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Simnotrelvir Tablets/Ritonavir Tablets(co-packaged) and Deuremidevir Hydrobromide Tablets for treating COVID-19 infection approved for marketing with conditions

CCFDIE|Updated: 2023-01-29

     

Recently, the class 1 innovative drug Simnotrelvir Tablets/Ritonavir Tablets(co-packaged) (Chinese trade name: 先诺欣) of Simcere Pharmaceutical Group Limited and Deuremidevir Hydrobromide Tablets (Chinese trade name: 民得维) of Shanghai Wangshi Biomedicine Technology Inc. are approved for marketing with conditions by China NMPA through emergency review and approval procedure in accordance with the relevant provisions of special review and approval prescribed in the Drug Administration Law.

The above-mentioned two drugs are both oral small molecular drugs for COVID-19 infection treatment, indicated for adult patients with mild to moderate SARS-CoV-2(COVID-19) infection. Patients should use drugs strictly according to the instructions under the guidance of doctors.

The MAHs are asked by NMPA to complete relevant research works of the conditional requirements within a time limit, and submit the follow-up research results as soon as possible.