Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 749 |
| INN | None |
| Status | Clinical |
| Drug code(s) | IAH0968 |
| 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) | HER2 |
| Indications of clinical studies | Gastric cancer, HER2+ colorectal cancer, solid tumors |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Phase 2/3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | July 06, 2021 |
| Start of Phase 2 | March 01, 2023 |
| Start of Phase 3 | May 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 | SUNHO (China) BioPharmaceutical Co. Ltd., Beijing Sunho Pharmaceutical Co. |
| Licensee/Partner | None |
| Comments about company or candidate | NCT06504732 Phase 2/3 in gastric cancer due to start in July 2024. NCT05673512 Phase 2/3 in colorectal cancer started in May 2023. NCT05991518 Phase 1/2 started in Mar 2023 NCT04934514 Phase 1/2 started in July 2021 |
| Full address of company | 5 Xingjian Road, Economic and Technological Development Zone, Nanjing City Asia China http://www.sunho-bio.com/en/ |
Afucosylated https://ascopubs.org/doi/abs/10.1200/JCO.2023.41.16_suppl.e15098
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |