China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) announced that a market filing for its epidermal growth factor receptor (EGFR) inhibitor Ameile (almonertinib) has been filed for review with the European Medicines Agency (EMA) by US-based partner EQRx Inc. Hansoh/EQRx’s targeted indication is as a first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR-sensitive mutations and locally advanced or metastatic NSCLC that is EGFR T790M mutation positive.
Clinical Trial Results
The filing is based on the results of the Phase III AENEAS study for Ameile versus gefitinib in first-line EGFR mutation-positive locally advanced or metastatic NSCLC, in which Ameile significantly improved progression-free survival (PFS) over gefitinib while demonstrating an improved safety profile.
Global Regulatory and Commercial Strategy
Ameile is the world’s second innovative third-generation EGFR-TKI after AstraZeneca’s Tagrisso (osimertinib). The drug won market approval in China in March 2020 for use in T790M-mutated locally advanced or metastatic NSCLC following first-line EGFR-TKI treatment and first-line treatment of locally advanced or metastatic NSCLC with EGFR exon 19 deletion or exon 21 (L858R) replacement mutation-positive in December 2021. Hansoh struck a licensing agreement with US firm EQRx Inc., in July 2020, reportedly worth USD 100 million, granting EQRx exclusive research and development (R&D), manufacturing, and commercialization rights to the drug outside of China.-Fineline Info & Tech
