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]

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。 ...

Core Viewpoint - The stock of Ailis has shown significant growth this year, with a year-to-date increase of 72.55%, indicating strong market performance and investor interest [1]. Group 1: Stock Performance - As of December 19, Ailis's stock price reached 101.98 yuan per share, with a trading volume of 55.59 million yuan and a turnover rate of 0.12%, resulting in a total market capitalization of 45.891 billion yuan [1]. - In the past five trading days, the stock has increased by 2.86%, while it has seen a 6.80% rise over the last 20 days, but a decline of 5.13% over the last 60 days [1]. Group 2: Financial Performance - For the period from January to September 2025, Ailis reported a revenue of 3.733 billion yuan, reflecting a year-on-year growth of 47.35%, and a net profit attributable to shareholders of 1.616 billion yuan, which is a 52.01% increase compared to the previous year [2]. Group 3: Shareholder and Institutional Holdings - As of September 30, 2025, the number of Ailis shareholders increased to 19,100, a rise of 46.82%, while the average number of circulating shares per person decreased by 31.89% to 23,551 shares [2]. - Ailis has distributed a total of 653 million yuan in dividends since its A-share listing [3]. - Among the top ten circulating shareholders, Hong Kong Central Clearing Limited is the fourth largest with 20.9471 million shares, an increase of 10.5693 million shares from the previous period [3].

Core Insights - The A-share market has shown a fluctuating upward trend since 2025, with the pharmaceutical and biotechnology sector performing exceptionally well, dominating the top ten stock fund rankings in the first half of the year [2] - Jin Xiaofei, a representative mid-generation fund manager at Penghua Fund, has achieved remarkable performance with his managed funds, utilizing a unique "dual-line resonance" framework to navigate crowded sectors [2][3] Investment Performance - Jin Xiaofei has been with Penghua Fund since July 2012, accumulating a tenure of 9 years and 174 days, managing assets totaling 5.375 billion yuan, with a best-term return of 239.59% [3] - The Penghua Medical Technology Stock A fund, under Jin's management, has shown significant excess returns, with a total return of 74.19% since its inception on June 2, 2015, and a return of 73.03% this year [5] - The Penghua Innovation Upgrade Mixed A fund has also performed well, with a year-to-date return of 88.72% and a one-year return of 74.60% [15] Investment Strategy - Jin's investment strategy is centered on "fundamental trend investing," integrating a dual-dimensional analysis framework that focuses on both visible driving factors and market sentiment [3][4] - The "bright line" strategy emphasizes significant industry changes, while the "dark line" strategy identifies undervalued opportunities through reverse analysis of market emotions and capital flows [4] - Jin's approach includes a three-dimensional decision-making framework that considers long-term, mid-term, and short-term performance metrics to ensure robust investment logic [14][16] Stock Holdings and Performance - The fund has made strategic purchases in various stocks, including: - 1,126,260 shares of Nuocheng Jianhua, which saw a price increase of 213% during the holding period [7] - 217,760 shares of Dizhe Pharmaceutical, with a price increase of 90.49% [9] - 119,040 shares of Baijishenzhou, which appreciated by 257% [11] - 211,230 shares of Rongchang Bio, with a price increase of 121% [13] - The fund's holdings in stocks like Hailan Pharmaceutical and Zexing Pharmaceutical also demonstrated significant price increases during their respective holding periods [18][20] Market Outlook - Jin Xiaofei anticipates a new investment cycle in the pharmaceutical sector, with institutional holdings recovering from historical lows, and emphasizes the importance of beta opportunities in the current market [5][16] - The need for continuous optimization of risk control systems is highlighted, as the industry faces increasing competition and innovation [25]

证券日报网讯 12月15日晚间，艾力斯发布公告称，2025年12月15日，公司召开了第三届董事会第二次 会议，审议通过了《关于使用部分暂时闲置募集资金进行现金管理的议案》。在保证不影响募集资金投 资项目实施、募集资金安全的前提下，公司及其全资子公司拟使用最高不超过人民币5.50亿元（含本 数）的暂时闲置募集资金进行现金管理，使用期限不超过12个月，期限内任一时点的交易金额（含投资 收益进行再投资的相关金额）不超过前述额度。在前述额度及期限范围内，公司可以循环滚动使用。本 事项无需提交公司股东会审批。 （文章来源：证券日报） ...