31 October 2022

Shield announces regulatory pathway and timelines for Accrufer® approval in the Republic of Korea

Shield Therapeutics plc (LSE: STX), announces that the Korean Food and Drug Administration has agreed that a single pharmacokinetic (PK) study is the only additional study requirement to support a New Drug Application (NDA) submission for Accrufer®.

The study is expected to be initiated in Q4 2022 and will be conducted by the Company’s partner, Korea Pharma Co. Ltd (Korea Pharma), who have development and commercialisation rights for Accrufer® in the Republic of Korea. Korea Pharma expects regulatory approval allowing the commercial launch of Accrufer® in the Republic of Korea in late 2023.

Greg Madison, CEO of Shield Therapeutics, stated: “We are delighted that the pathway to regulatory approval for commercialisation of Accrufer® in Korea has been established, and that our partner, Korea Pharma, is now ready to commence the study required to support the NDA submission. There are an estimated 5.2 million people in the Republic of Korea with iron deficiency and iron deficiency anemia, in need of novel treatment options. We look forward to supporting our partner as they continue on the pathway to potentially make Accrufer® available to patients.”

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