其中，伏美替尼一线及二线治疗适应症经医保谈判后继续纳入国家医保目录；戈来雷塞二线治疗适应症 通过医保谈判方式首次被纳入国家医保目录。 北京商报讯（记者 丁宁）12月7日晚间，艾力斯（688578）发布公告称，公司创新药品甲磺酸伏美替尼 片（商品名"艾弗沙"，以下简称"伏美替尼"）和枸橼酸戈来雷塞片（商品名"艾瑞凯"，以下简称"戈来 雷塞"）均被纳入《国家基本医疗保险、生育保险和工伤保险药品目录（2025 年）》（以下简称"国家 医保目录"）。 ...

其中，伏美替尼一线及二线治疗适应症经医保谈判后继续纳入国家医保目录；戈来雷塞二线治疗适应症 通过医保谈判方式首次被纳入国家医保目录。 目前，伏美替尼已被《CSCO非小细胞肺癌指南(2025年版)》、《中国驱动基因阳性非小细胞肺癌脑转 移临床诊疗指南(2025版)》等多项最新国内权威指南共识和诊疗规范纳入。在2025年9月举办的CSCO学 术年会上，全球首部聚焦EGFRPACC突变NSCLC的诊疗专业性文件《EGFRPACC突变晚期NSCLC诊疗 专家共识》指出，对于EGFRPACC突变的晚期NSCLC患者，基于目前证据，可考虑将伏美替尼作为一 线治疗选择。 甲磺酸伏美替尼片是一种表皮生长因子受体酪氨酸激酶抑制剂(EGFR-TKI)，为公司自主研发的1类新 药，属于小分子靶向药。临床研究结果显示，伏美替尼对多种EGFR突变展现出广泛的疗效，其一线治 疗适应症、20外显子插入突变一线及二线治疗适应症先后获得国家药品监督管理局(NMPA)药品评审中 心(CDE)突破性疗法认定，20外显子插入突变一线治疗适应症同时还获得美国食品药品监督管理局 (FDA)突破性疗法认定(BTD)。 伏美替尼用于EGFR20外显子插入突 ...

人民财讯12月7日电，艾力斯(688578)12月7日公告，公司创新药品甲磺酸伏美替尼片(商品名"艾弗沙"， 简称"伏美替尼")和枸橼酸戈来雷塞片(商品名"艾瑞凯"，简称"戈来雷塞")均被纳入《国家基本医疗保 险、生育保险和工伤保险药品目录(2025年)》(简称"国家医保目录")。其中，伏美替尼一线及二线治疗 适应症经医保谈判后继续纳入国家医保目录；戈来雷塞二线治疗适应症通过医保谈判方式首次被纳入国 家医保目录。 ...

证券代码：688578 证券简称：艾力斯 公告编号：2025-034 上海艾力斯医药科技股份有限公司自愿披露 关于公司创新药品纳入新版国家医保目录的公告 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。 根据国家医疗保障局（以下简称"国家医保局"）网站于 2025 年 12 月 7 日 发布的《国家医保局 人力资源社会保障部关于印发<国家基本医疗保险、生育保 险和工伤保险药品目录>以及<商业健康保险创新药品目录>（2025 年）的通知》， 上海艾力斯医药科技股份有限公司（以下简称"公司"）创新药品甲磺酸伏美替 尼片（商品名"艾弗沙®"，以下简称"伏美替尼"）和枸橼酸戈来雷塞片（商品 名"艾瑞凯®"，以下简称"戈来雷塞"）均被纳入《国家基本医疗保险、生育保 险和工伤保险药品目录（2025 年）》（以下简称"国家医保目录"）。其中，伏美 替尼一线及二线治疗适应症经医保谈判后继续纳入国家医保目录；戈来雷塞二线 治疗适应症通过医保谈判方式首次被纳入国家医保目录。现将相关情况公告如下： 一、药品及其纳入新版国家医保目录的情况 （一）甲 ...

Core Insights - The pharmaceutical sector is experiencing a rise, with the Shanghai Stock Exchange Sci-Tech Innovation Board Biomedicine Index increasing by 1.03% as of December 4, 2025, with notable gains from companies like Zai Lab (up 4.47%) and Rongchang Bio (up 4.14%) [1] Industry Overview - The pharmaceutical industry has undergone eleven rounds of national drug centralized procurement and multiple rounds of medical insurance negotiations, leading to an inevitable decline in the generic drug sector, which impacts the overall pharmaceutical industry [1] - From January to September 2025, the pharmaceutical manufacturing industry's revenue remained relatively stable, but the outlook for generic drugs is bleak, indicating a need for innovative drugs to drive future growth [1] Investment Perspective - According to Everbright Securities, future investments in the pharmaceutical sector should focus on the clinical value of drugs, addressing clinical needs of patients, as both domestic medical insurance policies and global expansion strategies increasingly emphasize clinical value [1] - The innovative drug industry chain and innovative medical devices are viewed positively based on the clinical value framework [1] Market Data - As of November 28, 2025, the top ten weighted stocks in the Shanghai Stock Exchange Sci-Tech Innovation Board Biomedicine Index include companies like United Imaging Healthcare and BeiGene, collectively accounting for 49.75% of the index [1]

Investment Rating - The investment rating for the industry is "Positive" and the rating has been maintained [2] Core Views - The pharmaceutical and biotechnology industry index experienced a decline of 4.40%, ranking 23rd among 31 primary industries, underperforming the CSI 300 index which fell by 2.19% [6][18] - The valuation of the pharmaceutical and biotechnology industry as of November 28, 2025, is a PE (TTM overall method, excluding negative values) of 29.46x, down from 30.89x in the previous period, indicating a downward trend and below the average [22] - The report highlights potential beneficiaries from the upcoming ASH data, particularly in blood diseases and companies with solid grassroots channels, as well as those with differentiated advantages in oncology, autoimmune, and rare disease products [10] Summary by Sections Industry Review - The pharmaceutical and biotechnology industry index fell by 4.40%, with chemical preparations and medical devices showing declines of 2.86% and 2.95% respectively, while offline pharmacies and vaccines saw larger declines of 8.22% and 6.42% [6][18] - The PE ratio for the pharmaceutical and biotechnology industry is 29.46x, with the highest valuations in the vaccine (47.56x), hospital (41.17x), and medical device (36.77x) sectors, while pharmaceutical circulation has the lowest at 14.58x [22] Important Industry News - The National Administration of Traditional Chinese Medicine and the National Healthcare Security Administration released a directory for traditional Chinese medicine diseases suitable for disease-based payment [26][27] - AstraZeneca's drug "Durvalumab" received FDA approval for a new indication in perioperative treatment of gastric cancer [32] - Otsuka Pharmaceutical's new drug for IgA nephropathy, "Sibeprenlimab," has been approved by the FDA [38] - Bayer's first-in-class lung cancer drug "Sevabertinib" has been approved by the FDA for specific patient populations [40] Investment Recommendations - Focus on innovative pharmaceutical companies that may benefit from the medical insurance or commercial insurance directories, blood cancer targets with imminent ASH data releases, and biotech and CXO leaders with solid technology platforms and international collaboration expectations [10]

Personnel Changes - Yunnan Baiyao announced the election of Zhang Wenxue as chairman and Dong Ming as vice chairman during the first meeting of the 11th board of directors on November 10, 2025 [2] - China National Pharmaceutical Group (Sinopharm) reported the resignation of Zhao Bingxiang from multiple positions, including non-executive director and chairman, with Jin Bin proposed as the new chairman [3] - Huatai Medical announced a board restructuring, nominating several candidates for its third board of directors, including current executives from Mindray Medical [4] - Hanyu Pharmaceutical reported the retirement of its executive director Pinxiang Yu and appointed two new executive directors, Shen Yaping and Tang Yangming [5] - GSK China appointed Sheng Feng as vice president, responsible for market access and commercial operations, effective December 1, 2025 [12] Executive Appointments - Medtronic appointed Larry Xu as vice president for orthopedic and neurosurgery business in China, effective November 10, 2025 [9] - Pfizer China announced the appointment of Su Tianyu as head of the broad market division, effective immediately [10][11] - Eli Lilly appointed Carole Ho as president of the neuroscience division, while Adrienne Brown was promoted to president of the immunology division [15] - Restore Medical appointed Chris Cleary, former senior vice president at Medtronic, as chairman of the board [18] Resignations - Johnson & Johnson announced the departure of Alex He, vice president and head of the PINS division, effective December 31, 2025 [8] - Several executives across various companies, including Chen Changbing from Sinopharm United and Wang Junbo from Guangyu Yuan, submitted their resignations due to work adjustments [3][5]

艾力斯（688578.SH）11月28日在投资者互动平台表示，公司全资子公司江苏艾力斯生物医药有限公司 新增年产1.5亿片甲磺酸伏美替尼片固体制剂生产线已于2025年7月取得江苏省药品监督管理局GMP符合 性证明文件，已满足药品监督管理部门的许可生产条件并获批投产，包括原有年产5000万片甲磺酸伏美 替尼片固体制剂生产线，公司已具备2亿片甲磺酸伏美替尼片固体制剂生产能力，进一步保障了产品供 应能力，为持续增长的市场需求提供有力支持。 （记者 张明双） 每经AI快讯，有投资者在投资者互动平台提问：尊敬的董秘您好，想咨询一下，伏美替尼的两条生产 线产能各多少？11月两条生产线产能复合利用率达到多少？谢谢！ ...

Core Insights - Shanghai Ailis Pharmaceutical Technology Co., Ltd. announced a strategic adjustment of its core technical personnel on November 28, 2025 [1] - The company has added Mr. Gao Changshou and Mr. You Fei as core technical personnel, while Mr. Luo Huibing and Mr. Xie Jingtian have left their positions due to personal reasons [2][5] - The departures of the two core technical personnel will not affect the company's intellectual property integrity or core competitiveness [7] Personnel Changes - Mr. Luo Huibing, who has over 20 years of new drug research experience, played a significant role in the development of key products, including the compound design and optimization of the core product, Fumetinin [4][6] - Mr. Xie Jingtian contributed to the formulation and production process development of key projects, including Fumetinin, during his tenure at the company [6] - Both departing personnel held shares in the company, with Mr. Luo holding 0.6454% and Mr. Xie holding 0.0561% [5][7] New Core Technical Personnel - The newly appointed core technical personnel, Mr. Gao Changshou and Mr. You Fei, have strong industry backgrounds and extensive research experience, both holding U.S. citizenship and doctoral degrees [8][9] - Mr. Gao Changshou is the current Chief Technology Officer and has a background in protein and antibody drug development, having previously worked at AstraZeneca and Innovent Biologics [9][10] - Mr. You Fei serves as the R&D Executive Director and has experience in innovative drug development from his time at AstraZeneca and Innovent Biologics [10] R&D Team Overview - Following the personnel adjustments, the company's core technical team now includes Gao Changshou, You Fei, Li Qing, Liang Chunqing, Jiang Yong, Zhang Qiang, and Zhou Huayong, covering key areas in small and large molecule drug development [10] - As of June 2025, the company's R&D team consists of 270 members, including 112 with master's degrees and 26 with doctoral degrees [11]

上海艾力斯医药科技股份有限公司 董事、高级管理人员薪酬管理制度 第一章 总则 第二章 薪酬管理机构 第四条 公司股东会负责审议董事的薪酬方案，公司董事会负责审议高级管理人员的 薪酬方案。 1 第一条 为进一步规范上海艾力斯医药科技股份有限公司（以下简称"公司"）董事、 高级管理人员的薪酬管理，建立科学有效的激励与约束机制，保证公司董事 有效地履行其职责和义务，有效调动公司高级管理人员的工作积极性，提高 公司的经营管理效率，进一步促进公司稳定持续发展，根据《中华人民共和 国公司法》、《上海证券交易所科创板股票上市规则》及《上海艾力斯医药 科技股份有限公司章程》（以下简称"《公司章程》"）的有关规定，结合 公司实际情况，制定本制度。 第二条 本制度适用于以下人员： （一） 董事会成员：包括非独立董事和独立董事。 （二） 高级管理人员：包括公司董事会聘任的总经理、执行副总经理、副总 经理、董事会秘书、财务负责人及《公司章程》认定的其他人员。 第三条 公司薪酬制度遵循以下原则： （一） 总体薪酬水平与公司经营规模、经营业绩相匹配原则； （二） 责、权、利相结合的原则，总体薪酬水平与承担的管理责任、权限相 对应； （三 ...