YAbS







Telikibart Clinical Naked monospecific

Antibody Information

Entry ID 675
INN Telikibart
Status Clinical
Drug code(s) GR1802, GR-1802
Brand name None
mAb sequence source mAb human
General Molecular Category Naked monospecific
Format, general category Full length Ab
Format details None
Isotype (Fc) IgG1
Light chain isotype kappa
Linker None
Ave. DAR None
Conjugated/fused moiety None
Discovery method/technology None

Therapeutic information

Target(s) IL-4R alpha
Indications of clinical studies Allergic rhinitis, asthma, chronic urticaria, rhinosinusitis, atopic dermatitis
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) Phase 3
Status Active
Start of clinical phase (IND filing or first Phase 1) May 21, 2021
Start of Phase 2 July 01, 2022
Start of Phase 3 January 15, 2024
Date BLA/NDA submitted to FDA
Year of first approval (global) None
Date of first US approval
INN, US product name None
US or EU approved indications None

Company information

Company Genrix (Shanghai) Biopharmaceutical Co. Ltd.
Licensee/Partner None
Comments about company or candidate Phase 3 study in Chronic Rhinosinusitis With Nasal Polyps (NCT06516302) started in September 2024
NCT06216392 / CTR20233857 Phase 3 in Atopic Dermatitis started in Jan 2024.
NCT05873803 Phase 2 in Chronic Rhinosinusitis With Nasal Polyps started in Feb 2023.
CTR20212483 Phase 1b/II started in Nov 2021.
CTR20211101 Phase 1 started in May 2021.
Full address of company Shanghai, China
Asia
China
http://www.genrixbio.com/

Description/comment

immunoglobulin G1-kappa, anti-[Homo sapiens IL4R (interleukin 4 receptor, IL4RA, IL-4RA, interleukin 13 receptor, CD124)], Homo sapiens monoclonal antibody;

Additional information

Anticipated events None
Factor(s) contributing to discontinuation None