
Chinese pharma Hansoh Pharma (HKEX: 3692) has secured approval from China’s National Medical Products Administration for an expanded use of its EGFR inhibitor Ameile (almonertinib). The decision clears the drug for first-line treatment in combination with chemotherapy for certain lung cancer patients.
The new indication covers Ameile given with pemetrexed and platinum-based chemotherapy for adult patients with locally advanced or metastatic non-small cell lung cancer with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations. It is the fifth approved indication for the drug in China.
The approval further entrenches Ameile in first-line EGFR-mutated lung cancer, where combination strategies are increasingly used to delay resistance. It also reinforces Hansoh’s effort to position the drug as a domestic alternative to imported EGFR inhibitors.
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