Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1727 |
| INN | Ongericimab |
| Status | Approved |
| Drug code(s) | JS002 |
| Brand name | 君适达® |
| 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) | PCSK9 |
| Indications of clinical studies | Hypercholesterolemia |
| Primary therapeutic area | Metabolic disorders |
| Most advanced stage of development (global) | Approved China |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | December 11, 2017 |
| Start of Phase 2 | January 15, 2019 |
| Start of Phase 3 | December 23, 2020 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | 2024 |
| Date of first US approval | |
| INN, US product name | Ongericimab |
| US or EU approved indications | None |
| Company | Shanghai Junshi Bioscience Co Ltd |
| Licensee/Partner | None |
| Comments about company or candidate | October 12, 2024: Junshi Biosciences Announces Ongericimab’s NDA Approval in China. [accessed 2024 Oct 15] https://www.junshipharma.com/en/君实生物宣布昂戈瑞西单抗（君适达）在中国获/ April 25, 2023 Shanghai Junshi Biosciences announced the acceptance of the new drug application for the company’s recombinant humanized anti-PCSK9 monoclonal antibody (product code: JS002) by the National Medical Products Administration Feb. 27, 2023: Shanghai Junshi Biosciences Co., Ltd announced the successful completion of two randomized, double-blind, placebo-controlled, multi-center phase III clinical studies (Study nos.: JS002-003 and JS002-006) evaluating the company’s product ongericimab (a recombinant humanized anti-PCSK9 monoclonal antibody, product code: JS002) for the treatment of primary hypercholesterolemia and mixed hyperlipidemia, and both studies have met their primary endpoints. YE 2021 report lists asset as in Phase 3; no mention of plans for regulatory submission NCT04781114 Phase 3 started in Dec 2020. NCT04469673 Phase 1/2 study started in May 2019. Jan 2019: Shanghai Junshi Bioscience Co Ltd registered a Phase II, randomized, double-blind, controlled trial evaluating the safety, tolerability, efficacy, and pharmacokinetic and pharmacodynamic characteristics of multiple doses of JS002 in patients with hyperlipidemia. The trial was registered with the China clinical trial registry. NCT04197817 Phase 1 started in Dec 2017. |
| Full address of company | 100, Pingjiaqiao Road, Shanghai, China Asia China https://www.junshipharma.com/en/contact-us/ |
JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody. S228P (hinge-stabilization)
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |