Delving into the Latest Updates on CMG2349 with Synapse

Overview

Basic Info

Drug Type

Multi-specific antibody

Synonyms

CMG2349

Target-

Action-

Mechanism-

Therapeutic Areas

Immune System DiseasesSkin and Musculoskeletal Diseases

Active Indication

Rheumatoid Arthritis

Inactive Indication-

Originator Organization

Chengdu Chimagen Biosciences Co. Ltd.

Active Organization

Chengdu Chimagen Biosciences Co. Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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主要目的：评估皮下注射CMG2349 在类风湿关节炎参与者的安全性和耐受性。次要目的：评估CMG2349在参与者的清除外周血B细胞及浆细胞的效应。评估CMG2349对总IgG，IgG亚型、IgA、IgM、IgE的效应。评估CMG2349对外周血游离轻链的效应。评估CMG2349在参与者的药代动力学数据。评估CMG2349的免疫原性。探索性研究目的: 评估参与者在CMG2349给药后26周内的感染风险。评估CMG2349对类风湿关节炎参与者26周的初步疗效。

[Translation]

Primary objective: To evaluate the safety and tolerability of subcutaneous CMG2349 in participants with rheumatoid arthritis. Secondary objectives: To evaluate the effect of CMG2349 on the clearance of peripheral blood B cells and plasma cells in participants. To evaluate the effects of CMG2349 on total IgG, IgG subtypes, IgA, IgM, and IgE. To evaluate the effect of CMG2349 on peripheral blood free light chains. To evaluate the pharmacokinetic data of CMG2349 in participants. To evaluate the immunogenicity of CMG2349. Exploratory study objectives: To evaluate the risk of infection in participants within 26 weeks after CMG2349 administration. To evaluate the preliminary efficacy of CMG2349 in rheumatoid arthritis participants at 26 weeks.

Start Date-

Sponsor / Collaborator

Chengdu Chimagen Biosciences Co. Ltd.

100 Clinical Results associated with CMG2349

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100 Translational Medicine associated with CMG2349

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100 Patents (Medical) associated with CMG2349

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100 Deals associated with CMG2349

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Rheumatoid Arthritis	Phase 1	China	Chengdu Chimagen Biosciences Co. Ltd.	20 Aug 2026

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Clinical Result

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Biosimilar

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