Database for
Therapeutic Antibodies
Therapeutic Antibodies
| 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 |
| Target(s) | IL-1 beta |
| Indications of clinical studies | Acute gout, Phase 1 in healthy subjects |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| 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 | 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 |
Recombinant anti-IL-1β Humanized Monoclonal Antibody
| Anticipated events | NDA submission expected in 2025 |
| Factor(s) contributing to discontinuation | None |