Ildong mulls seeking COVID-19 pill approval from Korea first

Ildong Pharmaceutical Co., a South Korean drugmaker, considers seeking approval for a COVID-19 anti-viral pill from the country as Japan postponed granting an emergency use authorization for the oral treatment jointly developed with Shionogi & Co.

A panel of Japan’s health ministry on Wednesday delayed making a decision on Xocova in a meeting to discuss an emergency use approval based on data from the phase 2 clinical trials submitted in February. That jeopardized Ildong’s initial plan to win approval from South Korea after Japan allows Shionogi to sell the pill.

“After the Japanese government postponed an emergency use authorization for Xocova, we are considering a few alternatives,” said Ildong President Choi Sungku on Thursday in Seoul. “It is one of them to seek approval in South Korea ahead of Japan.”

“We must have an effective treatment to curb COVID-19 without social distancing measures,” Choi emphasized, given the resurgence in the infection cases of the pandemic in South Korea.

The pill is expected to be available in Japan in November at the earliest as the panel delayed the decision. That prompted expectations that its launch in South Korea will be also postponed, knocking down Ildong’s share price on Thursday. Ildong’s stocks nosedived by the daily trading limit of 30% to 37,400 won on the day, far underperforming a 0.93% gain in the wider Kospi.

SHIONOGI IN TALKS WITH CHINESE AUTHORITIES

Ildong plans to discuss with Shionogi if it breaches a contract to get approval from South Korea first.

“Once Shionogi is OK, we will ask authorities here such as the Korea Disease Control and Prevention Agency to review if the existing data is enough for a use approval in Korea,” Choi said.

Ping An-Shionogi Co., a joint venture between China’s top insurer Ping An and the Japanese pharmaceutical company, has already been in talks with the Chinese authorities for Xocova’s approval since July 4.

If Ildong and Shionogi conclude that they need authorization from Japan first in the discussion, the South Korean company is poised to prepare data for approval as soon as possible. The drugmakers are currently conducting phase 3 clinical trials in South Korea, Japan and Vietnam with a schedule to conclude the patient tracking at the end of this month.

It usually takes about three months to prepare the final data to be submitted to authorities for approval, but Ildong aims to complete the data by end-August.

Write to Ji-Hyun Lee at bluesky@hankyung.com
Jongwoo Cheon edited this article.