• Jiji


Shionogi & Co. said Wednesday that it has delayed applying for Japanese government approval for what would be the first domestically produced drug against COVID-19.

The delay was due to the lack of enough participants for a clinical trial of the oral drug currently being developed by the Japanese pharmaceutical firm, as new COVID-19 cases were declining in Japan.

Starting the final phase of the drug trial last September, covering patients isolated at designated lodging facilities in Japan, Shionogi had hoped to file the application by the end of 2021.

The company now plans to also test the drug overseas, including in South Korea, aiming to file for the drug approval as soon as possible.

It is also looking at an option to use intermediate data for applying with the health ministry to manufacture and sell the drug, even before the clinical trial is finished.

The Shionogi drug is designed for COVID-19 patients with light or no symptoms and to curb the proliferation of the coronavirus in their bodies. By taking one dose per day for five days, patients are expected to avoid developing severe symptoms.

Shionogi has confirmed that the drug is also effective against the omicron variant of the virus.

The company has already started manufacturing the drug at a factory in Japan. It plans to produce the drug for 1 million people by the end of March.

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