Aumolertinib (Aumseqa): an EU authorisation revoked for leaning on protected data

What was decided

Regulatory data protection is usually a date on a spreadsheet: eight years from the reference product’s first EU authorisation before a generic or hybrid application may rely on its dossier, ten before the product may be sold. It is rarely the reason an approved medicine leaves the market. This is such a case.

Aumolertinib is a third-generation EGFR inhibitor developed by Hansoh in China for non-small cell lung cancer with EGFR mutations, the territory of AstraZeneca’s osimertinib (Tagrisso). Hansoh applied to the EMA in 2022 with its own Chinese phase III data against gefitinib and a small European pharmacokinetic study; almost no European patients had been treated. The committee’s positive opinion of 11 December 2025 drew on subgroup results from AstraZeneca’s FLAURA trial of osimertinib to support extrapolating the Chinese results to European patients, and the Commission granted the authorisation on 12 February 2026.

Osimertinib’s EU data protection ran from its first authorisation in February 2016 and so expired in 2024, after Hansoh’s application was made but before it was decided. On 7 May 2026 AstraZeneca asked the General Court to annul the grant (T-289/26) on two pleas: that the Commission had erred in assessing quality, safety and efficacy, and that the application had relied on clinical data that were still under protection when it was filed. The notice appeared in the Official Journal on 20 July 2026.

The Commission did not wait for the court. On 25 September 2026, 141 days after the action was lodged, it revoked the authorisation. According to the reporting of the decision, its reasoning was that once the protected osimertinib data were taken out of account the dossier did not adequately support extrapolating safety and efficacy from an Asian to a European population. Hansoh announced the revocation on 27 September, describing it as a procedural defect under the EU framework that had nothing to do with the medicine’s quality, safety, efficacy or clinical value, said it would resubmit on the basis of its original data, and reserved its right to challenge the decision in the EU courts. The product’s UK authorisation, granted by the MHRA in June 2025, is not affected.

Timeline

Date	Event
February 2016	Osimertinib (Tagrisso) first authorised in the EU; data protection starts
2022	Hansoh applies to the EMA for aumolertinib
2024	Osimertinib’s eight-year data protection ends
11 December 2025	CHMP positive opinion
12 February 2026	Commission grants the marketing authorisation
7 May 2026	AstraZeneca lodges T-289/26 for annulment
20 July 2026	Action published in the Official Journal
25 September 2026	Commission revokes the authorisation
27 September 2026	Hansoh announces it; says it will resubmit

What it means if you are…

A generics or launch planner. The lesson is about the date the clock is read against. Data protection is tested at the time the application is made, not when it is granted or when the product reaches the market. An application filed inside the eight years that leans on the reference dossier, even indirectly through the assessment, is exposed for as long as the authorisation stands. The same logic protects a generic or hybrid applicant that waited for the date: its reliance is lawful from day one. For a company planning a launch against a reference product, the first EU authorisation date on the register is the one that sets this clock, and this case shows the Commission will act on it.

A parallel trader. The product never reached most European markets in the seven months it was authorised. If you hold stock authorised under the revoked EU licence it cannot be placed on the market; the UK authorisation stands on its own and is a separate matter. Osimertinib itself is unaffected; its patent and SPC position should be read from the registers.

A wholesaler or buyer. A reminder that an EU authorisation can be withdrawn for reasons that have nothing to do with the medicine. Contracts for new products in a protected class are worth a clause for exactly this.

Status and what to watch

Hansoh’s resubmission to the EMA, which the company says the Agency has indicated it could assess on a shortened timetable; whether Hansoh challenges the revocation in the General Court within the two-month limit; and what becomes of AstraZeneca’s own action, which may have lost its object now that the decision it attacked has gone. The case is a first of its kind that we are aware of, and the Commission’s written reasoning, when it is public, will be the document to read.

This note is general information, not legal advice. The position for any product and country should be checked on the registers.