Xeligekimab Approved Naked monospecific

Antibody Information

Entry ID	1724
INN	Xeligekimab
Status	Approved
Drug code(s)	GR1501
Brand name	金立希
mAb sequence source	mAb human
General Molecular Category	Naked monospecific
Format, general category	Full length Ab
Format details	None
Isotype (Fc)	IgG4
Light chain isotype	kappa
Linker	None
Ave. DAR	None
Conjugated/fused moiety	None
Discovery method/technology	None

Therapeutic information

Target(s)	IL-17A
Indications of clinical studies	Psoriasis, Axial Spondyloarthritis
Primary therapeutic area	Immune-mediated / inflammatory disorders

Development stage information

Phase lengths*

*The graph represents early-stage clinical development phase lengths. For molecules approved or under evaluation for marketing authorization in the US is provided a complete overview of all clinical development phase lengths. Phase lengths are calculated from the start of the first in human (FIH) study (Start of clinical phase). “Start of Phase 2” bar represents Phase 1 length (Start of clinical phase to start of Phase 2); “Start of Phase 3” bar represents Phase 1+2 length (Start of clinical phase to start of Phase 3); “Date BLA/NDA submitted” bar represents Phase 1+2+3 length (Start of clinical phase to Date BLA/NDA submitted); and “Date of first US approval” bar represents Phase 1 to first US approval length (Start of clinical phase to Date of first US approval).

Most advanced stage of development (global)	Approved China
Status	Active
Start of clinical phase (IND filing or first Phase 1)	August 15, 2018
Start of Phase 2
Start of Phase 3	March 09, 2021
Date BLA/NDA submitted to FDA
Year of first approval (global)	2024
Date of first US approval
INN, US product name	Xeligekimab
US or EU approved indications	None

Company information

Company	Genrix (Shanghai) Biopharmaceutical Co. Ltd.
Licensee/Partner	None
Comments about company or candidate	Approved in China 19 Aug 2024. China marketing application acceptance date is Mar 25, 2023, sponsor is Chongqing Genrix Biopharmaceutical Co., Ltd. according to NMPA's CDE database. Phase 3 studies for: Plaque psoriasis (ChiCTR2100043223, on chinadrugtrials is "in progress, recruitment completed" ); Axial spondyloarthritis (NCT05881785 or ChiCTR20220952; the status on clinicaltrials.gov is active not recruiting as of May 31, 2023, the status on chinadrugtrials is "in progress recruiting") CTR20220952 Phase 3 in axial spondyloarthritis enrolled first subject in June 2022. ChiCTR2100043223 / CTR20210246 is a Phase 3 study to evaluate the efficacy and safety of gr1501 injection in the treatment of patients with chronic moderate to severe plaque psoriasis started in March 2021. Phase-I clinical trials in Plaque psoriasis in China (Parenteral) (ChiCTR1800017956)
Full address of company	Shanghai, China Asia China https://synapse.patsnap.com/organization/575cf201cc223eac2f65ac65cddb2931

Description/comment

Humanized according to IMGT, but described as human in multiple published reports.
GR1501, a human IL-17A-neutralizing IgG4 monoclonal antibody. GR1501 binds human, rhesus and cynomolgus IL-17A with high affinity but does not bind to mouse IL-17A or other IL-17 family members. GR1501 effectively blocks the interaction between IL-17A and its receptor IL-17RA, thereby inhibiting IL-17A-induced CXCL1 and IL-6 release in cells and mice. In mouse air pouch model, GR1501 effectively inhibits IL-17A induced leukocytes infiltration into the air pouch. GR1501 also reduces joint swelling and inflammation in mouse arthritis model. These data suggest that GR1501 is a potent and selective IL-17A-neutralizing monoclonal antibody and will support the clinical investigation of this monoclonal antibody in psoriasis and rheumatoid arthritis. https://www.sciencedirect.com/science/article/abs/pii/S0006291X19314329

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None