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Approval for ACCRUFeR in China expected in Q1 2026
Shield Therapeutics plc announced that its partner in China, ASK, expects to file for marketing authorisation for ACCRUFeR® in Q1 2026, including pediatric data. The China License Agreement has been updated to include a $7.9 million development milestone payment to Shield by January 31, 2026, which Shield will use to settle and terminate its AOP Milestone Monetisation Agreement. Revised terms also include up to $3 million in milestones linked to final pricing and up to 10% royalties on net sales, replacing a previous $11.4 million milestone. Disclaimer*
About this update from Shield Therapeutics Plc
[{"type":"text","content":"\n\nThe information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulation (EU) No. 596/2014 (as it forms part of domestic law in the United Kingdom by virtue of the European Union (Withdrawal) Act 2018). Upon the publication of this announcement via the Regulatory Information Service, this inside information is now considered to be in the public domain.\n \nShield Therapeutics plc\n(\"Shield\" or the \"Company\")\n \nFiling for marketing authorisation for the approval for ACCRUFeR® in China\nexpected in Q1 2026 and will include the pediatric data\n \nTerms of the China License Agreement with ASK updated to include a $7.9M\ndevelopment milestone to Shield by 31 January 2026\n \nShield to use the ASK development milestone payment to settle all payments and\nterminate the AOP Milestone Monetisation Agreement\n \n \nLondon, UK, January 30, 2026: Shield Therapeutics plc (LSE: STX), a commercial-stage pharmaceutical company specialising in iron deficiency announces that its partner in China, Beijing Aosaikang Pharmaceutical Co. Ltd (\"ASK\"), expects to submit the file for marketing authorisation to the China National Medical Products Administration (\"NMPA\") for the approval for ACCRUFeR® in China in Q1 2026. The Company and ASK have agreed to update various terms of the China License Agreement including a development milestone of $7.9M to Shield by 31 January 2026. Shield will use the ASK development milestone to settle its obligations under the AOP Milestone Monetisation Agreement and terminate the agreement.\n \nASK plans to include the positive data from Shield's Phase 3 pediatric clinical trial (FORTIS/ST10-01-305) that was used to receive US FDA approval to extend the indication for ACCRUFeR® in the US to include children 10 years and older with iron deficiency (ID) in its NMPA filing for Marketing Authorisation for ACCRUFeR® in China. The NMPA filing is anticipated in Q1 2026.\n \nIn addition to ASK agreeing to pay Shield a development milestone of $7.9M, the Company and ASK have agreed to update various terms of the China License Agreement including a milestone of up to $3M linked to the final price for ACCRUFeR® in China, and revised royalties of up to 10% based on annual net sales of ACCRUFeR®...