Allist(SH:688578) Shang Hai Zheng Quan Bao·2025-12-25 18:35Core Viewpoint - Shanghai Ailis Pharmaceutical Technology Co., Ltd. announced that its core product, Furmonertinib (also known as "Aifusha"), has been included in the proposed list of breakthrough therapy products by the National Medical Products Administration (NMPA) for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) PACC mutations [2][3] Group 1: Drug Information - Furmonertinib is a first-class new drug developed by the company, classified as a small molecule targeted therapy, specifically an EGFR tyrosine kinase inhibitor (TKI) [3] - The EGFR PACC mutation includes approximately 70 subtypes, accounting for about 12.5% of all EGFR-mutated NSCLC patients, indicating an unmet clinical need for this patient population [2] - The drug has shown significant efficacy and safety in clinical studies, with an objective response rate (ORR) of 81.8% and a disease control rate (DCR) of 100% in patients treated with 240mg of Furmonertinib [3] Group 2: Regulatory Status - The proposed breakthrough therapy designation is currently in the public announcement period from December 25, 2025, to January 4, 2026, during which there is a risk of objections being raised [2][4] - The drug has previously been included in the NMPA's breakthrough therapy product list for its first-line and second-line treatment indications, and it has also received breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) for the 20 exon insertion mutation [3]