REG - Shield Therapeutics - Chinese NMPA Accepts MAA Submission for ACCRUFeR®

Shield TherapeuticsAnnouncement

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RNS Number : 0224V  Shield Therapeutics PLC  03 March 2026

  Shield Therapeutics plc

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

 

Chinese NMPA Accepts MAA Submission for ACCRUFeR® (ferric maltol)

 

The MAA is supported by the data Package used to obtain USA FDA approval for
ACCRUFeR® for the treatment of iron deficiency in adults, supplemented by
Phase 3 data confirming the effectiveness of ACCRUFeR® in an adult Chinese
population.

 

London, UK, 03 March 2026: Shield Therapeutics plc (LSE: STX), a commercial
stage pharmaceutical company specialising in iron deficiency, announces the
filing, and acceptance by the Chinese National Medical Products Administration
('NMPA'), of a Marketing Authorisation Application ('MAA') for ACCRUFeR® for
the treatment of adults with Iron Deficiency by its licensing partner, Beijing
Aosaikang Pharmaceutical Co. Ltd ('ASK Pharm').  This follows the successful
completion and outcome of a Phase 3 efficacy and safety clinical study in
Chinese adults with iron deficiency anemia ('IDA') and inflammatory bowel
disease who are intolerant to oral ferrous products. The study demonstrated
clinically and statistically relevant efficacy and good tolerance in Chinese
adults.

 

Anders Lundstrom, CEO, Shield Therapeutics commented: "We are delighted that
our partner ASK has filed the MAA after successfully completing the clinical
development in China and generating Phase 3 data in a Chinese population
showing comparable levels of efficacy to prior trials with adults from other
ethnicities.  Subsequent approval of the MAA will allow ASK to bring this
revolutionary product to patients in China with iron deficiency. further
expanding the global patient population who can benefit from a safe and
effective oral iron treatment."

 

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
 https://shieldtherapeutics.com/link/eNwdNr
 (https://shieldtherapeutics.com/link/eNwdNr)

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

 Joint Broker

 Cavendish Ltd

 Geoff Nash/ Rory Sale/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.

 

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
(http://www.feraccru.com) .

 

China's iron deficiency anemia (IDA) therapy market is growing rapidly,
projected to double from around $280 million in 2022 to over $600 million by
2030. This growth is driven by increased healthcare access, government
initiatives, and rising awareness. High-risk groups include women of
reproductive age, pregnant women, and children-particularly in central-south
and western regions.

 

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 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. FeRACCRU® is also commercialised in Canada by Kye
Pharmaceuticals Inc. 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, and with
Medleap Pharma Company Limited, a subsidiary of VITAL-NET Inc. for Japan.

 

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

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

 

Details of the Chinese Phase 3 study

The double-blind placebo-controlled randomized Phase 3 study included adults
with mild to moderate iron-deficiency anemia (IDA) and Inflammatory Bowel
Disease (IBD) who are intolerant to oral ferrous product, and who also had
serum ferritin levels below 100 μg/L and transferrin saturation below 20%.
Subjects were randomized 1:1 to receive either ferric maltol (N=60) or placebo
(N = 61) bid for 12 weeks.

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