Shield Therapeutics Unlocks $7.9m China Milestone as ACCRUFeR® Moves Toward NMPA Filing

Shield Therapeutics (LSE:STX) has revised its licensing agreement with Beijing Aosaikang Pharmaceutical for ACCRUFeR® in China, confirming that its partner now expects to submit a marketing authorisation application to China’s National Medical Products Administration in the first quarter of 2026. The filing will incorporate positive Phase 3 paediatric data, which also supported the recent expansion of the US label to include children aged 10 and above. The regulatory step marks a key advance for ACCRUFeR® in one of the world’s largest pharmaceutical markets.

Under the updated terms, Shield is due to receive a $7.9m development milestone by 31 January 2026, alongside new pricing-related milestones of up to $3m and royalties of up to 10% on future Chinese sales. The company said it plans to use the milestone proceeds to fully repay and terminate its AOP Milestone Monetisation Agreement, doing so at a lower cost than originally expected. This move is intended to simplify Shield’s capital structure and improve its financial flexibility as it continues to build out its commercial strategy in China.

From an investment standpoint, the outlook is supported by strong share price momentum and the positive impact of recent corporate developments, including progress toward regulatory submission in China. These positives are balanced against ongoing financial and valuation challenges, with management acknowledging that financial stability remains a key risk despite the strategic importance of the Chinese market opportunity.

More about Shield Therapeutics

Shield Therapeutics is a commercial-stage specialty pharmaceutical company focused on the treatment of iron deficiency and iron deficiency anaemia through its proprietary oral iron therapy ACCRUFeR®/FeRACCRU® (ferric maltol). The product benefits from patent protection into the mid-2030s and is marketed in the United States through an exclusive collaboration with Viatris, while being licensed to partners across Europe, Canada, China, Japan and other Asia-Pacific territories, addressing a large and growing global market for iron deficiency therapies.