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Synonyms: IBI-306 | IBI306 | Sintbilo®
tafolecimab is an approved drug (China (2023))
Compound class:
Antibody
Comment: Tafolecimab (IBI-306; Innovent Biologics) is a fully human proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibody. Based on protein sequence alignments, we suspect that tafolecimab is one of the monoclonals that are claimed in Innovent Biologics' patent US11485795: Anti-PCSK9 antibody and use thereof [4].
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| No information available. |
Summary of Clinical Use  |
| Tafolecimab (IBI-306) was progressed to clinical evaluations to determine efficacy as a treatment for hypercholesterolemia [2]. First international approval was granted in August 2023 in China; indicated to treat primary hyperlipidemia [3]. |
| Clinical Trials | |||||
| Clinical Trial ID | Title | Type | Source | Comment | References |
| NCT04179669 | Safety and Efficacy of IBI306 in HeFH Patients | Phase 3 Interventional | Innovent Biologics (Suzhou) Co. Ltd. | 1 | |
| NCT04289285 | Safety and Efficacy of IBI306 in Chinese Subjects With Non-familial Hypercholesterolemia | Phase 3 Interventional | Innovent Biologics (Suzhou) Co. Ltd. | ||
| NCT04759534 | Application of PCSK9 Inhibitors in Patients With Heterozygous Familial Hypercholesterolemia | Phase 3 Interventional | Shenzhen People's Hospital | ||
