Drug intelligence / Profile preview

QL2401

Development stage
Phase 2
Lead developer
Qilu Pharmaceutical
Modality
Fc-Fusion Proteins → Carrier/Scaffold Proteins → Recombinant Proteins and Enzymes
Administration
Subcutaneous
01

Overview

QL2401 is a long-acting recombinant human fibroblast growth factor 21 (FGF21)-Fc fusion protein developed by Qilu Pharmaceutical for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). As an analog of the metabolic hormone FGF21, QL2401 functions by activating the fibroblast growth factor receptor (FGFR) complex, specifically the 1c, 2c, and 3c isoforms, in conjunction with the obligate co-receptor beta-Klotho. This activation regulates key metabolic pathways to reduce hepatic fat accumulation, improve insulin sensitivity, and decrease inflammation and fibrogenesis in the liver. The fusion of the FGF21 moiety to an immunoglobulin Fc fragment significantly extends the drug's half-life compared to native FGF21, allowing for a less frequent subcutaneous dosing regimen. QL2401 is currently undergoing early-phase clinical evaluation to assess its safety, tolerability, and metabolic efficacy.

02

Targets

FGFR2 (Keratinocyte growth factor receptor)FGFR1 (Fibroblast growth factor receptor 1)KLB (Beta-Klotho)FGFR3 (Fibroblast growth factor receptor 3)

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