内分泌适应证多肽药物非临床安全性评价的回顾性思考  

Retrospective thinking on non-clinical safety evaluation of endocrine indication polypeptide drugs

作　　者：尹茂山 李慧 董田甜 李峥 尹华静 王寅 吴爽 赵华琛 于冰 笪红远 YIN Mao-shan;LI Hui;DOND Tian-tian;LI Zheng;YIN Hua-jing;WANG Yin;WU Shuang;ZHAO Hua-chen;YU Bing;DA Hong-yuan(Centre for Drug Evaluation,National Medical Products Administration,Beijing 100163,China;TriApex Laboratories Co.,Ltd.,Nanjing 210031,Jiangsu Province,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100163 [2]江苏鼎泰药物研究(集团)股份有限公司,江苏南京210031

出　　处：《中国临床药理学杂志》2024年第23期3501-3508,共8页The Chinese Journal of Clinical Pharmacology

摘　　要：多肽药物以其适应证广泛等特点,在药物研发领域备受瞩目,尤其是在糖尿病、骨质疏松等内分泌相关适应证的新药研发关注度更高。随着多肽合成和递送技术的进步,多肽药物的研究和应用取得了较大的突破。但多肽药物的研发和非临床安全性评价仍面临诸多挑战,国内外尚未制定针对此类药物非临床安全性评价的指导原则。本文聚焦内分泌适应证领域,通过分析已批准上市的多肽药物的非临床研究,结合多肽药物的研发现状和监管要求,提出了多肽药物非临床安全性评价的关注点,包括相关动物种属的选择、主要研究内容、含有非天然氨基酸多肽药物的特殊评价要求等。本文旨在为优化和改进多肽药物的非临床安全性评价提供参考,促进该类药物的研发。Polypeptide drugs have attracted much attention in the field of drug research and development due to their wide range of indications,especially in pharmaceutical R&D of new drugs with endocrine related indications such as diabetes and osteoporosis.With the advancement of peptide synthesis and delivery technologies,the research and application of peptide drugs have made significant breakthroughs.However,the R&D and nonclinical safety assessment of peptide drugs still face many challenges,and there are no specific guidelines for the nonclinical safety evaluation of this class of drugs domestically or abroad.This article focuses on the field of endocrine indications.By analyzing the nonclinical studies of approved peptide drugs,and considering the current R&D status and specific regulatory requirements,this paper proposes considerations on the nonclinical safety assessment of peptide drugs,including the selection of relevant animal species,key study contents,specific considerations for peptides containing non-natural amino acids,etc.The aims are to provide references for optimizing and improving the nonclinical safety evaluation of peptide drugs.

关 键 词：多肽药物 内分泌适应证 非临床安全性评价 关注点 回顾性思考 

分 类 号：R97[医药卫生—药品]