The Third-generation EGFR Inhibitor 'Ametinib' is Filed for Listing in the UK

On June 15, Hansoh Pharma announced that its overseas partner, EQRx, has submitted a New Drug Application (MAA) for the third-generation EGFR inhibitor Almetinib to the UK Medicines and Healthcare Products Regulatory Agency (MHRA) and has been accepted as a first-line treatment. EGFR-mutant advanced or metastatic NSCLC. This is the first marketing authorization application for Almetinib outside of China.

This application is based on data from the AENEAS study evaluating the Phase III clinical trial. The AENEAS study is a randomized, double-blind, controlled, multicenter Phase III clinical study investigating Almetinib versus Gefitinib as first-line treatment for patients with EGFR mutation-positive locally advanced or metastatic NSCLC. The study met its primary endpoint, with Almetinib significantly extending progression-free survival and having a better safety profile than Gefitinib.

According to the Insight database, on July 23, 2020, Hansoh Pharma entered into a strategic collaboration and license agreement with EQRx, granting it research, development, manufacturing and commercialization of cancer, cancer-related and immune-inflammatory diseases outside of China exclusive rights. Under the partnership, Hansen will receive an upfront payment and registration and development milestone payments of approximately $100 million, as well as other potential commercial milestone payments and tiered royalties based on net sales.

EQRx is a company with a me-too strategy, aiming to provide similar innovative drugs to overseas markets at affordable prices and become a "disruptor". This company has carried out close cooperation with domestic enterprises, including not only Hansoh Pharmaceuticals, but also CStone Pharmaceuticals and Insilico.

Ametinib is the first domestically produced third-generation EGFR-TKI approved for marketing in China. After the UK application, it has also become the first innovative drug of its kind to go overseas. In China, both its second-line and first-line NSCLC indications have been approved. The former has entered the medical insurance category B catalog through negotiations last year, and the latter is about to launch a sprint this year. At the same time, according to the Insight database, Ametinib has also deployed adjuvant therapy indications, and the corresponding Phase III clinical (NCT) is underway.