Alice (688578.SH): Application for marketing of vometinib mesylate tablets accepted for new indications

Zhitong Finance App News, Alice (688578.SH) issued an announcement. Recently, the company received the “Notice of Acceptance” approved and issued by the State Drug Administration. The marketing application for vometinib mesylate tablets (“vometinib”) submitted by the company for adjuvant treatment after tumor resection in adult patients with epidermal growth factor receptor (EGFR) exon 19 deficiency or exon 21 (L858R) replacement mutations was accepted.

As a third-generation domestic EGFR-TKI, vormetinib is a class 1 small-molecule targeted drug independently developed by the company. It has the characteristics of “strong brain transformation, excellent curative effect, good safety, and wide treatment window”. Its core compound patented innovation technology (pyridylaminopyrimidine derivatives, their preparation method and application) has won the 25th China Patent Gold Award jointly awarded by the State Intellectual Property Office and the World Intellectual Property Organization. Multiple indications have also successively received CDE or US Food and Drug Administration (FDA) breakthrough therapy certification (BTD). Results of several clinical studies have shown that vometinib has clear anti-tumor efficacy and good safety characteristics, and is highly accepted by patients for long-term use. Currently, vometinib has been incorporated and recommended by many of the latest domestic authoritative guidelines, consensus and guidelines, including the “CSCO Guidelines for Non-small Cell Lung Cancer (2026 Edition)”.