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Ildong Pharm seeks approval to produce Japan’s Covid-19 drug in S. Korea

Collected: 2023.12.28

Distributed: 2023.12.29

Source: Go Direct

Ildong Pharm’s headquarters [Courtesy of Ildong Pharm]

South Korea’s Ildong Pharmaceutical is pushing for approval from health authorities to manufacture Xocova (ensitrelvir) developed by Japan’s Shionogi as an antiviral medication to treat Covid-19 infections.

Ildong Pharm recently completed a license deal and trial production of the drug and finalized an agreement with Shionogi on the transfer of manufacturing technology. Based on its collected data, Ildong Pharm submitted a drug manufacturing and marketing license application to the Ministry of Food and Drug Safety on Wednesday.

Ildong Pharm had been seeking an import license from the ministry for ensitrelvir, while simultaneously working on the transfer of manufacturing technology from Shionogi. As both the technology transfer and trial production procedures for the drug have been completed, the company has revised its strategy to pursue a manufacturing and marketing license instead of an import license.

Compared to an import license, marketing authorization allows for a more timely and reliable supply of the drug to patients.

“Given the current changes in prevalence and considerations about supply stability, obtaining a manufacturing license is deemed more advantageous. Although the severity of Covid-19 infections has somewhat eased, this approach will enable us to respond to the evolving pandemic landscape more effectively,” said a company official.

By Kim Jee-hee and Minu Kim

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