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Allist's Third Generation EGFR-TKI Receives Marketing Approval for Lung Cancer in China

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.

 

References:

  1. https://www.allist.com.cn/product/1
  2. https://www.nmpa.gov.cn/yaowen/ypjgyw/20210303144734196.html
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