March 3, 2021
Furmonertinib Mesilate (AST2818), developed by Shanghai Allist Pharmaceutical Technology Co., Ltd. (“Allist”) (SHSE: 688578), has received marketing approval by the National Medical Products Administration (NMPA) of China through priority review, for the treatment (second-line) of the non-small cell lung cancer (NSCLC) with EGFR sensitive mutation and EGFR T790M drug-resistant mutation.
AST2818 is an irreversible and highly selective EGFR inhibitor independently discovered and developed by Allist. It has the potential to become the best-in-class drug in the third-generation EGFR-TKIs. Data from the preclinical studies and the completed clinical studies show that AST2818 has the following advantages: 1) AST2818 has good target selectivity and tissue distribution specificity; 2) The objective response rate of AST2818 for the patients with locally advanced or metastatic NSCLC with EGFR T790M mutation is outstanding, reaching 74.1% in the key registration clinical study; 3) AST2818 has a good safety profile and is well-tolerated; 4) AST2818 and its active metabolites have a superior ability to penetrate the blood-brain barrier, and have a good therapeutic efficacy on brain metastases frequently seen in patients with NSCLC.
AST2818 is being evaluated for treatment (first-line treatment) of the patients with locally advanced or metastatic NSCLC with EGFR sensitive mutation in a phase-III clinical trial.