Aidea Pharma(688488)
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艾迪药业:江苏世纪同仁律师事务所关于江苏艾迪药业股份有限公司2023年第二次临时股东大会的法律意见书
2023-08-16 09:42
江苏世纪同仁律师事务所 关于江苏艾迪药业股份有限公司 2023 年第二次临时股东大会的 法 律 意 见 书 江苏艾迪药业股份有限公司: 根据《中华人民共和国公司法》(以下简称"《公司法》")、《中华人民 共和国证券法》《上市公司股东大会规则》和《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》等法律、法规和规范性文件以及《公司章程》 的规定,本所受公司委托,指派本所律师出席公司 2023年第二次临时股东大会, 并就本次股东大会的召集、召开程序、出席会议人员资格、召集人资格、表决程 序以及表决结果的合法有效性等事项出具法律意见。 为出具本法律意见书,本所律师对本次股东大会所涉及的有关事项进行了审 查,查阅了相关会议文件,并对有关问题进行了必要的核查和验证。 本所律师同意将本法律意见书随公司本次股东大会决议一并公告,并依法对 本法律意见书承担相应的责任。 本所律师根据相关法律、法规和规范性文件的要求,按照律师行业公认的业 务标准、道德规范和勤勉尽责精神,出具法律意见如下: 一、关于本次股东大会的召集、召开程序 1、本次股东大会的召集 本次股东大会由董事会召集。2023年7月31日,公司召开了第 ...
艾迪药业:艾迪药业2023年第二次临时股东大会决议公告
2023-08-16 09:40
证券代码:688488 证券简称:艾迪药业 公告编号:2023-036 江苏艾迪药业股份有限公司 2023 年第二次临时股东大会决议公告 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 一、 会议召开和出席情况 (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 | 12 | | --- | --- | | 普通股股东人数 | 12 | | 2、出席会议的股东所持有的表决权数量 | 31,938,186 | | 普通股股东所持有表决权数量 | 31,938,186 | | 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 | 13.9524 | | (%) | | | 普通股股东所持有表决权数量占公司表决权数量的比例(%) | 13.9524 | (四) 表决方式是否符合《公司法》及公司章程的规定,大会主持情况等。 本次股东大会由公司董事会召集,董事长傅和亮先生主持,采用现场投票与 (一) ...
艾迪药业:艾迪药业2023年第二次临时股东大会会议资料
2023-08-08 08:14
江苏艾迪药业股份有限公司 2023 年第二次临时股东大会会议资料 二○二三年八月 江苏艾迪药业股份有限公司 2023 年第二次临时股东大会会议资料 江苏艾迪药业股份有限公司 2023 年第二次临时股东大会会议资料目录 | 2023年第二次临时股东大会会议须知 3 | | --- | | 2023年第二次临时股东大会会议议程 5 | | 2023年第二次临时股东大会会议议案 6 | | 议案1 关于增加2023年度日常关联交易额度预计的议案 6 | 2 江苏艾迪药业股份有限公司 2023 年第二次临时股东大会会议资料 江苏艾迪药业股份有限公司 2023 年第二次临时股东大会会议须知 为了维护全体股东的合法权益,确保公司股东大会的正常秩序和议事效率, 根据《中华人民共和国公司法》《中华人民共和国证券法》《上市公司股东大会规 则(2022 年修订)》《江苏艾迪药业股份有限公司章程》和《江苏艾迪药业股份有 限公司股东大会议事规则》等相关规定,制订以下会议须知,请出席股东大会的 全体人员遵照执行。 一、会议期间,全体出席人员应以维护股东的合法权益、保证大会的正常秩 序和议事效率为原则,认真履行法定义务,自觉遵守大会纪律 ...
艾迪药业(688488) - 2022 Q4 - 年度财报
2023-05-31 16:00
Financial Performance - The company reported a loss of approximately 124.20 million yuan for the period, indicating a significant financial downturn [4]. - The company's operating revenue for 2022 was ¥244,219,269.82, a decrease of 4.49% compared to ¥255,709,508.81 in 2021 [25]. - The net profit attributable to shareholders of the listed company for 2022 was -¥124,202,733.73, compared to -¥29,985,621.49 in 2021, indicating a significant loss [25]. - The net cash flow from operating activities was -¥92,554,664.86 in 2022, a decline from -¥12,371,065.29 in 2021 [25]. - The company has not achieved profitability since its listing, which poses ongoing financial risks [4]. - The company reported a decrease in revenue from core business activities, with a total of ¥242,860,347.08 in 2022, down 4.75% from ¥254,972,066.18 in 2021 [25]. - The company experienced a cash flow deficit from operating activities of approximately -92.55 million yuan, compared to -12.37 million yuan in the previous year [123]. - The company reported a significant increase in asset impairment losses and credit impairment losses totaling approximately 36.30 million yuan, impacting overall profitability [120]. Revenue Sources - Revenue from human-derived protein business was approximately 143.42 million yuan, a decrease of about 25.82% compared to the previous year [6]. - The company’s revenue from human protein products is currently its main income source, while it is also expanding its pipeline of human protein formulations [68]. - The company achieved operating revenue of 244.22 million yuan in 2022, with a quarter-on-quarter increase in revenue, driven by rapid growth in HIV innovative drug sales and other pharmaceutical sales [38]. - The HIV new drug (Ainovelin tablets) generated revenue of CNY 33.50 million, a year-on-year increase of 2,352.50%, with a gross margin of 57.51%, an increase of 13.39 percentage points [125]. - The company’s total revenue from domestic sales was CNY 242.85 million, a decrease of 3.50% year-on-year, with a gross margin of 42.91%, an increase of 9.68 percentage points [126]. Research and Development - The company plans to increase R&D investment in the fields of anti-HIV new drug development and human-derived protein formulations [5]. - Research and development (R&D) expenses accounted for 37.14% of operating revenue, an increase of 7.17 percentage points from the previous year [28]. - The total R&D investment for the year was ¥90,703,657.61, an increase of 18.37% compared to the previous year, with a significant rise in expense-based R&D investment by 46.22% to ¥63,907,634.83 [86][87]. - The company has 21 projects in its pipeline, including 8 Class 1 new drugs and 3 Class 2 new drugs [49]. - The company is actively pursuing innovative business models to enhance its commercialization efforts in the HIV treatment sector [51]. - The company is developing generic drugs for Darunavir and Dolutegravir to meet diverse clinical needs and expand its product offerings in the HIV treatment market [43]. - The company is advancing the clinical trial of ACC008, a drug for treated patients, with 762 participants enrolled and data analysis currently underway [42]. Market Position and Strategy - The company is focusing on expanding its market presence overseas and strengthening its commercialization team in 2023 [107]. - The domestic anti-HIV drug market is expected to exceed 11 billion yuan by 2027, driven by increasing patient numbers and improved treatment rates [71]. - The company is leveraging industry policies that promote innovation and development in the pharmaceutical sector, enhancing its research capabilities and product offerings [69]. - The company has established a leading position in the human protein industry, supported by over ten years of industry experience and proprietary technology [77]. - The company is actively involved in the HIV diagnostics market, participating in tenders and price negotiations to secure orders from hospitals and disease control centers [66]. Governance and Compliance - The company held a total of 6 shareholder meetings in 2022, including 1 annual and 5 extraordinary meetings [200]. - All meetings complied with legal regulations and the company's articles of association, ensuring proper governance [200]. - The company implemented measures to protect minority shareholders' rights, including independent director voting and separate counting for small investors [200]. - No incidents of infringement on minority shareholders' rights occurred during the meetings [200]. Challenges and Risks - The company faces risks related to the uncertainty of new drug development timelines and potential increases in R&D expenditures [5]. - The company is heavily reliant on Nanda Pharmaceutical for its human-derived protein business, which poses a risk if the partnership weakens [116]. - The company anticipates potential delays in the implementation of fundraising investment projects due to the complexity and regulatory scrutiny of innovative drug development [113]. - The regulatory environment is tightening, which may lead to the exit of less competitive companies, while compliant firms will gain more development space [188].
艾迪药业(688488) - 2023 Q1 - 季度财报
2023-04-24 16:00
Financial Performance - The company's revenue for Q1 2023 reached ¥112,621,308.59, representing a significant increase of 220.85% compared to the same period last year[4] - Net profit attributable to shareholders was ¥486,169.74, while the net profit after deducting non-recurring gains and losses was -¥5,449,520.91[4] - Total operating revenue for Q1 2023 reached CNY 112,621,308.59, a significant increase from CNY 35,101,031.38 in Q1 2022, representing a growth of 220.5%[21] - Net profit for Q1 2023 was CNY 486,169.74, a recovery from a net loss of CNY 22,302,749.04 in Q1 2022[22] - The company reported a gross profit margin of approximately 57.5% for Q1 2023, compared to 30.0% in Q1 2022[22] Cash Flow - The net cash flow from operating activities was -¥56,422,901.15, indicating increased cash outflows compared to the previous year[4] - Cash inflow from operating activities for Q1 2023 was CNY 67,546,626.96, a decrease of 18.8% from CNY 83,211,064.39 in Q1 2022[26] - Net cash outflow from operating activities was CNY -56,422,901.15, compared to CNY -25,653,518.27 in the same period last year[26] - Cash inflow from investment activities increased significantly to CNY 423,235,853.56 in Q1 2023, up from CNY 184,550,729.26 in Q1 2022[26] - Net cash flow from investment activities was CNY 101,645,922.92, a turnaround from a net outflow of CNY -210,694,569.73 in Q1 2022[26] - Cash inflow from financing activities was CNY 52,400,000.00, slightly up from CNY 50,000,000.00 in Q1 2022[27] - The total cash and cash equivalents at the end of Q1 2023 was CNY 186,643,934.15, compared to CNY 237,639,377.81 at the end of Q1 2022[27] Assets and Liabilities - Total assets at the end of the reporting period were ¥1,697,708,847.37, reflecting a 2.57% increase from the end of the previous year[5] - Total liabilities increased to CNY 495,282,021.64 in Q1 2023 from CNY 456,230,439.66 in Q1 2022, marking an increase of 8.6%[19] - The company’s total current assets reached CNY 827.82 million, slightly up from CNY 802.46 million at the end of the previous year[16] - The company’s long-term equity investments were reported at CNY 90.58 million[17] - The company has long-term borrowings of 60,000,000.00, indicating reliance on debt financing[31] Research and Development - R&D investment totaled ¥15,488,455.18, which decreased by 22.78% year-on-year, and accounted for 13.75% of revenue, a reduction of 43.39 percentage points[4][7] - Research and development expenses for Q1 2023 were CNY 9,828,619.27, down from CNY 13,727,379.60 in Q1 2022, indicating a decrease of 28.5%[22] Company Developments - The company received approval for its innovative drug AINOMI tablets, marking a significant milestone in the HIV treatment field[12] - The company aims to enhance its product pipeline and maintain its first-mover advantage in the HIV treatment sector with the launch of AINOMI tablets[13] - The company has strengthened its talent pool by hiring several senior management personnel, including a Chief Operating Officer and a Chief Medical Officer[14] Financial Reporting - The company did not conduct an audit for the Q1 financial statements[3] - The report was published by the board of directors on April 24, 2023, indicating the date of financial disclosure[31] - The company implemented new accounting standards starting January 1, 2023, affecting the financial statements[27]
艾迪药业:艾迪药业关于召开2022年度暨2023年第一季度业绩说明会的公告
2023-04-19 08:48
证券代码:688488 证券简称:艾迪药业 公告编号:2023-021 江苏艾迪药业股份有限公司 关于召开 2022 年度暨 2023 年第一季度业绩说明会 的公告 本次投资者说明会以网络互动形式召开,公司将针对 2022 年度 及 2023 年第一季度的经营成果及财务指标的具体情况与投资者进行 互动交流和沟通,在信息披露允许的范围内就投资者普遍关注的问题 进行回答。 二、说明会召开的时间、地点 (一)会议召开时间:2023 年 4 月 27 日下午 16:00-17:00 (二)会议召开地点:上证路演中心 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: 会议召开方式:上证路演中心网络互动 投资者可于 2023 年 4 月 20 日(星期四)至 4 月 26 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 ad@aidea.com.cn 进行提问。公司将在说明会上对投资者普遍 关注的问题进行回答。 江苏艾迪药业股份有限公司(以下简称"公司")已于 2023 年 ...
艾迪药业(688488) - 2022 Q4 - 年度财报
2023-04-14 16:00
Financial Performance - The company reported a loss of approximately 124.20 million yuan for the period, indicating a significant financial downturn [4]. - The company's operating revenue for 2022 was ¥244,219,269.82, a decrease of 4.49% compared to ¥255,709,508.81 in 2021 [26]. - The net profit attributable to shareholders of the listed company for 2022 was -¥124,202,733.73, compared to -¥29,985,621.49 in 2021 [26]. - The net cash flow from operating activities for 2022 was -¥92,554,664.86, a significant decline from -¥12,371,065.29 in 2021 [26]. - The company reported a decrease in revenue from main business activities, with adjusted operating revenue of ¥242,860,347.08, down 4.75% from ¥254,972,066.18 in 2021 [26]. - The basic and diluted earnings per share for 2022 were both -0.30 CNY, a significant decline compared to -0.07 CNY in 2021, indicating a year-over-year loss increase of 328.57% [28]. - The net profit attributable to shareholders decreased by 314.21%, primarily due to an increase in sales and management expenses by 79.33 million CNY and a rise in asset impairment losses by 36.30 million CNY [28]. - The cash flow from operating activities showed a net outflow increase of 648.15%, attributed to decreased sales revenue and increased cash expenses [28]. Sales and Revenue - Sales of human-derived protein products amounted to about 143.42 million yuan, a decrease of approximately 25.82% compared to the previous year [6]. - The company achieved operating revenue of 244.22 million yuan in 2022, with a quarter-on-quarter increase in revenue, driven by rapid growth in HIV innovative drug sales and other pharmaceutical sales [38]. - The company reported a total revenue of 110.14 million CNY in Q4 2022, with a net loss attributable to shareholders of -47.21 million CNY for the same quarter [30]. - The revenue from human-derived protein business was approximately 143.42 million yuan, down 25.82% year-on-year, primarily due to sales to Nanda Pharmaceutical and Henan Eureka Biotechnology [121]. - The company’s revenue from human-derived protein products is currently its main income source, while it is also expanding its pipeline of human-derived protein formulations [68]. Research and Development - The company plans to increase R&D investment in the development of anti-HIV drugs and human-derived protein formulations, which may lead to higher R&D expenses and further losses [5]. - Research and development expenses accounted for 37.14% of operating revenue, an increase of 7.17 percentage points from the previous year, highlighting the company's focus on new product development [28]. - The total R&D investment for the year was CNY 90,703,657.61, an increase of 18.37% compared to the previous year, with a significant rise in expense-based R&D investment by 46.22% to CNY 63,907,634.83 [86][87]. - The company has a robust pipeline with 8 Class 1 new drugs and 3 Class 2 new drugs under development, covering various treatment areas including HIV and inflammation [105]. - The company is actively expanding its product offerings to improve patient compliance and convenience in HIV treatment [91]. Drug Development and Pipeline - The innovative drug AINOMITAB tablets received approval for marketing on December 30, 2022, marking a significant milestone in HIV treatment in China [39]. - The company is advancing its pipeline with ongoing clinical trials for ACC008 and ACC017, with 762 participants enrolled in the ACC008 trial as of March 2022 [42]. - The company is developing generic drugs for Darunavir and Dolutegravir to enhance its product offerings in the HIV treatment market [43]. - The company is conducting a Phase III clinical trial for the combination drug ACC008, which targets previously treated patients, with 762 participants enrolled [52]. - The company aims to enhance drug safety and provide better options for HIV patients through its innovative drug development pipeline [91]. Operational Challenges and Risks - The company is facing risks related to the uncertainty of new drug development timelines and potential increases in operational costs [4]. - The company has not achieved profitability since its listing, which poses ongoing financial risks [4]. - The company is at risk of delays in the implementation of fundraising investment projects due to the high costs and complexities associated with innovative drug development [113]. - The company anticipates that the commercialization of its innovative HIV drugs may not meet expectations due to the early stage of market acceptance [115]. - The company is facing risks related to new drug development not meeting expectations and potential competition in the human protein field [109][108]. Market Position and Strategy - The domestic anti-HIV drug market is expected to exceed 11 billion yuan by 2027, driven by increasing patient numbers and improved treatment rates [71]. - The company is focusing on expanding its market presence in India for human protein products, aiming to increase production capacity [45]. - The company is actively pursuing the development of human-derived protein products, with ongoing research in anti-inflammatory drugs and stroke treatments [54]. - The company is preparing to submit clinical research application materials to the FDA for ADB115, aimed at providing new treatment options for acute pancreatitis in the U.S. [93]. - The company is focusing on the HIV field and human-derived protein sector, with plans to accelerate the commercialization of innovative HIV drugs and expand its research pipeline [184]. Financial Management and Investments - The company has not utilized its bank credit line of 80 million yuan, indicating potential for future financing [107]. - The company signed a framework cooperation agreement with its subsidiary to jointly develop antiviral 3CL protease inhibitors, with the project currently in the preclinical stage [56]. - The company received an initial payment of 30 million yuan for the technology transfer of the anti-tumor pipeline project ACC006, which was officially effective after shareholder approval [57]. - The company has established a procurement system for raw materials, including human-derived proteins and pharmaceutical preparations, ensuring supplier evaluation and management [59]. - The company has made significant equity investments totaling 87,750,000 RMB, a 706.66% increase from the previous year's investment of 10,878,197.28 RMB [178].
艾迪药业(688488) - 2022年6月投资者关系活动记录表
2022-11-17 14:22
投资者关系活动记录表 1 股票名称:艾迪药业 股票代码:688488 编号:2022-001 | --- | --- | --- | |-----------------------|------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- ...
艾迪药业(688488) - 2022 Q3 - 季度财报
2022-10-28 16:00
2022 年第三季度报告 证券代码:688488 证券简称:艾迪药业 江苏艾迪药业股份有限公司 2022 年第三季度报告 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。 第三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 单位:元 币种:人民币 | 项目 | 本报告期 | 本报告期 | | 年初至报告期 | | --- | --- | --- | --- | --- | | | | 比上年同 | 年初至报告期 | 末比上年同期 | | | | 期增减变 | 末 | 增减变动幅度 | | | | 动幅度(%) | | (%) | | 营业收入 | 60,301,417.27 | 14.63 | 134,080,192. ...
艾迪药业(688488) - 2022 Q2 - 季度财报
2022-09-29 16:00
2022 年半年度报告 公司代码:688488 公司简称:艾迪药业 江苏艾迪药业股份有限公司 2022 年半年度报告 1 / 191 2022 年半年度报告 重要提示 一、本公司董事会、监事会及董事、监事、高级管理人员保证半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、重大风险提示 1、本期人源蛋白粗品业务销售规模持续缩减 报告期内,天普生化向公司采购人源蛋白粗品约 870 万元,较上年同期减少 86.94%;报告期 内,公司人源蛋白业务实现收入约 4,052.40 万元,较上年同期减少约 69.30%。由于目前人源蛋白 业务为公司主要的收入及利润来源,公司人源蛋白业务收入规模的缩减,会直接导致公司盈利水 平下降。 2、业绩大幅下滑或亏损的风险 本期公司亏损约 6,819.16 万元,若公司出现人源蛋白粗品业务销售规模持续下滑、抗 HIV 新 药无法取得预期的销售规模或市场占有率、在研产品临床进度不及预期或者研发投入持续加大, 或公司无法有效控制运营成本及费用等情况,均可能导致公司亏损状态持续存在或持续扩大。 3、公司新药研发不达预期以及研发投 ...