Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1282 |
| INN | Tizetatug rezetecan |
| Status | Clinical |
| Drug code(s) | SHR-A1921 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | ADC |
| Format, general category | Full length Ab conjugate |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | Undisclosed |
| Ave. DAR | 4 |
| Conjugated/fused moiety | Topoisomerase I inhibitor, SHR9265 |
| Discovery method/technology | None |
| Target(s) | TROP-2 |
| Indications of clinical studies | Ovarian cancer, Solid tumors, B cell 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, 2021 |
| Start of Phase 2 | May 15, 2023 |
| Start of Phase 3 | May 15, 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 Hengrui Pharmaceutical Co. Ltd. |
| Licensee/Partner | Suzhou Suncadia Biopharmaceuticals Co. Ltd., Atridia Pty Ltd. |
| Comments about company or candidate | NCT06394492 Phase 3 in ovarian cancer started in May 2024. NCT06211023 / CTR20240254 Phase 2/3 study in ovarian cancer due to start in Feb 2024. NCT05765032 Phase 1/2 started in May 2023. NCT05113069 Phase 1 in B cell lymphoma started in Dec 2021 still recruiting as of last update on April 18, 2022. NCT05154604 Phase 1 is due to start in Dec 2021. Atridia Pty Ltd (Atridia) is an independent Pharmaceutical company headquartered in Sydney, acting for Jiangsu Hengrui Medicine Co., Ltd. On October 25 2021, the official website of CDE showed that Hengrui Medicine's SHR-A1921 clinical trial application was approved by the China Food and Drug Administration. This is the first time that SHR-A1921 has been approved for clinical use. |
| Full address of company | Jiangsu, China Asia China https://www.hengrui.com/en/index.html |
SHR-A1921 is an antibody-conjugated drug (ADC) for the treatment of advanced malignant solid tumors. immunoglobulin G1-kappa, anti-[Homo sapiens TACSTD2 (tumor-associated calcium signal transducer 2, membrane component chromosome 1 surface marker 1, M1S1, gastrointestinal tumorassociated antigen GA7331, pancreatic carcinoma marker protein GA733-1, epithelial glycoprotein-1, EGP-1, trophoblast antigen-2, cell surface glycoprotein Trop-2, TROP2)], humanized monoclonal antibody; conjugated on an average of four cysteinyl residues to rezetecan; It is a humanized anti-TROP-2 IgG1 mAb attached to a DNA topoisomerase I inhibitor via a tetrapeptide-based cleavable linker. DOI: 10.1016/j.annonc.2024.08.1367
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |