Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 149 |
| INN | Adebrelimab |
| Status | Approved |
| Drug code(s) | SHR-1316, HTI-1088 |
| Brand name | Arelili® |
| 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-L1 |
| Indications of clinical studies | Gastric cancer, Breast cancer, Non-small cell lung cancer, Small cell lung cancer, Solid tumors |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved China |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | June 26, 2017 |
| Start of Phase 2 | |
| Start of Phase 3 | January 22, 2021 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | 2023 |
| Date of first US approval | |
| INN, US product name | Adebrelimab |
| US or EU approved indications | None |
| Company | Jiangsu HengRui Medicine Co. Ltd |
| Licensee/Partner | Atridia Pty Ltd. |
| Comments about company or candidate | March 7, 2023 notice: Recently Shanghai Shengdi Pharmaceutical Co., Ltd., a subsidiary of Hengrui Medicine, received the "Drug Registration Certificate" issued by the National Medical Products Administration (NMPA), approving the company's self-developed PD-L1 inhibitor adelbelimab (Arebelimab) ®) in combination with carboplatin and etoposide for the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC). https://www.hengrui.com/media/detail-309.html Jiangsu Hengrui Medicine website accessed Aug 10, 2022: The NDA of SHR-1316 in combination with chemotherapy for SCLC has been filed to NMPA Atridia is a Sydney based company that serves as the local Sponsor for Jiangsu Hengrui Medicine Co.,Ltd for clinical trials in Australia. NCT04691063 Phase 3 study in SCLC started enrolling by invitation in Jan 2021. NCT04316364 Phase 3 in NSCLC not yet recruiting when first posted on March 20, 2020. NCT04041011 Phase 1 in small cell lung cancer not yet recruting as of Aug 1, 2019. NCT03474289 Phase 1 study started in March 2018 recruiting as of Aug 2018. NCT03133247 Phase 1 started in June 2017. |
| Full address of company | No.7 Kunlunshan Road, Lianyungang Eco & Tech Development Zone, Jiangsu, 222000 Asia China https://www.globaldata.com/company-profile/jiangsu-hengrui-medicine-co-ltd/#:~:text=Jiangsu%20Hengrui%20is%20headquartered%20in%20Lianyungang%2C%20Jiangsu%20Province%2C%20China. |
Immune checkpoint target
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |