美罗华®）在CD20阳性B细胞非霍奇金淋巴瘤患者单次静脉滴注给药后的药代动力学参数，药效动力学参数和免疫原性。评价重组人鼠嵌合抗CD20单克隆抗体注射液与利妥昔单克隆抗体注射液（美罗华®）在CD20阳性B细胞非霍奇金淋巴瘤患者的安全性。

[Translation]

To compare the pharmacokinetic parameters, pharmacodynamic parameters and immunogenicity of recombinant human-mouse chimeric anti-CD20 monoclonal antibody injection and rituximab monoclonal antibody injection (MabThera®) in patients with CD20-positive B-cell non-Hodgkin's lymphoma after a single intravenous infusion. To evaluate the safety of recombinant human-mouse chimeric anti-CD20 monoclonal antibody injection and rituximab monoclonal antibody injection (MabThera®) in patients with CD20-positive B-cell non-Hodgkin's lymphoma.

Start Date11 Oct 2018

Sponsor / Collaborator

Shanghai Institute of Biological Products Co., Ltd.

100 Clinical Results associated with Rituximab biosimilar (Shanghai Institute of Biological Products)

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100 Translational Medicine associated with Rituximab biosimilar (Shanghai Institute of Biological Products)

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100 Patents (Medical) associated with Rituximab biosimilar (Shanghai Institute of Biological Products)

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77

Literatures (Medical) associated with Rituximab biosimilar (Shanghai Institute of Biological Products)

01 Jul 2023·Therapies

Adverse effect of Pneumocystis Jirovecii infection associated with rituximab therapy for autoimmune disease are more frequently reported in older vs. younger patient

Article

Author: Michot, Joëlle ; Jonville-Béra, Annie Pierre ; Maillot, Francois ; Lemoine, Léa ; Agier, Marie Sara ; Chouchana, Laurent ; Audemard-Verger, Alexandra

INTRODUCTIONRituximab is a chimeric anti-CD20 antibody commonly used to treat patients with autoimmune diseases. Such diseases mainly affect young people, but older patients may also be concerned. So far, very little data exist concerning the safety of rituximab in older patients with autoimmune diseases.METHODSThis study was intended to describe the adverse reaction profile of rituximab in patients over 75 years of age treated for autoimmune diseases and to compare such profile to those observed in patients below 75 years of age. Adverse reactions related to rituximab were reported to the French Pharmacovigilance Network. From such reports, a descriptive analysis as well as a disproportionality analysis were performed to identify safety signals.RESULTS1096 reports of rituximab-related adverse reactions reported in France between 2006 and 2019, were included in the study, such as 127 in the older group (>75 years) and 969 in the younger group (<75 years). Infusion reactions were less frequently reported than other adverse drug reaction in older patients (11 vs. 27%, P<0.001). By contrast, a higher rate of opportunistic infection due to Pneumocystis jirovecii was reported in the older subject group (3.9 vs. 0.6%, P<0.001), along with neutropenia (22.8 vs. 9.3%, P<0.0001). These results were confirmed by the disproportionality analysis.CONCLUSIONPneumocystis jirovecii infection was significatively more reported in older patients treated by Rituximab which probably reflects a higher incidence in this population. The use of anti-pneumocystis prophylaxis should be considered in this population.

10 Jan 2023·Journal of Clinical Oncology

Rituximab Chimeric Anti-CD20 Monoclonal Antibody Therapy for Relapsed Indolent Lymphoma: Half of Patients Respond to a Four-Dose Treatment Program

Article

Author: Lister, J ; Wey, K ; Dallaire, B K ; Link, B K ; Grillo-López, A J ; McLaughlin, P ; Williams, M E ; Cabanillas, F ; Jain, V ; Czuczman, M S ; Ho, A D ; Heyman, M R ; Bence-Bruckler, I ; Shen, D ; Levy, R ; White, C A

PURPOSE The CD20 antigen is expressed on more than 90% of B-cell lymphomas. It is appealing for targeted therapy, because it does not shed or modulate. A chimeric monoclonal antibody more effectively mediates host effector functions and is itself less immunogenic than are murine antibodies. PATIENTS AND METHODS This was a multiinstitutional trial of the chimeric anti-CD20 antibody, IDEC-C2B8. Patients with relapsed low grade or follicular lymphoma received an outpatient treatment course of IDEC-C2B8 375 mg/m2 intravenously weekly for four doses. RESULTS From 31 centers, 166 patients were entered. Of this intent-to-treat group, 48% responded. With a median follow-up duration of 11.8 months, the projected median time to progression for responders is 13.0 months. Serum antibody levels were sustained longer after the fourth infusion than after the first, and were higher in responders and in patients with lower tumor burden. The majority of adverse events occurred during the first infusion and were grade 1 or 2; fever and chills were the most common events. Only 12% of patients had grade 3 and 3% grade 4 toxicities. A human antichimeric antibody was detected in only one patient. CONCLUSION The response rate of 48% with IDEC-C2B8 is comparable to results with single-agent cytotoxic chemotherapy. Toxicity was mild. Attention needs to be paid to the rate of antibody infusion, with titration according to toxicity. Further investigation of this agent is warranted, including its use in conjunction with standard chemotherapy.

01 Nov 2022·Pediatric Dermatology

Management of pediatric pemphigus vulgaris with rituximab: A case report and review of the literature

Review

Author: Levy, Rebecca ; Mistry, Bhavik Dipak ; Lee, David Michael ; Leis, Maria

AbstractPemphigus vulgaris (PV), an acquired autoimmune bullous disease, is caused by autoantibodies targeting desmosomal proteins in the skin and mucous membranes. Recent data from the adult PV population supports the use of rituximab, a chimeric anti‐CD20 IgG1 antibody, as a primary treatment strategy, but limited data exist regarding treatment in the pediatric population. We report the case of a 13‐year‐old male with PV treated successfully with systemic corticosteroids and rituximab, and review the literature supporting the treatment of pediatric PV with rituximab.

100 Deals associated with Rituximab biosimilar (Shanghai Institute of Biological Products)

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
CD20 positive Diffuse Large B-Cell Lymphoma	CN	Shanghai Institute of Biological Products Co., Ltd.	19 Mar 2024
Chronic Lymphocytic Leukemia	CN	Shanghai Institute of Biological Products Co., Ltd.	19 Mar 2024
Follicular Lymphoma	CN	Shanghai Institute of Biological Products Co., Ltd.	19 Mar 2024