Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 145 |
| INN | Ripertamab |
| Status | Approved |
| Drug code(s) | SCT400 |
| Brand name | Anpingxi® |
| mAb sequence source | mAb chimeric |
| 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) | CD20 |
| Indications of clinical studies | Non-Hodgkin's lymphoma |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved China |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | May 15, 2012 |
| Start of Phase 2 | May 15, 2015 |
| Start of Phase 3 | June 15, 2016 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | 2022 |
| Date of first US approval | |
| INN, US product name | Ripertamab |
| US or EU approved indications | None |
| Company | Sinocelltech Ltd |
| Licensee/Partner | CSPC Pharmaceutical Group Ltd |
| Comments about company or candidate | Approved by NMPA for newly diagnosed CD20-positive diffuse large B-cell non-Hodgkin's lymphoma in August 2022. July 2021: Sinocelltech website indicates that State Drug Administration has accepted the listing application. Mar 2019: CSPC Pharmaceutical in-licenses SCT 400 from Sinocelltech Oct 2018: Phase-III clinical trials in Non-Hodgkin's lymphoma (Combination therapy, Second-line therapy or greater) in China (IV) NCT02772822 Phase 3 study Comparing the Efficiency and Safety of S-CHOP(Cyclophosphamide, Hydroxydaunomycin, Oncovin, and Prednisone) Versus R-CHOP in Untreated CD20(Cluster of Differentiation Antigen 20)-Positive DLBCL Patients has not been updated since first posted in May 2016. |
| Full address of company | No. 31, Kechuang 7th Street, Beijing Economic and Technological Development Zone Asia China http://www.sinocelltech.com/ |
immunoglobulin G1-kappa, anti-[Homo sapiens MS4A1 (membrane-spanning 4-domains subfamily A member 1, CD20)], chimeric monoclonal antibody
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |