证券代码：688578 证券简称：艾力斯 公告编号：2023-040 上海艾力斯医药科技股份有限公司 2023年半年度募集资金存放与实际使用情况专项报告 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。 根据中国证券监督管理委员会于 2020 年 10 月 12 日签发的证监许可 [2020]2559 号文《关于同意上海艾力斯医药科技股份有限公司首次公开发行股票 注册的批复》，公司在境内首次公开发行 90,000,000 股人民币普通股 A 股股票， 每股发行价格为人民币 22.73 元，股款以人民币缴足，计人民币 2,045,700,000.00 元，扣除承销及保荐费用、律师费、审计验资费、信息披露费以及其他发行手续 费共计人民币 113,150,354.39 元（不含增值税），净募集资金共计人民币 1,932,549,645.61 元（以下简称"募集资金"），上述资金于 2020 年 11 月 25 日到 位，业经普华永道中天会计师事务所（特殊普通合伙）予以验证并出具普华永道 中天验字（2020）第 1031 号验资报告 ...

证券代码：688578 证券简称：艾力斯 公告编号：2023-038 上海艾力斯医药科技股份有限公司自愿披露关于 伏美替尼用于具有 EGFR PACC 突变或 EGFR L861Q 突变 的局部晚期或转移性 NSCLC 成人患者的一线治疗 III 期临 床试验获得药物临床试验批准通知书的公告 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。 1 （Polymerase Chain Reaction，PCR），预计会检测到更多携带非经典 EGFR 突变 的患者，这可能会增加 EGFR PACC 突变的总体检出率。 重要内容提示： 上海艾力斯医药科技股份有限公司（以下简称"公司"）于近日收到国家 药品监督管理局核准签发的《药物临床试验批准通知书》，甲磺酸伏美替尼片 （以下简称"伏美替尼"）适用于具有 EGFR PACC突变或 EGFR L861Q突变的 局部晚期或转移性非小细胞肺癌（NSCLC）成人患者的一线治疗 III 期临床试验 获得药物临床试验批准。现将相关情况公告如下： 一、基本情况 | 药品名称 | 甲磺酸伏美替尼片 ...

公司代码：688578 公司简称：艾力斯 2022 年年度报告 上海艾力斯医药科技股份有限公司 2022 年年度报告 1 / 213 2022 年年度报告 重要提示 一、 本公司董事会、监事会及董事、监事、高级管理人员保证年度报告内容的真实性、准确性、 完整性，不存在虚假记载、误导性陈述或重大遗漏，并承担个别和连带的法律责任。 二、 公司上市时未盈利且尚未实现盈利 □是 √否 三、 重大风险提示 公司已在本报告中详细阐述在经营过程中可能面临的各种风险因素，具体请查阅本报告"第 三节 管理层讨论与分析"之"四、风险因素"。 四、 公司全体董事出席董事会会议。 五、 普华永道中天会计师事务所（特殊普通合伙）为本公司出具了标准无保留意见的审计报告 六、 公司负责人杜锦豪、主管会计工作负责人王林及会计机构负责人（会计主管人员）王林声明： 保证年度报告中财务报告的真实、准确、完整。 七、 董事会决议通过的本报告期利润分配预案或公积金转增股本预案 公司2022年度利润分配预案为：不派发现金红利，不送股，不以资本公积金转增股本。以上 利润分配预案已经公司第二届董事会第二次会议审议通过，尚需公司2022年年度股东大会审议通 ...

2023 年第一季度报告 单位：元 币种：人民币 1 / 14 证券代码：688578 证券简称：艾力斯 上海艾力斯医药科技股份有限公司 2023 年第一季度报告 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。 重要内容提示 公司董事会、监事会及董事、监事、高级管理人员保证季度报告内容的真实、准确、完整，不存 在虚假记载、误导性陈述或重大遗漏，并承担个别和连带的法律责任。 公司负责人、主管会计工作负责人及会计机构负责人（会计主管人员）保证季度报告中财务信息 的真实、准确、完整。 第一季度财务报表是否经审计 □是 √否 一、 主要财务数据 (一)主要会计数据和财务指标 | --- | --- | --- | --- | |-----------------------------------------------|------------------|------------------|---------------------------------------| | 项目 | 本报告期 | | 本报告期比上年同期增减 ...

证券代码：688578 证券简称：艾力斯 公告编号：2023-031 上海艾力斯医药科技股份有限公司 关于召开 2022 年度暨 2023 年第一季度业绩说明会的公告 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、准确性和完整性承担个别及连带责任。 重要内容提示： 投资者可于 2023 年 5 月 4 日（星期四）至 5 月 10 日（星期三）16:00 前登录 上证路演中心网站首页，点击"提问预征集"栏目，或通过公司邮箱 ir@allist.com.cn 进行提问。上海艾力斯医药科技股份有限公司（以下简称"公 司"）将在说明会上对投资者普遍关注的问题进行回答。 公司已于 2023 年 4 月 27 日、2023 年 4 月 29 日在上海证券交易所网站 （www.sse.com.cn）披露了公司 2022 年年度报告及 2023 年第一季度报告，为加 强与投资者的深入交流，在上海证券交易所的支持下，公司计划于 2023 年 5 月 11 日（星期四）下午 15:00-16:30 举行 2022 年度暨 2023 年第一季度业绩说明会， 就投资者关心的问 ...

Financial Performance - The company reported a profit distribution plan for 2022, which includes no cash dividends, no stock bonuses, and no capital reserve transfers to increase share capital[4]. - The company has not achieved profitability since its listing[3]. - The audit report issued by PwC confirms the financial statements are true, accurate, and complete[4]. - The company's operating revenue for 2022 was CNY 791,002,454.27, representing a 49.22% increase compared to CNY 530,094,158.47 in 2021[20]. - The net profit attributable to shareholders for 2022 was CNY 130,520,677.23, a significant increase of 614.22% from CNY 18,274,567.01 in the previous year[20]. - The net cash flow from operating activities reached CNY 91,629,611.67, up 212.82% from CNY 29,291,075.24 in 2021[20]. - The company achieved sales revenue of CNY 790,323,498.88 from the product Fumetin, marking a 235.29% increase compared to the previous year[22]. - Basic earnings per share for 2022 were CNY 0.29, a 625.00% increase from CNY 0.04 in 2021[21]. - The weighted average return on net assets was 4.24%, an increase of 3.62 percentage points compared to 0.62% in the previous year[21]. - The company reported a net profit of CNY 79,374,984.63 after deducting non-recurring gains and losses, marking a turnaround from a loss in the previous year[22]. - Total assets at the end of 2022 were CNY 3,442,172,227.84, a 9.96% increase from CNY 3,130,259,503.93 at the end of 2021[20]. - The company's net assets attributable to shareholders increased to CNY 3,187,055,657.81, reflecting a 7.19% growth from CNY 2,973,264,920.91 in 2021[20]. Research and Development - The company plans to invest RMB 200 million in research and development for innovative drugs over the next two years[10]. - Research and development expenses totaled CNY 191,750,085.89, a decrease of 13.86% year-over-year, with R&D expenses accounting for 24.24% of operating revenue[23]. - The company has multiple new drug candidates in preclinical research, with plans to submit IND applications for these projects in the future[41]. - The company is currently in the preclinical stage for the KRAS G12D inhibitor, with a cumulative investment of ¥5,719.64 million[79]. - The company has established a complete new drug research and development system, focusing on innovative drug development as its core strategy[72]. - The company has a strong pipeline with multiple products in various stages of development, indicating a commitment to expanding its oncology portfolio[122]. Product Development and Market Strategy - The company is advancing its core product, Vomeletinib, which is a third-generation EGFR-TKI, aimed at treating advanced non-small cell lung cancer (NSCLC) with EGFR mutations[10]. - Future guidance includes an expected revenue growth of 30% for 2023, driven by the anticipated launch of new products and market expansion strategies[10]. - The company is focusing on expanding its market presence in North America and Europe, targeting a 15% market share in these regions by 2025[10]. - The company is exploring potential mergers and acquisitions to bolster its product pipeline and expand its therapeutic offerings[10]. - The company aims to complete ongoing research and submit for conditional approval for drugs that address severe life-threatening diseases with no effective treatments available[14]. - The company is focused on obtaining priority review for innovative drugs that are urgently needed for major infectious diseases and rare diseases[14]. - The company is conducting a randomized, double-blind, placebo-controlled Phase III trial to compare the efficacy and safety of the drug in patients with EGFR mutation-positive NSCLC[13]. Corporate Governance - The company has not disclosed any special arrangements for corporate governance[5]. - The company has established a governance structure that complies with relevant laws and regulations, ensuring effective operation and management[141]. - The company held its first extraordinary general meeting of 2022 on March 28, 2022, where four proposals, including the election of non-independent directors, were approved[143]. - The annual report for 2022 indicates that the company has maintained its governance structure without any significant changes in the reporting period[144]. - The company has a total of 10 directors, with 5 being independent directors, ensuring a balanced governance structure[146]. - The company has not engaged in any significant related-party transactions that could affect its independence[145]. - The company has established specialized committees under the board, including audit, nomination, compensation, and strategic committees[167]. Environmental and Social Responsibility - The company invested 1.75 million yuan in environmental protection during the reporting period, demonstrating its commitment to sustainable practices[192]. - The company is not listed as a key pollutant discharge unit by the Shanghai Environmental Protection Department, indicating compliance with environmental regulations[193]. - The company has not faced any administrative penalties related to environmental issues during the reporting period, reflecting its adherence to environmental laws[194]. - The company has implemented carbon reduction measures, resulting in a decrease of approximately 60 tons of CO2 equivalent emissions annually[200]. - The company has established a new 64KW solar water heating system for the cafeteria and showers, expected to save 60,000 KW.H of electricity per year[200]. - The company promotes green office practices and resource conservation to enhance efficiency in electricity and water usage[197]. Market and Competitive Landscape - The domestic anti-tumor drug market reached RMB 28.1 billion in 2019, growing 46.35% from RMB 19.2 billion in 2016, with projections to exceed RMB 101.8 billion by 2030[60]. - The non-small cell lung cancer market in China grew from RMB 17.2 billion in 2016 to RMB 44.9 billion in 2020, with expectations to reach RMB 118.6 billion by 2025[62]. - The global anti-tumor drug expenditure was approximately USD 143.4 billion in 2019, with a year-on-year growth of 11.9%[59]. - The company faces risks related to reliance on a single product, Vorinostat, which may limit its operational sustainability[88]. - The competitive landscape for Vorinostat includes several approved and in-development third-generation EGFR-TKIs, increasing market competition risks[88]. Employee and Talent Management - The company emphasizes talent acquisition and training to strengthen its workforce in R&D and sales[36]. - The total number of employees in the parent company is 393, while the total number of employees in major subsidiaries is 477, resulting in a combined total of 870 employees[173][174]. - The company has implemented a competitive compensation policy that considers internal equity and industry standards, providing various benefits and incentives to attract and retain talent[176]. - A digital learning platform named "Aixuetang" was launched in 2021 to enhance employee training and development, offering various courses and resources[179]. Risk Management - The company has detailed various risk factors it may face during operations in the report[4]. - The report includes a forward-looking statement risk declaration, indicating that future plans and strategies do not constitute a substantive commitment to investors[5]. - The company is exposed to potential regulatory changes in the pharmaceutical industry, which could adversely affect its operations[90]. - If Vorinostat is removed from the medical insurance catalog, it may significantly impact its market share and sales revenue[91].