Entry ID | 702 |
INN | None |
Status | Clinical |
Drug code(s) | HB0034 |
Brand name | None |
mAb sequence source | mAb humanized |
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-36R |
Indications of clinical studies | Generalized pustular psoriasis, Phase 1 in healthy adults |
Primary therapeutic area | Immune-mediated / inflammatory disorders |
Most advanced stage of development (global) | Phase 2/3 |
Status | Active |
Start of clinical phase (IND filing or first Phase 1) | July 01, 2022 |
Start of Phase 2 | February 29, 2024 |
Start of Phase 3 | September 15, 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 | Shanghai Huaota Biopharmaceutical Co. Ltd. |
Licensee/Partner | None |
Comments about company or candidate | NCT06477536 Phase 2/3 in Generalized Pustular Psoriasis started in Sep 2024. NCT06231381 Phase 2 in generalized pustular psoriasis started in Feb 2024. NCT05460455 Phase 1 started in Oct 2022; NCT05512598 Phase 1 due to start in Oct 2022. NCT05064345 is A Phase Ia, Randomized, Double-blind, Placebo-controlled, Single Dose-escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HB0034 in Adult Healthy Subjects |
Full address of company | 538 Cailun Road, Zhangjiang High Tech Park, Pudong New District, Shanghai Asia China https://www.huaota.com/en/contact.html |
None
Anticipated events | None |
Factor(s) contributing to discontinuation | None |