TAbS







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


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

Company information

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/

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