Hansoh Pharma (03692) announced that the EU marketing authorization for ametinib (overseas brand name: Aumseqa®) as a monotherapy was withdrawn following a decision by the European Commission's Directorate-General for Health and Food Safety on September 25, 2026, after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had issued a positive opinion.
The withdrawal decision was made after the European Commission initiated a revocation procedure, reportedly without awaiting the outcome of a lawsuit (T-289/26) filed by AstraZeneca against the European Commission at the General Court of the European Union concerning that marketing authorization.
The marketing application submitted in 2022 included the company's complete, independently generated Phase III clinical data and European pharmacokinetic bridging data. However, the decision was primarily based on the fact that certain clinical results of Tagrisso® (TAGRISSO®), which the company cited as a background reference in the data package, were still within their data protection period at the time (that protection period expired in 2024), constituting a procedural issue in the regulatory assessment process.
Therefore, the decision relates only to a procedural flaw under the EU regulatory framework and has no connection whatsoever to the product's quality, safety, efficacy, or clinical value. The group has reserved all rights to challenge the decision, including through EU court proceedings if necessary. The group also intends to resubmit the marketing application for the product to the EMA as soon as possible based on the original data package.
The board is cautiously optimistic about obtaining a new marketing authorization within a reasonably short period, with the specific timeline depending on the regulatory review process. Currently, the EMA has indicated its willingness to shorten the standard assessment timeline. As of the date of this announcement, the group has not generated any sales revenue for the product outside China, and the decision is not expected to have any impact on any sales of the product in China.
The board believes that the decision and the process of resubmitting the application will not have any material adverse impact on the group's current financial condition or business operations. The announcement stated that the group will continue to advance additional applications for the product currently under review or being prepared for submission with regulatory authorities in different jurisdictions. The group remains firmly committed to its innovation and internationalization strategy, upholding its mission of "continuous innovation to improve human life quality," and strives to bring high-quality innovative medicines to patients worldwide.