Roconkibart Clinical Naked monospecific

Antibody Information

Entry ID	864
INN	Roconkibart
Status	Clinical
Drug code(s)	JS005
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-17A
Indications of clinical studies	Plaque Psoriasis, Psoriatic arthritis, spondylitis
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)	August 01, 2019
Start of Phase 2	July 01, 2021
Start of Phase 3	August 15, 2023
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 Junshi Bioscience Co Ltd
Licensee/Partner	None
Comments about company or candidate	NCT05975268 Phase 3 in Plaque Psoriasis started in Aug 2023. Listed as Phase 2 asset in Junshi pipeline accessed Mar 2023. CTR20212214 Phase 2 in axial spondyloarthritis started in Dec 2021. CTR20212392 Phase 2 in ankylosing spondylitis started in Dec 2021. Listed as Phase 2 as of Nov 2021 (https://junshi-biosciences-umb.azurewebsites.net/media/x04lnf3x/junshi-2021-q3-en-1104.pdf) JS005 (anti-IL-17A monoclonal antibody) has received the Clinical Trial Approval from NMPA in August 2019. Phase I clinical trial of JS005 is expected to complete the first patient enrollment in the first half of 2020 (http://www.globenewswire.com/news-release/2020/03/30/2008564/0/en/Junshi-Biosciences-Announces-Full-Year-2019-Financial-Results-and-Business-Updates.html)
Full address of company	100, Pingjiaqiao Road, Shanghai, China Asia China https://www.junshipharma.com/en/contact-us/

Description/comment

JS005 is a recombinant humanized anti-IL-17A monoclonal antibody for injection

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None