Hansoh Pharmaceutical Group Co., Ltd. announced that its drug Ameile (Aumolertinib Mesylate Tablets) has received regulatory approval in China for a new indication. The newly approved use is Ameile in combination with pemetrexed and platinum-based chemotherapy as a first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions or exon 21 (L858R) mutations. This approval is supported by results from the Phase III AENEAS 2 study, which demonstrated a significant improvement in progression-free survival and objective response rate compared to monotherapy, with no new safety concerns. This marks the fifth approved indication for Ameile in China, enabling full-course treatment coverage for EGFR-mutated NSCLC.

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