Hansoh(03692.HK): EU revokes Aumolertinib approval, EMA resubmission planned

NewTimeSpace News: Hansoh Pharmaceutical Group Company Limited (03692.HK) said in a voluntary announcement on 27 September that the Directorate-General for Health and Food Safety of the European Commission published an implementing decision on 25 September 2026, pursuant to which the marketing authorisation of Aumolertinib, marketed as Aumseqa® outside China, in the European Union was revoked. The authorisation had been granted as monotherapy following the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).

The Decision was made after the EC initiated revocation proceedings, apparently following and without awaiting the outcome of the annulment proceedings brought by AstraZeneca against the EC before the General Court of the EU in respect of the Marketing Authorization (T-289/26). The marketing application submitted in 2022 contains the company's complete, independently generated Phase 3 clinical data and European pharmacokinetic bridging data. However, the Decision primarily found that certain TAGRISSO® clinical results contextually referenced by the company in the Data Package were at the time still within the data protection period (which expired in 2024), constituting a procedural issue in the regulatory assessment process. Accordingly, the Decision relates solely to a procedural issue under the EU regulatory framework and is not related to the quality, safety, efficacy or clinical value of the product.

The group has reserved all rights to challenge the Decision, including through EU court proceedings if necessary, and intends to resubmit the marketing application to the EMA based on the original Data Package as soon as possible. The board is cautiously optimistic that a new authorisation can be obtained within a reasonably short timeframe. As at the date of the announcement, the group has not generated any sales revenue from the product outside of China, and the Decision is not expected to have any impact on sales of the product in China, nor any material adverse impact on the group's current financial position or business operations.

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