HB0034 Clinical TBD

Antibody Information

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

Therapeutic information

Target(s)	IL-36R
Indications of clinical studies	Generalized pustular psoriasis, Phase 1 in healthy adults
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 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 information

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

Description/comment

None

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None