SSGJ-613 Clinical TBD

Antibody Information

Entry ID	1315
INN	None
Status	Clinical
Drug code(s)	SSGJ-613
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-1 beta
Indications of clinical studies	Acute gout, 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)	August 13, 2021
Start of Phase 2	June 15, 2022
Start of Phase 3	January 13, 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	Aug 2024: Included as a key candidate with possible 2025 submission (https://www.3sbio.com/ImgUpload/files/202408/2024082206302528344.pdf) CTR20233982 Phase 3 in Chinese subjects with acute gouty arthritis started in Jan 2024 NCT06169891 Phase 3 in Chinese participants with gout due to start in Dec 2023. NCT05966701 Phase 1 in healthy subjects. NCT05588908 Phase 1/2 in gout started in June 2022. Sep 2022 3SBio report: Anti-IL1 β mAb (613): The Group received an IND approval from the NMPA for 613 in acute gout (AG) indication in March 2022, and the FPI of phase Ib/II trial has been completed. NCT05027373 is a Phase 1 Trial of Safety, Tolerability and Pharmacokinetic of Recombinant Anti-IL-1β Humanized Monoclonal Antibody by Single Subcutaneous Injection in Healthy Subjects started in Aug 2021.
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

Recombinant anti-IL-1β Humanized Monoclonal Antibody

Additional information

Anticipated events	NDA submission expected in 2025
Factor(s) contributing to discontinuation	None