Shield Therapeutics' ACCRUFeR Receives Marketing Approval in South Korea for Iron Deficiency Treatment
Key Insights
The Korean Ministry of Food and Drug Safety (search) has granted regulatory approval for ACCRUFeR (ferric maltol) to treat iron deficiency (search) in adult subjects in South Korea.
The approval follows successful completion of a pharmacokinetic study confirming comparable iron absorption between South Korean patients and populations from key clinical studies.
Shield Therapeutics (search) is eligible to receive payments upon first sale, performance-based sales milestones, and royalties on net sales through its partnership with Korea Pharma (search).
Shield Therapeutics (search) plc announced that the Korean Ministry of Food and Drug Safety (search) (MFDS) has granted regulatory approval for ACCRUFeR (ferric maltol) in South Korea for the treatment of iron deficiency (search) in adult subjects. The approval represents a significant milestone for the commercial-stage pharmaceutical company focused on addressing iron deficiency globally.
Regulatory Pathway and Clinical Evidence
The approval follows the successful completion of a pharmacokinetic study that confirmed the absorption of iron from ACCRUFeR was comparable between patients in South Korea and the patient population enrolled in the key clinical studies supporting ACCRUFeR's effectiveness and safety. Korea Pharma (search) submitted a New Drug Application in 2024 based on these findings.
ACCRUFeR is a novel, stable, non-salt-based oral therapy for adults with iron deficiency (search), with or without anemia. The drug features a novel mechanism of absorption compared to other oral iron therapies and has demonstrated efficacy and tolerability in clinical trials.
Market Opportunity and Commercial Terms
The approval addresses a substantial unmet medical need in South Korea, where 5.2 million people are living with iron deficiency (search), with or without anemia, according to the 'Prevalence and risk factors for iron deficiency anemia (search) in the Korean population: results of the fifth Korea National Health and Nutrition Examination Survey.'
Shield Therapeutics (search) is eligible to receive payments upon the first sale, as well as performance-based sales milestones and royalties on net sales of ACCRUFeR in South Korea through its partnership with Korea Pharma (search).
Global Expansion Strategy
"We are delighted with this approval of ACCRUFeR in South Korea and commend Korea Pharma (search) for their dedication and expertise throughout the regulatory process," said Anders Lundstrom, Chief Executive Officer of Shield Therapeutics (search). "This achievement reinforces our commitment to making ACCRUFeR available to patients globally and highlights the strength of our international partnerships."
The South Korean approval adds to Shield's global commercialization strategy. In the United States, ACCRUFeR is the first and only FDA-approved oral iron to treat iron deficiency (search) with or without anemia, representing what the company describes as a $2.3 billion market opportunity affecting about 20 million people. The drug is now the leading branded prescription oral iron in the US market for iron deficiency.
Partnership Network
Outside the US, Shield has established licensing agreements with specialty pharmaceutical companies across multiple regions. FeRACCRU is commercialized in the UK and European Union by Norgine B.V., which also holds marketing rights in Australia and New Zealand. Additional partnerships include Beijing Aosaikang Pharmaceutical Co., Ltd. (search) for China, Hong Kong, Macau and Taiwan; Kye Pharmaceuticals Inc. for Canada; and VITAL-NET for Japan.
Korea Pharma (search), the South Korean partner, is a prescription pharmaceutical company focusing on central nervous system and gastrointestinal products. The company has experience in specialty pharmaceutical distribution, including an exclusive agreement for PLENVU, a PEG-based bowel preparation drug.
ACCRUFeR/FeRACCRU maintains patent coverage until the mid-2030s, providing extended market exclusivity for the iron deficiency (search) treatment across its approved territories.