SHR-1703 Clinical Naked monospecific

Antibody Information

Entry ID	1270
INN	None
Status	Clinical
Drug code(s)	SHR-1703
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	kappa
Linker	None
Ave. DAR	None
Conjugated/fused moiety	None
Discovery method/technology	None

Therapeutic information

Target(s)	IL-5
Indications of clinical studies	Eosinophilic Asthma, Eosinophilic Granulomatosis With Polyangiitis, Asthma
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 3
Status	Active
Start of clinical phase (IND filing or first Phase 1)	October 15, 2019
Start of Phase 2	December 22, 2022
Start of Phase 3	November 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 HengRui Medicine Co. Ltd.
Licensee/Partner	Atridia Pty Ltd.
Comments about company or candidate	NCT06653322 Phase 3 started in Nov 2024 NCT06441812 Phase 2 in Eosinophilic Asthma due to start in June 2024 NCT05979051 Phase 2/3 in Eosinophilic Granulomatosis With Polyangiitis started in Nov 2023 NCT05522439 Phase 2 in Asthma With Eosinophilic Phenotype started in Dec 2022. NCT04855591 and NCT04480762 are Phase 1 studies in healthy subjects. On October 17, 2019, the clinical trial application submitted by the company to the State Food and Drug Administration was accepted.
Full address of company	Lianyungang, Jiangsu Province, China. Asia China https://www.hengrui.com/en/about.html

Description/comment

SHR-1703 is a novel long-acting subcutaneously administered IgG1 (Kappa) subtype humanized monoclonal antibody targeting IL-5 with high affinity. Furthermore, the Fc segment of SHR-1703 has undergone protein engineering (with ‘YTE’ amino acid mutations), which can reduce the clearance of antibodies in humans and primates, and extend the antibody half-life, aiming to achieve prolonged dosing intervals and less frequency dosing in future clinical practice.
SHR-1703 can bind to IL-5 to inhibit the IL-5/IL-5R signaling pathway, thereby inhibiting the proliferation and activation of eosinophils, reducing the number of asthma attacks in patients with eosinophilic asthma, and improving lung function in patients. https://www.cmocro.com/news_detail/Hengrui+Pharmaceutical%26%23039%3Bs+Innovative+Drug+SHR-1703+Injec/544250/index.html

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None