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Qiangke
- Development stage
- Phase 3
- Lead developer
- Shanghai Celgen Biopharma
- Modality
- Fc-Fusion Proteins → Carrier/Scaffold Proteins → Recombinant Proteins and Enzymes
- Administration
- Subcutaneous
01
Overview
**Qiangke** is a recombinant human tumor necrosis factor (TNF) receptor-IgG fusion protein for injection, developed as a copy biological (intended copy) of etanercept (Enbrel) by Shanghai Celgen Bio-Pharmaceutical, with ownership stake by Simcere Pharmaceutical Group. It functions by binding TNF to inhibit its pro-inflammatory activity, primarily indicated for ankylosing spondylitis and also used in rheumatoid arthritis, psoriatic arthritis, and plaque psoriasis. Approved in China in 2011 via a new drug pathway (pre-biosimilar guidelines), it shows structural differences from the originator including atypical purity profiles, altered N-glycan species with reduced sialylation, and variable charge distribution, though potency in TNF neutralization is comparable in some assays.[1][7]
- Brand names
- Qiangke
02
Targets
TNFA (Tumor necrosis factor alpha (soluble))
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