Allist: The indication for second-line treatment of EGFR20 exon insertion mutation NSCLC with Furmonertinib tablets is proposed to be included in the priority review process
I'm LongbridgeAI, I can summarize articles.Allist announced that its product, furmonertinib mesylate tablets, is intended for the treatment of adult patients with locally advanced or metastatic NSCLC who have disease progression or intolerance to platinum-based chemotherapy after platinum-containing chemotherapy and have EGFR exon 20 insertion mutations. The marketing authorization application for this drug has been included in the priority review process by the Center for Drug Evaluation of the National Medical Products Administration, with a public comment period from July 8, 2025, to July 15, 2025
According to the Zhitong Finance APP, Allist (688578.SH) announced that the application for the marketing authorization of its product, furmonertinib mesylate tablets (hereinafter referred to as "furmonertinib"), intended for the treatment of "adult patients with locally advanced or metastatic NSCLC who have disease progression during or after platinum-based chemotherapy, or who are intolerant to platinum-based chemotherapy, and have been confirmed by testing to have epidermal growth factor receptor (EGFR) exon 20 insertion mutations," has recently been included in the list of varieties for priority review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration. The public notice period is from July 8, 2025, to July 15, 2025.
Furmonertinib mesylate tablets are an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI), a class of new drugs independently developed by the company, belonging to small molecule targeted drugs. It is currently the company's core product used for the treatment of advanced NSCLC, and furmonertinib has been recognized by the CDE as a breakthrough therapy for the second-line treatment indication of NSCLC with EGFR exon 20 insertion mutations