据悉，该药物拟用于治疗具有表皮生长因子受体(EGFR)外显子19缺失或外显子21置换突变，并伴有中 枢神经系统转移的局部晚期或转移性非小细胞肺癌(NSCLC)成人患者的一线治疗。此次被纳入优先评 审，标志着甲磺酸艾多替尼片的审评进程将全面提速，有望更早上市，为中国患者提供新的治疗选择。 消息面上，同源康医药公布，公司在研1类新药甲磺酸艾多替尼片(TY-9591片)被国家药品监督管理局 (NMPA)药品审评中心(CDE)纳入优先审评品种名单。 同源康医药-B(02410)早盘涨超13%，截至发稿，涨8.94%，报13.52港元，成交额4070.33万港元。 ...

Core Viewpoint - Chengdu Shengdi Pharmaceutical, a subsidiary of Hengrui Medicine, has announced that its HRS-5965 capsules are proposed to be included in the priority review list by the National Medical Products Administration (NMPA) of China, indicating a significant step towards potential market approval for a treatment targeting paroxysmal nocturnal hemoglobinuria in adults who have not previously received complement inhibitors [1] Drug Information - Drug Name: HRS-5965 Capsules [1] - Dosage Form: Capsule [1] - Applicant: Chengdu Shengdi Pharmaceutical Co., Ltd. [1] - Proposed Indication: Treatment for adult patients with paroxysmal nocturnal hemoglobinuria who have not previously received complement inhibitor therapy [1] Priority Review Justification - The application meets the requirements outlined in the "Drug Registration Management Measures" and the announcement regarding the "Review Procedures for Breakthrough Therapy Drugs" issued by the NMPA [1] - The drug is categorized under priority review for "clinically urgent shortage drugs, innovative drugs, and modified new drugs for the prevention and treatment of major infectious diseases and rare diseases" [1]