Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1279 |
| INN | Trastuzumab rezetecan |
| Status | Regulatory review |
| Drug code(s) | SHR-A1811 |
| 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 | 5.3 to 6.4 |
| Conjugated/fused moiety | Topoisomerase I inhibitor, SHR9265 |
| Discovery method/technology | None |
| Target(s) | HER2 |
| Indications of clinical studies | Gynecological malignancies, HER2+ Gastric Cancer/Gastroesophageal Junction Adenocarcinoma, Breast cancer, non-small cell lung cancer, gastric cancer or colorectal 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) | September 03, 2020 |
| Start of Phase 2 | |
| Start of Phase 3 | July 29, 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 | Jiangsu HengRui Medicine Co. Ltd. |
| Licensee/Partner | Suzhou Suncadia Biopharmaceuticals Co. Ltd. |
| Comments about company or candidate | Sep 2024: Suzhou Suncadia Biopharmaceuticals Co. Ltd. submits NDA for HER2-mutant NSCLC to NMPA that is accepted on Sep 14, 2024. NCT06430437 / CTR20241861 in NSCLC not yet recruiting. NCT06199973 Phase 3 in colorectal cancer started in Mar 2024. NCT06123494 Phase 3 in HER2-positive Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma started in Jan 2024 NCT06057610 Phase 3 in breast cancer not yet recruiting Phase 3 studies for Breast cancer (NCT05424835 is recruiting as of August 10, 2022, NCT05814354 is not yet recruiting as of April 14, 2023. April 10, 2023 press release "Breakthrough Therapy Designations were granted to SHR-A1811 by the China National Medical and Products Administration for three indications, which include: For the treatment of HER2-mutant, advanced NSCLC after platinum-based chemotherapy; For the treatment of HER2-positive, recurrent or metastatic breast cancer; For the treatment of HER2-low, recurrent or metastatic breast cancer" https://www.hengrui.com/en/media/detail-320.html NCT05424835 is a Phase 3 study in breast cancer started in July 2022. NCT04818333 is a Phase I/II Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-A1811 for Injection in Subjects With Advanced Non-small Cell Lung Cancer Who Have HER2 Expression , Amplification, or Mutation due to start in April 2021. NCT04446260 is a Phase 1 study in solid tumors. NCT04513223 is a Phase 1 study of the Safety, Tolerability, Pharmacokinetics, and Antitumour Activity of SHR-A1811, in Patients With HER2-expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma and Colorectal Cancer. July 2020: Hengrui Pharmaceuticals received the "Drug Clinical Trial Approval Notice" approved and issued by the National Medical Products Administration, approving the company's innovative drug SHR-A1811 for injection to carry out clinical trials for the treatment of advanced solid tumors with HER2 expression or mutation. |
| Full address of company | Lianyungang, Jiangsu Province, China. Asia China https://www.hengrui.com/en/about.html |
SHR-A1811 for injection is a HER2 antibody drug conjugate (ADC) independently developed by Hengrui Medicine. Trastuzumab conjugated on an average of 5.3 to 6.4 cysteinyl, with (3RS)-1-[(2R,10S)-10- benzyl-2-cyclopropyl-1-{[(1S,9S)-9-ethyl-5-fluoro-9-hydroxy-4- methyl-10,13-dioxo-2,3,9,10,13,15-hexahydro-1H,12Hbenzo[de]pyrano[3',4':6,7]indolizino[1,2-b]quinolin-1-yl]amino}- 1,6,9,12,15,18-hexaoxo-3-oxa-5,8,11,14,17-pentaazatricosan23-yl]-2,5-dioxopyrrolidin-3-yl (rezetecan) groups
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |