On December 2, 2022, Hansoh Pharma (03692.HK), a Hong Kong-listed company, announced that the European Medicines Agency ("EMA") had accepted the marketing authorization application ("MAA") from its partner EQRx for aumolertinib (a novel third-generation epidermal growth factor receptor tyrosine kinase inhibitor ("EGFR-TKI") being developed and commercialized under a license agreement), for the first-line treatment of adult patients with locally advanced or metastatic NSCLC who have EGFR sensitizing mutations and for the treatment of adult patients with locally advanced or metastatic NSCLC who are EGFR T790M mutation positive. This is the second MAA for aumolertinib filed outside the People's Republic of China.
Aumolertinib is one of the company's core products. As of the date of this announcement, aumolertinib has been approved for two indications in China and is under approval by the MHRA for the first-line treatment of adult patients with locally advanced or metastatic NSCLC who have EGFR sensitizing mutations and for the treatment of adult patients with locally advanced or metastatic NSCLC who are EGFR T790M mutation positive. This MAA is primarily based on data from the Phase III study evaluating aumolertinib for the first-line treatment of locally advanced or metastatic NSCLC with EGFR mutations ("AENEAS Study"). Aumolertinib is also currently being evaluated in a number of other clinical studies for lung cancer.
