FB2001 (generic name: Bofutrelvir) is a SARS-CoV-2 3CL protease inhibitor under clinical development for hospitalized patients as well as for post-exposure prophylaxis of Covid-19. It is a peptidomimetic compound targeting 3CL-protease based on three-dimensional crystal structure of the protease. Preclinical data has shown it has potent activities in vitro and in vivo against SARS-CoV-2 variants such as Alpha, Beta, Delta, and Omicron. Clinical data from two phase 1 trials conducted in the US and China has shown that Bofutrelvir is safe and tolerable with a PK profile (without using a booster like ritonavir) supporting further clinical development. It is currently in a pivotal global phase 2/3 clinical trial for hospitalized Covid-19 patients.