Hansoh Pharma's Ameile (Almonertinib) Marketing Authorization Application Accepted by European Medicines Agency
Hansoh Pharma
Pharmaceutical Research, Production, and Sales
EQRx
New Drug Research and Development, Manufacturer
European Medicines Agency
The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU), located in London. It began operations in 1995. The agency is responsible for the scientific evaluation, supervision, and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. By ensuring that all medicines available on the EU market are safe, effective, and of high quality, the EMA protects public and animal health in the 28 EU Member States and countries of the European Economic Area.
On December 2, Hansoh Pharmaceutical Group Company Limited (hereinafter referred to as "Hansoh Pharma") issued a voluntary announcement that the European Medicines Agency (EMA) has officially accepted the marketing authorization application (MAA) submitted by its partner EQRx, Inc. (EQRx) for the third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) Aumolertinib Mesylate Tablets. The MAA is for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR-sensitive mutations and for the treatment of adult patients with locally advanced or metastatic NSCLC who are positive for the EGFR T790M mutation. This marks the second marketing authorization application for Aumolertinib outside of China, following the UK MHRA submission in June 2022.
Lung cancer is the third most commonly diagnosed cancer in Europe and one of the malignant tumors with the highest incidence and mortality rates. It is estimated that nearly one-third of global non-small cell lung cancer patients (approximately 85% of lung cancer patients) have EGFR mutations. As the first China-developed third-generation EGFR-TKI, Aumolertinib can irreversibly and highly selectively inhibit both EGFR-sensitive mutations and T790M resistance mutations. It not only demonstrates good efficacy and safety but also shows significant clinical advantages for patients with brain metastases. To date, two indications have been approved in China, and multiple clinical studies targeting lung cancer are actively underway.
In July 2020, Hansoh Pharma signed an overseas cooperation agreement with EQRx, under which EQRx is responsible for the research, development, production, and commercialization of Aumolertinib outside of Greater China, further expanding the therapeutic potential of Aumolertinib and accelerating the international layout of Hansoh Pharma's innovative achievements. In June 2022, the UK Medicines and Healthcare products Regulatory Agency (MHRA) officially accepted the marketing application for Aumolertinib, which is currently under review. (Zhu Wen)