Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 71 |
| INN | Tafolecimab |
| Status | Approved |
| Drug code(s) | IBI306 |
| Brand name | SINTBILO |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG2 |
| 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) | November 27, 2017 |
| Start of Phase 2 | March 07, 2019 |
| Start of Phase 3 | December 20, 2019 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | 2023 |
| Date of first US approval | |
| INN, US product name | Tafolecimab |
| US or EU approved indications | None |
| Company | Innovent Biologics (Suzhou) Co. Ltd. |
| Licensee/Partner | None |
| Comments about company or candidate | August 16, 2023 -- Innovent Biologics, Inc. announces that China's National Medical Products Administration (NMPA) has approved SINTBILO® (tafolecimab injection, anti-PCSK9 monoclonal antibody) for the treatment of adult patients with primary hypercholesterolemia (including heterozygous familial and non-familial hypercholesterolemia) and mixed dyslipidemia. June 13, 2022: Innovent Biologics, Inc. announced that the China's National Medical Products Administration (NMPA) has formally accepted the New Drug Application (NDA) for tafolecimab injection (anti-PCSK-9 antibody, R&D code: IBI306) for the treatment of primary hypercholesterolemia (including heterozygous familial hypercholesterolemia and non-familial hypercholesterolemia) and mixed dyslipidemia. As of February 2022, three key registration studies of IBI306 have been completed and successfully met the primary endpoint, where CREDIT-2 study for the treatment of Chinese HeFH patients was the first to meet the primary endpoint in August 2021. Innovent plans to communicate with the Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA) on the submission of a new drug application (NDA) for IBI306 in patients with primary hypercholesterolemia and combined hyperlipidemia. Aug 2021: Innovent Biologics, Inc. announces that the primary endpoint was met in the phase 3 study CREDIT-2 (NCT04759534) of recombinant fully human anti-PCSK-9 monoclonal antibody (R&D code: IBI306, independently developed by Innovent) for the treatment of Chinese heterozygous familial hypercholesterolemia (HeFH). NCT04709536 Phase 3 study not yet recruiting when first posted on Jan 14, 2021. IBI-306, a novel anti-PCSK9 monoclonal antibody was accepted into the National Major New Drugs Innovation and Development Program. As of year end 2019: • Completed a Phase 2 clinical trial in China for non-familial hypercholesterolemia. • Completed first patient dosing in: – a Phase 3 clinical trial in China for heterozygous familial hypercholesterolemia (“HeFH”); and – a pivotal Phase 2b/3 clinical trial in China for homozygous familial hypercholesterolemia (“HoFH”). NCT04289285 Phase 3 study not yet recruiting as of March 3, 2020. NCT04179669 Phase 3 study started recruiting in Dec 2019. NCT04031742 Phase 2/3 study in Homozygous Familial Hypercholesterolemia not yet recruiting as of Sep 23, 2019. NCT03815812 Phase 2 study in Chinese patients with hypercholesterolemia recruiting as of March 2019. NCT03366688 Phase 1 study recruiting as of Aug 2018 |
| Full address of company | 168 Dongping Street, Suzhou Industrial Park Asia China https://www.innoventbio.com/AboutUs/ContactUs |
IBI306 is a fully human monoclonal antibody that binds proprotein convertase substilisin/kexin type 9 (PCSK9), preventing its interaction with the low-density lipoprotein cholesterol receptor (LDL-R) and thereby restoring LDL-R recycling and low-density lipoprotein cholesterol（LDL-C）uptake
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |