Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1007 |
| INN | None |
| Status | Clinical |
| Drug code(s) | MIL62 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| 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 | Systemic Lupus Erythematosus, Primary Membranous Nephropathy, Neuromyelitis Optica Spectrum Disorder, Non-Hodgkin's lymphoma |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | October 15, 2019 |
| Start of Phase 2 | |
| Start of Phase 3 | June 02, 2021 |
| 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 | Beijing Mabworks Biotech Co. Ltd. |
| Licensee/Partner | None |
| Comments about company or candidate | Phase 2/3 and 3 studies for: Neuromyelitis optica spectrum disorder (NCT05314010) is recruiting as of November, 2024; Follicular lymphoma and marginal zone lymphoma (NCT04834024) is recruiting as of November, 2024; Systemic Lupus Erythematosus (NCT05796206) is recruiting as of March 2024; Primary Membranous Nephropathy (NCT05862233) is recruiting as of November, 2024. Phase 2/3 and 3 studies for: Neuromyelitis optica spectrum disorder (NCT05314010) is recruiting as of August 24, 2022; Follicular lymphoma and marginal zone lymphoma (NCT04834024) is recruiting as of November 14, 2022; Systemic Lupus Erythematosus (NCT05796206) is not yet recruiting as of April 3, 2023. Aug 2022: H2 2024 NDA submission is upcoming milestone. Partnered with Jiangsu Hengrui Pharmaceutical Co., Ltd. in 2021, but partnership terminated in 2023. NCT04834024 Phase 3 in follicular lymphoma started in June 2021. NCT04304040 Phase 1/2 study in B-cell lymphoma not yet recruiting when posted on March 11, 2020. NCT04110301 Phase 1 study started in Nov 2019 (https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(24)00281-5/fulltext) |
| Full address of company | Room 25, Tower 1, HAN'S Plaza, No. 2 Ronghua South Road, Beijing Economic-Technological Development Area Asia China http://www.mab-works.com/en/contactus.html |
Humanized glycoengineered type Ⅱ anti-CD20 monoclonal antibody, with a nearly completely afucosylated N-glycans in Fc region (https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(24)00281-5/fulltext)
| Anticipated events | Marketing application possible in 2024 |
| Factor(s) contributing to discontinuation | None |