Hansoh Pharmaceutical's Ameile® NDA for EGFR-Mutated NSCLC Adjuvant Therapy Accepted by NMPA

Hansoh Pharma (03692) announced that Almonertinib (brand name: Amelior), a Class 1 innovative drug developed by its subsidiary Jiangsu Hansoh Pharmaceutical Group Co., Ltd.,^®The marketing authorization application for the adjuvant treatment of adult patients with non-small cell lung cancer (NSCLC) who have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations after tumor resection has been accepted by the National Medical Products Administration of the People's Republic of China. This application is for the third indication of Ameile.

It is reported that Almonertinib Mesylate Tablets (Brand name: Amelie) is the first domestically developed third-generation EGFR-TKI innovative drug in China. In December 2021, Amelie was approved as a first-line treatment for adult patients with locally advanced or metastatic NSCLC who have positive EGFR exon 19 deletions or exon 21(L858R) substitution mutations. It was included in the 2022 National Reimbursement Drug List (NRDL) of China through negotiations in January 2023. Additionally, it was approved in 2020 for patients with locally advanced or metastatic NSCLC who progressed after prior EGFR-TKI therapy and are T790M mutation-positive, and successfully renewed its inclusion in the 2022 NRDL in January 2023.