REG - Shield Therapeutics - ACCRUFeR receives Authorisation by Korean Ministry

Shield TherapeuticsAnnouncement

07/11/2025 07:05

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RNS Number : 6560G  Shield Therapeutics PLC  07 November 2025

 

Shield Therapeutics plc

("Shield" or the "Company" or the "Group")

 

ACCRUFeR® receives Marketing Authorisation by Korean Ministry of Food and
Drug Safety (MFDS)

 

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."

 

For further information please contact:

 Shield Therapeutics plc                                                                        www.shieldtherapeutics.com (http://www.shieldtherapeutics.com/)
 Anders Lundstrom, CEO                                                                          +44 (0) 191 511 8500

 Santosh Shanbhag, CFO                                                                          Investorrelations@shieldtx.com

 Stephanie Hicks, Investor Relations

 Nominated Adviser and Joint Broker

 Peel Hunt LLP
 James Steel                                                                                    +44 (0)20 7418 8900
 Joint Broker

 Cavendish Ltd

 Geoff Nash/ Isaac Hooper/Nigel Birks/Harriet
 Ward

                                                                                                +44 (0)20 7220 0500

 

 

About Iron Deficiency and ACCRUFeR®/FeRACCRU®

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).

ACCRUFeR®/FeRACCRU® (ferric maltol) is a novel, stable, non-salt-based oral
therapy for adults with ID/IDA. The drug has a novel mechanism of absorption
compared to other oral iron therapies and has been shown to be an efficacious
and well-tolerated therapy in a range of clinical trials. More information
about ACCRUFeR®/FeRACCRU®, including the product label, can be found at:
www.accrufer.com (http://www.accrufer.com) and www.feraccru.com
(https://www.feraccru.com) .

 

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.

 

About Shield Therapeutics plc

Shield is a commercial stage specialty pharmaceutical company that delivers
ACCRUFeR®/FeRACCRU® (ferric maltol), an innovative and differentiated
pharmaceutical product, to address a significant unmet need for patients
suffering from iron deficiency, with or without anemia. The Company has
launched ACCRUFeR® in the U.S. with an exclusive, multi-year collaboration
agreement with Viatris. Outside of the U.S., the Company has licensed the
rights to five specialty pharmaceutical companies. FeRACCRU® is
commercialised in the UK and European Union by Norgine B.V., which also has
marketing rights in Australia and New Zealand. Shield also has an exclusive
license agreement with Beijing Aosaikang Pharmaceutical Co., Ltd., for the
development and commercialisation of ACCRUFeR®/FeRACCRU® in China, Hong
Kong, Macau and Taiwan, with Korea Pharma Co., Ltd. for the Republic of Korea,
with Kye Pharmaceuticals Inc. for Canada, and with VITAL-NET for Japan.

 

ACCRUFeR®/FeRACCRU® has patent coverage until the mid-2030s.

ACCRUFeR®/FeRACCRU® are registered trademarks of Shield Therapeutics.

 

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