By Fineline Cube 
China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) announced that its epidermal growth factor receptor (EGFR) inhibitor Ameile (almonertinib) has received approval from the National Medical Products Administration (NMPA) for a fourth indication. The new approval covers the treatment of adult patients with stage II-IIIB non-small cell lung cancer (NSCLC) harboring EGFR exon 19 deletion or exon 21 (L858R) substitution mutations who have undergone surgical resection. The decision to administer adjuvant chemotherapy remains at the physician’s discretion.
Previous Approvals and Market Performance
Ameile, a third-generation EGFR-TKI developed in China, first gained market approval in March 2020 for the treatment of T790M-mutated locally advanced or metastatic NSCLC following first-line EGFR-TKI treatment. It further secured approval in December 2021 for first-line treatment of locally advanced or metastatic NSCLC with EGFR exon 19 deletion or exon 21 (L858R) replacement mutations. In March 2025, the NMPA approved its use in unresectable locally advanced EGFR exon 19 deletion or exon 21 (L858R) replacement mutation-positive NSCLC with no disease progression after platinum-based radical radiotherapy and chemotherapy.-Fineline Info & Tech