Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1002 |
| INN | Comekibart |
| Status | Clinical |
| Drug code(s) | MG-K10, BC005 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| 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-4R alpha |
| Indications of clinical studies | Atopic Dermatitis, Asthma |
| 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) | July 15, 2022 |
| Start of Phase 2 | August 15, 2022 |
| Start of Phase 3 | January 05, 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 | Shanghai Meiji Biotechnology Co Ltd |
| Licensee/Partner | None |
| Comments about company or candidate | CTR20232813 Phase 3 in AD started in Jan 2024. On June 29, 2023, Maiji Biotech announced that its Phase II clinical study of MG-K10 (comekibart) humanized monoclonal antibody injection for the treatment of patients with moderate to severe atopic dermatitis achieved the primary clinical endpoint. NCT05466877 Phase 2 started in Aug 2022. NCT05382910 Phase 1/2 started in July 2022 |
| Full address of company | Room C, 11th Floor, Shanghai Industrial Investment Building, 18 North Caoxi Road Asia China http://www.shmeiji.com/contact.html |
Humanized IgG4 monoclonal antibody that specifically recognizes human IL-4Rα and can effectively block the cytokines IL-4 and IL-13 and their interaction of the coreceptor subunit IL-4Rα, according to http://www.mabgeek.com/index.php?c=show&id=18
| Anticipated events | BLA possible in AD in 2025 |
| Factor(s) contributing to discontinuation | None |