Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692), a leading biopharmaceutical company based in China, has announced the submission of a market filing application for its epidermal growth factor receptor (EGFR) inhibitor, Ameile (almonertinib), to the National Medical Products Administration (NMPA). The application seeks approval for Ameile as an adjuvant therapy for patients with non-small cell lung cancer (NSCLC) who have undergone tumor resection and test positive for EGFR exon 19 deletion or exon 21 (L858R) substitution mutations.
Ameile received its initial market approval in China in March 2020 for the treatment of T790M-mutated locally advanced or metastatic NSCLC after first-line EGFR tyrosine kinase inhibitor (TKI) treatment. It was further approved in December 2021 for the first-line treatment of locally advanced or metastatic NSCLC with EGFR exon 19 deletion or exon 21 (L858R) substitution mutation-positive. The drug’s potential approval as an adjuvant therapy would mark another significant milestone in the treatment of NSCLC in China.- Flcube.com