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 |
Target(s) | IL-17A |
Indications of clinical studies | Ankylosing spondylitis |
Primary therapeutic area | Immune-mediated / inflammatory disorders |
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 | 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/ |
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
Anticipated events | None |
Factor(s) contributing to discontinuation | None |