**Summary**
Shield Therapeutics PLC announced that its partner in China, Beijing Aosaikang Pharmaceutical Co. Ltd (ASK), expects to file for marketing authorization of ACCRUFeR® in China with the China National Medical Products Administration (NMPA) in Q1 2026. The submission will include positive pediatric data from a Phase 3 trial, which supported the drugs expanded indication in the U.S. for children aged 10 and older with iron deficiency (ID).
Key updates to the China License Agreement include
1. A $7.9 million development milestone payment from ASK to Shield by January 31, 2026.
2. Replacement of a previous $11.4 million milestone with a new structure, including up to $3 million tied to ACCRUFeR®s final price in China and revised royalties of up to 10% based on annual net sales.
Shield will use the $7.9 million payment to settle and terminate its AOP Milestone Monetisation Agreement, significantly reducing financial obligations and simplifying its capital structure. This move strengthens Shield’s financial position as it advances its commercial strategy.
ACCRUFeR®, a novel oral iron therapy for ID/IDA, is already approved in the U.S. and other regions, addressing a significant unmet medical need. The China submission marks a critical step in expanding its global reach.