EU Revokes Marketing Authorization for Hansoh Pharma's Aumseqa
核心洞察
The European Commission revoked the EU marketing authorization for Hansoh Pharma's aumolertinib (搜索) mesylate tablets, marketed overseas as Aumseqa (搜索), on September 25, 2026.
Hansoh said the revocation stems from a procedural defect in the regulatory assessment and is unrelated to the drug's quality, safety or efficacy.
The trigger was AstraZeneca's General Court lawsuit over the authorization, and Hansoh plans to resubmit its application to the EMA as soon as possible.
Hansoh Pharma announced on September 27 that the European Commission has revoked the EU marketing authorization for its lung cancer drug aumolertinib (搜索) mesylate tablets, marketed overseas as Aumseqa (搜索). The Directorate-General for Health and Food Safety issued the implementing decision on September 25, 2026. The product had received European Commission approval on February 12, 2026, for monotherapy treatment of specific types of non-small cell lung cancer (搜索), following a positive opinion from the EMA's Committee for Medicinal Products for Human Use.
The revocation was triggered by AstraZeneca's lawsuit against the aumolertinib (搜索) marketing authorization filed with the General Court of the European Union (Case No. T-289/26), and the European Commission initiated the revocation procedure without waiting for the litigation outcome. Hansoh said its 2022 application included complete, independently generated Phase III clinical data and European pharmacokinetic bridging data, but the Commission determined that certain clinical results from Tagrisso, cited as background reference in the data package, were still within their data protection period at the time, which it treated as a procedural defect. Tagrisso is another AstraZeneca lung cancer targeted therapy whose data protection period expired in 2024.
Hansoh stated 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, and intends to resubmit its marketing application to the EMA based on the original data package. The EMA has indicated willingness to shorten the standard assessment timeline. Hansoh has generated no sales revenue from aumolertinib (搜索) outside China, expects no effect on Chinese sales, and said the UK marketing authorization obtained in 2025 remains valid. Aumolertinib is a third-generation EGFR (搜索)-TKI developed by Hansoh for EGFR mutation-positive non-small cell lung cancer (搜索).
Source: BigGo Finance