XIANNUOXIN^®: China’s First Anti-SARS-CoV-2 Drug Targeting 3C-like Protease

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.