Group 1: Company Overview - Ailis is an innovative pharmaceutical company focused on cancer treatment, particularly in the non-small cell lung cancer (NSCLC) sector, with a strong R&D pipeline [3] - The company aims to develop first-in-class and best-in-class drugs to meet unmet clinical needs globally [3] - Ailis reported a significant growth in business performance in the first three quarters of 2023, driven by the inclusion of its core product, Furmetinib, in the national medical insurance directory [4] Group 2: Financial Performance - In the first three quarters of 2023, Ailis expects to achieve a revenue of CNY 1.349 billion, an increase of CNY 0.831 billion, representing a year-on-year growth of 160.52% [4] - The projected net profit attributable to the parent company is CNY 0.397 billion, up CNY 0.343 billion, with a year-on-year increase of 636.61% [4] - The net profit excluding non-recurring gains is expected to be CNY 0.366 billion, an increase of CNY 0.347 billion, reflecting a growth of 1,796.78% year-on-year [4] Group 3: Product Development and Clinical Trials - Furmetinib has received IND approval for multiple clinical trials, including a Phase III trial for first-line treatment of EGFR 20 insertion mutation NSCLC [5][11] - The drug has shown promising results in clinical trials, with an objective response rate (ORR) of 78.6% for the initial treatment group at 240 mg [11] - Furmetinib's safety profile is favorable, with most treatment-related adverse events (TRAEs) being grade 1-2 [11][12] Group 4: Market Strategy and Expansion - Ailis has established a marketing team covering over 1,000 hospitals across 30 provinces, with commercial partners reaching over 2,000 hospitals [10] - The company is actively exploring partnerships to enhance its product pipeline, including collaborations for combination therapies with Furmetinib [16] - Ailis plans to maintain high R&D investment, with CNY 132 million allocated in the first half of 2023, focusing on expanding indications for Furmetinib and developing new drugs [12][13] Group 5: Future Outlook - The company anticipates continued growth in R&D investment in the coming years, particularly in addressing rare mutations and expanding treatment options for NSCLC [13][15] - Ailis is preparing for negotiations to renew medical insurance coverage for Furmetinib, which was first included in 2022 [13] - The company is committed to addressing unmet clinical needs in the lung cancer treatment space, particularly for patients with rare mutations [15]

Financial Performance - The company achieved total revenue of CNY 749 million in the first half of 2023, representing a year-on-year increase of 149.24% [4] - Net profit attributable to the parent company reached CNY 208 million, a growth of 678.69% compared to the previous year [4] - The net profit attributable to the parent company after deducting non-recurring gains and losses was CNY 184 million, up 3,976.33% year-on-year [4] Market Coverage - The company's marketing team has covered over 1,000 hospitals across more than 30 provinces and cities [5] - The commercial partner, Jiangsu Fuxing Pharmaceutical Co., Ltd., has reached over 2,000 hospitals [5] Product Development and Research - The company invested CNY 132 million in R&D in the first half of 2023, with CNY 113 million being expensed and CNY 19.06 million capitalized [8] - As of June 30, 2023, the R&D team comprised 167 members, including 68 with master's degrees and 18 with doctoral degrees [8] Clinical Trials and Efficacy - The FAVOUR study showed an objective response rate (ORR) of 78.6% for the initial treatment group at 240 mg, with a median duration of response (DoR) of 15.2 months [6] - The safety profile of the drug was favorable, with most treatment-related adverse events (TRAEs) being grade 1-2 [7] Regulatory and Market Strategy - The drug was included in the national medical insurance reimbursement list as of March 1, 2023, which is expected to support sales performance for the year [4] - The company plans to continue expanding its R&D investments and product pipeline, focusing on new indications for the drug [8] Competitive Advantages - The drug is recognized for its differentiated competitive advantages, including high efficacy, safety, and a wide therapeutic window [12] - The company is actively pursuing business development opportunities, particularly in the lung cancer field, to enhance its product offerings [11]

2023 年上半年持续督导跟踪报告 中信证券股份有限公司（以下简称"中信证券""保荐机构"）作为上海艾 力斯医药科技股份有限公司（以下简称"艾力斯"或"公司"）首次公开发行股 票并在科创板上市项目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》等相关规定，负责艾力斯上市后 的持续督导工作，并出具 2023 年上半年（以下简称"报告期"）持续督导跟踪 报告。 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 一、持续督导工作情况 | 序号 | 工作内容 | 实施情况 | | --- | --- | --- | | | 建立健全并有效执行持续督导工作制 | 保荐机构已建立健全并有效执行了持续 | | 1 | 度，并针对具体的持续督导工作制定相 | 督导制度，并制定了相应的工作计划。 | | | 应的工作计划。 | | | | 根据中国证监会相关规定，在持续督导 | 保荐机构已与艾力斯签订承销及保荐协 | | | 工作开始前，与上市公司签署持续督导 | 议，该协议明确了双方在持续督导期间 | | 2 | 协议，明确双方在持续督导期间的权利 | 的权利和义务，并报 ...

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：2023-042 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 ...

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《 ...

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 ...

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 ...