Core 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]

Core Viewpoint - The company艾力斯 (688578.SH) has announced that its core product,甲磺酸伏美替尼片 (brand name "艾弗沙®"), has been included in the list of proposed breakthrough therapies by the National Medical Products Administration (NMPA) of China, targeting first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR PACC mutations [1] Group 1 - The proposed indication for伏美替尼 is for adult patients with locally advanced or metastatic NSCLC with EGFR PACC mutations [1] - The public announcement period for this proposed breakthrough therapy is from December 25, 2025, to January 4, 2026 [1]

Core Viewpoint - The company艾力斯 announced that its core product,甲磺酸伏美替尼片 (brand name "艾弗沙"), has been included in the list of proposed breakthrough therapies by the National Medical Products Administration (NMPA) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR PACC mutations [1] Group 1 - The proposed indication for伏美替尼 is as a first-line treatment for adult patients with locally advanced or metastatic NSCLC [1] - The public announcement period for this proposed breakthrough therapy is from December 25, 2025, to January 4, 2026 [1]

Core Viewpoint - The company艾力斯(688578.SH) has announced that its core product,甲磺酸伏美替尼片 (brand name "艾弗沙®", abbreviated as "伏美替尼"), has been included in the list of proposed breakthrough therapies by the National Medical Products Administration (NMPA) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) PACC mutations [1] Group 1 - The proposed indication for 伏美替尼 is as a first-line treatment for adult patients with locally advanced or metastatic NSCLC with EGFR PACC mutations, with the public announcement period set from December 25, 2025, to January 4, 2026 [1] - 伏美替尼 is an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) and is a first-class new drug independently developed by the company, classified as a small molecule targeted therapy [1] - Clinical research results indicate that 伏美替尼 shows broad efficacy against various EGFR mutations, with its first-line treatment indication and the 20 exon insertion mutation first and second-line treatment indications included in the NMPA's breakthrough therapy list [1] Group 2 - The 20 exon insertion mutation first-line treatment indication has also received breakthrough therapy designation (BTD) from the U.S. Food and Drug Administration (FDA) [1] - Currently, both first-line and second-line treatment indications for 伏美替尼 have been included in the National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug Catalog (2025) [1]

Core Viewpoint - The company艾力斯(688578.SH) announced that its core product,甲磺酸伏美替尼片 (trade name "艾弗沙", abbreviated as "伏美替尼"), has been included in the list of proposed breakthrough therapies by the National Medical Products Administration (NMPA) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR PACC mutations [1] Group 1 - The proposed indication for伏美替尼 is as a first-line treatment for adult patients with locally advanced or metastatic NSCLC with EGFR PACC mutations, with the public announcement period set from December 25, 2025, to January 4, 2026 [1] - 伏美替尼 is an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) and is a first-class new drug independently developed by the company, classified as a small molecule targeted therapy [1] - Clinical research results indicate that伏美替尼 demonstrates broad efficacy against various EGFR mutations, with its first-line treatment indication and the 20 exon insertion mutation first and second-line treatment indications included in the NMPA's breakthrough therapy list [1] Group 2 - The 20 exon insertion mutation first-line treatment indication has also received breakthrough therapy designation (BTD) from the U.S. Food and Drug Administration (FDA) [1] - Currently, both first-line and second-line treatment indications for伏美替尼 have been included in the National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug Catalog (2025) [1]

证券代码：688578 证券简称：艾力斯 公告编号：2025-036 上海艾力斯医药科技股份有限公司自愿披露 关于甲磺酸伏美替尼片 EGFR PACC 突变 NSCLC 一线治疗适应症纳入拟突破性治疗品种公示的公告 | 药品名称 | 甲磺酸伏美替尼片 | | | --- | --- | --- | | 受理号 | CXHL2300625 | | | 药品类型 | 化药 | | | 注册分类 | 2.4 | | | 申请日期 | 年 月 日 2025 18 | 11 | | 拟定适应症（或 | 本品适用于具有表皮生长因子受体（EGFR）PACC 突变的局部晚期或转 | | | 功能主治） | 移性非小细胞肺癌（NSCLC）成人患者的一线治疗。 | | | 理由及依据 | 经审核，本申请符合《药品注册管理办法》和《国家药监局关于发布< 突破性治疗药物审评工作程序（试行）>等三个文件的公告》（2020 年第 | | | | 号），同意纳入突破性治疗药物程序。 82 | | 一、药品基本情况 EGFR PACC突变主要包含大约 70种突变亚型，约占所有 EGFR 突变NSCLC 1 患者的 12.5%。目前国内尚无针 ...

Core Viewpoint - The company艾力斯 announced that its core product,甲磺酸伏美替尼片 (brand name "艾弗沙®"), has been included in the list of proposed breakthrough therapies by the National Medical Products Administration (NMPA) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) PACC mutations [1] Group 1 - The proposed indication for伏美替尼 is as a first-line treatment for specific NSCLC patients [1] - The public announcement period for this proposed breakthrough therapy is from December 25, 2025, to January 4, 2026 [1]

Investment Rating - The report maintains an investment rating of "Outperform" with a target of A [7] Core Insights - The report highlights the positive results from Takeda's new generation oral TYK2 inhibitor, zasocitinib (TAK-279), for treating moderate to severe plaque psoriasis, with over 50% of participants achieving skin clearance or nearly clear skin (PASI 90) at week 16, and about 30% achieving complete clearance (PASI 100) [3][4] - The report suggests that there are multiple catalysts expected in the sector, including academic conferences and data readouts, which could provide investment opportunities [2] - The report emphasizes the potential of other TYK2 inhibitors, particularly Eifang Biopharma's D-2570, which has shown promising phase 2 clinical data [4][22] Summary by Sections Weekly New Drug Market Review - From December 15 to December 21, 2025, the top five gainers in the new drug sector were: Yahu Medicine (+12.03%), Cloudtop New Medicine (+9.32%), Aidi Pharmaceutical (+9.06%), Shiyao Group (+7.05%), and Ailis (+3.94%). The top five losers were: Chuangsheng Group (-16.03%), Beihai Kangcheng (-12.33%), Kedi (-11.88%), WuXi AppTec (-11.15%), and Nuocheng Jianhua (-10.99%) [1][17] Weekly Focus on Recommended Stocks - The report recommends focusing on companies with high certainty for overseas expansion, such as Sanofi Biopharma, Lianbang Pharmaceutical, and Kelun Biotech. It also highlights companies with potential overseas data catalysts, including Betta Pharmaceuticals, Hutchison China MediTech, and Ying'en Biopharma [2][21] Weekly New Drug Industry Analysis - Takeda's phase 3 clinical trials for zasocitinib have shown consistent results with previous phase 2 trials, indicating strong data reliability. The report also notes the potential for TYK2 inhibitors in treating Crohn's disease and ulcerative colitis [3][4][22] Weekly New Drug Application Approval & Acceptance - No new drug or new indication applications were approved domestically this week, but 11 new drug or new indication applications were accepted [5][26] Weekly New Drug Clinical Application Approval & Acceptance - This week, 55 new drug clinical applications were approved, and 47 new drug clinical applications were accepted [11][28]

Core Viewpoint - The company emphasizes "innovation" as its core competitive advantage and is committed to an innovation-driven development strategy, aiming to expand its international product layout to benefit global patients [2] Group 1 - The company is actively promoting its internationalization strategy for innovative drugs [2] - The focus on innovation is central to the company's competitive strategy [2]

证券日报网讯12月19日，艾力斯在互动平台回答投资者提问时表示，随着伏美替尼一线及二线治疗适应 症进入国家医保报销范围，有效降低了患者的用药负担，进一步扩大了国内肺癌患者受益群体的数量。 此外，伏美替尼针对EGFR经典突变的辅助治疗适应症、20外显子插入突变一线及二线治疗适应症、 PACC突变的一线治疗适应症、针对EGFR敏感突变伴脑转移患者的治疗、EGFR非经典突变的辅助治疗 等均处于注册临床阶段，随着相关适应症在未来陆续获批，伏美替尼的市场空间会进一步扩大。对于耐 药患者的治疗，现有药物在疗效、安全性和可及性仍有进一步提升的空间。目前伏美替尼已经和c-MET ADC、TROP2/HER3ADC以及口服PD-L1抑制剂开展了联合用药临床研究，并得到了积极的初步疗效及 安全性数据，相关临床研究仍在持续推进中。 ...