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艾德生物:第三届董事会第十三次会议决议公告
2023-09-08 11:28
表决结果:9票赞成,0票反对,0票弃权,本议案获表决通过。 证券代码:300685 证券简称:艾德生物 公告编号:2023-044 厦门艾德生物医药科技股份有限公司 第三届董事会第十三次会议决议公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整,没有 虚假记载、误导性陈述或重大遗漏。 一、董事会会议召开情况 厦门艾德生物医药科技股份有限公司(以下简称"公司"或"艾德生物") 第三届董事会第十三次会议于2023年9月8日在厦门市海沧区鼎山路39号公司 会议室以通讯和现场表决相结合的方式召开,会议应到董事9人,实到董事9人, 符合公司章程规定的法定人数。公司监事和高级管理人员列席了本次会议。本次 会议通知于2023年9月5日以电子邮件等形式发出,会议的通知和召开符合《公 司法》与《公司章程》的规定。本次会议由公司董事长LI-MOU ZHENG先生主 持。 二、董事会会议审议情况 1、审议通过《关于公司<2023年限制性股票激励计划(草案)>及其摘要 的议案》 为进一步建立、健全公司长效激励与约束机制,吸引和留住优秀人才,充分 调动公司核心管理人员及核心技术(业务)骨干的积极性,有效地将股东利益、 公司 ...
艾德生物:关于公司获得医疗器械注册证的公告
2023-09-08 07:43
证券代码:300685 证券简称:艾德生物 公告编号:2023-043 关于公司获得医疗器械注册证的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整,没有 虚假记载、误导性陈述或重大遗漏。 厦门艾德生物医药科技股份有限公司(以下简称"公司")于近日获得由 国家药品监督管理局(以下简称"NMPA")颁发的《中华人民共和国医疗器 械注册证》,具体情况如下: | 产品名称 | 基因测序仪 | | --- | --- | | 型号、规格 | ADx-SEQ200 Plus | | 注册分类 | III类 | | 注册证有效期 | 2023年9月6日至2028年9月5日 | | 注册证编号 | 国械注准20233221286 | | 适用范围 | 该产品采用联合探针锚定聚合测序技术,在临床上用于对来 | | | 源于人体样本中的人脱氧核糖核酸(DNA)或人核糖核酸(RNA) | | | 进行测序,以检测人相关基因序列,这些基因序列可能导致 | | | 疾病或疾病易感性。该仪器在临床上仅限于与药品监督管理 | | | 部门批准的体外诊断试剂以及软件配合使用,不用于人类全 | | | 基因组的测序或从头测序。 ...
艾德生物:关于与阿斯利康达成抗体偶联药物(ADC)伴随诊断合作的公告
2023-08-15 08:58
证券代码:300685 证券简称:艾德生物 公告编号:2023-042 厦门艾德生物医药科技股份有限公司 关于与阿斯利康达成抗体偶联药物(ADC)伴随诊断合作 的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整,没有 虚假记载、误导性陈述或重大遗漏。 一、合作的情况 1、合作的基本情况 近日,厦门艾德生物医药科技股份有限公司(以下简称"公司"或"艾德生 物")与AstraZeneca UK Limited(以下简称"阿斯利康")签署了合作协议 (以下简称"本协议"或"协议")。公司自主研发的人类10基因突变联合检测 试剂盒(可逆末端终止测序法)1将基于ENHERTU®药物开发伴随诊断用途,用 以筛选HER2(ERBB2)突变阳性的非小细胞肺癌(NSCLC)患者。 2、协议对方的基本情况 阿斯利康是一家全球性生物制药企业,专注于研发、生产及营销处方类药品。 ENHERTU®是一种靶向HER2的抗体偶联药物(ADC),由阿斯利康和第一三 共(TSE:4568)联合开发和商业化。在中国,ENHERTU®获准用于治疗既往接 受过治疗的HER2低表达和HER2阳性的转移性乳腺癌患者。在其他国家, ENHE ...
艾德生物:关于公司监事近亲属误操作导致短线交易及致歉的公告
2023-08-09 13:08
厦门艾德生物医药科技股份有限公司 关于公司监事近亲属误操作导致短线交易及致歉的公告 截至本公告披露日,杜立威先生持有公司1,440股。 二、本次短线交易的处理情况及公司采取的措施 公司知悉此事后高度重视,并及时核查了解相关情况,公司监事杜琦先生及 其近亲属杜立威先生亦积极配合。本次事项的处理情况及已采取的措施如下: 证券代码:300685 证券简称:艾德生物 公告编号:2023-041 本公司及董事会全体成员保证公告内容的真实、准确、完整,没有虚假记载、 误导性陈述或重大遗漏。 厦门艾德生物医药科技股份有限公司(以下简称"艾德生物"或"公司") 于近日收到公司监事杜琦先生出具的《关于本人近亲属买卖艾德生物股票的情况 说明及致歉函》,获悉其近亲属杜立威先生于2023年8月8日通过集中竞价方式 卖出并买入公司股票,根据《中华人民共和国证券法》(以下简称"《证券法》") 《深圳证券交易所创业板股票上市规则》《深圳证券交易所上市公司自律监管指 引第10号——股份变动管理》等有关规定,上述交易构成短线交易。现将相关情 况公告如下: 一、本次短线交易的基本情况 | 交易日期 | 交易方向 | 交易股数 | 成交价格 | ...
艾德生物(300685) - 2023 Q2 - 季度财报
2023-07-31 16:00
Financial Performance - The company's operating revenue for the first half of 2023 was CNY 458.71 million, representing a 16.87% increase compared to CNY 392.51 million in the same period last year[23]. - The net profit attributable to shareholders was CNY 126.76 million, up 41.97% from CNY 89.29 million year-on-year[23]. - The net cash flow from operating activities increased by 102.90%, reaching CNY 142.98 million compared to CNY 70.47 million in the previous year[23]. - Basic earnings per share rose to CNY 0.32, a 45.45% increase from CNY 0.22 in the same period last year[23]. - The company achieved a gross profit margin of 90.54% for testing reagents, with a revenue increase of 29.99% year-on-year[64]. - The company reported a significant increase in other income to ¥16,874,165.91, up from ¥6,622,238.55, an increase of 154.1%[153]. - The net profit for the first half of 2023 was ¥126,761,239.87, representing a significant increase of 41.8% from ¥89,560,249.87 in the previous year[153]. - The total revenue from sales of goods and services was CNY 465,519,088.48, compared to CNY 391,739,146.46 in the first half of 2022, marking a growth of 18.8%[160]. Assets and Liabilities - Total assets at the end of the reporting period were CNY 1.71 billion, a 3.67% increase from CNY 1.65 billion at the end of the previous year[23]. - The company's equity increased to CNY 1,559,808,625.29 from CNY 1,499,727,525.25, reflecting a growth of approximately 4%[148]. - Total liabilities stood at CNY 151,651,543.91, slightly up from CNY 151,197,385.37, indicating a marginal increase of around 0.3%[148]. - Cash and cash equivalents increased to ¥542,903,804.54, representing 31.72% of total assets, up from 29.96% last year, primarily due to increased sales receipts[68]. - Accounts receivable stood at ¥459,129,431.84, accounting for 26.83% of total assets, a slight decrease of 0.56% from the previous year[68]. - The total amount of financial assets at fair value was ¥259,295,057.48, with a fair value change of ¥3,407,446.03 during the period[70]. - The total liabilities decreased to ¥142,227,934.53 from ¥152,633,923.32, a reduction of 6.8%[153]. Research and Development - The company plans to continue investing in R&D to develop new products that meet market demands, emphasizing the importance of timely product registration and approval[4]. - R&D investment reached CNY 91.87 million in the reporting period, a year-on-year increase of 18.02%, accounting for 20.03% of revenue[52]. - The company has 60 patent authorizations, including 52 invention patents and 8 utility model patents, with core patents authorized in China, the US, the EU, and Japan[52]. - The company’s R&D team comprises 491 professionals across various fields, ensuring a robust and innovative research environment[53]. Market and Competition - The company is focused on continuous product development to meet market demands and maintain competitive advantages in the in vitro diagnostics industry[83]. - The domestic in vitro diagnostic market is expected to grow rapidly, driven by economic development and increasing disposable income, but competition is intensifying, shifting from technology-driven to price-driven[86]. - The company aims to enhance profitability through strict cost control, quality improvement, and capacity utilization, while also expanding its domestic and overseas market share for stable revenue growth[85]. Corporate Governance and Shareholder Information - The company has experienced changes in its board of directors, with new appointments and departures in 2023[91]. - The total number of shares is 398,156,535, with 99.86% being unrestricted shares[129]. - The largest shareholder, Forward Investment (Hong Kong) Limited, holds 22.03% of shares, totaling 87,701,616 shares[132]. - The company completed a share buyback of 3,943,726 shares, accounting for 0.99% of the total share capital, with a total transaction amount of 112 million yuan[129]. - The company did not distribute cash dividends or issue bonus shares for this reporting period[5]. Social Responsibility and Compliance - The company actively engages in social responsibility initiatives, including public awareness campaigns for cancer prevention and early diagnosis[99]. - The company adheres to environmental protection laws and promotes sustainable development practices in its operations[99]. - The financial statements comply with the accounting standards issued by the Ministry of Finance, reflecting the financial status as of June 30, 2023[195].
艾德生物:艾德生物业绩说明会
2023-05-13 10:10
编号:2023-002 | | □特定对象调研 □分析师会议 | | --- | --- | | 投资者关系活 | 业绩说明会 □媒体采访 | | 动类别 | □新闻发布会 □路演活动 | | | □现场参观 | | | □其他 | | 参与单位名称 | 社会公众投资者 | | 及人员姓名 | | | 时间 | 2023 年 5 月 12 日 14:30~16:15 | | 地点 | 全景网"投资者关系互动平台"(http://rs.p5w.net) | | | 董事、轮值总经理 罗捷敏先生 | | 上市公司接待 | 财务总监、董事会秘书 陈英女士 | | 人员姓名 | | | | 独立董事 蔡宁女士 | | | 1、三年新冠疫情,国内增加了很多体外诊断企业,行业竞争是否变 | | | 成激烈,公司的竞争优势是否还成在? | | | 您好。疫情期间,公司专注主业,继续聚焦肿瘤精准医疗检测技术的 | | | 创新和产品转化,扎实推进国际化战略,海外收入持续攀升,药企合作硕 | | | 果累累,国内市场虽在 2022 年短期波动,但长期增长趋势没有变化。公 | | | 司的核心竞争力,您可查阅 2022 年年度 ...
艾德生物(300685) - 关于举行2022年度网上业绩说明会暨参加厦门辖区上市公司投资者网上集体接待日活动的公告
2023-05-05 13:31
Group 1: Event Details - The annual performance briefing will be held on May 12, 2023, from 14:30 to 16:15 [1] - The event will be conducted online, allowing investors to participate via the "Panjing Roadshow" website, WeChat, or the Panjing Roadshow APP [1] - Company executives will discuss the 2022 performance, governance, development strategy, and operational status during the event [1] Group 2: Participation and Interaction - Investors are encouraged to submit questions in advance via email by May 11, 2023, at 17:00 [2] - The company aims to address commonly raised investor concerns during the performance briefing [2] - Key attendees include the rotating general manager, financial director, and independent director [1] Group 3: Company Assurance - The company and its board members guarantee the accuracy and completeness of the disclosed information [1]
艾德生物(300685) - 2023 Q1 - 季度财报
2023-04-21 16:00
Financial Performance - The company's operating revenue for Q1 2023 was ¥195,164,302.80, a decrease of 5.28% compared to ¥206,049,845.51 in the same period last year[6] - Net profit attributable to shareholders was ¥57,317,259.24, representing an increase of 6.91% from ¥53,614,836.90 year-on-year[6] - Basic earnings per share for the period was ¥0.14, up 7.69% from ¥0.13 in the previous year[6] - Total operating revenue for Q1 2023 was ¥195,164,302.80, a decrease of 5.8% compared to ¥206,049,845.51 in Q1 2022[20] - Net profit for Q1 2023 was ¥57,317,259.24, representing an increase of 7.4% from ¥53,336,627.60 in Q1 2022[22] - Basic and diluted earnings per share for Q1 2023 were both ¥0.14, up from ¥0.13 in the same period last year[23] Cash Flow - The net cash flow from operating activities surged by 141.62% to ¥67,559,006.96, compared to ¥27,961,142.84 in the previous year[6] - Cash inflows from operating activities totaled $231,654,038.82, compared to $198,916,694.38 in the prior period, indicating an increase of about 16.5%[24] - Cash outflows from operating activities decreased to $164,095,031.86 from $170,955,551.54, reflecting a reduction of approximately 4.7%[24] - The net cash flow from investing activities was negative at -$88,181,521.96, compared to -$140,286.55 in the previous period, showing a significant improvement[25] - The net cash flow from financing activities was -$13,392,007.96, an improvement from -$17,034,520.27 in the previous period, indicating a reduction in cash outflow by about 21.5%[25] Assets and Liabilities - Total assets at the end of the reporting period were ¥1,671,421,950.98, reflecting a 1.24% increase from ¥1,650,924,910.62 at the end of the previous year[6] - The total current assets at the end of the first quarter amounted to ¥1,306,200,106.03, an increase from ¥1,285,141,149.89 at the beginning of the year, reflecting a growth of approximately 1.8%[17] - Total liabilities decreased to ¥126,695,415.85 from ¥151,197,385.37, a reduction of 16.2%[19] - The company reported a significant increase in other non-current assets by 55.78% to ¥12,884,143.57, primarily due to increased equipment procurement prepayments[10] Shareholder Information - The total number of shares held by the top 10 unrestricted shareholders is 299,000,000 shares, with the largest shareholder holding 87,701,616 shares, accounting for 22.03%[13] - The company has a total of 607,499 shares under lock-up at the end of the period, with 37,969 shares newly restricted[15] Government Support and Investments - The company received government subsidies amounting to ¥11,895,115.39, a significant increase of 399.63% compared to ¥2,380,790.56 in the previous year[10] - The company’s investment income showed a loss of ¥1,486,582.20, a decline of 183.77% due to losses from joint ventures[10] - Research and development expenses for Q1 2023 were ¥36,988,744.69, slightly down from ¥38,760,861.03 in Q1 2022[20] Management Outlook - The company is focused on expanding its market presence and developing new products, although specific figures were not disclosed in the report[15] - The management indicated a positive outlook for the upcoming quarters, emphasizing strategic investments and potential acquisitions to enhance growth[15]
艾德生物(300685) - 2022 Q4 - 年度财报
2023-04-14 16:00
Financial Performance - The company's operating revenue for 2022 was ¥842,180,427.77, a decrease of 8.16% compared to ¥917,033,391.28 in 2021[23] - The net profit attributable to shareholders for 2022 was ¥263,743,023.32, an increase of 10.09% from ¥239,573,622.91 in 2021[23] - The net profit attributable to shareholders after deducting non-recurring gains and losses was ¥156,986,572.23, a decrease of 27.21% compared to ¥215,656,757.15 in 2021[23] - The basic earnings per share for 2022 was ¥0.67, compared to ¥1.09 in 2021, reflecting a decrease of 38.5%[23] - The total assets at the end of 2022 amounted to ¥1,650,924,910.62, an increase of 8.62% from ¥1,519,881,333.25 at the end of 2021[23] - The net assets attributable to shareholders at the end of 2022 were ¥1,499,727,525.25, a rise of 9.90% from ¥1,364,580,687.78 at the end of 2021[23] - The net cash flow from operating activities for 2022 was ¥149,036,792.06, down 11.37% from ¥168,161,324.14 in 2021[23] - The weighted average return on net assets for 2022 was 18.42%, a decrease of 0.77% from 19.19% in 2021[23] Market and Product Development - The company has received approval for 24 types of single-gene and multi-gene tumor testing products, making it a leading enterprise in the industry with the most comprehensive product offerings[34] - The company has applied for over 60 invention patents, with 49 patents granted, highlighting its commitment to innovation and technology development[35] - The company is focusing on precision diagnostics in oncology, which is expected to see increased demand due to rising cancer rates and an aging population[33] - The company has developed a comprehensive companion diagnostic product system that covers targeted therapy and immunotherapy, enhancing its market position[34] - The company is actively pursuing market expansion and product innovation, with several products already approved for reimbursement in local healthcare systems[35] - The company has developed a rich line of LDT products in accordance with Class III IVD product development standards, including HRR and HRD products for guiding cancer treatments[36] - The company has established partnerships with major pharmaceutical companies for companion diagnostics, enhancing clinical trial success rates[52] Research and Development - The company has invested significantly in R&D, developing advanced technologies and holding multiple patents in precision oncology diagnostics[58] - The company invested CNY 174.53 million in R&D, representing a year-on-year increase of 11.79% and accounting for 20.72% of total revenue[62] - The company’s R&D team consists of 465 professionals, ensuring a multidisciplinary approach to innovation[63] - The company has a structured approach to governance, ensuring that compensation aligns with performance metrics and industry standards[150] Regulatory and Compliance - The company emphasizes innovation and compliance, aligning with regulatory requirements and industry trends to meet clinical demands for accurate and rapid diagnostics[37] - The company has received regulatory approval for multiple companion diagnostic products, including ROS1 and PCR-11, which are also covered by local health insurance in Japan[40] - The company has successfully completed the renewal of registration for several Class III medical devices, ensuring compliance with regulatory standards[44] - The company has obtained registration for 68 in vitro diagnostic reagent products classified as Class I[47] - The company has established a governance structure that complies with relevant laws and regulations, ensuring transparency and fairness in shareholder meetings[118] Corporate Governance - The company maintains independence from its controlling shareholder, ensuring no interference in its operational decisions[119] - The board of directors consists of 9 members, including 3 independent directors, complying with legal and regulatory requirements[120] - The company has established a performance evaluation and incentive system for senior management, ensuring transparency and compliance with laws and regulations[123] - The company emphasizes investor relations management, ensuring transparent communication with shareholders through various channels[124] Social Responsibility and Community Engagement - The company has conducted a public health project, providing free low-dose spiral CT lung cancer screenings for over 3,000 high-risk patients[182] - The company has actively participated in social responsibility initiatives, aligning economic benefits with social and environmental goals[180] - The company emphasizes teamwork and collaboration, aiming for mutual benefits among society, customers, employees, and shareholders[183] Financial Management - The company has a cash dividend policy that aligns with its articles of association, with a cash dividend of 1.4 yuan per 10 shares (including tax) proposed for distribution[166] - The total cash dividend amount (including other methods) is 155,169,115.64 yuan, which accounts for 100% of the total profit distribution[166] - The company has a significant increase in government subsidies, contributing ¥20,075,855.92, or 7.02% of total profit[93] Internal Controls - The company maintained effective internal controls with no significant defects identified in financial and non-financial reporting during the reporting period[175] - The internal control evaluation report indicated that 100% of the total assets and operating income of the evaluated units were included in the company's consolidated financial statements[175] - The company plans to continuously update its internal control measures in line with business expansion to enhance employee awareness of internal controls[173]
艾德生物(300685) - 2022 Q3 - 季度财报
2023-04-14 16:00
Financial Performance - The company's revenue for Q3 2022 was CNY 206.75 million, a decrease of 16.22% compared to CNY 246.78 million in the same period last year[5]. - Net profit attributable to shareholders for Q3 2022 was CNY 134.87 million, an increase of 106.75% from CNY 65.23 million year-on-year[5]. - Basic earnings per share for Q3 2022 increased by 112.50% to CNY 0.34 from CNY 0.16 in the same period last year[6]. - Total operating revenue for Q3 2022 was CNY 599,258,982.80, a decrease of 7.2% compared to CNY 645,735,626.15 in Q3 2021[22]. - The net profit for Q3 2022 was CNY 224,157,836.85, an increase of 27% compared to CNY 176,496,035.76 in Q3 2021[23]. - The total comprehensive income for the period was CNY 224,506,263.64, compared to CNY 176,068,226.97 in the previous year[23]. - The total profit before tax was CNY 255,655,771.92, an increase from CNY 196,187,785.20 in Q3 2021[23]. Assets and Liabilities - Total assets as of the end of the reporting period were CNY 1.63 billion, reflecting a growth of 7.34% from CNY 1.52 billion at the beginning of the year[6]. - Total assets reached CNY 1,631,372,496.37, up from CNY 1,519,881,333.25 at the start of the year, indicating growth in the company's asset base[20]. - Total liabilities decreased to CNY 149,736,431.01 from CNY 150,250,223.95, reflecting improved financial management[20]. - The company's equity attributable to shareholders increased to CNY 1,481,636,065.36 from CNY 1,364,580,687.78, demonstrating strong retained earnings[20]. Cash Flow - Cash and cash equivalents decreased by 200.80% to -¥29,921,267.86, mainly due to an increase in unrealized financial products[12]. - The cash flow from operating activities showed a net increase of CNY 95,723,486.86, down from CNY 124,291,686.18 in the same period last year[24]. - The company reported a decrease in cash and cash equivalents, ending the period with CNY 205,867,355.89, compared to CNY 351,613,750.41 at the end of the previous year[25]. - Net cash flow from investment activities improved by 28.16% to -¥54,574,928.34, driven by cash received from the transfer of SDC2 products[12]. - The net cash flow from financing activities decreased by 87.27% to -¥100,863,405.50, primarily due to increased cash used for share repurchases[12]. - The net cash flow from financing activities was negative at CNY -100,863,405.50, compared to CNY -53,858,840.69 in the same period last year[25]. Operational Highlights - The company completed the delivery of materials related to the SDC2 product and the transfer of intellectual property rights, resulting in a non-operating income of CNY 94.48 million[7]. - The company completed the transfer of SDC2 product rights and the equity of its subsidiary, Aizhiwei, with the necessary approvals obtained[17]. - Total operating costs for Q3 2022 were CNY 452,266,245.86, down from CNY 457,191,133.58 in the same period last year, reflecting a cost reduction strategy[22]. - Research and development expenses increased to CNY 121,508,871.96, up from CNY 109,167,134.77, indicating a focus on innovation[22]. - Operating profit for Q3 2022 was CNY 256,234,697.00, compared to CNY 197,012,147.36 in Q3 2021, showing a significant improvement[22]. Shareholder Information - The total number of common shareholders at the end of the reporting period was 21,998[13]. - The largest shareholder, Forward Investment (Hong Kong) Limited, holds 22.03% of shares, totaling 87,701,616 shares[13]. Investment and Income - Investment income increased by 145.17% to ¥6,835,699.20 due to higher returns from matured financial products[12]. - Fair value changes in investment decreased by 97.83% to ¥48,272.54, primarily due to unrealized changes in financial products[12]. - Asset disposal income surged by 5219.51% to ¥94,550,129.44, attributed to the transfer of SDC2 products and related intellectual property[12]. - Income tax expenses rose by 59.95% to ¥31,497,935.07, mainly due to increased earnings from the transfer of SDC2 products[12]. - The company experienced a foreign exchange gain of CNY 29,793,579.12 during the quarter[25]. Future Outlook - Future outlook includes continued investment in R&D and potential market expansion strategies to enhance competitive positioning[22].