Hansoh Pharmaceutical (HKG:3692) said it will challenge the European Commission's decision to revoke the marketing authorization for Aumolertinib, marketed as Aumseqa outside China, in the European Union, according to a Sunday Hong Kong bourse filing.
The decision relates to a procedural issue involving clinical results for AstraZeneca's Tagrisso that were referenced in its 2022 marketing application.
The relevant data protection period expired in 2024, Hansoh said.
Hansoh said the decision does not relate to the product's quality, safety, efficacy or clinical value.
The company plans to challenge the decision if necessary and resubmit its marketing application to the European Medicines Agency based on the original data package.
