ongericimab   Click here for help

GtoPdb Ligand ID: 13787

Synonyms: JS-002 | JS002 | Junshida®
Approved drug
ongericimab is an approved drug
Compound class: Antibody
Comment: Ongericimab (JS002) is a subcutaneous humanized anti-proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibody [1]. It blocks binding between circulating PCSK9 and the LDL receptor on hepatocytes. This reduces LDL receptor degradation, thus increasing the number of LDL receptors on cells, and effectively increasing hepatic removal LDL cholesterol (LDL-C) from the circulation. Ongericimab was developed for patients at high risk for cardiovascular disease, as an add-on treatment when standard lipid-lowering therapy fails to achieve LDL-C target level.
No information available.
Summary of Clinical Use Click here for help
The Chinese drug regulator (NMPA) approved ongericimab (Junshida®) in 2024, to treat primary hypercholesterolemia (non-familial) and mixed dyslipidemia when target LDL-C cannot be achieved with either statins alone or statins + ezetimibe.
Clinical Trials
Clinical Trial ID Title Type Source Comment References
NCT05621070 Efficacy and Safety of JS002 as Monotherapy in Patients With Primary Hypercholesterolaemia and Mixed Dyslipidemia Phase 3 Interventional Shanghai Junshi Bioscience Co., Ltd.
NCT05532800 The Efficacy and Safety of JS002 PFS and AI in Patients With Primary Hypercholesterolemia and Mixed Hyperlipidemia Phase 3 Interventional Shanghai Junshi Bioscience Co., Ltd.
NCT04781114 The Safety and Efficacy of Multiple-dose of JS002 in Subject With Hyperlipidemia Phase 3 Interventional Shanghai Junshi Bioscience Co., Ltd. 3
NCT05325203 A Study to Evaluate the Efficacy and Safety of JS002 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH). Phase 3 Interventional Shanghai Junshi Bioscience Co., Ltd. 2