Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 625 |
| INN | None |
| Status | Clinical |
| Drug code(s) | FDA018, FDA018-ADC |
| Brand name | None |
| mAb sequence source | mAb - source TBD |
| General Molecular Category | ADC |
| Format, general category | TBD |
| Format details | TBD |
| Isotype (Fc) | TBD |
| Light chain isotype | TBD |
| Linker | Undisclosed |
| Ave. DAR | ___ |
| Conjugated/fused moiety | Topoisomerase I inhibitor, SN38 (irinotecan active metabolite) |
| Discovery method/technology | None |
| Target(s) | TROP-2 |
| Indications of clinical studies | Triple-negative Breast Cancer, Solid tumors |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | March 15, 2021 |
| Start of Phase 2 | |
| Start of Phase 3 | August 09, 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 Fudan-Zhangjiang Bio-Pharmaceutical Co. Ltd |
| Licensee/Partner | None |
| Comments about company or candidate | NCT06519370 / CTR20242630 Phase 3 in Triple-negative Breast Cancer started in Aug 2024. NCT05174637 Phase 1: First patient dosed Oct 22 2021. The clinical trial application for the Coupling Agent Project”) was accepted in April 2021, and the "Drug" approved and issued by CDE was approved in June 2021. April 2021: China-based Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd’s clinical trial filing for FDA018, an anti-trophoblast cell-surface antigens2 (TROP2) antibody drug conjugate (ADC), has been accepted for review by the National Medical Products Administration. The drug, filed as a Category 1 therapeutic biologic product, will be assessed as a treatment for solid tumors. |
| Full address of company | 308 Cailun Rd., Z.J.Hi-tech Park, Shanghai, P.R.China Asia China http://www.fd-zj.com/desktopmodules/ht/English/ContactUs/Index.aspx?LS=1 |
Anti-Trop2 antibody-coupled SN38 drug for the treatment of advanced malignant solid tumors (also known as “FDA018 antibody for injection").
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |