Shanghai Allist Pharmaceuticals Co.,Ltd. (SH: 688578) has announced that it recently received the "Acceptance Notice" issued by China's National Medical Products Administration (NMPA).

The company's supplemental New Drug Application for furmonertinib mesylate tablets (referred to as "Furmonertinib") has been formally accepted for review. This new indication targets the adjuvant treatment of adult patients with non-small cell lung cancer (NSCLC) who have undergone surgical resection and harbor either EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.

Furmonertinib is a self-developed Class 1 small-molecule targeted therapy, standing as a domestically produced third-generation EGFR-TKI. It is distinguished by potent efficacy against brain metastases, outstanding clinical response, a favorable safety profile, and a broad therapeutic window.

The drug's core compound patent—covering pyridylaminopyrimidine derivatives, their preparation methods, and applications—has earned the 25th China Patent Gold Award, jointly conferred by the China National Intellectual Property Administration and the World Intellectual Property Organization. Furthermore, multiple indications for Furmonertinib have successively received Breakthrough Therapy Designation (BTD) from both the CDE (China's drug evaluation center) and the U.S. Food and Drug Administration (FDA).

Data from multiple clinical studies have demonstrated that Furmonertinib delivers definitive antitumor efficacy and a robust safety profile, supporting high long-term patient adherence.

Currently, Furmonertinib is included and recommended in numerous latest domestic authoritative guidelines, consensus statements, and guiding principles, including the CSCO Guidelines for Non-Small Cell Lung Cancer (2026 Edition).