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]

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].

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 ...

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].