Shield's Accrufer MA application accepted in China

(Sharecast News) - Shield Therapeutics said the Chinese National Medical Products Administration has accepted a marketing authorisation application for Accrufer, or ferric maltol, for the treatment of iron deficiency in adults. The AIM-traded firm said the application was filed by Shield's licensing partner, Beijing Aosaikang Pharmaceutical Co, following completion of a phase three efficacy and safety study in Chinese adults with iron deficiency anaemia and inflammatory bowel disease who are intolerant to oral ferrous products.

It said the study demonstrated clinically and statistically relevant efficacy and good tolerance in the Chinese population.

The submission was supported by the data package previously used to secure US Food and Drug Administration (FDA) approval for Accrufer in adults, supplemented by the new phase three data generated in China.

"We are delighted that our partner ASK has filed the MAA after successfully completing the clinical development in China and generating phase three data in a Chinese population showing comparable levels of efficacy to prior trials with adults from other ethnicities," said chief executive Anders Lundstrom.

"Subsequent approval of the MAA will allow ASK to bring this revolutionary product to patients in China with iron deficiency, further expanding the global patient population who can benefit from a safe and effective oral iron treatment."

Acceptance of the MAA by the NMPA marked the start of the regulatory review process in China, with potential approval enabling commercialisation of Accrufer in one of the world's largest pharmaceutical markets.

At 1620 GMT, shares in Shield Therapeutics were down 5.03% at 9.26p.

Reporting by Josh White for Sharecast.com.