Shanghai Allist Pharmaceuticals Co., Ltd. (688578.SH): Marketing application for a new indication of Furmonertinib Mesilate Tablets has been accepted

Shanghai Allist Pharmaceuticals Co., Ltd. (688578.SH) announced that the company recently received the "Notice of Acceptance" issued upon approval by the National Medical Products Administration. The company's marketing application for a new indication of Furmonertinib Mesilate Tablets (referred to as "Furmonertinib") for adjuvant treatment after tumor resection in adult patients with non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) substitution mutations has been accepted. As a domestic third-generation EGFR-TKI, Furmonertinib is a Class 1 small molecule targeted drug independently developed by the company, featuring "potent efficacy against brain metastases, excellent efficacy, favorable safety, and a wide therapeutic window." Its core compound patent innovation technology (pyridinamine pyrimidine derivatives, their preparation methods and applications) has been awarded the 25th China Patent Gold Award jointly by the China National Intellectual Property Administration and the World Intellectual Property Organization. Multiple indications have also successively received Breakthrough Therapy Designation (BTD) from the CDE or the U.S. Food and Drug Administration (FDA). Results from multiple clinical studies show that Furmonertinib has demonstrated definitive antitumor efficacy and a favorable safety profile, with high long-term tolerability among patients. Currently, Furmonertinib has been included and recommended by multiple latest domestic authoritative guidelines, consensuses, and guiding principles, including the "CSCO Non-Small Cell Lung Cancer Guidelines (2026 Edition)."