REG - Shield Therapeutics - Approval for ACCRUFeR in China expected in Q1 2026

Shield TherapeuticsAnnouncement

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RNS Number : 0029R  Shield Therapeutics PLC  30 January 2026

The 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
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Shield Therapeutics plc

("Shield" or the "Company")

 

Filing for marketing authorisation for the approval for ACCRUFeR® in China

expected in Q1 2026 and will include the pediatric data

 

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."

 

For further information please contact:

 

 Shield Therapeutics plc                                                                        www.shieldtherapeutics.com (http://www.shieldtherapeutics.com/)
 Anders Lundstrom, CEO                                                                          +44 (0) 191 511 8500

 Santosh Shanbhag, CFO                                                                          Investorrelations@shieldtx.com

 Stephanie Hicks, Investor Relations

 https://shieldtherapeutics.com/link/y0z57r
 (https://shieldtherapeutics.com/link/y0z57r)

 Nominated Adviser and Joint Broker
 Peel Hunt LLP
 James Steel                                                                                    +44 (0)20 7418 8900
 Joint Broker

 Cavendish Ltd

 Geoff Nash/ Isaac Hooper/Nigel Birks/Harriet
 Ward

                                                                                                +44 (0)20 7220 0500

 

About Iron Deficiency and ACCRUFeR®/FeRACCRU®

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).

 

ACCRUFeR®/FeRACCRU® (ferric maltol) is a novel, stable, non-salt-based oral
therapy for adults with ID/IDA. The drug has a novel mechanism of absorption
compared to other oral iron therapies and has been shown to be an efficacious
and well-tolerated therapy in a range of clinical trials. More information
about ACCRUFeR®/FeRACCRU®, including the product label, can be found at:
www.accrufer.com (http://www.accrufer.com) and www.feraccru.com
(http://www.feraccru.com) .

 

About Shield Therapeutics plc

Shield is a commercial stage specialty pharmaceutical company that delivers
ACCRUFeR®/FeRACCRU® (ferric maltol), an innovative and differentiated
pharmaceutical product, to address a significant unmet need for patients
suffering from iron deficiency, with or without anemia. The Company has
launched ACCRUFeR® in the U.S. with an exclusive, multi-year collaboration
agreement with Viatris. Outside of the U.S., the Company has licensed the
rights to five specialty pharmaceutical companies. FeRACCRU® is
commercialised in the UK and European Union by Norgine B.V., which also has
marketing rights in Australia and New Zealand. FeRACCRU® is also
commercialised in Canada by Kye Pharmaceuticals Inc. Shield also has an
exclusive license agreement with Beijing Aosaikang Pharmaceutical Co., Ltd.,
for the development and commercialisation of ACCRUFeR®/FeRACCRU® in China,
Hong Kong, Macau and Taiwan, with Korea Pharma Co., Ltd. for the Republic of
Korea, and with Medleap Pharma Company Limited, a subsidiary of VITAL-NET Inc.
for Japan.

 

ACCRUFeR®/FeRACCRU® has patent coverage until the mid-2030s.

ACCRUFeR®/FeRACCRU® are registered trademarks of Shield Therapeutics.

 

 

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