TAbS







Betinukibart Clinical Naked monospecific

Antibody Information

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

Therapeutic information

Target(s) IL-17A
Indications of clinical studies Ankylosing spondylitis, Psoriasis, Phase 1 in healthy volunteers
Primary therapeutic area Immune-mediated / inflammatory disorders

Development stage information


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 information

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

Description/comment

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

Additional information

Anticipated events None
Factor(s) contributing to discontinuation None