The European Commission has revoked the EU marketing authorization for China-based Hansoh Pharmaceutical Group Company Limited’s (HKEX: 3692) aumolertinib (Aumseqa) after concluding that its 2022 application improperly referenced clinical data for AstraZeneca’s osimertinib (Tagrisso) while those data remained under EU regulatory data protection. Hansoh said the decision was procedural and unrelated to aumolertinib’s quality, safety, efficacy, or clinical value, and plans to resubmit the application to the European Medicines Agency (EMA).
The European Commission's (EC) Directorate-General for Health and Food Safety published an implementing decision on September 25, 2026, revoking the authorization that was granted by the EC on February 12, 2026.
The revocation rests on a procedural defect in Hansoh's 2022 marketing application: the data package contextually referenced clinical results from AstraZeneca's osimertinib (Tagrisso), which were within their EU regulatory data protection period at the time of submission and during the regulatory assessment. That data protection period expired in 2024, but the EC concluded the procedural irregularity was sufficient to ground revocation. The underlying concern is that referencing protected data can constitute a breach of the regulatory data exclusivity framework that EU law affords to originator products, regardless of whether the protection has since lapsed. The EC did not await the outcome of annulment proceedings brought by AstraZeneca against the EC to challenge the original grant of the authorization.
Aumolertinib and AstraZeneca’s osimertinib (Tagrisso) are both third-generation EGFR tyrosine kinase inhibitors developed for EGFR-mutated NSCLC, including tumors with the T790M resistance mutation. Because osimertinib was already an established treatment in these settings, its clinical results formed part of the therapeutic context against which aumolertinib’s efficacy and safety were assessed, explaining why Tagrisso data were referenced in Hansoh’s application.