Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 379 |
| INN | None |
| Status | Clinical |
| Drug code(s) | BAT5906 |
| 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) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | VEGF |
| Indications of clinical studies | Vitreous Age-related Macular Degeneration, Wet age-related macular degeneration |
| Primary therapeutic area | Ophthalmic disorders |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | October 15, 2018 |
| Start of Phase 2 | September 03, 2020 |
| Start of Phase 3 | July 28, 2022 |
| 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 | Bio-Thera Solutions Ltd. |
| Licensee/Partner | None |
| Comments about company or candidate | Included in Bio-Thera’s 2024 semi-annual report; noted as new drug. NCT05439629 Phase 3 in Neovascular (Wet) Age-related Macular Degeneration started in July 2022 recruiting as of last update in Feb 2023. Phase 2 in Vitreous Age-related Macular Degeneration started in Sep 2020. Listed in company pipeline as of June 2021. NCT04151212 Phase 1 started in Oct 2018. Phase-I clinical trials in Wet age-related macular degeneration (In the elderly, In adults) in China (Intravitreous) (ChiCTR1800019080) |
| Full address of company | Floor 5, Building A6, 11 Kai-Yuan Blvd, Huangpu District, Guangzhou, China Asia China https://www.bio-thera.com/plus/list.php?tid=67 |
Confirmed BAT5906 is a new drug (not biosimilar). BAT5906 is an IgG1 monoclonal antibody specifically designed for the treatment of ocular fundus lesions and inhibits angiogenesis by neutralizing VEGF, inhibiting the binding of VEGF to its receptor VEGFR, and is intended for wAMD, DME, and diabetic Retinal disease (DR) and other retinal lesions treatment. https://www.bio-thera.com/plus/list.php?tid=54
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |