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作 者:窦树珍 周治寰 邹慧[1] 刘少金 DOU Shuzhen;ZHOU Zhihuan;ZOU Hui;LIU Shaojin(Institute of Science and Technology Strategy,Jiangxi Academy of Sciences,Nanchang 330096,China)
机构地区:[1]江西省科学院科技战略研究所,南昌330096
出 处:《中国生物工程杂志》2024年第11期110-122,共13页China Biotechnology
基 金:江西省自然科学基金(20234BAA10W058);江西省科学院省级科技计划项目包干制试点示范(2022YSBG21023、2021YSBG22038)资助项目。
摘 要:近年来,小分子药物研发日趋困难,抗体等大分子药物趋于同质化。随着肽合成技术的迭代更新和对疾病生理学的深入研究,多肽药物作为大小分子之间的“独特药物”得到快速发展。因具有适应证广、安全性高、疗效显著、特异性强等优点,多肽药物被广泛应用于肿瘤、心脑血管疾病、糖尿病等的预防、诊断和治疗,开发前景广阔,已成为新型药物研发领域的热点之一。为进一步推动我国多肽药物行业的创新发展,概述了多肽药物的合成技术,探讨了其开发过程中的技术难点,结合定量和定性分析方法,深入剖析了国内外多肽药物的研发现状、市场格局和面临的机遇及挑战,明确了我国在多肽药物领域的发展潜力,展望了未来发展前景,并从技术研发、市场主体和行业规范等方面提出针对性建议,以期为研究人员、行业从业者及相关政府部门提供有益参考。In recent years,the development of small-molecule drugs has become increasingly challenging,while antibodies and other macromolecular drugs have tended to become more homogeneous.Peptide drugs,characterized by their unique molecular size,have experienced rapid growth due to continuous advances in peptide synthesis technology and extensive research into disease physiology.Owing to the advantages of broad indications,high safety profile,significant efficacy,and strong specificity,peptide drugs have been widely used in the diagnosis,prevention and treatment of various diseases,including oncology,cardiovascular and cerebrovascular diseases,and diabetes.As a result,they have immense potential and have become a major focus of new drug discovery and development.In order to promote the innovative development of peptide drugs in China,this paper provides a comprehensive summary of the synthesis technology utilized in peptide drug production while exploring the technical challenges encountered during its development process.By employing quantitative and qualitative analysis methods,a thorough analysis of the current status of peptide drug research and development along with market patterns at home and abroad is conducted.Furthermore,this study provides a comprehensive analysis of the opportunities and challenges faced by the industry participants.Finally,it assesses the future prospects for peptide drug development in China and provides targeted suggestions regarding technology research and development,key market players and industry standards,providing valuable references for researchers,industry practitioners,and relevant government departments.
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