Database for
Therapeutic Antibodies
Therapeutic Antibodies
| 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 |
| Target(s) | IL-17A |
| Indications of clinical studies | Psoriasis, Axial Spondyloarthritis |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| 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 | 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 |
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
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |