The COVID-19 treatment candidate ‘Zokoba (ingredient name encitrelvir, development name S-217622)’, jointly developed by Japanese pharmaceutical companies Shionogi Pharmaceutical and Ildong Pharmaceutical, was recognized for its effectiveness at an expert meeting and moved one step closer to emergency use approval. .
On the 22nd, Japan’s Ministry of Health, Labor and Welfare held a pharmaceutical and food hygiene review council through a video conference and deliberated on whether to approve the emergency use of Zokoba, a candidate substance for COVID-19 treatment.
The review committee members acknowledged the effectiveness of Zokova for the treatment of Omicron mutant virus and agreed to the emergency use authorization of Zokova according to a majority decision.
Usually, the consent of the expert meeting is considered the final gateway before emergency use approval by the Ministry of Health, Labor and Welfare, the permitting authority.
Zokova is a 3CL-protease inhibitor that inhibits proteolytic enzymes that only exist in SARS-CoV-2, such as Pfizer’s oral corona treatment ‘Paxlobid’.
Previously, Shionogi aimed for emergency use approval through phase 2 results, but suffered a defeat once.
In response, Shionogi Pharmaceutical disclosed some of the results of a global phase 3 clinical trial in September and announced that it had significantly shortened the symptom relief period for five representative symptoms of the Omicron mutation of the coronavirus.
The acquisition of Japanese approval for Zokoba is expected to affect Ildong Pharmaceutical, a co-developer.
Ildong Pharmaceutical signed a joint development agreement with Shionogi in November of last year and conducted Phase 2/3 of Zokova in Korea.
The cooperation between the two companies includes not only domestic commercialization, but also the production of Ildong Pharmaceutical’s finished product of Zocoba.
In addition, Ildong Pharmaceutical is also negotiating with Shionogi regarding the production of the original drug for Zokoba.
Regarding the results of this expert meeting, Ildong Pharmaceutical said, “We plan to continue the preparations and activities necessary for domestic use approval.”
