| 摘要: |
| 礼舒替尼是全球第三款以JAKs激酶为靶点的兽用药物，也是国内首款犬用JAK制剂，为国内治疗犬瘙痒症提供了新的选择。针对一类创新药，农业农村部兽药评审中心坚持国际评审标准开展科学评审，确保产品的安全性、有效性和质量可控性。本评估报告根据《欧盟兽医药品评估报告编制原则指南》（EMA/CVMP/450781/2015）[1]撰写，全面阐述了产品的评审要点，以期为国内一类创新药研发提供指导与帮助。 |
| 关键词: 礼舒替尼 礼舒替尼片 创新药 评估 |
| DOI： |
| 投稿时间：2025-02-07修订日期：2025-02-07 |
| 基金项目: |
|
| Lirucitinib and Lirucitinib tablets assessment report |
|
| (China Institute of Veterinary Drug Control) |
| 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. |
| Key words: Lirucitinib Lirucitinib tablets Innovative drugs assessment |
