{"title":"Recaticimab: First Approval.","authors":"Yvette N Lamb","doi":"10.1007/s40265-025-02199-5","DOIUrl":null,"url":null,"abstract":"<p><p>Recaticimab (<sup>®</sup>), a humanized monoclonal immunoglobulin G1 antibody that targets proprotein convertase subtilisin/kexin type 9 (PCSK9), is being developed by Suzhou Suncadia Biopharmaceutical for the treatment of hypercholesteremia and mixed dyslipidemia. Recaticimab received its first approval on 8 January 2025 in China, as an adjunct to diet, in combination with statins (with or without other lipid-lowering therapies) in adults with primary hypercholesterolemia (including heterozygous familial and non-familial hypercholesterolemia) and mixed dyslipidemia who have not achieved their low-density lipoprotein cholesterol (LDL-C) target despite receiving moderate or higher doses of statins, and for use as monotherapy in adults with non-familial hypercholesterolemia and mixed dyslipidemia to reduce LDL-C, total cholesterol, and apolipoprotein B levels. This article summarizes the milestones in the development of recaticimab leading to this first approval for hypercholesterolemia and mixed dyslipidemia.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":""},"PeriodicalIF":13.0000,"publicationDate":"2025-06-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Drugs","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s40265-025-02199-5","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0
Abstract
Recaticimab (®), a humanized monoclonal immunoglobulin G1 antibody that targets proprotein convertase subtilisin/kexin type 9 (PCSK9), is being developed by Suzhou Suncadia Biopharmaceutical for the treatment of hypercholesteremia and mixed dyslipidemia. Recaticimab received its first approval on 8 January 2025 in China, as an adjunct to diet, in combination with statins (with or without other lipid-lowering therapies) in adults with primary hypercholesterolemia (including heterozygous familial and non-familial hypercholesterolemia) and mixed dyslipidemia who have not achieved their low-density lipoprotein cholesterol (LDL-C) target despite receiving moderate or higher doses of statins, and for use as monotherapy in adults with non-familial hypercholesterolemia and mixed dyslipidemia to reduce LDL-C, total cholesterol, and apolipoprotein B levels. This article summarizes the milestones in the development of recaticimab leading to this first approval for hypercholesterolemia and mixed dyslipidemia.
Recaticimab（®）是一种人源化单克隆免疫球蛋白G1抗体，靶向蛋白转化酶subtilisin/kexin type 9 (PCSK9)，由苏州Suncadia生物制药有限公司开发，用于治疗高胆固醇血症和混合性血脂异常。Recaticimab于2025年1月8日在中国首次获批，用于原发性高胆固醇血症（包括杂合子家族性和非家族性高胆固醇血症）和混合性血脂异常（尽管接受了中等或更高剂量的他汀类药物，但仍未达到低密度脂蛋白胆固醇（LDL-C）目标）的成人患者，作为饮食辅助药物与他汀类药物（伴或不伴其他降脂疗法）联合使用。并用于非家族性高胆固醇血症和混合性血脂异常的成人单药治疗，以降低LDL-C、总胆固醇和载脂蛋白B水平。本文总结了recaticimab在高胆固醇血症和混合性血脂异常治疗中的里程碑式进展。
期刊介绍：
Drugs is a journal that aims to enhance pharmacotherapy by publishing review and original research articles on key aspects of clinical pharmacology and therapeutics. The journal includes:
Leading/current opinion articles providing an overview of contentious or emerging issues.
Definitive reviews of drugs and drug classes, and their place in disease management.
Therapy in Practice articles including recommendations for specific clinical situations.
High-quality, well designed, original clinical research.
Adis Drug Evaluations reviewing the properties and place in therapy of both newer and established drugs.
AdisInsight Reports summarising development at first global approval.
Moreover, the journal offers additional digital features such as animated abstracts, video abstracts, instructional videos, and podcasts to increase visibility and educational value. Plain language summaries accompany articles to assist readers with some knowledge of the field in understanding important medical advances.
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