ACCRUFeR receives Authorisation by Korean Ministry

London, UK, 07 November 2025: Shield Therapeutics plc (LSE: STX), a commercial-stage pharmaceutical company focused on addressing iron deficiency, is pleased to announce that the Korean Ministry of Food and Drug Safety (MFDS) has granted regulatory approval for ACCRUFeR® (Ferric Maltol) in the Republic of Korea (South Korea) for the treatment of iron deficiency in adult subjects.

This approval is an important milestone and follows the successful completion of a pharmacokinetic (PK) study which confirmed that 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® effectiveness and safety and the subsequent submission of a New Drug Application (NDA) by Korea Pharma ("KP") in 2024. This approval marks a significant step forward in expanding access to ACCRUFeR® for patients in South Korea suffering from iron deficiency.

Shield 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.

Anders Lundstrom, Chief Executive Officer, commented: We are delighted with this approval of ACCRUFeR® in South Korea and commend Korea Pharma for their dedication and expertise throughout the regulatory process. This achievement reinforces our commitment to making ACCRUFeR® available to patients globally and highlights the strength of our international partnerships. Shield looks forward to supporting Korea Pharma in the commercial launch of ACCRUFeR® in South Korea and continuing its mission to improve the lives of patients with iron deficiency worldwide."

Clinically low iron levels (aka iron deficiency, ID) can cause serious health problems for adults of all ages, across multiple therapeutic areas. Together, ID and ID with anemia (IDA) affect about 20 million people in the US and represent a $2.3B market opportunity. As the first and only FDA approved oral iron to treat ID/IDA, ACCRUFeR® has the potential to meet an important unmet medical need for both physicians and patients and is now the leading #1 branded prescription oral iron the market today for ID/IDA (data source - IQVIA Xponent PlanTrak).

Korea ID/IDA Market

There are currently 5.2M people in Korea living with ID/IDA as stated in the 'Prevalence and risk factors for iron deficiency anemia in the Korean population: results of the fifth Korea National Health and Nutrition Examination Survey'.

About Korea Pharma Co.,Ltd

Korea Pharma is a prescription pharmaceutical company focusing on CNS (central nervous system) and GI (gastro-intestinal) products. Korea Pharma has previously signed an exclusive distribution agreement With Norgine BV, a global PEG-based bowel cleansing agent development company, for distribution of PLENVU®, the world's first one-litre PEG (polyethylene glycol) bowel preparation drug, and is developing a liquid type PEG laxative.