HANSOH PHARMA(03692): Almonertinib EU marketing authorization withdrawn, plans to resubmit marketing application

HANSOH PHARMA (03692) announced that regarding almonertinib (overseas trade name: Aumseqa) monotherapy, which was approved for marketing in the European Union (EU) following a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP), the Directorate-General for Health and Food Safety of the European Commission (EC) issued an implementing decision on September 25, 2026, pursuant to which the aforementioned marketing authorization was withdrawn. The decision was made after the European Commission initiated a withdrawal procedure, which is understood to have been initiated after AstraZeneca filed a lawsuit against the European Commission before the General Court of the European Union (T-289/26) regarding the marketing authorization, without waiting for the outcome of that annulment action. The marketing application dossier for the product, submitted in 2022, contained the Company's complete, independently and autonomously generated Phase III clinical data and European pharmacokinetic bridging data. However, the main basis for the decision was that certain clinical results of TAGRISSO, which the Company cited as a background reference in the data package, were still within the data protection period at the time (that data protection period expired in 2024), which constituted a procedural issue in the regulatory assessment process. Therefore, the decision relates solely to a procedural defect under the EU regulatory framework and has no connection whatsoever to the quality, safety, efficacy, or clinical value of the product. The Group has reserved all rights to challenge the decision, including through proceedings before the Court of Justice of the European Union 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 of time, 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 from the product outside of 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 aforementioned resubmission process 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 that are 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 the mission of "continuous innovation to improve human life quality," and striving to bring high-quality innovative medicines to patients worldwide.