Entry ID | 698 |
INN | Betinukibart |
Status | Clinical |
Drug code(s) | HB0017 |
Brand name | None |
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 | Ankylosing spondylitis, Psoriasis, Phase 1 in healthy volunteers |
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) | October 02, 2020 |
Start of Phase 2 | July 15, 2023 |
Start of Phase 3 | March 29, 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 | Huabo Biopharm Co. Ltd. |
Licensee/Partner | None |
Comments about company or candidate | NCT06477237 / CTR20240521 Phase 3 in plaque psoriasis started Mar 29, 2024 CTR20230990 Phase 2 in ankylosing spondylitis started in July 2023. NCT05531682 Phase 2 in psoriasis due to start in Oct 2022. NCT05442788 Phase 1 in psoriasis started in Sep 2021. NCT04505033 is a A Phase I, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HB0017 Following a Single Dose in Adult Healthy Volunteers |
Full address of company | 1800 Cailun Road, Zhangjiang High Tech Park, Pudong New District, Shanghai Asia China https://www.huabobio.com/en/contact.html |
Humanized IgG1 kappa, described in https://doi.org/10.1016/j.ijbiomac.2022.01.119 Described in patent ANTIBODY TARGETING INTERLEUKIN 17A AND PREPARATION METHOD AND APPLICATION THEREOF United States Patent Application 20200071394
Anticipated events | None |
Factor(s) contributing to discontinuation | None |