Ildong Pharmaceutical has shifted its strategy toward manufacturing Xocova (ensitrelvir fumaric acid; S-217622 in development name), a Covid-19 treatment it co-developed with Japan’s Shionogi, from importing it.

Ildong said Wednesday that it applied for a manufacturing and sales license for Xocoba to the Ministry of Food and Drug Safety (MFDS). It has been about a year since the company applied for an import license for Xocoba to the MFDS this past January.

Ildong Pharmaceutical, which signed a joint development agreement with Shionogi for Xocova in November 2021, sought emergency use approval (EUA) in Korea after completing phase 2/3 clinical trials in the country. However, the health authorities determined the need for domestic introduction was insignificant.

After failing to receive EUA, Ildong applied for a full product license to the MFDS, but a year passed without approval.

Ildong said it recently revised its strategy to pursue a manufacturing and sales license instead of an import license as the technology transfer and trial production procedures for Xocova were completed. The company has withdrawn its previous application for an import license.

Ildong emphasized that compared to an import license, a manufacturing and sales license ensures a timely and stable supply of therapeutic drugs to patients.

"Considering the current environmental changes and supply stability, we believe it is more advantageous to obtain a manufacturing license," an Ildong Pharmaceutical official said. "Although the severity of the coronavirus has eased somewhat, we will be able to respond more effectively to coronavirus issues that change frequently.”