Shield Thera Regulatory News (STX)

  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:

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 and 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 ?g/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.