Shionogi & Co., Ltd. announced that the company has begun consultation with Pharmaceuticals and Medical Devices Agency (PMDA) on how to submit the clinical trial results of S- 217622, an oraly administered antiviral drug for COVID-19, from January, 20, 2022. As expressed in the related notifications, Shionogi has been consulting with PMDA from the early stages of S-217622 development. Shionogi has already been submitting non-clinical and
manufacturing/CMC data, and January, 20, 2022, Shionogi submitted the Phase 1 clinical trials data and initiated to discuss how to submit the Phase 2/3 clinical trial data. In the Phase 2a part of the Phase 2/3 clinical trials, antiviral effects have been confirmed, and Shionogi will continue to submit clinical trial data sequentially, as it is obtained. S-217622, a therapeutic drug for COVID-19, is a 3CL protease inhibitor created through joint research
between Hokkaido University and Shionogi. SARS-CoV-2 has an enzyme called 3CL protease, which is essential for the replication of the virus. S-217622 suppresses the replication of SARS-CoV-2 by selectively inhibiting 3CL protease. Phase 2b/3 Part of a domestic Phase 2/3 clinical trials is currently underway in mild, moderate, or asymptomatic COVID-19 patients in January 2022.