Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1310 |
| INN | None |
| Status | Clinical |
| Drug code(s) | SSGJ-608, 608 |
| Brand name | None |
| mAb sequence source | mAb - source TBD |
| 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 |
| Target(s) | IL-17A |
| Indications of clinical studies | Ankylosing Spondylitis, Axial Spondyloarthritis, Psoriasis |
| 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) | July 15, 2019 |
| Start of Phase 2 | April 15, 2021 |
| Start of Phase 3 | January 01, 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 | 3SBio |
| Licensee/Partner | Sunshine Guojian Pharmaceutical (Shanghai) Co. Ltd. |
| Comments about company or candidate | NCT06299982 Phase 3 in plaque psoriasis due to start in May 2024. NCT06242652 Phase 2 in Ankylosing Spondylitis due to start in Mar 2024 April 14, 2023 "Sunshine Guojian’s anti-IL-17A humanized monoclonal antibody (608) completed the enrollment of all subjects in the Phase III clinical trial of moderate to severe plaque psoriasis". https://www.3s-guojian.com/news/details/181.html. NCT05536726 Phase 3 started in Jan 2023. Listed as Phase 3 in 3SBio presentation dated Aug 2022. NCT05604898 Phase 2 in psoriasis started in April 2021. As of end of 2020: The Group has completed a dose-escalating phase I clinical trial of its anti-IL17A antibody (608) in healthy volunteers. A phase II trial in patients with plaque psoriasis is expected to start soon. The clinical trial application of 3SBio’s recombinant humanized anti-interleukin-17A monoclonal antibody injection solution (development code: 608) was approved by the NMPA on 31 July 2019. 608 is used for treatment of moderate to severe plaque psoriasis. The Group is currently actively preparing for initiating the clinical trial of this product. |
| 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 |
None
| Anticipated events | NDA submission expected in 2024 |
| Factor(s) contributing to discontinuation | None |