SHANGHAI, China, July 04, 2022 - Ping An-Shionogi Co., Ltd. (Head Office: Shanghai, China; Chairman and CEO: Tatsumori Yoshida, hereafter "Ping An-Shionogi") today announced the initiation of submitting the preparation materials for the new drug application of S-217622, an orally administered antiviral drug for COVID-19 to the Center for Drug Evaluation, NMPA (hereafter "CDE").

Prior to the formal submission of the new drug application, Ping An-Shionogi has submitted a communication meeting application to the CDE to facilitate the new drug application process.

S-217622 is an oral antiviral agent administered once daily for 5 days that is capable of suppressing the growth of SARS-CoV-2 by selectively inhibiting the 3CL protease. So far, S-217622 has shown the ability to rapidly reduce viral load. It is expected to contribute to the COVID-19 treatment in China after approval.

Ping An-Shionogi will continue to strive to contribute to society by providing S-217622 to fight against COVID-19.

About S-217622
S-217622, a therapeutic drug for COVID-19, is a 3CL protease inhibitor created through joint research between Hokkaido University (Japan) and Shionogi & Co., Ltd (Osaka, Japan). 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. Currently the Phase 3 part of a Phase 2/3 clinical trial in patients with mild/moderate symptoms and the Phase 2b/3 part in patients with asymptomatic/only mild symptoms are in progress.

Forward-Looking Statements
This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.

For Further Information, Contact:
Ping An-Shionogi Website Inquiry Form :