Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 621 |
| INN | Rulonilimab |
| Status | Clinical |
| Drug code(s) | F520 |
| Brand name | None |
| 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) | PD-1 |
| Indications of clinical studies | Non-small cell lung cancer, cervical carcinoma, Peripheral T Cell Lymphoma, Hepatocellular Carcinoma, Urothelial Cell Carcinoma |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Phase 2/3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | March 01, 2019 |
| Start of Phase 2 | November 01, 2020 |
| Start of Phase 3 | November 01, 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 | Shandong New Time Pharmaceutical Co. LTD |
| Licensee/Partner | None |
| Comments about company or candidate | NCT05408221 Phase 2/3 study started in Nov 2022 is recruiting as of last update in March 2023. As of March 2022, 4 Phase 2 studies are listed as not yet recruiting, e.g., NCT05178836 Phase 2 in diffuse large B-cell lymphoma due to start in Jan 2022. NCT06226350 Phase 2 in cervical cancer started in Mar 2021. NCT04636515 Phase 2 in Urothelial Carcinoma due to start in January 2021. NCT04457830 Phase 1 in Peripheral T Cell Lymphoma. NCT03657381 Phase 1 study started in March 2019. Recombinant Programmed death-1(PD-1) humanized monoclonal antibody injection (company code: F520) jointly developed by Shandong New Time Pharmaceutical Co., LTD |
| Full address of company | No. 209, Hongqi Road, Linyi City, Shandong Province, China Asia China http://lunanpharma.com/contact/ |
Immune checkpoint target; described as humanized by company
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |