Hansoh Pharmaceutical (03692): Ameile® (Almonertinib Mesilate Tablets) Granted Third Indication by China's NMPA

Hansoh Pharma (03692) announced that the group's innovative drug Ameile^®(Hansoh Pharma's Aumetinib Mesylate Tablets) received the drug registration certificate issued by China's National Medical Products Administration (NMPA), approving the addition of the indication "for the treatment of patients with unresectable locally advanced epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21(L858R) substitution mutation non-small cell lung cancer (NSCLC) who have not experienced disease progression after platinum-based radical chemoradiotherapy." This is Ameile.^®The third approved indication.

Ameile^®(Amutinib Mesylate Tablets) is China's first domestically developed third-generation EGFR-TKI innovative drug. It has previously been approved for two indications in China: In March 2020, it was approved for patients with locally advanced or metastatic NSCLC who had progressed after prior EGFR-TKI treatment and were positive for the T790M mutation; in December 2021, it was approved as a first-line treatment for adult patients with locally advanced or metastatic NSCLC harboring EGFR exon 19 deletions or exon 21 (L858R) substitution mutations. Both indications have been renewed and included in the 2024 National Reimbursement Drug List as of November 2024.

Ameile^®Two additional New Drug Application (NDAs) have been accepted by the NMPA, respectively: for adjuvant treatment in adult patients with NSCLC who are positive for EGFR exon 19 deletions or exon 21(L858R) substitution mutations following tumor resection; and in combination with pemetrexed and platinum-based chemotherapy for first-line treatment of adult patients with locally advanced or metastatic NSCLC harboring EGFR exon 19 deletions or exon 21(L858R) substitution mutations.