The European Commission has revoked the European Union marketing authorization for Hansoh Pharmaceutical’s Aumseqa, an aumolertinib-based lung cancer treatment, following a legal challenge from AstraZeneca over the use of protected clinical data in the drug’s regulatory application.
The decision removes Aumseqa’s EU authorization several months after the European Commission approved the drug in February 2026. Hansoh has said it plans to resubmit the application once the relevant data-protection period has expired.
Summary
- The European Commission revoked Aumseqa’s EU marketing authorization on Sept. 25, 2026.
- AstraZeneca challenged the authorization over the use of clinical data associated with Tagrisso.
- EMA had previously issued a positive opinion on Hansoh’s application.
- The dispute concerns regulatory data protection rather than the medicine’s quality, safety or efficacy.
- Hansoh said the relevant Tagrisso data-protection period expired in 2024.
- The company plans to submit a new EU application.
Aumseqa’s EU Approval Has Been Withdrawn
Aumseqa, known as aumolertinib outside China, was approved by the European Commission in February for use as a monotherapy in certain patients with EGFR-mutated non-small cell lung cancer (NSCLC).
Hansoh described the treatment as its first original third-generation EGFR tyrosine kinase inhibitor to receive EU approval. The authorization covered adults with advanced NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as well as patients with advanced EGFR T790M mutation-positive disease.
The authorization followed a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use.
That approval has now been revoked following a regulatory dispute initiated after AstraZeneca challenged the authorization.
AstraZeneca Raised Concerns About Tagrisso Data
AstraZeneca’s challenge centered on data protection associated with Tagrisso, its EGFR-targeting cancer medicine containing osimertinib.
According to the European Commission’s decision described by Fierce Pharma, Hansoh’s partner SFL Pharma submitted its application in 2022 and referenced AstraZeneca’s clinical data for Tagrisso. The European Commission determined that certain Tagrisso clinical results remained within their data-protection period when the application was submitted.
Hansoh has disputed the characterization of its application, saying its dossier contained independently generated Phase 3 clinical data along with European pharmacokinetic bridging data.
The company said the regulatory issue related to its reference to certain Tagrisso results rather than the underlying safety or effectiveness of Aumseqa.
Revocation Does Not Address Aumseqa’s Safety
The European Commission’s action concerns the regulatory basis for the marketing authorization rather than a finding that Aumseqa is unsafe or ineffective.
Hansoh has said the product’s EU authorization was revoked because of the data-protection issue. The company maintains that the relevant protection period for the referenced Tagrisso data expired in 2024.
That distinction is important because the European Medicines Agency had previously concluded that Aumseqa could be authorized after reviewing the application and issuing a positive opinion.
Tagrisso itself remains authorized across the EU. The EMA lists osimertinib as an approved treatment for several forms of EGFR-mutated NSCLC.
AstraZeneca and Hansoh Are Also Involved in UK Patent Litigation
The EU regulatory dispute is separate from ongoing patent litigation involving the two companies.
AstraZeneca initiated a patent infringement action in the UK High Court in March 2026 against Hansoh Pharmaceutical Group, Jiangsu Hansoh Pharmaceutical and other parties concerning the prospective commercialization of aumolertinib.
According to AstraZeneca’s latest disclosures, no trial date has been set in that case.
The UK case focuses on intellectual property rights, while the EU proceedings concern the regulatory use of protected clinical data.
Tagrisso Is a Major EGFR-Targeted Cancer Drug
Tagrisso is an established treatment for EGFR-mutated NSCLC and has been authorized in Europe since 2016.
The medicine works by blocking EGFR, a protein involved in cancer-cell growth and division. The EMA says clinical studies have demonstrated its ability to shrink tumors and delay disease progression in patients with relevant EGFR mutations.
AstraZeneca has continued to expand Tagrisso’s use across different stages of EGFR-mutated lung cancer. In December 2024, the European Commission approved Tagrisso for patients with unresectable, locally advanced EGFR-mutated NSCLC following platinum-based chemoradiation, based on results from the Phase 3 LAURA trial.
Hansoh Plans to Resubmit Aumseqa
Hansoh has indicated that it intends to seek EU authorization again.
The company said the revocation was procedural and linked to the data-protection status of information referenced in its original application. Because the relevant protection period has since expired, Hansoh plans to resubmit its application under the applicable regulatory framework.
The timing and outcome of any new application will depend on the European regulatory review process.
Decision Highlights Regulatory Risks for Oncology Entrants
The dispute illustrates how regulatory data-protection rules can affect the timing of competing oncology medicines even when a product has received a positive scientific assessment.
For companies developing medicines that rely partly on existing clinical information, determining when protected reference data can legally be used can be an important part of the European approval process.
For Hansoh, the immediate consequence is the loss of Aumseqa’s EU marketing authorization and the need to pursue a new regulatory pathway.
For AstraZeneca, the decision removes Aumseqa’s current EU authorization while separate patent proceedings over the prospective commercialization of the medicine continue in the UK.
What Happens Next
Hansoh is expected to work toward a new EU application for Aumseqa now that the relevant Tagrisso data-protection period has expired.
Meanwhile, AstraZeneca’s UK patent case remains ongoing. The outcome of that litigation and any future EU regulatory submission will determine the company’s next steps toward commercialization of aumolertinib in Europe.
Hansoh has faced a regulatory setback in Europe after the European Commission withdrew the marketing authorization for Aumseqa (aumolertinib), a targeted treatment for patients with EGFR-mutated non-small cell lung cancer. The authorization had been granted in February 2026, making the subsequent withdrawal particularly notable.
The decision followed a legal challenge from AstraZeneca concerning the European authorization. According to reports, the European Commission initiated revocation proceedings while AstraZeneca’s challenge was still before the EU General Court.
Hansoh and the Data Protection Dispute
Hansoh’s application involved its own clinical data along with other supporting information. The dispute centered on the use of clinical information associated with AstraZeneca’s Tagrisso (osimertinib) and the applicable period of data protection.
