Entry ID | 1387 |
INN | None |
Status | Clinical |
Drug code(s) | TQH2722 |
Brand name | None |
mAb sequence source | mAb human |
General Molecular Category | TBD |
Format, general category | TBD |
Format details | TBD |
Isotype (Fc) | TBD |
Light chain isotype | TBD |
Linker | None |
Ave. DAR | None |
Conjugated/fused moiety | None |
Discovery method/technology | None |
Target(s) | IL-4R alpha |
Indications of clinical studies | Chronic Sinusitis With or Without Nasal Polyps, Atopic dermatitis, Phase 1 in healthy volunteers |
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) | June 01, 2022 |
Start of Phase 2 | June 15, 2023 |
Start of Phase 3 | September 27, 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 | Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co. Ltd. |
Licensee/Partner | None |
Comments about company or candidate | NCT06552520 / CTR20242940 Phase 3 in AD started in Sep 2024. NCT06439381 Phase 2 in chronic sinusitis with or without nasal polyps due to start in June 2024. NCT06089278 Phase 2 in chronic sinusitis due to start in Nov 2023. NCT05970432 is a Phase 2 in atopic dermatitis. NCT05409326 a Phase I Study of TQH2722 Injection to Evaluate the Safety, Tolerability, Pharmacokinetics, Efficacy and Immunogenicity in Healthy Adult Subjects |
Full address of company | No. 369 South Yuzhou Rd, Haizhou District, Lianyungang, Jiangsu Province, P. R. China 222062 Asia China https://www.cttq.com/en/contact/index.htm |
TQH2722 is a fully human monoclonal antibody directed against the interleukin (IL)-4 receptor α subunit (IL-4Rα) of IL-4 heterodimeric type I and type II receptors that mediate IL-4/IL-13 signaling through this pathway.
Anticipated events | None |
Factor(s) contributing to discontinuation | None |