QX002N Clinical Naked monospecific

Antibody Information

Entry ID	1161
INN	None
Status	Clinical
Drug code(s)	QX002N
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	TBD
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
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 15, 2019
Start of Phase 2	September 15, 2021
Start of Phase 3	September 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

Description/comment

QX002N, an innovative first-in-class biological product, is a high affinity recombinant humanized IgG1 monoclonal antibody against human IL-17A. QX002N was produced using Chinese hamster ovary cells and supplied by Qyuns Therapeutics Co., Ltd. (Taizhou, Jiangsu, China). https://www.frontiersin.org/articles/10.3389/fphar.2021.794054/full

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None

Company	Jiangsu Qyuns Therapeutics Co. Ltd.
Licensee/Partner	None
Comments about company or candidate	CTR20232574 Phase 3 in active ankylosing spondylitis started in Sep 2024. Phase 1 study identifier ChiCTR1900023040.
Full address of company	No.907 Yaocheng Avenue, Taizhou, Jiangsu, China Asia China https://www.qyuns.net/en/