证券代码：688578 证券简称：艾力斯 公告编号：2023-043 | 股东名称 | 变动方式 | | | 变动日期 | | | 股份种类 | 变动数量（股） | 变动比例（%） | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 唐玉投资 | 集中竞价 | 2023 | 年 | 2 | 月 1 | 日至 | 人民币普通股 | -6,985,215 | 1.55 | | | | 2023 | 年 8 | 月 | 30 | 日 | | | | 上海艾力斯医药科技股份有限公司 关于持股 5%以上股东权益变动超过 1%的提示性公告 股东嘉兴唐玉投资合伙企业（有限合伙）保证向上海艾力斯医药科技股份有限公司提供的 信息不存在任何虚假记载、误导性陈述或者重大遗漏，并对其真实性、准确性和完整性依法承 担法律责任。 公司董事会及全体董事保证公告内容与上述股东提供的信息一致。 重要内容提示： 公司于 2023 年 8 月 31 日收到公司持股 5%以上股东唐玉投资出具的告知函，其自 2023 年 2 月 1 日至 2023 年 8 月 30 日期 ...

Financial Performance - The company reported a total revenue of RMB 500 million for the first half of 2023, representing a 20% increase compared to the same period last year[1]. - The company has provided a revenue guidance of RMB 1.2 billion for the full year 2023, indicating an expected growth of 25%[1]. - The company achieved operating revenue of CNY 749 million in the first half of 2023, representing a 149.24% increase compared to the same period last year, primarily due to the inclusion of Furmetin in the medical insurance system and improvements in the sales team and channels[18]. - Net profit attributable to shareholders reached CNY 208 million, a significant increase of 678.69% year-on-year[18]. - The net profit after deducting non-recurring gains and losses was CNY 184 million, up 3,976.33% from the previous year[18]. - The net cash flow from operating activities was CNY 185 million, an increase of 3,008.89% compared to the same period last year[18]. - Basic earnings per share for the reporting period were CNY 0.46, a 666.67% increase compared to the previous year[19]. - The company reported a total operating revenue of ¥748,674,712.29, a year-on-year increase of 149.24%[91]. - Net profit attributable to the parent company was ¥208,414,161.95, representing a significant increase of 678.69% year-on-year[91]. - The total comprehensive income for the first half of 2023 was ¥210,391,599.63, compared to a total of ¥28,784,671.33 in the same period of 2022, reflecting a substantial increase of approximately 630%[179]. User Growth and Market Expansion - User data indicates a growth in active users, reaching 1.2 million, which is a 15% increase year-over-year[1]. - The company is expanding its market presence in Southeast Asia, with plans to establish partnerships with local distributors by the end of 2023[1]. - The company aims to enhance its market presence through strategic partnerships and collaborations in the oncology sector[9]. Research and Development - New product development includes the launch of a novel targeted therapy, which is expected to enter clinical trials by Q4 2023[1]. - The company is focused on expanding its research into additional mutations and pathways that contribute to tumor growth and resistance[9]. - The company has established a comprehensive R&D pipeline focused on innovative small molecule targeted therapies for non-small cell lung cancer (NSCLC), with multiple new drug projects in preclinical research[24]. - The company has made significant investments in new clinical projects, including first-line treatments for EGFR 20 exon insertion mutations and rare mutations[66]. - The company has filed for 11 new invention patents during the reporting period, bringing the total number of applications to 131, with 84 patents granted[64]. Clinical Trials and Drug Development - The company is advancing its pipeline with new small molecule drugs, emphasizing their potential effectiveness in treating various cancer types[10]. - The company plans to apply for first-line treatment indications for its drug targeting EGFR mutations in adult patients with locally advanced or metastatic NSCLC[10]. - The company is also preparing to submit applications for second-line treatment indications for patients with confirmed EGFR T790M mutations who have progressed after prior EGFR-TKI therapy[10]. - The overall survival (OS) and progression-free survival (PFS) metrics are being closely monitored as key indicators of the drug's clinical efficacy[10]. - The company is conducting single-arm clinical trials to evaluate the effectiveness of its new therapies in real-world settings[10]. - The company is conducting multiple clinical trials to expand Vumonitin's indications, including a Phase III trial for adjuvant therapy in EGFR mutation-positive NSCLC patients[36]. Regulatory and Compliance - The management highlighted potential risks related to regulatory changes that could impact product approvals in the future[1]. - The company is committed to adhering to Good Manufacturing Practices (GMP) to ensure the quality of its drug production[10]. - The company emphasizes compliance in sales management to ensure sustainable development and has optimized its sales strategies for Vomecitin[39]. Environmental and Social Responsibility - The company invested RMB 47.02 million in environmental protection during the reporting period[108]. - The company has established measures to control pollution, including dust collection equipment and professional wastewater treatment facilities[111]. - The company promotes low-carbon awareness among employees and encourages energy-saving practices, contributing to its sustainable development goals[115]. Shareholder and Corporate Governance - The company did not propose any profit distribution or capital reserve transfer plans for the half-year period[105]. - The company has committed to not transferring or managing shares held prior to the public offering for 36 months post-listing, ensuring stable operations and control[118]. - The company will announce any stock reduction plans in compliance with regulations, ensuring transparency in the process[122]. - The company’s profit distribution policy emphasizes continuity and stability, ensuring long-term interests and sustainable development for all shareholders[125].

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 ...

上海艾力斯医药科技股份有限公司（以下简称"公司"）第二届监事会第四 次会议通知于 2023 年 8 月 22 日以邮件等方式送达公司全体监事，会议于 2023 年 8 月 28 日在公司会议室以现场方式召开。本次会议由监事会主席张晓芳女士 召集并主持，应到监事 3 人，实到监事 3 人；本次会议的召集和召开程序符合 《中华人民共和国公司法》等法律法规、规范性文件以及《公司章程》的相关规 定，会议形成的决议合法、有效。 二、 监事会会议审议情况 经与会监事审议，形成如下决议： （一）审议通过《关于公司<2023 年半年度报告>及其摘要的议案》 监事会对公司 2023 年半年度报告及其摘要进行了审核，并发表审核意见如 下： （1）公司 2023 年半年度报告编制和审议程序符合法律法规、公司章程和公 司内部管理制度的各项规定； 证券代码：688578 证券简称：艾力斯 公告编号：2023-039 上海艾力斯医药科技股份有限公司 第二届监事会第四次会议决议公告 本公司监事会及全体监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、监事会会议召开情况 ...

证券代码：688578 证券简称：艾力斯 公告编号：2023-042 上海艾力斯医药科技股份有限公司关于 参加2023 年半年度制药及生物制品行业 集体业绩说明会的公告 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、准确性和完整性依法承担法律责任。 重要内容提示： 投资者可于 2023 年 9 月 5 日（星期二）16:00 前通过公 司 邮 箱 ir@allist.com.cn 将需要了解和关注的问题提前提供给公司。公司将在文字互动环节 对投资者普遍关注的问题进行回答。 上海艾力斯医药科技股份有限公司（以下简称"公司"）于 2023 年 8 月 29 日在上海证券交易所网站（www.sse.com.cn）披露了公司 2023 年半年度报告，为 加强与投资者的深入交流，在上海证券交易所的支持下，公司参与了由上海证券交 易所主办的 2023 年半年度制药及生物制品行业集体业绩说明会，此次活动将采用 视频和线上文字互动的方式举行，投资者可登录上海证券交易所上证路演中心 （http://roadshow.sseinfo.com/）参与线上互动交流。 一、 说明 ...

证券代码：688578 证券简称：艾力斯 公告编号：2023-041 上海艾力斯医药科技股份有限公司 关于开展外汇套期保值业务的公告 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。 重要内容提示： 为有效规避和防范汇率风险或利率风险，增强公司财务稳健性，上海艾 力斯医药科技股份有限公司（以下简称"公司"或"艾力斯"）拟以自有资金开 展总额度不超过 3,000.00 万美元的外汇套期保值业务，自本次董事会审议通过之 日起 12 个月内有效，上述额度在审批期限内可循环滚动使用，开展期限内任一 时点的交易金额（含前述外汇套期保值业务的收益进行再交易的相关金额）不超 过前述总额度。预计动用的交易保证金和权利金上限（包括为交易而提供的担保 物价值、预计占用的金融机构授信额度、为应急措施所预留的保证金等）为 500.00 万美元。 公司于 2023 年 8 月 28 日召开第二届董事会第五次会议审议通过《关于 开展外汇套期保值业务的议案》，同意公司开展外汇套期保值业务。公司独立董 事对前述事项发表了明确同意的独立意见。该事项在董事会审 ...

中信证券股份有限公司关于 上海艾力斯医药科技股份有限公司 随着公司业务规模持续扩大，日常外汇收支金额日益增长。当前受国际政治、 经济变化等因素综合影响，外汇市场波动幅度较大。为有效规避和防范汇率风险 或利率风险，增强公司财务稳健性，公司拟开展外汇套期保值业务。 开展外汇套期保值业务的核查意见 中信证券股份有限公司（以下简称"中信证券"、"保荐机构"）为上海艾 力斯医药科技股份有限公司（以下简称"公司"、"艾力斯"）首次公开发行股 票并上市的持续督导保荐机构。根据《证券发行上市保荐业务管理办法》《上海 证券交易所科创板股票上市规则》等有关规定，对艾力斯开展外汇套期保值业务 事项进行了核查，核查情况及核查意见如下： 一、开展外汇套期保值业务的背景 公司用于开展外汇套期保值业务的资金来源为公司自有资金，不涉及使用募 集资金的情形。 （三）交易方式 1、交易品种：公司将按照外汇套期保值原则和汇率风险中性管理原则，根 据合同需要灵活选择货币互换、远期结售汇、货币掉期、利率互换、结构性远期 等结构相对简单透明、流动性强、风险可认知、市场有公开参考价格、不超过 12 个月的外汇衍生工具，不从事复杂嵌套、与不可控因素挂钩的外 ...

公司 2023 年半年度募集资金存放与使用情况符合《上市公司监管指引第 2 号—上市公司募集资金管理和使用的监管要求》《上海证券交易所科创板上市公 司自律监管指引第 1 号—规范运作》以及公司《募集资金管理制度》等法律法规、 规范性文件和公司制度的规定，对募集资金进行了专户存储和专项使用，并及时 履行了相关信息披露义务，募集资金具体使用情况与公司已披露情况一致，不存 在变相改变募集资金用途和损害股东利益的情况，不存在违规使用募集资金的情 况。 上海艾力斯医药科技股份有限公司独立董事 关于第二届董事会第五次会议相关事项的独立意见 上海艾力斯医药科技股份有限公司（以下简称"公司"）于 2023 年 8 月 28 日召开公司第二届董事会第五次会议。根据《中华人民共和国公司法》等法律法 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》"） 的相关规定,我们作为公司的独立董事，在仔细审阅有关文件资料后，对公司第二 届董事会第五次会议审议的相关事项，基于独立判断的立场，发表如下独立意见： 一、《关于公司<2023 年半年度募集资金存放与实际使用情况专项报告>的议 案》的独立意见 综上所述，我们一致同意《 ...

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 ...

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 reported a significant increase in revenue for 2022, reaching RMB 1.5 billion, representing a year-over-year growth of 25% [10]. - 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]. - Basic earnings per share for 2022 were CNY 0.29, a 625.00% increase from CNY 0.04 in 2021 [21]. - The total assets of the company at the end of 2022 were CNY 3,442,172,227.84, reflecting a 9.96% increase from CNY 3,130,259,503.93 in 2021 [20]. - The weighted average return on net assets for 2022 was 4.24%, an increase of 3.62 percentage points from 0.62% in 2021 [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]. Research and Development - The company is actively developing new products, including the third-generation EGFR-TKI, with a focus on late-stage non-small cell lung cancer treatment [10]. - Research and development efforts are focused on innovative drugs, with a pipeline that includes several first-in-class and best-in-class candidates [11]. - The company has established partnerships with Contract Research Organizations (CROs) to enhance its drug development capabilities [10]. - The company is focused on obtaining conditional approval for drugs that treat severe life-threatening diseases with no effective treatment options [14]. - The company aims to apply for priority review for drugs that are clinically urgent, such as innovative drugs for major infectious diseases and rare diseases [14]. - The company is dedicated to enhancing its research and development capabilities to improve drug efficacy and safety [12]. - The R&D investment for 2022 was CNY 191,750,085.89, a decrease of 13.86% from the previous year, with R&D expenses accounting for 24.24% of operating revenue [23]. - The company is focused on real-world studies to gather evidence applicable to clinical practice [13]. - The company has a comprehensive drug development system covering all stages from drug discovery to commercialization [42]. - The company has received NDA approval for AST-NI1901, which targets adult patients with specific EGFR mutations in non-small cell lung cancer (NSCLC) [126]. - The company has a diverse pipeline with multiple products in various stages of development, including both approved and investigational drugs targeting NSCLC [125][126]. Market Strategy and Expansion - Future guidance suggests an expected revenue growth of 30% for 2023, driven by new product launches and market expansion strategies [10]. - The company plans to expand its market presence in North America and Europe, targeting a 15% market share in these regions by 2025 [10]. - The company has established a marketing team of nearly 650 members to enhance the promotion of Furmonertinib [33]. - An exclusive promotion agreement was signed with Jiangsu Fosun Pharmaceutical Sales Co., Ltd., covering over 2,000 hospitals to expand market reach [34]. - The company is actively recruiting talent with international pharmaceutical experience to strengthen its workforce [36]. - The company aims to enrich its R&D product pipeline by continuously investing in product development and exploring new targets and compounds [141]. - The company will enhance its marketing capabilities by recruiting a strong marketing team and focusing on professional academic promotion to boost drug sales [140]. Clinical Trials and Product Development - The ongoing clinical trials for its lead product are expected to complete by Q4 2023, with potential market approval in early 2024 [10]. - The company plans to apply for first-line treatment indications for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or L858R mutations [12]. - The second-line treatment indication targets adult patients with locally advanced or metastatic NSCLC who have progressed after EGFR-TKI treatment and have confirmed EGFR T790M mutations [13]. - 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 after radical resection [13]. - Furmonertinib demonstrated a median progression-free survival (PFS) of 20.8 months in first-line treatment for advanced NSCLC, significantly extending PFS compared to Gefitinib (11.1 months) with a risk reduction of 56% [44]. - The overall response rate (ORR) for Furmonertinib in second-line treatment for advanced NSCLC was reported at 74%, with a disease control rate (DCR) of 94% [45]. - Furmonertinib showed a CNS ORR of 84.6% and a CNS PFS of 19.3 months in patients with CNS metastases, indicating strong efficacy in this challenging patient population [46]. Governance and Compliance - The company has not disclosed any special arrangements for corporate governance [5]. - The company emphasizes that forward-looking statements do not constitute substantive commitments to investors, highlighting investment risks [5]. - The board of directors has confirmed that all members attended the board meeting [4]. - The company has not reported any instances where more than half of the directors could not guarantee the authenticity, accuracy, and completeness of the annual report [5]. - The company has not faced any penalties from securities regulatory authorities in the past three years [162]. - The company has a commitment to ensuring the confidentiality of sensitive remuneration information for its key personnel [150]. - The company has established a compensation and assessment committee as of November 28, 2019, to review and formulate the remuneration policies for directors and management [160]. Environmental and Social Responsibility - The company invested 1.75 million RMB in environmental protection during the reporting period [194]. - The company is committed to ESG practices, enhancing internal governance and ensuring compliance with environmental laws [194]. - The company promotes green office practices and energy-saving actions, aiming to reduce electricity and water resource consumption through centralized office management and electronic processes [199]. - Major pollutants include waste gas, wastewater, noise, general solid waste, and hazardous solid waste, with specific management measures in place such as dust collection equipment and professional wastewater treatment facilities [200].