Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1738 |
| INN | Vunakizumab |
| Status | Approved |
| Drug code(s) | SHR-1314 |
| Brand name | (Pending) |
| mAb sequence source | mAb humanized |
| 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-17A |
| Indications of clinical studies | Graves' Orbitopathy, Lupus Nephritis, Ankylosing Spondylitis, Plaque Psoriasis, axial spondyloarthritis, Phase 1 in healthy volunteers |
| 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, 2016 |
| Start of Phase 2 | November 09, 2019 |
| Start of Phase 3 | June 01, 2021 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | 2024 |
| Date of first US approval | |
| INN, US product name | Vunakizumab |
| US or EU approved indications | None |
| Company | Jiangsu Hengrui Medicine Co. |
| Licensee/Partner | Atridia Pty Ltd. |
| Comments about company or candidate | Approved in China Aug 19 2024. Aug 2023: Listed in Hengrui pipeline as NDA submitted for vunakizumab as a single agent to treat moderate-to-severe plaque psoriasis. Phase 2/3 study for Ankylosing spondylitis status (CTR20210745) is "in progress, recruitment completed" and Phase 3 study for Plaque psoriasis CTR20210753 status is "competed". Mar 2023: Vunakizumab is a phase III humanized monoclonal lgG1 antibody to address IL-17 related autoimmune diseases with fast response and dosing convenience. Two registrational trials are ongoing in China for severe plaque psoriasis and ankylosing spondylitis. More indications are under development. (https://www.hengrui.com/en/pipeline.html) NCT04840485 Phase 2/3 in Ankylosing Spondylitis started in June 2021. NCT04839016 Phase 3 in plaque psoriasis due to start in April 2021. NCT04121143 Phase 2 in plaque psoriasis started in Nov 2019 but suspended in March 2020 (sponsor decision). NCT03710681 Phase 1 in plaque psoriasis started in Aug 2018 still recruiting as of Aug 2019. NCT03704428 Phase 1 study in AS started in April 2018. NCT03463187 Phase 1/2 study in Plaque Psoriasis started in Dec 2017 still recruiting as of Aug 2019. NCT02934412 Phase 1 completed in June 2017. Atridia Pty Ltd (Atridia) is an independent Pharmaceutical company headquartered in Sydney, acting for Jiangsu Hengrui Medicine Co., Ltd. |
| Full address of company | None Asia China None |
immunoglobulin G1-kappa, anti-[Homo sapiens IL17A (interleukin 17A, IL-17A)], humanized monoclonal antibody.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |