China Approves Two More Home-Grown COVID-19 Antivirals

Top-line results for two newly approved COVID-19 antivirals in China showed roughly 1.5- to two-day cuts in median time to symptom resolution or recovery in mild-to-moderate Omicron patients versus placebo.

endpoint of symptom resolution
time to symptom resolution or recovery a top pick for primary endpoint in COVID antiviral trials • Source: Shutterstock

China’s drug regulator has conditionally approved Shanghai Junshi Biosciences Co., Ltd.’s deuremidevir (JT001/VV116) and Simcere Pharmaceutical Group’s combination antiviral simnotrelvir plus ritonavir (SIM0417) as the latest additional home-grown oral antivirals for COVID-19, in a way that reflected the Japanese approval of Shionogi & Co. Ltd.’s Xocova (ensitrelvir).

The regulatory decision, announced by the National Medical Products Administration (NMPA) on 29 January, was based on interim analyses of positive outcomes from two placebo-controlled Phase III trials

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