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

Phase lengths*

*The graph represents early-stage clinical development phase lengths. For molecules approved or under evaluation for marketing authorization in the US is provided a complete overview of all clinical development phase lengths. Phase lengths are calculated from the start of the first in human (FIH) study (Start of clinical phase). “Start of Phase 2” bar represents Phase 1 length (Start of clinical phase to start of Phase 2); “Start of Phase 3” bar represents Phase 1+2 length (Start of clinical phase to start of Phase 3); “Date BLA/NDA submitted” bar represents Phase 1+2+3 length (Start of clinical phase to Date BLA/NDA submitted); and “Date of first US approval” bar represents Phase 1 to first US approval length (Start of clinical phase to Date of first US approval).

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