证券日报网讯 2月3日，艾力斯发布公告称，公司自主研发的1类小分子靶向药甲磺酸伏美替尼片用于 EGFR20号外显子插入突变NSCLC二线治疗适应症注册申请状态已更新为"审批完毕-待制证"，该适应症 适用于既往含铂化疗进展或不耐受且检测确认EGFR20号外显子插入突变的局部晚期或转移性NSCLC成 人患者，II期临床显示ORR44.3%、中位PFS8.3个月、中位OS22.9个月，有望扩大患者覆盖并提升销 售。 （文章来源：证券日报） ...

| 药品名称 | 甲磺酸伏美替尼片 | | --- | --- | | 申报事项 | 境内生产药品注册上市许可 | | 药品注册分类及子类 | 化学药品 类 2.4 | | 加快注册上市程序 | 优先审评审批程序 | | 受理号/备案号 | CXHS2500084 | | 获批适应症 | 本品适用于既往经含铂化疗治疗时或治疗后出现疾病 进展，或不耐受含铂化疗，并且经检测确认存在表皮生 | | | 长因子受体（EGFR）20 号外显子插入突变的局部晚期 | | | 或转移性 的成人患者。 NSCLC | 证券代码：688578 证券简称：艾力斯 公告编号：2026-002 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 20号外显子插入突变NSCLC 二线治疗适应症药品注册进展的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 上海艾力斯医药科技股份有限公司（以下简称"公司"）近日从国家药品监 督管理局（以下简称"国家药监局"）药品业务应用系统查询获悉，公司提交的 甲磺酸伏美替尼片EGFR 20号外 ...

截至2026年2月3日 10:48，中证医药及医疗器械创新指数(931484)成分股方面涨跌互现，爱美客领涨 2.18%，新产业上涨1.94%，东阿阿胶上涨1.71%；海思科领跌。医疗创新ETF(516820)最新报价0.35元。 数据显示，截至2026年1月30日，中证医药及医疗器械创新指数(931484)前十大权重股分别为药明康 德、迈瑞医疗、恒瑞医药、爱尔眼科、片仔癀、新和成、华东医药、康龙化成、艾力斯、甘李药业，前 十大权重股合计占比63.9%。 风险提示：基金有风险，投资需谨慎。基金管理人承诺以诚实信用、勤勉尽责的原则管理和运用基金资 产，但不保证本基金一定盈利，也不保证最低收益。基金管理人提醒投资人基金投资的"买者自负"原 则，在做出投资决策后，基金运营状况与基金净值变化引致的投资风险，由投资人自行负担。基金的过 往业绩及其净值高低并不预示其未来业绩表现，基金管理人管理的其他基金的业绩不构成对本基金业绩 表现的保证。投资人购买基金，既可能按其持有份额分享基金投资所产生的收益，也可能承担基金投资 所带来的损失。投资人应当认真阅读《基金合同》《招募说明书》等基金法律文件，全面认识本基金的 风险收益特征 ...

Investment Rating - The report gives a "Buy" rating for the company, indicating a positive outlook for its stock performance in the next 12 months [9]. Core Insights - The company is expected to achieve a revenue of 5.2 billion yuan in 2025, representing a year-on-year increase of 46.15%, and a net profit of 2.15 billion yuan, up 50.37% from the previous year [2][9]. - The growth is primarily driven by the company's focus on precision treatment for lung cancer, particularly through its commercialized product, Furmetinib, which has gained recognition in the industry [2][3]. - The company has optimized resource allocation and leveraged synergies among its commercial products, contributing to sustained operational performance [2]. Financial Projections - Revenue projections for 2025-2027 are 5.2 billion, 6.395 billion, and 8.193 billion yuan, with growth rates of 46.2%, 23.0%, and 28.1% respectively [9][10]. - Net profit estimates for the same period are 2.15 billion, 2.461 billion, and 3.187 billion yuan, with growth rates of 50.3%, 14.5%, and 29.5% respectively [9][10]. - Earnings per share (EPS) are projected to be 4.78, 5.47, and 7.08 yuan for 2025, 2026, and 2027, respectively [9][10]. Product Development and Market Strategy - The company is actively conducting multiple clinical trials for Furmetinib, targeting various lung cancer mutations, which are expected to provide growth momentum for its commercialization [3][4]. - The collaboration with ArriVent to develop Furmetinib for rare mutations is progressing well, with ongoing global Phase III clinical trials [3][4]. - The company has strengthened its commercialization capabilities, with a marketing team of over 1,400 covering 31 provinces and more than 5,000 hospitals [8]. Regulatory and Market Access - Furmetinib, along with other products like Goretinib and Pralsetinib, has been included in the new national medical insurance catalog, effective January 1, 2026, enhancing market access [8][9]. - The company has successfully negotiated with the National Healthcare Security Administration to include its products in the insurance directory, which is expected to boost sales [8].

Investment Rating - The report gives a "Buy" rating for the company, indicating a positive outlook for its stock performance in the next 12 months [9]. Core Insights - The company is expected to achieve a revenue of 5.2 billion yuan in 2025, representing a year-on-year increase of 46.15% [2]. - The net profit attributable to shareholders is projected to be 2.15 billion yuan, reflecting a growth of 50.37% compared to the previous year [2]. - The growth is primarily driven by the company's focus on precision treatment for lung cancer, particularly through its commercialized product, Furmetinib, which has gained recognition in the industry [2]. - The company has optimized resource allocation and leveraged synergies among its commercial products, contributing to sustained operational performance [2]. Financial Projections - Revenue projections for 2025, 2026, and 2027 are 5.2 billion, 6.395 billion, and 8.193 billion yuan, respectively, with growth rates of 46.2%, 23.0%, and 28.1% [10]. - Net profit forecasts for the same years are 2.15 billion, 2.461 billion, and 3.187 billion yuan, with growth rates of 50.3%, 14.5%, and 29.5% [10]. - Earnings per share (EPS) are expected to be 4.78, 5.47, and 7.08 yuan for 2025, 2026, and 2027, respectively [10]. Product Development and Market Strategy - The company is actively conducting multiple clinical trials for Furmetinib, targeting various indications in non-small cell lung cancer (NSCLC), which is expected to provide growth momentum for its commercialization [3][4]. - The collaboration with ArriVent to develop Furmetinib for rare mutations in NSCLC is progressing well, with ongoing global Phase III clinical trials [3]. - The company has introduced additional products, such as Goretinib and Pralsetinib, enhancing its portfolio in the lung cancer treatment market [5][9]. Market Position and Competitive Advantage - The company has strengthened its commercialization capabilities, with a marketing team of over 1,400 personnel covering 31 provinces and more than 5,000 hospitals [8]. - All core products, including Furmetinib, Goretinib, and Pralsetinib, have been included in the new national medical insurance directory, effective January 1, 2026, which is expected to enhance market accessibility [8][9].

公告中指出，业绩增长主要得益于其商业化产品在肺癌精准治疗领域的成功推广，以及国家医保政策的 支持，使得核心产品销售收入持续增长。此外，公司优化资源配置和产品间的协同效应也推动了经营业 绩的提升。 近日，艾力斯发布公告，公司预计2025年度实现营业收入52亿元，同比增加46.15%。同时，预计归母 净利润为21.5亿元，同比增加50.37%。归母净利润扣除非经常性损益后预计为20亿元，同比增加 46.95%。 ...

Macro Economic Group - The Federal Reserve decided to maintain the federal funds rate in the range of 3.5-3.75%, aligning with market expectations, marking the first pause in rate cuts since September of the previous year [5] - The statement from the Fed changed its description of economic activity from "moderate expansion" to "steady expansion," indicating a more optimistic view on the labor market and inflation [5] - Powell emphasized that inflation risks have somewhat diminished and that the impact of tariffs on the economy is expected to dissipate by mid-2026 [6] Industry Comprehensive Group - Industrial Fulian (601138.SH) projected a net profit of 35.1 to 35.7 billion yuan for 2025, a year-on-year increase of 51% to 54%, driven by a significant rise in cloud server and AI server revenues [9] - Ailis (688578.SH) expects a revenue increase of 46.15% for 2025, with net profit projected at 2.15 billion yuan, supported by strong demand for its third-generation EGFR-TKI inhibitor [10] - True Love Home anticipates a net profit of 202 to 296 million yuan for 2025, a substantial increase attributed to one-time non-recurring gains from land compensation [14] - Yiming Foods forecasts a net profit of 47 to 55 million yuan for 2025, with significant growth driven by the recovery of its core milk bar business and expansion into B-end channels [15] - Aofei Entertainment expects a net profit of 6 to 8 million yuan for 2025, marking a turnaround due to improved cost control and recovery in overseas sales [16] Advanced Manufacturing Group - The pickup market sold 52,000 units in December 2025, a year-on-year increase of 8.8%, with total sales for the year reaching 589,000 units, up 11.8% [12] - Exports of pickups in December 2025 reached 28,000 units, a year-on-year increase of 12%, contributing significantly to overall market growth [12] - The new energy pickup segment saw a cumulative increase of 243% for the year, indicating strong growth potential driven by external demand and product upgrades [12]

◎记者 王墨璞嘉 上海张江药谷，正不断孕育生物医药的创新力量。 艾力斯就是其中之一。这家以"精 准聚焦+深度开发"为底色的企业，凭借核心大单品伏美替尼实现稳健增长，从本土崛起到全球布局， 诠释着本土创新药企"专注者行远"的故事。 "艾力斯不盲目铺管线，要做就做肿瘤领域的首创药或同类 最佳药。"展望"十五五"，艾力斯董事长杜锦豪对上海证券报记者表示，"坚守创新初心不变。" 从多元 赛道收缩到肿瘤领域深耕，艾力斯的破局之路、增长之钥，藏着果断取舍的智慧与长期主义的坚守。 锚定肿瘤"主峰"全力攀登 "创新药研发不是'撒胡椒面'，找市场大、产品价格高、竞争对手少的赛道集 中发力，才能在激烈竞争中突围。"杜锦豪表示。艾力斯的专注，始于一场关键的战略抉择，而这份抉 择的背后，是创始团队的初心与坚守。 2003年的美国，杜锦豪与郭建辉相遇。两位怀揣"让中国创新药 不落后于国际"梦想的实干家，仅用3小时就敲定了创业共识。 次年，郭建辉从美国回到上海，杜锦豪 也投入多年积累的财富，正式在张江药谷成立艾力斯。公司早期管线覆盖心血管、糖尿病、肿瘤等多个 领域，试图在多赛道中寻找突破口。 2012年，艾力斯迎来重要转折点，公司自主研 ...

2025年年度业绩预增公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏，并对其内容 的真实性、准确性和完整性依法承担法律责任。 一、本期业绩预告情况 （一）业绩预告期间 证券代码：688578 证券简称：艾力斯 公告编号： 2026-001 上海艾力斯医药科技股份有限公司 3、公司预计2025年度实现归属于母公司所有者扣除非经常性损益后的净利润为200,000.00万元，比上年 同期增加63,903.18万元，同比增加46.95%。 （三）本次业绩预告相关财务数据未经注册会计师审计。 二、上年同期业绩情况 2024年度，公司实现营业收入355,793.02万元，利润总额161,852.13万元，归属于母公司所有者的净利润 为142,984.71万元，归属于母公司所有者的扣除非经常性损益后的净利润为136,096.82万元。2024年度基 本每股收益为3.18元。 三、本期业绩变化的主要原因 公司商业化产品聚焦肺癌精准治疗领域，通过差异化的临床治疗优势和专业化的学术推广策略受到业内 专家的高度认可。受益于国家医保政策"让新药、好药更加触手可及"的支持与覆盖，公司核心产品销售 ...

上海张江药谷，正不断孕育生物医药的创新力量。 艾力斯就是其中之一。这家以"精准聚焦+深度开发"为底色的企业，凭借核心大单品伏美替尼实现稳健 增长，从本土崛起到全球布局，诠释着本土创新药企"专注者行远"的故事。 2003年的美国，杜锦豪与郭建辉相遇。两位怀揣"让中国创新药不落后于国际"梦想的实干家，仅用3小 时就敲定了创业共识。 次年，郭建辉从美国回到上海，杜锦豪也投入多年积累的财富，正式在张江药谷成立艾力斯。公司早期 管线覆盖心血管、糖尿病、肿瘤等多个领域，试图在多赛道中寻找突破口。 2012年，艾力斯迎来重要转折点，公司自主研发的中国首个抗高血压一类新药阿利沙坦获批，正当企业 迈向新阶段时，核心研发带头人郭建辉却因病离世。 站在"何去何从"的十字路口，杜锦豪决定，以10.2亿元将阿利沙坦酯专利出售给信立泰，回笼资金后全 面砍掉心血管等非核心管线，集中所有资源攻坚肿瘤治疗赛道。"肿瘤靶向药赛道具有'高价值、少竞 争'的特性，是一个值得全力攀登的'主峰'。"杜锦豪下定决心。 此后，艾力斯确立了围绕EGFR、KRAS等关键驱动基因构建产品矩阵的路线，在郭建辉留下的研发团 队基础上，集中化学、制剂、分析、药理等核心 ...