Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1737 |
| INN | Recaticimab |
| Status | Regulatory review |
| Drug code(s) | SHR-1209 |
| Brand name | (Pending) |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| 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, Hyperlipidemia |
| Primary therapeutic area | Metabolic disorders |
| Most advanced stage of development (global) | Regulatory review China |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | August 30, 2018 |
| Start of Phase 2 | September 01, 2020 |
| Start of Phase 3 | April 20, 2021 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | Recaticimab |
| US or EU approved indications | None |
| Company | Jiangsu HengRui Medicine Co. Ltd |
| Licensee/Partner | None |
| Comments about company or candidate | Aug 2023: Listed as NDA filed in Hengrui pipeline Phase 3 studies are currently either completed or active non recruiting: studies for Hypercholesterolemia and hyperlipidemia (NCT04849000 completed in May 19, 2023, NCT04885218 is active non recruiting since May 24, 2022); Primary hypercholesterolemia (NCT04844125 completed in April 25, 2023). No recent relevant news on Hengrui website. Aug 2022: No information found regarding plans for NDA/BLA submission. Phase 1b/2 study published in Jan 2022 (BMC Medicine volume 20, Article number: 13 (2022)) NCT04844125 Phase 3 in Primary Hypercholesterolemia started in April 2021 has primary completion date in April 2022. NCT04885218 Phase 3 in Hypercholesterolemia Hyperlipidemia started in June 2021 has primary completion date in October 2023. |
| 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. |
immunoglobulin G1-kappa, anti-[Homo sapiens PCSK9 (proprotein convertase subtilisin/kexin type 9, neural apoptosis-regulated convertase 1, NARC1, NARC-1, proproteine convertase 9, PC9)], monoclonal antibody;
| Anticipated events | Regulatory review China - anticipate approval |
| Factor(s) contributing to discontinuation | None |