SSGJ-610, 610 Clinical Naked monospecific

Antibody Information

Entry ID	1312
INN	None
Status	Clinical
Drug code(s)	SSGJ-610, 610
Brand name	None
mAb sequence source	mAb humanized
General Molecular Category	Naked monospecific
Format, general category	Full length Ab
Format details	None
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-5
Indications of clinical studies	Asthma, Phase 1 in healthy subjects
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)	June 15, 2020
Start of Phase 2	September 30, 2022
Start of Phase 3	June 24, 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	Sunshine Guojian Pharmaceutical (Shanghai) Co. Ltd
Licensee/Partner	3SBio
Comments about company or candidate	NCT06323213 / CTR20241581 Phase 3 in severe asthma start June 24 2024 CTR20222078 Phase 2 study of recombinant anti-IL-5 humanized monoclonal antibody injection (610) in the treatment of adult subjects with severe eosinophilic asthma completed; first patient enrolled in Sep 2022. NCT05528679 Phase 2 in asthma due to start in Sep 2022. NCT04445038 is A Randomized, Double-blind, Placebo-controlled Parallel Trial of Safety, Tolerability and Pharmacokinetic of Recombinant Anti-IL-5 Humanized Monoclonal Antibody by Single Subcutaneous Injection in Healthy Subjects started in June 2020.
Full address of company	1st 3, 10th Road, Economic and Technological Development Zone, Shenyang, China Asia China https://www.3sbio.com/en/contactus/index.aspx

Description/comment

610 is a recombinant Anti-IL-5 humanized IgG1 type 1 monoclonal antibody https://www.3s-guojian.com/en/news/details/28.html

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None