Chinese NMPA Accepts MAA Submission for ACCRUFeR®

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."

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.

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.

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.