Ildong Pharmaceutical’s shares plunged to the lower limits on Thursday, as the Japanese regulator delayed giving emergency use approval (EUA) for Xocova, an oral Covid-19 treatment co-developed by Ildong and its Japanese partner, Shionogi Pharmaceutical.

Ildong Pharmaceutical shares plummeted after the Japanese health authorities postponed granting a EUA to Xocova, an oral Covid-19 pill under development by Ildong and Japan’s Shionogi Pharmaceutical.
Ildong Pharmaceutical shares plummeted after the Japanese health authorities postponed granting a EUA to Xocova, an oral Covid-19 pill under development by Ildong and Japan’s Shionogi Pharmaceutical.

As of noon, Ildong’s shares stood at 37,400 won ($28.50), a 29.96 percent drop from the previous trading day.

According to industry insiders, health experts at a Japanese screening committee voted to support a motion that they would watch more data from ongoing clinical trials and resume discussions in November.

The decision dealt a blow to Ildong’s ambitions to market the viral pill in Korea.

Ildong had completed patient administration of Xocova for a domestic phase 3 clinical trial and planned to begin the EUA process in Korea if Shionogi received approval in Japan. The postponement marked the second time the Japanese health officials postponed granting a EUA for Xocova.

In April, the Japanese health ministry panel postponed a ruling on the drug because of uncertainty over its effectiveness and animal studies showing it could pose a risk to pregnancies.

At the time, Shionogi said the treatment’s potential harm in an animal study would not affect the drug approval. However, the stock market reacted negatively to the news, and Ildong’s shares dropped to 27,350 won, the lowest in the previous three months.

Ildong and Shionogi agreed to co-develop the drug in November last year.

The two companies had aimed to obtain emergency use approval for the treatment in Korea in the first half of 2022. Ildong also planned to produce the treatment locally through technology transfer if everything had gone well.

Industry watchers expected that the company would have to wait at least until November when the Japanese health authorities will hold another meeting to grant EUA for Xocova.

Ildong was unavailable immediately for comments on the news.

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