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 |
Target(s) | IL-4R alpha |
Indications of clinical studies | Allergic rhinitis, asthma, chronic urticaria, rhinosinusitis, atopic dermatitis |
Primary therapeutic area | Immune-mediated / inflammatory disorders |
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 | 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/ |
immunoglobulin G1-kappa, anti-[Homo sapiens IL4R (interleukin 4 receptor, IL4RA, IL-4RA, interleukin 13 receptor, CD124)], Homo sapiens monoclonal antibody;
Anticipated events | None |
Factor(s) contributing to discontinuation | None |