EUA for Zochova was not requested

Future development plans?

It is expected to bypass the domestic introduction strategy with 'conditional approval' instead of emergency approval

The government also keeps the door open to "monitoring overseas situations"...U.S.

 

and Europe are under review.

 

Ildong Pharmaceutical is expected to shift its strategy of introducing oral COVID-19 treatment Zochova (s-217622) in Korea from the EUA to conditional permission.

 

On the 28th, the Central Disease Control Headquarters announced that it would not request Zochova's EUA from the Ministry of Food and Drug Safety.

 

The Central Disease Control Headquarters explained that the decision was made after discussing the safety of Zochova and the necessity of emergency introduction in Korea three times with related ministries and infectious disease management committees.

 

The pharmaceutical industry predicts that although the EUA has failed, Ildong Pharmaceutical will continue to push for the introduction of Zochova in Korea due to conditional approval.

 

The EUA is not applied by a developer, but if the Korea Centers for Disease Control and Prevention deems it necessary, it asks the Ministry of Food and Drug Safety to approve it, and the Ministry of Food and Drug Safety quickly reviews and approves it.

 

Conditional approval is applied by a developer and judged by the Ministry of Food and Drug Safety.

 

It is expected that there will be an application for conditional approval from Ildong Pharmaceutical in the near future.

 

A pharmaceutical industry official familiar with the company's internal situation said, "It means that there is no urgent need to introduce the drug in Korea, not the drug itself," adding, "It is expected to turn its domestic introduction strategy with conditional permission instead of EUA." "It has become a EUA in Japan and has begun reviewing emergency use approval in the U.S.

 

and Europe," he said.

 

"If the U.S.

 

and Europe decide to introduce drugs, it will also help with domestic conditional approval." The government, too, has not completely blocked the possibility of introducing Zochova in the country.

 

An official from the Korea Centers for Disease Control and Prevention said, "We will continue to monitor whether Zochova is approved for overseas emergency use, follow-up clinical results, and purchase and utilization situations." Zochova is an oral antiviral drug containing Ensitrelvir.

 

It is a mechanism to selectively suppress 3CL-protease to prevent the proliferation of the SARS-CoV-2 virus that causes COVID-19.

 

As a result of phase 2 and 3 clinical trials conducted in Japan and Korea, it took about 167.9 hours based on the median value to improve the symptoms of COVID-19 when Zochova was administered, which was significantly reduced compared to 192.2 hours in the placebo group, proving its effectiveness.

 

The reduction of viral RNA in the body, a secondary evaluation variable, also met the criteria for validation.

 

On the 4th day of the clinical trial after 3 doses of Zochova, viral RNA was found to have decreased in the Ensitrelvir administration group by 1.4 log10 copies/ml compared to the placebo group.

 

Regarding the safety of the drug, no serious side effects or deaths occurred, and the drug resistance was also excellent.

 

Unlike conventional treatments that require two or three tablets a day for five days, Zochova can be administered one tablet a day for five days.