Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1278 |
| INN | None |
| Status | Clinical |
| Drug code(s) | SHR-8068 |
| Brand name | None |
| mAb sequence source | mAb human |
| General Molecular Category | TBD |
| Format, general category | TBD |
| Format details | TBD |
| Isotype (Fc) | TBD |
| Light chain isotype | TBD |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | CTLA-4 |
| Indications of clinical studies | Gastric Adenocarcinoma and Esophageal Squamous Cell Carcinoma, Non-small cell lung cancer, hepatocellular carcinoma |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | July 15, 2022 |
| Start of Phase 2 | July 15, 2024 |
| Start of Phase 3 | October 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 | Hengrui Pharmaceutical |
| Licensee/Partner | Suzhou Suncadia Biopharmaceuticals Co. Ltd. |
| Comments about company or candidate | NCT06618664 /CTR20243670 Phase 3 in hepatocellular carcinoma started in Oct 2024. NCT06465563 Phase 2 in Biliary Tract Cancer started in July 2024. NCT06247956 / CTR20240377 Phase 2 in Advanced Gastric Adenocarcinoma and Esophageal Squamous Cell Carcinoma started in Mar 2024. NCT05444088 / CTR20221602 Phase 1/2 in hepatocellular carcinoma listed as in progress as of Jan 2024. NCT05416775 / CTR20221333 Phase 1/2 study in NSCLC started in Aug 2022. May 2022: Recently, Shanghai Shengdi Pharmaceutical Co., Ltd. and Suzhou Shengdia Biopharmaceutical Co., Ltd., the subsidiaries of Hengrui Pharmaceutical, received the "Drug Clinical Trial Approval Notice" approved and issued by the State Drug Administration, approving the company to carry out SHR-8068 combined with Ader An open-label, multicenter phase Ib/II clinical study of belimumab and bevacizumab or platinum-containing chemotherapy in the treatment of advanced solid tumors. |
| Full address of company | Jiangsu, China Asia China https://www.hengrui.com/en/index.html |
SHR-8068 is a fully human monoclonal antibody that can enhance anti-tumor immune effects. https://www.hengrui.com/en/pipeline.html
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |