Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1736 |
| INN | Enlonstobart |
| Status | Approved |
| Drug code(s) | SG001, SYSA1802 |
| Brand name | Enshuxing, 恩舒幸® |
| mAb sequence source | mAb human |
| 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-1 |
| Indications of clinical studies | Triple Negative Breast Cancer, Epithelial Ovarian Cancer, uterine cervical 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) | May 23, 2019 |
| Start of Phase 2 | July 31, 2021 |
| Start of Phase 3 | |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | 2024 |
| Date of first US approval | |
| INN, US product name | Enlonstobart |
| US or EU approved indications | None |
| Company | CSPC ZhongQi Pharmaceutical Technology Co. Ltd. |
| Licensee/Partner | None |
| Comments about company or candidate | June 28, 2024: CSPC announces Enlonstobart Injection (brand name: Enshuxing), a new Class 1 therapeutic biological product developed by the Group, has obtained conditional marketing approval granted by the National Medical Products Administration (NMPA) of the People’s Republic of China. The approved indication of the Product is for the treatment of recurrent or metastatic cervical cancer patients with positive PD-L1 (CPS≥1) expression who have previously failed to respond to platinum-based chemotherapy. https://www1.hkexnews.hk/listedco/listconews/sehk/2024/0628/2024062802643.pdf March 10, 2023: The board of directors (the “Board”) of CSPC Pharmaceutical Group Limited is pleased to announce that the application for marketing approval of enlonstobart for injection (brand name: Enshuxing) of CSPC Megalith Biopharmaceutical Co., Ltd* (石藥集團巨石生物製藥有限公司), a subsidiary of the Company, has been accepted by the National Medical Products Administration (NMPA) of the People’s Republic of China with eligibility for the conditional approval pathway. It is applied as a Class 1 therapeutic biological product for the treatment of recurrent or metastatic cervical cancer patients with positive PD-L1 expression who have failed to respond to first-line platinum-based chemotherapy. NCT05715840 Phase 3 in cervical cancer due to start in Jan 2023. NCT04983550 Phase 2 due to start in Sep 2021. NCT04886700 and NCT05068141 Phase 2 studies recruiting as of March 2022. NCT03852823 Phase 1 study not yet recruiting as of last record update in Feb 2019 |
| Full address of company | No.226 Huanghe Street,, Shijiazhuang, Hebei Province,, PRC 050035 Asia China https://www.cspc.com.hk/en/contacts/contactus.php |
Enlonstobart for injection is a recombinant fully human anti-PD-1 monoclonal antibody developed by the Group, belonging to IgG4 monoclonal antibody drug.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |