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新药研发前沿动态 / 医药领域趋势进展

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陆磊, 吴琪, 王峰. 先诺欣®——国产首款靶向3C样蛋白酶的抗新冠病毒创新药[J]. 药学进展, 2023, 47(7): 484-488. DOI: 10.20053/j.issn1001-5094.2023.07.002
引用本文: 陆磊, 吴琪, 王峰. 先诺欣®——国产首款靶向3C样蛋白酶的抗新冠病毒创新药[J]. 药学进展, 2023, 47(7): 484-488. DOI: 10.20053/j.issn1001-5094.2023.07.002
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LU Lei, WU Qi, WANG Feng. XIANNUOXIN®: China’s First Anti-SARS-CoV-2 Drug Targeting 3C-like Protease[J]. Progress in Pharmaceutical Sciences, 2023, 47(7): 484-488. DOI: 10.20053/j.issn1001-5094.2023.07.002
Citation: LU Lei, WU Qi, WANG Feng. XIANNUOXIN®: China’s First Anti-SARS-CoV-2 Drug Targeting 3C-like Protease[J]. Progress in Pharmaceutical Sciences, 2023, 47(7): 484-488. DOI: 10.20053/j.issn1001-5094.2023.07.002
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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

    摘要
  • 摘要: 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。

     

    Abstract: 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.

     

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