Osaka, Aug. 25 (Jiji Press)–Shionogi & Co. <4507> plans to supply its novel coronavirus drug now under development in enough doses for 10 million people in Japan and abroad, officials said Wednesday.
The company will finish its preparations for the massive supplies by next March, according to the officials.
In Japan, Shionogi will complete its preparations to supply an amount large enough for one million to two million people in Japan by year-end.
The Osaka-based company is considering outsourcing production of the drug to overseas companies for supplies abroad.
The orally taken drug, intended for COVID-19 patients with mild symptoms, curbs an increase in the virus inside the body.
When administered at an early stage of the disease, the drug is expected to help prevent severe symptoms and reduce fever and other symptoms.
In Japan, Shionogi aims to apply for fast-track government approval for the drug by year-end under the country’s conditional early authorization system.
The system gives approval for drugs for which clinical trials are difficult to carry out, on condition that evaluations are made after sales begin.
For the drug, Shionogi hopes to obtain U.S. government approval for emergency use as soon as March next year.
Shionogi started its clinical trial of the drug in Japan in July this year. It plans to complete the second phase covering patients with mild or no symptoms by November.
The company is expected to begin a final-phase trial on a large scale in multiple countries within this year for supplies aboard.