Database for
Therapeutic Antibodies
Therapeutic Antibodies
| 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 |
| Target(s) | IL-5 |
| Indications of clinical studies | Asthma, 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) | 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 | 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 |
610 is a recombinant Anti-IL-5 humanized IgG1 type 1 monoclonal antibody https://www.3s-guojian.com/en/news/details/28.html
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |