Drotokibart Clinical Naked monospecific

Antibody Information

Entry ID	1273
INN	Drotokibart
Status	Clinical
Drug code(s)	SHR-1819
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

Therapeutic information

Target(s)	IL-4R alpha
Indications of clinical studies	Atopic Dermatitis, Asthma
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)	November 20, 2020
Start of Phase 2	September 15, 2023
Start of Phase 3	June 19, 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	Shanghai Hengrui Pharmaceutical Co. Ltd.
Licensee/Partner	Atridia Pty Ltd.
Comments about company or candidate	NCT06554509 Phase 2/3 in Prurigo Nodularis started in Sep 2024. NCT06468956 Phase 3 in atopic dermatitis start in June 2024. NCT06012812 Phase 2 in Atopic Dermatitis enrolling by invitation starting in Sep 2023. Not listed in Hengrui pipeline dated Sep 2022. As of Feb 2023, two Phase 1 studies are completed and two studies are not yet recruiting NCT05549947 / CTR20222411 Phase 2 in atopic dermatitis due to start in Oct 2022. NCT05549947 Phase 1 due to start in Jan 2022. NCT04561128 is a Phase 1 in healthy subjects; NCT04772365 is a Phase 1 in asthma complete as of Nov 2022.
Full address of company	Jiangsu, China Asia China https://www.hengrui.com/en/index.html

Description/comment

SHR-1819 targets IL-4R https://www.hengrui.com/en/pipeline.html
immunoglobulin G4-kappa, anti-[Homo sapiens IL4R (interleukin 4 receptor, IL4RA, IL-4RA, interleukin 13 receptor, CD124)], humanized monoclonal antibody; Fc engineered with S228P mutation for hinge stabilization.

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None