Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 656 |
| INN | None |
| Status | Regulatory review |
| Drug code(s) | Gensci-048, Ginalimb, Genakumab, Genalumab (not WHO-assigned names) |
| Brand name | (Pending) |
| mAb sequence source | mAb - source TBD |
| 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 | Juvenile Idiopathic Arthritis, Solid tumors, acute gout |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Regulatory review China |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | April 22, 2019 |
| Start of Phase 2 | May 22, 2021 |
| Start of Phase 3 | January 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 | GeneScience Pharmaceuticals Co. Ltd. |
| Licensee/Partner | None |
| Comments about company or candidate | On April 11 2024, Changchun GeneScience Pharmaceuticals Co., Ltd. (GenSci) received the "Acceptance Notice" from the National Medical Products Administration (NMPA), signaling the acceptance of their marketing application for GenSci's Genakumab. This development is auspicious, as Genakumab's indication for acute gouty arthritis has been recognized. NCT05983445 Phase 3 study in gout started in Jan 2023. Phase 2 studies for gout: NCT05936268 is recruiting as of July 11, 2023, NCT05936281 is not yet recruiting. Phase 2 study for Active Systemic Juvenile Idiopathic Arthritis NCT05925452 is not yet recruiting as of July 7, 2023. NCT05925452 Phase 1 in juvenile RA due to start in July 2023. NCT05894148 Phase 1 in healthy subjects started in March 2023. NCT05441046 Phase 1 is solid tumors started in June 2022. |
| Full address of company | No. 72 Tianhe Street, Changchun High-Tech Industrial Development Zone, Changchun, Jilin Province, China, Postal code: 130012 Asia China https://en.gensci-china.com/contactus.html |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |