Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 377 |
| INN | None |
| Status | Clinical |
| Drug code(s) | BAT4406F |
| 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) | CD20 |
| Indications of clinical studies | Neuromyelitis Optica Spectrum Disorders |
| 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) | November 15, 2019 |
| Start of Phase 2 | August 15, 2023 |
| Start of Phase 3 | |
| 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 | NCT06044350 Phase 2/3 started in Aug 2023 still recruiting as of last update in Oct 2024.. July 2023: Listed as Phase 3 in BioThera pipeline; Phase 2/3 trial CTR20231610 for Neuromyelitis optica spectrum disorder started July 31, 2023 (chinadrugtrials) Listed as Phase 2 asset in company pipeline accessed Feb 2023. Listed in company pipeline as of June 2021. NCT04146285 Phase I Clinical Trial of BAT4406F Injection in Patients With Neuromyelitis Optica Spectrum Disorders originally posted in Oct 2019 as not yet recruiting was never updated. IND approval for BAT4406F received from the NMPA in July 2019. As of the Latest Practicable Date, the NMPA did not raise any objections or material concerns with respect to the development of BAT4406F. Completion of the phase I clinical trial in subjects with NMOSD is expected in 2022. |
| 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 |
Anti-CD20 antibody BAT4406F produced with CHO-BAT-KF cells. https://www1.hkexnews.hk/app/sehk/2021/103301/a108027/sehk21032301240.pdf. BAT4406 is an investigational ADCC-enhanced anti-CD20 mAb candidate in clinical development for the treatment of autoimmune diseases. BAT4406F is currently being evaluated in NMOSD, an orphan indication with an estimated prevalence of 0.5 to 10 per 100,000. BAT4406 is a type I glyco-engineered mAb that binds specifically to CD20 on B-cells, kills the B-cells by CDC, and enhances ADCC effect. B cells have been implicated in the pathogenesis of a number of autoimmune diseases, including the CNS disorders, multiple sclerosis (MS) and NMOSD. Depletion of B-cells could provide meaningful relief for these autoimmune diseases.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |