Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1255 |
| INN | Finotonlimab |
| Status | Regulatory review |
| Drug code(s) | SCT-I10A, SCTI-10A |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG4 |
| 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 | Esophageal Squamous Cell Carcinoma, Colorectal Cancer, NSCLC, Head and neck cancer, Solid tumors |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Regulatory review China |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | December 13, 2018 |
| Start of Phase 2 | October 31, 2019 |
| Start of Phase 3 | October 22, 2019 |
| 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 | Sinocelltech Ltd |
| Licensee/Partner | None |
| Comments about company or candidate | NDA accepted on Jan 17, 2024 for Patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy. NDA accepted on Nov 30, 2023 for Head and Neck Squamous Cell Carcinoma. CTR20201974 and CTR20201976 Phase 2/3 studies in hepatocellular carcinoma in progress Aug 2022: No company news from 2022 on website CTR20220917 Phase 1b started in June 2022. Nov 2020: Phase-II/III clinical trials in Liver cancer (Combination therapy, Late-stage disease, First-line therapy) in China (IV) (NCT04560894) CTR20192593 Phase 3 study in NSCLC started in April 2020. NCT04171284 Phase 3 study started in Oct 2019. NCT04229537 Phase 1 in combination with SCT200 in Esophageal Squamous Cell Carcinoma and Colorectal Cancer not yet recruiting as of Jan 16 2020. NCT04146181 Phase 2 study in head and neck cancer started recruiting on Oct 31, 2019. NCT03821363 Phase 1 study started in Dec 2018. |
| Full address of company | No. 31, Kechuang 7th Street, Beijing Economic and Technological Development Zone Asia China http://www.sinocelltech.com/ |
Immune checkpoint target; humanized anti- PD-1 monoclonal antibody
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |