Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1270 |
| INN | None |
| Status | Clinical |
| Drug code(s) | SHR-1703 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | IL-5 |
| Indications of clinical studies | Eosinophilic Asthma, Eosinophilic Granulomatosis With Polyangiitis, Asthma |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Phase 2/3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | October 15, 2019 |
| Start of Phase 2 | December 22, 2022 |
| Start of Phase 3 | November 15, 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 | Jiangsu HengRui Medicine Co. Ltd. |
| Licensee/Partner | Atridia Pty Ltd. |
| Comments about company or candidate | NCT06653322 Phase 3 due to start in Oct 2024 NCT06441812 Phase 2 in Eosinophilic Asthma due to start in June 2024 NCT05979051 Phase 2/3 in Eosinophilic Granulomatosis With Polyangiitis started in Nov 2023 NCT05522439 Phase 2 in Asthma With Eosinophilic Phenotype started in Dec 2022. NCT04855591 and NCT04480762 are Phase 1 studies in healthy subjects. On October 17, 2019, the clinical trial application submitted by the company to the State Food and Drug Administration was accepted. |
| Full address of company | Lianyungang, Jiangsu Province, China. Asia China https://www.hengrui.com/en/about.html |
SHR-1703 is a novel long-acting subcutaneously administered IgG1 (Kappa) subtype humanized monoclonal antibody targeting IL-5 with high affinity. Furthermore, the Fc segment of SHR-1703 has undergone protein engineering (with ‘YTE’ amino acid mutations), which can reduce the clearance of antibodies in humans and primates, and extend the antibody half-life, aiming to achieve prolonged dosing intervals and less frequency dosing in future clinical practice. SHR-1703 can bind to IL-5 to inhibit the IL-5/IL-5R signaling pathway, thereby inhibiting the proliferation and activation of eosinophils, reducing the number of asthma attacks in patients with eosinophilic asthma, and improving lung function in patients. https://www.cmocro.com/news_detail/Hengrui+Pharmaceutical%26%23039%3Bs+Innovative+Drug+SHR-1703+Injec/544250/index.html
| Anticipated events | Phase 3 pending |
| Factor(s) contributing to discontinuation | None |