On December 2, 2022, Hansoh Pharmaceutical Group Company Limited (3692.HK, "Hansoh Pharma") issued a voluntary announcement stating that the European Medicines Agency ("EMA") had formally accepted the Marketing Authorization Application ("MAA") from Hansoh Pharma's partner EQRx INC. ("EQRx") for the use of aumolertinib, a third-generation epidermal growth factor receptor-tyrosine kinase inhibitor ("EGFR-TKI"), for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer ("NSCLC") with sensitizing EGFR mutations and for the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC. This is the second MAA for aumolertinib filed outside China, following the first MAA filed with the UK's Medicines and Healthcare products Regulatory Agency ("MHRA") in June 2022.
Lung cancer is the third most diagnosed cancer in Europe and the malignancy with the highest incidence and mortality. It is estimated that nearly one-third of patients with NSCLC worldwide (approximately 85% of lung cancer patients) have EGFR mutations. As the first third-generation EGFR-TKI originally developed in China, aumolertinib can irreversibly and highly selectively inhibit EGFR sensitizing and T790M resistance mutations, showing not only superior efficacy and safety, but also a significant clinical advantage for patients with brain metastases. To date, aumolertinib has two indications approved in China and is currently being evaluated in several clinical development programs for lung cancer.
In July 2020, Hansoh Pharma signed an overseas collaboration agreement with EQRx, according to which EQRx would be responsible for the research, development, manufacturing and commercialization of aumolertinib outside Greater China to further expand its reach as a potential treatment and to accelerate the global presence of Hansoh Pharma's innovations. In June 2022, the UK's MHRA formally accepted the MAA for aumolertinib, which is currently under review.
About Aumolertinib
Ameile (aumolertinib mesilate tablets) is China's first original third-generation EGFR-TKI independently developed by Hansoh Pharma with favorable pharmacologic properties that selectively inhibits both EGFR sensitizing and resistance mutations. The National Medical Products Administration (NMPA) of China has approved aumolertinib for the first- and second-line treatment of patients with locally advanced or metastatic EGFR-mutated NSCLC.
About the AENEAS Study
The AENEAS Study is a multicenter, randomized, double-blind, controlled phase III trial of aumolertinib versus gefitinib as the first-line treatment for patients with locally advanced or metastatic EGFR-mutated NSCLC, with a total of 400+ subjects enrolled. The study met its primary endpoint, demonstrating statistically significant improvement in progression-free survival and a favorable safety profile as compared to gefitinib. On May 18, 2022, JCO published the results of the AENEAS study, which was the first publication of clinical data of a Chinese original third-generation EGFR-TKI in the official ASCO journal.
