Approval for ACCRUFeR in China expected in Q1 2026

Terms of the China License Agreement with ASK updated to include a $7.9M

development milestone to Shield by 31 January 2026

Shield to use the ASK development milestone payment to settle all payments and

terminate the AOP Milestone Monetisation Agreement

London, 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.

ASK 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.

In 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®. The updated milestones replace the $11.4M milestone which was conditional upon receipt of a subsequently expected marketing approval in China.

The Company will use the $7.9M development milestone payment from ASK to settle all its obligations under the terms of the AOP Milestone Monetisation Agreement. The final payment amount to AOP will fully discharge the Company's financial obligations to AOP under that agreement. This payment is significantly below the amount which would have been due to AOP if the full $11.4M marketing approval milestone payment had been received by Shield from ASK.

Santosh Shanbhag, CFO at Shield, commented: "We are pleased to see the continued progress of our partner ASK towards the planned submission for marketing authorisation of ACCRUFeR® in China in the first quarter of 2026. We believe that the inclusion of the recently approved US pediatric Phase 3 data strengthens the overall submission package and supports the long‑term value of ACCRUFeR® in this important market. In parallel, the amended terms of the agreement with ASK allows Shield to use the development milestone payment from ASK to fully cover the final payment due to AOP and terminate the AOP Milestone Monetisation Agreement earlier and at lower cost than previously planned. This further simplifies our capital structure and places Shield in a stronger financial position as we continue to execute our commercial strategy."

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 and is America's #1 branded prescription oral iron for ID/IDA (data source - IQVIA Xponent PlanTrak).