中国兽药杂志2025，Vol.59Issue(4)：8-17,10.DOI:10.11751/ISSN.1002-1280.2025.4.02
礼舒替尼和礼舒替尼片评估报告
Lirucitinib and Lirucitinib Tablets Assessment Report
李丹 1徐倩 1张雪 2李丹妮 2段聪 1沈欣 1苏富琴 1汪霞 1梁先明1
作者信息
- 1. 中国兽医药品监察所(农业农村部兽药评审中心),北京 100081
- 2. 格格巫(珠海)生物科技有限公司,广东 珠海 100020
- 折叠
摘要
Abstract
Lirucitinib is the third veterinary drug targeting JAKs kinase in the world and the first JAK preparation for dogs in China,providing a new choice for the treatment of pruritus in dogs in China.For a class of innovative drugs,the Veterinary Drug Evaluation Center of the Ministry of Agriculture and Rural Affairs adheres to international evaluation standards to carry out scientific evaluation to ensure product safety,effectiveness and quality control.This assessment report is prepared in accordance with the CVMP guideline on the principles for preparing assessment reports for veterinary medicinal products(EMA/CVMP/450781/2015),and comprehensively expounds the main points of product evaluation,in order to provide guidance and help for the domestic research and development of a class of innovative drugs.关键词
礼舒替尼/礼舒替尼片/创新药/评估Key words
Lirucitinib/Lirucitinib tablets/Innovative drugs/assessment分类
农业科技引用本文复制引用
李丹,徐倩,张雪,李丹妮,段聪,沈欣,苏富琴,汪霞,梁先明..礼舒替尼和礼舒替尼片评估报告[J].中国兽药杂志,2025,59(4):8-17,10.
