New COVID-19 drug developed by Shionogi & Co., Ltd. and Hokkaido University approved in Japan

On Tuesday, November 22, the Ministry of Health, Labour and Welfare (MHLW) of Japan approved Shionogi’s Xocova® Tablets 125 mg (Generic name: ensitrelvir fumaric acid, Code No.: S-217622) for the treatment of COVID-19. This is the first manufacturing and marketing approval under the emergency regulatory approval system and the first domestically produced oral agent against the virus. Xocova suppresses the replication of SARS-CoV-2 by selectively inhibiting the viral 3CL protease, which is essential to viral replication.

The development of Xocova was conducted jointly by Shionogi and the International Institute for Zoonosis Control (IIZC) at Hokkaido University. Professor Hirofumi Sawa (Division of Molecular Pathobiology of IIZC and Hokkaido University, Institute for Vaccine Research and Development: HU-IVReD) commented, “The members of Division of Anti-Virus Drug Research, Shonogi & Co., Ltd have been working very hard to conduct plenty of experiments day and night at our Bio-Safety Level (BSL-3) facilities which led to the discovery of the seed compounds. As a researcher in academia, I am very happy to have experienced the entire process of development of anti-COVID-19 drug with the members of Shionogi & Co., Ltd. I’m extremely pleased that Xocova has been approved as a treatment option for patients.”

The BSL3 facility at the International Institute for Zoonosis Control, Hokkaido University (Photo provided by Michihito Sasaki).

Akihiko Sato, a Visiting Professor from Shionogi who leads the division, said, “First of all, I hope that Xocova will help patients’ quick recovery from COVID-19.” He also mentioned, “Shionogi was able to develop the new drug in a short period of two years by investing vast human resources into the project. Hokkaido University’s research capabilities also played an essential role in the development of this drug.”

By combining AI technology and wet lab experiments, Shionogi first identified multiple compounds that were the drug candidates. Then, Hokkaido University’s IIZC assessed their antiviral activities, using the cellular system and model animals that IIZC developed soon after the onset of the pandemic. Based on the results, Shionogi developed Xocova by fine-tuning the chemical structure of the most promising compound. Akihiko Sato declared, “The development of Xocova wasn’t possible without the collaboration with Hokkaido University. We would like to continue this joint research to develop drugs for other emerging infectious diseases to answer the unmet needs.”

Members of the Division of Molecular Pathology and the Shionogi Division of Anti-Virus Drug Research at the International Institute for Zoonosis Control, Hokkaido University (Photo provided by the Division of Molecular Pathology)

Originally written in Japanese

Rearranged by Naoki Namba

Related articles:

Xocova® (Ensitrelvir Fumaric Acid) Tablets 125mg Approved in Japan for the Treatment of SARS-CoV-2 Infection, under the Emergency Regulatory Approval System

https://www.shionogi.com/global/en/news/2022/11/e20221122.html

International Institute for Zoonosis Control

https://www.czc.hokudai.ac.jp/en/