Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 864 |
| INN | Roconkibart |
| Status | Clinical |
| Drug code(s) | JS005 |
| 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-17A |
| Indications of clinical studies | Plaque Psoriasis, Psoriatic arthritis, spondylitis |
| 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) | August 01, 2019 |
| Start of Phase 2 | July 01, 2021 |
| Start of Phase 3 | August 15, 2023 |
| 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 Junshi Bioscience Co Ltd |
| Licensee/Partner | None |
| Comments about company or candidate | NCT05975268 Phase 3 in Plaque Psoriasis started in Aug 2023. Listed as Phase 2 asset in Junshi pipeline accessed Mar 2023. CTR20212214 Phase 2 in axial spondyloarthritis started in Dec 2021. CTR20212392 Phase 2 in ankylosing spondylitis started in Dec 2021. Listed as Phase 2 as of Nov 2021 (https://junshi-biosciences-umb.azurewebsites.net/media/x04lnf3x/junshi-2021-q3-en-1104.pdf) JS005 (anti-IL-17A monoclonal antibody) has received the Clinical Trial Approval from NMPA in August 2019. Phase I clinical trial of JS005 is expected to complete the first patient enrollment in the first half of 2020 (http://www.globenewswire.com/news-release/2020/03/30/2008564/0/en/Junshi-Biosciences-Announces-Full-Year-2019-Financial-Results-and-Business-Updates.html) |
| Full address of company | 100, Pingjiaqiao Road, Shanghai, China Asia China https://www.junshipharma.com/en/contact-us/ |
JS005 is a recombinant humanized anti-IL-17A monoclonal antibody for injection
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |