Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1280 |
| INN | None |
| Status | Clinical |
| Drug code(s) | SHR-A1904 |
| 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 | TBD |
| Linker | Cleavable linker |
| Ave. DAR | ___ |
| Conjugated/fused moiety | Topoisomerase I inhibitor |
| Discovery method/technology | None |
| Target(s) | Claudin-18.2 |
| Indications of clinical studies | Gastric or Gastroesophageal Junction Adenocarcinoma, Pancreatic cancer, Solid tumors |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | January 29, 2021 |
| Start of Phase 2 | |
| Start of Phase 3 | May 28, 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 | Merck KGaA |
| Comments about company or candidate | NCT06649292 Phase 3 in gastric cancer due to start in Nov 2024. CTR20241158 Phase Ib/III clinical study of SHR-A1904 combined with other drugs in the treatment of CLDN18.2-positive advanced solid tumors recruiting as of Sep 9, 2024. October 30, 2023: Merck KGaA announced a strategic collaboration with Jiangsu Hengrui Pharmaceuticals Co. Ltd. (Hengrui). The agreement includes an option to an exclusive license worldwide (ex-China) to develop, manufacture and commercialize Hengrui’s Claudin-18.2 antibody-drug conjugate (ADC) SHR-A1904. In addition, Merck KGaA has the option to co-promote the asset in China. NCT05277168 Phase 1/2 started in May 2022 recruiting as of last update in Jan 2023. NCT04928625 is a Phase 1 in pancreatic cancer started in Aug 2021 NCT04877717 is An Open-Label, Single-Arm, Multi-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-A1904 in Patients With Advanced Solid Tumors started in July 2021. According to CDE official website,Hengrui Class 1 New Drug"SHR-A1904 for injection"Approved clinical (Acceptance number CXSL2100034); application submitted Jan 29, 2021. |
| Full address of company | Jiangsu, China Asia China https://www.hengrui.com/en/index.html |
SHR-A1904 is a novel ADC comprised of an IgG1 mAb targeting CLDN18.2, a cleavable linker, and a topoisomerase I inhibitor payload.
| Anticipated events | Phase 3 pending |
| Factor(s) contributing to discontinuation | None |