Shanghai Allist Pharmaceuticals Co., Ltd. (688578.SH): The inclusion of gefitinib tablets for the first-line treatment of EGFRPACC mutations in NSCLC as a breakthrough therapy candidate has been announced.

Shanghai Allist Pharmaceuticals Co., Ltd. (688578.SH) announced that its core product Gefitinib Mesylate Tablets (trade name "Evafsa", abbreviated as "Gefitinib") has recently been included in the national Drug Evaluation Center's list of potential breakthrough therapeutic varieties, with proposed indications for first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in adult patients with epidermal growth factor receptor (EGFR) PACC mutation. The public notice period is from December 25, 2025, to January 4, 2026. Gefitinib Mesylate Tablets is a type 1 new drug independently developed by the company, which is an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) and belongs to small molecule targeted therapy drugs. Clinical research results have shown that Gefitinib has shown a wide range of effectiveness against various EGFR mutations. Its first-line treatment indications and 20 exon insertion mutation first-line and second-line treatment indications have been successively included in the National Medical Products Administration (NMPA) Drug Evaluation Center (CDE) list of breakthrough therapeutic varieties. The 20 exon insertion mutation first-line treatment indication has also been granted Breakthrough Therapy Designation (BTD) by the United States Food and Drug Administration (FDA). Currently, both first-line and second-line treatment indications for Gefitinib have been included in the "National Basic Medical Insurance, Maternity Insurance and Work Injury Insurance Drug Catalog (2025)".