先诺欣■——国产首款靶向3C样蛋白酶的抗新冠病毒创新药

XIANNUOXIN■:China's First Anti-SARS-CoV-2 Drug Targeting 3C-like Protease

新型冠状病毒流行是近3年来全球范围传播速度最快、感染范围最广、防控难度最大的突发公共卫生事件。国产首款靶向3C样蛋白酶的抗新冠病毒创新药先诺欣■(先诺特韦片/利托那韦片组合包装)的获批上市,为我国新型冠状病毒感染的治疗提供了新的用药选择。简介先诺欣■的研发与新药申请历程及相关经验,旨在为突发公共卫生事件急需药物的研发及注册提供参考。

The SARS-CoV-2 pandemic is a global public health emergency with the fastest spread,most widespread infection and most challenging prevention and control in the past three years.The approval of the first homegrown innovative anti-SARS-CoV-2 drug XIANNUOXIN■[simnotrelvir tablets/ritonavir tablets(co-packaged)]targeting 3C-like protease has provided a new choice for the treatment of COVID-19 in China.This article introduces the process and relevant experience of the development and New Drug Application(NDA)of XIANNUOXIN■,aiming to provide a reference for the development and registration of urgently needed drugs in public health emergencies.