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。 证券代码：688578 证券简称：艾力斯 公告编号：2025-013 上海艾力斯医药科技股份有限公司自愿披露 关于枸橼酸戈来雷塞片新药上市申请获得批准的公告 得益于创新的药物共晶设计和稳定的构型,戈来雷塞有良好的安全性特征， ≥3 级治疗相关不良事件发生率更低，且具有良好的消化道安全性特征。戈来雷 塞是目前国内已获批的 KRAS G12C 抑制剂中，唯一实现每日单次口服给药的 KRAS G12C 抑制剂，患者服用更加方便。 二、对公司的影响 戈来雷塞非小细胞肺癌二线治疗适应症的上市申请完成审批，标志着戈来雷 塞商业化的正式开始，有利于丰富公司的商业化管线，提升公司的销售收入。公 司已组建了专业化的营销团队，将充分利用戈来雷塞的临床治疗优势，不断完善 产品的学术推广及产品营销策略，扩大戈来雷塞获批适应症的患者群体覆盖，提 升戈来雷塞的产品销售收入，并积极推动戈来雷塞非小细胞肺癌二线治疗适应症 尽快纳入国家医保目录，惠及更多肺癌患者。 上海艾力斯医药科技股份有限公司（以下简称"公 ...

Group 1 - The company's KRAS G12C inhibitor, citric acid gorasetinib (brand name "Airikai"), has received approval from the National Medical Products Administration for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutations who have received at least one systemic therapy [1] - As of September 28, 2024, a total of 119 NSCLC patients were included in the analysis [1] - The confirmed objective response rate (cORR) assessed by the Independent Radiologic Review Committee (IRC) reached 49.6% (40.2%-59.0%) [1] - The disease control rate (DCR) was 86.3% (78.7%-92.0%) [1] - The median duration of response (DOR) was 14.5 months (9.6-NE) [1] - The median progression-free survival (PFS) was 8.2 months (5.2-11.1) [1] - The median overall survival (OS) was 17.5 months (13.6-NE) [1]

Core Viewpoint - The National Medical Products Administration has conditionally approved the innovative drug Glecirasib (brand name: Airikai) developed by Elysium, which is indicated for adult patients with advanced non-small cell lung cancer (NSCLC) harboring KRAS G12C mutations who have received at least one prior systemic therapy [1] Group 1 - The drug Glecirasib is classified as a first-class innovative drug [1] - The approval was granted through a priority review and approval process [1] - The target patient population includes adults with advanced NSCLC and specific genetic mutations [1]

Summary of the Conference Call for Ailis Company Overview - Ailis is focused on the oncology sector, particularly lung cancer treatments, with its core product being Furmetinib, a third-generation EGFR TKI [2][3][4][7]. Key Points and Arguments Product Performance and Market Potential - Furmetinib's sales are projected to exceed 3.5 billion yuan in 2024, with a peak domestic sales estimate of 8 billion yuan [2][3]. - The product has achieved significant commercial success since its launch, with cumulative sales surpassing 6.5 billion yuan since 2021 [2][8]. - Ailis is expanding its indications for Furmetinib, currently involved in six registered clinical studies [3][4]. - The company has partnered with ArriVent to develop a first-line therapy for EGFR 20 exon insertion mutation lung cancer, with top-line data expected by the end of 2025 and a market entry anticipated in 2027 [2][3][9]. Financial Projections and Valuation - Ailis's estimated average PE ratio for 2025 is 21.16, compared to 28 times for comparable companies like Betta Pharmaceuticals and Terbium Biotech [2][6][17]. - The total pipeline valuation is projected at 47.03 billion yuan, indicating a potential growth of 20%-30% [2][6][17]. - The company expects a net profit of 1.85 to 1.9 billion yuan for 2024, with a sales expense ratio reduced to around 40% [2][5][8]. Collaborations and New Drug Introductions - Ailis has introduced KRAS G12C and RET inhibitors, with expectations for approval and inclusion in medical insurance by 2025, which will synergize with Furmetinib [2][4][9]. - The introduction of new drugs is expected to significantly contribute to revenue growth, with projections for the sales of these new drugs reaching approximately 700 million yuan [2][15]. Market Dynamics and Competitive Landscape - The third-generation EGFR TKI market is projected to reach 28 billion yuan in 2023, with Ailis's products positioned to capture a significant share [12][13]. - The company is also exploring the development of fourth-generation EGFR TKIs, although the R&D challenges are acknowledged [10]. Future Opportunities - Ailis is targeting various opportunities in non-small cell lung cancer treatment, including addressing rare mutations and overcoming resistance to third-generation EGFR TKIs [11]. - The company is expanding its marketing team to enhance its reach, covering 31 provinces and 4,800 hospitals [8]. Additional Important Insights - The competitive landscape for KRAS G12C inhibitors is noted to be challenging, with Ailis's product expected to capture a market share of around 1.8 billion yuan [16]. - The collaboration with ArriVent is highlighted as a strategic move to enhance Ailis's market presence internationally [9][17]. This summary encapsulates the critical insights from the conference call, focusing on Ailis's strategic positioning, product performance, financial outlook, and market opportunities.

Investment Rating - The report maintains a "Buy" rating for the company, indicating an expected relative price increase of over 20% compared to the market benchmark within the next six months [5][22]. Core Insights - The company has demonstrated impressive performance with a revenue of 3.56 billion yuan in 2024, reflecting a year-on-year growth of 76.3%, and a net profit of 1.43 billion yuan, up 122% year-on-year [2][5]. - The sales expense ratio has improved, decreasing by 5.9 percentage points to 39.7% in 2024, while the net profit margin increased by 8.27 percentage points to 40.2% [2][3]. - The innovative pipeline is progressing steadily, with multiple clinical trials for the drug Vomeletin ongoing, targeting various indications [4][5]. Financial Performance - In Q4 2024, the company achieved a revenue of 1.02 billion yuan, a 52.8% increase year-on-year, and a net profit of 370 million yuan, up 57% year-on-year [2]. - For Q1 2025, the company reported a revenue of 1.1 billion yuan, a 47.9% increase year-on-year, and a net profit of 410 million yuan, reflecting a 34.1% growth [3]. - The projected net profits for 2025, 2026, and 2027 are estimated at 1.7 billion yuan, 2.03 billion yuan, and 2.49 billion yuan, respectively, indicating a strong growth trajectory [5]. Cost Management - The company has effectively optimized its cost structure, with a decrease in the management expense ratio to 4.6% in 2024, down 1.9 percentage points year-on-year [2]. - The research and development expense ratio also saw a decline to 8.8%, down 6.7 percentage points year-on-year, indicating efficient allocation of resources [2]. Market Position and Growth Potential - The company is in a rapid growth phase with Vomeletin's market expansion and the introduction of new products, highlighting its long-term growth potential [5]. - The introduction of the KRASG12C inhibitor, Goretinib, is expected to enhance the company's product offerings and market presence [4][5].

SHANGHAI 68 Yin Chena Road Middle 上海市通力律师事务所关于上海艾力斯医药科技股份有限公司 2024 年年度股东大会的法律意见书 致:上海艾力斯医药科技股份有限公司 上海市通力律师事务所(以下简称"本所")接受上海艾力斯医药科技股份有限公 司(以下简称"公司")的委托,指派本所郭珣律师、俞挺律师(以下简称"本所律师") 根据《中华人民共和国公司法》《中华人民共和国证券法》《上市公司股东会规则》等 法律法规和规范性文件(以下统称"法律法规")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")的规定就公司 2024年年度股东大会(以下简称"本 次股东大会"）相关事宜出具法律意见。 本所律师已经对公司提供的与本次股东大会有关的法律文件及其他文件、资料予以 了核查、验证。在进行核查验证过程中,公司已向本所保证,公司提供予本所之文件中 的所有签署、盖章及印章都是真实的,所有作为正本提交给本所的文件都是真实、准确、 完整和有效的,且文件材料为副本或复印件的,其与原件一致和相符。 在本法律意见书中,本所仅对本次股东大会召集和召开的程序、出席本次股东大会 人员资格和召集人资格及 ...

证券代码：688578 证券简称：艾力斯 公告编号：2025-011 上海艾力斯医药科技股份有限公司 2024年年度股东大会决议公告 本公司董事会及全体董事保证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。 重要内容提示： 本次会议是否有被否决议案：无 审议结果：通过 一、 会议召开和出席情况 （一） 股东大会召开的时间：2025 年 5 月 14 日 （二） 股东大会召开的地点：上海市浦东新区周浦镇凌霄花路 268 号公司会议 室 （三） 出席会议的普通股股东、特别表决权股东、恢复表决权的优先股股东及 其持有表决权数量的情况： | 1、出席会议的股东和代理人人数 | 170 | | --- | --- | | 普通股股东人数 | 170 | | 2、出席会议的股东所持有的表决权数量 | 276,877,303 | | 普通股股东所持有表决权数量 | 276,877,303 | | 3、出席会议的股东所持有表决权数量占公司表决权数量的比例（%） | 61.5282 | | 普通股股东所持有表决权数量占公司表决权数量的比例（%） | 61.5282 | ...

Core Insights - The pharmaceutical and biotechnology sector in A-shares has revealed significant disparities in employee compensation, with innovative drug companies dominating the highest salary rankings [1][2] Group 1: Highest Employee Compensation - The top ten companies in the pharmaceutical and biotechnology sector for employee compensation in 2024 are primarily innovative drug firms, with BeiGene (百济神州) leading at an average salary of 905,000 yuan [1][2] - Other companies in the top ten include Dizhihua Pharmaceutical (迪哲医药) with 686,700 yuan, Yahui Pharmaceutical (亚虹医药) with 627,400 yuan, and others, with salaries ranging from 480,600 yuan to 905,000 yuan [1][2] Group 2: R&D Personnel Impact - Innovative drug companies have a high proportion of R&D personnel, which contributes to elevated overall salary levels; BeiGene employs approximately 11,100 staff, with 3,905 in R&D, making up about 35% of the workforce [2] - The average salary for R&D personnel at BeiGene is 956,000 yuan, with domestic R&D staff earning 592,000 yuan and international R&D staff earning 1,586,000 yuan [2] Group 3: Lowest Employee Compensation - In contrast, the lowest ten companies in the sector have an average salary as low as 70,500 yuan, with a significant representation from traditional Chinese medicine firms [5][6] - The lowest salaries are reported for companies like Yisheng Pharmaceutical (益盛药业) at 70,500 yuan and others, with the majority of these companies experiencing declines in net profit [5][6] Group 4: Performance Trends - Among the top ten companies, eight have seen an increase in average salaries compared to 2023, with the highest increase at 13.62% for Ailisi (艾力斯) [4] - Ailisi's revenue reached 3.558 billion yuan in 2024, marking a 76.29% increase, while net profit rose by 121.97% to 1.43 billion yuan [4] Group 5: Challenges in the Sector - Companies like Te Yi Pharmaceutical (特一药业) have faced significant challenges, with a 91.9% decline in net profit attributed to changes in marketing strategies and reduced sales of key products [6][7] - The retail pharmacy sector is experiencing a downturn, with companies like Yixin Hall (一心堂) and Shuyuan Pingmin (漱玉平民) reporting over 69% declines in net profit due to increased competition and changes in consumer purchasing behavior [7][8]

Investment Rating - The report assigns a "Buy" rating to the company with a target price of 104.5, compared to the last closing price of 87.32 [1]. Core Insights - The company has established a strong presence in the lung cancer treatment sector, with a product matrix gradually taking shape, primarily centered around the drug Vomeletinib [4][5]. - Vomeletinib has rapidly gained market traction after being included in the national medical insurance directory, with projected commercial revenue of 3.5 billion in 2024 and a profit of 1.4 billion [4]. - The company is expanding its product line through collaborations and new drug developments, aiming to enhance its competitive edge in the lung cancer treatment market [5][19]. Summary by Sections Company Overview - The company has evolved into a comprehensive biopharmaceutical enterprise with capabilities in research, production, and sales since its establishment in 2004 [13][14]. - It has developed a full lifecycle drug research system, successfully launching two first-class new drugs [14]. Product Development and Pipeline - Vomeletinib is the only third-generation EGFR-TKI effective against all four types of EGFR mutations, with ongoing clinical trials for various indications [5][19]. - The company is collaborating with ArriVent to expand Vomeletinib's international market presence, which will further enhance its revenue potential [5][21]. - The introduction of new drugs like KRAS inhibitors and SHP2 inhibitors is expected to complement Vomeletinib and address treatment resistance issues [19][64]. Financial Projections - The company anticipates significant revenue growth, with projected sales of 3.56 billion in 2024, increasing to 7.45 billion by 2027, reflecting a compound annual growth rate of over 100% for Vomeletinib [8][41]. - The net profit is expected to rise from 1.43 billion in 2024 to 2.89 billion in 2027, indicating strong profitability growth [8]. Market Potential - The EGFR-TKI market in China is projected to grow significantly, with a compound annual growth rate of 34.8% from 2017 to 2022, reaching 205 billion by 2027 [46][49]. - The company is well-positioned to capture market share in the rapidly expanding lung cancer treatment sector, particularly with the increasing prevalence of EGFR mutations among patients [45][57].

上海艾力斯医药科技股份有限公司 2024 年年度股东大会会议资料 二零二五年五月 目 录 | 2024 | 年年度股东大会会议须知 - 2 - | | --- | --- | | 2024 | 年年度股东大会会议议程 - 4 - | | 2024 | 年年度股东大会会议议案 - 5 - | | 议案一：关于公司《2024 | 年年度报告》及其摘要的议案 - 5 - | | 议案二：关于公司《2024 | 年度董事会工作报告》的议案 - 6 - | | 附件一：上海艾力斯医药科技股份有限公司 | 2024 年度董事会工作报告 - 7 - | | 议案三：关于公司《2024 | 年度监事会工作报告》的议案 - 12 - | | 附件二：上海艾力斯医药科技股份有限公司 | 年度监事会工作报告 - 2024 13 - | | 议案四：关于公司《2024 | 年度财务决算报告》的议案 - 16 - | | 附件三：上海艾力斯医药科技股份有限公司 | 2024 年度财务决算报告 - 17 - | | 议案五：关于公司《2024 | 年度独立董事述职报告》的议案 - 24 - | | 附件四：上海艾力斯医药科技股份有限公司 ...