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+ [1]

Active Indication-

Inactive Indication

CD20 positive B-Cell LymphomaDiffuse Large B-Cell LymphomaRheumatoid Arthritis

Originator Organization

Eden Biologics, Inc.

Active Organization-

Inactive Organization

Eden Biologics, Inc.

Chime Biologics Ltd.

Drug Highest PhaseSuspendedPhase 3

First Approval Date-

Regulation-

Gene Sequence

Sequence Code 83181H

The sequence is quoted from: *****

Sequence Code 27145L

The sequence is quoted from: *****

Clinical Trials associated with Rituximab biosimilar(Eden Biologics, Inc.)

CTR20181725 / SuspendedPhase 3

JHL1101与利妥昔单抗注射液联合CHOP方案在弥漫大B细胞淋巴瘤初治患者中的疗效和安全性国际多中心研究

[Translation] An international multicenter study on the efficacy and safety of JHL1101 combined with rituximab injection and CHOP regimen in patients with diffuse large B-cell lymphoma who had never been treated

主要目的：在DLBCL初治患者中，比较两组用药治疗6个周期后的总缓解率。次要目的：在初治DLBCL患者中，比较两组用药1.治疗的安全性；2.6个周期后完全缓解率、1年无进展生存率、1年无事件生存率和1年总生存率；3.免疫原性；4.分析在两组用药患者中的群体药代动力学特征及发生输液相关反应患者的药代动力学特征以及药效学。

[Translation]

Primary objective: To compare the total remission rate after 6 cycles of treatment between the two groups in patients with DLBCL who have never been treated. Secondary objectives: To compare the two groups of drugs in patients with DLBCL who have never been treated: 1. The safety of treatment; 2. The complete remission rate, 1-year progression-free survival rate, 1-year event-free survival rate, and 1-year overall survival rate after 6 cycles; 3. Immunogenicity; 4. To analyze the population pharmacokinetic characteristics of the two groups of patients and the pharmacokinetic characteristics and pharmacodynamics of patients with infusion-related reactions.

Start Date26 Dec 2018

Sponsor / Collaborator

Chime Biologics Ltd.

EUCTR2018-002342-36-HU / Not yet recruitingPhase 3

A Multinational, Randomized, Double-blind, Positive-controlled, Parallel Group Clinical Study to Compare the Efficacy and Safety of the JHL1101 in Combination with CHOP (J-CHOP) versus Rituximab in Combination with CHOP (R-CHOP) in Patients with Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL)

Start Date17 Dec 2018

Sponsor / Collaborator-

NCT03670888 / TerminatedPhase 1

"A Multicenter, Randomized, Double-blind, Parallel-controlled Trial to Compare the Bioequivalence and Safety of the Recombinant Human-Mouse Chimeric Anti-CD20 Monoclonal Antibody Injection (JHL1101) and Rituximab Injection in CD20 Positive B Cell Lymphoma Patients"

This is a multicenter, randomized, double-blind, parallel group study to compare the PK, safety, tolerability, immunogenicity and PD of JHL1101 vs Rituxan in subjects with CD20-positive B cell lymphoma. The study duration is 13 weeks. Approximately 128 eligible subjects will be randomized in a 1:1 ratio to receive either JHL1101 (n=64) or Rituxan (n=64). Each subject will receive one intravenous (IV) infusions of the investigational product (IP) at the dose of 375mg/m2 on Day 1. Assessments of PK, safety, tolerability, immunogenicity, PD, and efficacy will be collected over the following 13-week period.

Start Date16 Nov 2018

Sponsor / Collaborator

Eden Biologics, Inc.

100 Clinical Results associated with Rituximab biosimilar(Eden Biologics, Inc.)

100 Translational Medicine associated with Rituximab biosimilar(Eden Biologics, Inc.)

100 Patents (Medical) associated with Rituximab biosimilar(Eden Biologics, Inc.)

100 Deals associated with Rituximab biosimilar(Eden Biologics, Inc.)

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L01XC02	-

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diffuse Large B-Cell Lymphoma	Phase 3	CN	Eden Biologics, Inc.	13 Nov 2018
Diffuse Large B-Cell Lymphoma	Phase 3	CN	Eden Biologics, Inc.	13 Nov 2018
Rheumatoid Arthritis	Phase 3	BA	Eden Biologics, Inc.	27 Feb 2017
Rheumatoid Arthritis	Phase 3	CZ	Eden Biologics, Inc.	27 Feb 2017
Rheumatoid Arthritis	Phase 3	TW	Eden Biologics, Inc.	27 Feb 2017
Rheumatoid Arthritis	Phase 3	BG	Eden Biologics, Inc.	27 Feb 2017
Rheumatoid Arthritis	Phase 3	PL	Eden Biologics, Inc.	27 Feb 2017
Rheumatoid Arthritis	Phase 3	LT	Eden Biologics, Inc.	27 Feb 2017
Rheumatoid Arthritis	Phase 3	DE	Eden Biologics, Inc.	27 Feb 2017
Rheumatoid Arthritis	Phase 3	GB	Eden Biologics, Inc.	27 Feb 2017

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