Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 359 |
| INN | None |
| Status | Clinical |
| Drug code(s) | B001 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| 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) | CD20 |
| Indications of clinical studies | Neuromyelitis optica |
| 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) | March 15, 2018 |
| Start of Phase 2 | |
| Start of Phase 3 | July 17, 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 | Shanghai Pharmaceuticals Holding |
| Licensee/Partner | None |
| Comments about company or candidate | NCT06413654 / CTR20241605 Phase 2/3 in NMO sponsored by Shanghai Jiaolian Drug Research and Development Co., Ltd started in July 2024 NCT05145361 in NMO Spectrum Disorder started in April 7, 2022. NCT03332121 Phase 1 in CD20 Positive B Cell Non-Hodgkin's Lymphoma started in March 2018 |
| Full address of company | Shanghai Pharma Biotherapeutics USA Inc. 3545 John Hopkins Ct., Ste 160 San Diego, CA 92121 North America United States of America https://www.sphbio.com/view/contact/contact.html |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |