Hansoh Pharma (03692.HK) announced on October 22 that the Phase III registration trial AENEAS2 evaluating the combination of Almonertinib with chemotherapy as a first-line treatment for locally advanced (IIIB~IIIC stage) or metastatic (stage IV) epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) has achieved its primary endpoint of progression-free survival (PFS).

In patients with advanced lung cancer with EGFR mutations, the improvement in PFS shown by the combination of Almonertinib with chemotherapy is statistically significant and clinically meaningful. Detailed results of the study will be presented at future medical conferences and submitted to regulatory agencies. Almonertinib (Almonertinib mesylate tablets) is the first original third-generation EGFR-TKI innovative drug in China. In March 2020, Almonertinib was approved for the treatment of locally advanced or metastatic NSCLC patients who had previously progressed on EGFR-TKI therapy and tested positive for the T790M mutation, and was successfully renewed in January 2023 for inclusion in the 2022 National Medical Insurance Catalog. In December 2021, Almonertinib was approved for first-line treatment of adult patients with locally advanced or metastatic NSCLC who have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, and was included in the 2022 National Medical Insurance Catalog in January 2023. In July 2024, the NDA application for Almonertinib for adjuvant therapy after tumor resection in adult NSCLC patients with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations was accepted by the China National Medical Products Administration (NMPA). In August 2024, the NDA for the treatment of locally advanced unresectable NSCLC patients with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations who had not experienced disease progression after definitive platinum-based chemoradiotherapy with Almonertinib was accepted by NMPA.