EU revokes Hansoh Pharma's lung cancer drug approval on procedural grounds after AstraZeneca challenge
On September 27, 2026, Hansoh Pharma announced the European Commission revoked the EU marketing authorization for its lung cancer drug almonertinib (Ameile/Aumseqa), initially approved in February 2026. The revocation, triggered by AstraZeneca's lawsuit (Case T-289/26), was based on a procedural issue: Hansoh had cited AstraZeneca's Tagrisso clinical data as background reference while it was still under data protection (expired in 2024). Hansoh stated the decision does not reflect on the drug's quality, safety, or efficacy, and plans to reapply.
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Hansoh Pharma Responds to EU Revocation of Aumseqa Approval, Plans to Reapply
Hansoh Pharma announced on September 27 that the European Commission (EC) has revoked the marketing authorization for its drug Aumseqa® (almonertinib mesylate) in the EU, which was originally approved on February 12, 2026. The company stated that the revocation resulted from a lawsuit filed by AstraZeneca against the EC, and the reason was a procedural issue in the regulatory assessment process, not related to the drug's quality, safety, or efficacy. Hansoh Pharma emphasized that it will quickly reapply for EU marketing authorization and remains committed to its innovation and internationalization strategy. The drug has not yet generated actual sales overseas, and its UK approval from 2025 remains valid. Market expectations indicate no impact on Hansoh Pharma's financial performance.
Read sourceHansoh Pharma Says EU Revoked Aumolertinib Approval on Procedural Grounds, Not Quality Issues
On September 27, Hansoh Pharma announced that the European Commission (EC) revoked the marketing authorization for its drug aumolertinib mesylate (brand name: Ameile) in the EU. The authorization had been granted on February 12, 2026. The revocation was triggered by a lawsuit (T-289/26) filed by AstraZeneca at the European General Court. Hansoh's application included its own Phase III clinical data and European pharmacokinetic bridging data, but the decision was based on a procedural issue: Hansoh had referenced certain clinical results from AstraZeneca's Tagrisso® as background, which were still under data protection at the time (the protection expired in 2024). Hansoh emphasized that the decision relates solely to a regulatory procedural flaw and not to the product's quality, safety, efficacy, or clinical value. The company reserved the right to challenge the decision, including through EU court proceedings, and stated it will quickly reapply for EU marketing authorization while remaining committed to its innovation and internationalization strategy.
Read sourceEU Revokes Aumseqa Marketing Authorization on Procedural Grounds; Hansoh Pharma Says No Impact
On September 27, Hansoh Pharma announced that the European Commission (EC) has revoked the marketing authorization for its drug Aumseqa® (almonertinib) in the EU. The drug was initially approved in the EU in February 2026. Hansoh stated the decision is based solely on procedural issues within the EU regulatory framework and is unrelated to the drug's quality, safety, efficacy, or clinical value. Almonertinib is China's first original third-generation EGFR-TKI, approved for five indications in China covering the full course of EGFR-mutated non-small cell lung cancer. It was approved in the UK in 2025, becoming the first domestic EGFR-TKI to achieve overseas marketing, and that UK approval remains valid. The article notes that almonertinib has not yet generated actual sales overseas, and the market expects this event to have no impact on Hansoh Pharma's current operating performance. Hansoh said it will restart the EU marketing application as soon as possible using original data. The report frames the legal dispute as having a background of market competition, as the drug's entry into Europe could challenge existing market structures and pricing.
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EU Revokes Marketing Authorization for Hansoh Pharma's Almonertinib on Procedural Grounds
On September 27, 2026, Hansoh Pharma announced that the European Commission has revoked the marketing authorization for its drug almonertinib (Ameile) in the European Union. The decision, triggered by AstraZeneca, is attributed solely to procedural flaws in the EU regulatory framework and is not related to the drug's quality, safety, efficacy, or clinical value. Almonertinib is China's first original third-generation EGFR-TKI, approved for five indications covering the full course of EGFR-mutated non-small cell lung cancer in China, and received UK approval in 2025, becoming the first domestic EGFR-TKI to be marketed overseas. The UK authorization remains valid. Hansoh Pharma stated it reserves the right to challenge the decision, including through EU court proceedings, and will promptly resubmit a marketing application to the European Medicines Agency (EMA) using original data. The drug has not yet generated overseas sales, so the event is not expected to impact Hansoh Pharma's financial performance.
Read sourceHansoh Pharma's Aumseqa Marketing Authorization Revoked by EU Over Data Protection Issue
On September 27, Hansoh Pharma (stock code 03692) announced that the European Commission issued an implementing decision on September 25, 2026, revoking the marketing authorization for its drug Aumseqa (almonertinib) in the EU. The decision was based on a procedural issue: certain clinical results cited in the marketing application were still under data protection, affecting the regulatory assessment process. The company emphasized that the revocation is unrelated to the product's quality, safety, efficacy, or clinical value. Hansoh Pharma stated it reserves the right to challenge the decision and plans to resubmit a marketing application using original data. The company expressed cautious optimism about obtaining new approval within a reasonable timeframe, depending on regulatory review. Currently, the product has generated no sales revenue outside China, and the company expects no material adverse impact on its financial condition or business operations from this decision or the reapplication process.
Read sourceHansoh Pharma's Aumolertinib EU Marketing Authorization Revoked; Company Plans to Reapply
On September 27, Hansoh Pharma (03692.HK) issued a voluntary announcement stating that the European Commission issued an implementing decision on September 25, 2026, revoking the EU marketing authorization for its drug Aumolertinib. The company emphasized that the decision relates solely to procedural deficiencies under the EU regulatory framework and is not connected to the product's quality, safety, efficacy, or clinical value. Hansoh Pharma intends to resubmit a marketing application to the European Medicines Agency as soon as possible. The company stated that the revocation is not expected to affect Aumolertinib's sales in China or have a material adverse impact on its current financial condition or business operations. The report originates from Southern Finance Network.
Read sourceHansoh Pharma Says EU Withdrawal of Aumseqa Approval Is Procedural, Not Quality-Related
Hansoh Pharma announced on September 27 that the European Commission (EC) has revoked the marketing authorization for its drug Aumseqa® (almonertinib mesylate tablets) in the EU. The product was originally approved by the EC on February 12, 2026. According to the company's announcement, the revocation stems from a procedural issue and is unrelated to product quality. Hansoh Pharma stated it will quickly reapply for marketing authorization in the EU and remains committed to its innovation and internationalization strategy. The drug has not yet generated actual sales overseas, and its UK marketing authorization, granted in 2025, remains valid. Market expectations indicate no impact on Hansoh Pharma's financial performance. The report is sourced from Securities Times and published on East Money's company news channel.
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