Drug intelligence / Profile preview

etanercept biosimilar QL0902

Development stage
Phase 3
Lead developer
Qilu Pharmaceutical
Modality
Fc-Fusion Proteins → Carrier/Scaffold Proteins → Recombinant Proteins and Enzymes
Administration
Subcutaneous
01

Overview

QL0902 is a biosimilar to etanercept, developed by Qilu Pharmaceutical. It is a recombinant human type II tumor necrosis factor (TNF) receptor-antibody fusion protein designed for subcutaneous injection. The drug acts as an inhibitor of both tumor necrosis factor alpha (TNF-α) and lymphotoxin alpha (LTα), thereby modulating inflammatory processes involved in autoimmune diseases such as rheumatoid arthritis and ankylosing spondylitis. Clinical studies have demonstrated that the pharmacokinetic characteristics, efficacy, safety, and immunogenicity profile of QL0902 are similar to those of reference etanercept[1][3][4][5][9]. The approved clinical dose is 50 mg administered via subcutaneous injection[5].

Brand names
QL0902QL-0902QL 0902
Other names
recombinant human type II tumor necrosis factor receptor-antibody fusion protein for injection重组人II型肿瘤坏死因子受体-抗体融合蛋白(齐鲁制药)重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白(齐鲁制药)
02

Targets

LTA (Lymphotoxin-alpha)TNFA (Tumor necrosis factor alpha (soluble))

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