EC revokes Hansoh's aumolertinib EU authorization over osimertinib data reference
核心洞察
The European Commission revoked the EU marketing authorization for Hansoh Pharmaceutical's aumolertinib (搜索) after finding its 2022 application improperly referenced protected osimertinib clinical data.
Hansoh said the decision is procedural and unrelated to aumolertinib (搜索)'s quality, safety, efficacy or clinical value, and plans to resubmit to the EMA.
The revocation followed AstraZeneca's General Court challenge to the original authorization, and the EC acted without waiting for that litigation to conclude.
The European Commission has revoked the EU marketing authorization for aumolertinib (搜索) (Aumseqa (搜索)), the third-generation EGFR (搜索) tyrosine kinase inhibitor developed by China-based Hansoh Pharmaceutical Group (搜索), after concluding that the company's 2022 application improperly referenced clinical data belonging to AstraZeneca's osimertinib (Tagrisso) while those data remained under EU regulatory data protection.
The EC's Directorate-General for Health and Food Safety issued the implementing decision on September 25, 2026, revoking the authorization that had been granted on February 12, 2026, for monotherapy treatment of specific types of non-small cell lung cancer (搜索). That approval followed a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (搜索).
The procedural defect
According to Hansoh's disclosure, the 2022 marketing application contained complete, independently generated Phase III clinical data and European pharmacokinetic bridging data. The EC determined, however, that certain clinical results from Tagrisso cited as background reference in the data package were still within their data protection period at the time of submission and during the regulatory assessment, constituting a procedural defect.
That 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 breach the regulatory data exclusivity framework EU law affords to originator products, regardless of whether the protection has since lapsed.
Aumolertinib (搜索) and osimertinib are both third-generation EGFR (搜索) 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, which explains why Tagrisso data appeared in Hansoh's application.
AstraZeneca litigation and the regulator's timing
The trigger for the revocation was AstraZeneca's lawsuit against the aumolertinib (搜索) marketing authorization, filed with the General Court of the European Union under Case No. T-289/26. The European Commission initiated the revocation procedure without waiting for the outcome of that litigation.
Hansoh stated that the decision relates solely to a procedural defect under the EU regulatory framework and bears no connection to the product's quality, safety, efficacy or clinical value. The company has reserved all rights to challenge the decision, including through EU court proceedings if necessary.
Resubmission plans
Hansoh intends to resubmit the marketing application to the EMA based on the original data package as soon as possible. The EMA has indicated its willingness to shorten the assessment timeline relative to the standard 210-day procedure, according to the company. The board said it is cautiously optimistic that a new marketing authorization can be obtained within a reasonably short timeframe, depending on the regulatory assessment process.
The company also said it will continue to progress additional applications for aumolertinib (搜索) that are under review or in preparation with regulatory authorities in other jurisdictions.
Commercial and regulatory footprint
Aumolertinib (搜索) is approved in the UK, where the Medicines and Healthcare products Regulatory Agency granted authorization in June 2025 for first-line EGFR (搜索)-mutated and T790M-positive advanced NSCLC, the drug's first approval outside China. That UK authorization remains valid and is unaffected by the EU decision.
The molecule has achieved commercial sales in the Chinese market. As of the announcement date, Hansoh has not generated any sales revenue from aumolertinib (搜索) outside China, and the company said the decision is not expected to affect any sales of the product in China. The board believes the decision and the resubmission process will not have any material adverse impact on the group's current financial position or business operations.