证券代码：605116 证券简称：奥锐特 公告编号：2023-043 奥锐特药业股份有限公司 关于全资子公司通过美国 FDA 现场检查的公告 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、准确性和完整性承担法律责任。 奥锐特药业股份有限公司（以下简称"公司"）全资子公司扬州奥锐特药业 有限公司（以下简称"扬州奥锐特"）于2023年08月07日-11日接受了来自美国食 品药品监督管理局（以下简称"FDA"）的cGMP（现行药品生产质量管理规范）现 场检查，检查内容为布立西坦原料药的批准前检查。 近日，扬州奥锐特收到美国FDA的通知函和针对本次检查签发的现场检查报 告（EIR，Establishment Inspection Report），按照美国21CFR法规（美国联邦 法规第21章）的法规规定，FDA确认本次检查已结束。该通知说明扬州奥锐特的 质量管理体系符合美国FDA的标准，顺利通过了美国FDA的批准前检查。现将相关 信息公告如下： 一、FDA现场检查的相关信息 二、生产车间、设备产能及生产品种 | 生产车间/生产线名称 | 设备产能 | 主要生产品 ...

Financial Performance - Basic earnings per share for the current period (1-6 months) is CNY 0.24, a decrease of 17.24% compared to the same period last year[41]. - Diluted earnings per share for the current period is also CNY 0.24, reflecting a 17.24% decline year-over-year[41]. - The company's end-of-period book value is CNY 15,093,001.78, down from the beginning of the period value of CNY 16,623,191.83, indicating a decrease of approximately 9.2%[118]. - The net profit attributable to shareholders decreased by 17.85% year-on-year, amounting to approximately ¥95.90 million[153]. - The net profit after deducting non-recurring gains and losses was approximately ¥94.12 million, down 16.68% from the previous year[153]. - The company's revenue for the first half of 2023 reached approximately ¥552.65 million, representing an increase of 8.59% compared to the same period last year[153]. - The net cash flow from operating activities significantly increased by 104.20%, totaling approximately ¥147.57 million[153]. - The net assets attributable to shareholders increased by 3.08%, reaching approximately ¥1.73 billion[153]. Assets and Liabilities - The total assets at the end of the period amounted to ¥2,618,215.00, an increase from ¥1,415,172.00 at the beginning of the period, reflecting an increase of approximately 84.8%[6]. - The total amount of long-term borrowings at the end of the period is 3,569,499.91 RMB, compared to 4,218,499.93 RMB at the beginning of the period, indicating a decrease of approximately 15.4%[77]. - The total accounts payable at the end of the period is 135,967,841.43 RMB, an increase of 17.2% from 115,179,058.15 RMB at the beginning of the period[86]. - The total amount of fixed assets increased by ¥63,332,314.96 during the period, with the total at the end of the period being ¥877,005,434.86[23]. - The total amount of accounts receivable for goods is 86,737,758.61 RMB, which is an increase of 28.0% from 67,722,995.23 RMB at the beginning of the period[86]. - The total amount of trade financial liabilities at the end of the period is 2,217,660.50 RMB, which is a new addition during the period[84]. Investments and Projects - The company has ongoing projects with a total investment of ¥813,123,500.00, with various stages of completion and funding sources primarily from self-financing[29]. - The company reported a total of ¥62,354,682.00 for the newly built production line for specialty raw materials, with a budget of ¥589,672,100.00, representing 10.57% of the budget completion[40]. - The company has invested ¥12,057,483.75 in the new production line for Semaglutide raw materials, with a budget of ¥130,000,000.00, achieving 9.27% of the budget completion[40]. - The company’s production line for 308 tons of specialty raw materials and 200 million anti-tumor formulations is under construction, with some facilities already completed[194]. Research and Development - The company has established six major engineering technology innovation platforms for drug development, employing 278 R&D personnel, accounting for 18.53% of total employees[185]. - The company has 29 products currently in the research and development stage, with a total R&D expenditure of CNY 55.91 million, showing a slight increase year-on-year[192]. - The company received approval for the registration certificate of Dydrogesterone tablets, marking a significant milestone as the first generic drug of its kind in China[189]. - The company is accelerating patent authorization and registration to enhance its competitive edge[170]. - The company submitted 11 new invention patent applications during the reporting period, bringing the total number of domestic invention patent applications to 101[193]. Market Position and Strategy - The company's main business involves the R&D, production, and sales of complex active pharmaceutical ingredients and intermediates, with over 90% of products exported internationally[138]. - The company has established a competitive brand and has received certifications from regulatory bodies such as NMPA, FDA, and WHO, enhancing its market position[138]. - The company focuses on customer demand, selecting products with good market prospects for R&D and production, leading to successful product launches[139]. - The marketing team utilizes various methods, including market research and participation in global pharmaceutical exhibitions, to expand market reach[140]. - The company is actively expanding its domestic market presence, collaborating with leading domestic pharmaceutical companies[188]. Government Support and Subsidies - The company received government subsidies totaling 10,061,680.29 RMB, which includes an increase of 3,205,500.00 RMB during the period[95]. - The company received government subsidies amounting to CNY 3,828,425.57, which are closely related to its normal business operations[134]. Financial Ratios and Metrics - The weighted average return on equity decreased to 5.57%, down by 1.89 percentage points from the previous year[41]. - The return on equity after deducting non-recurring gains and losses is 5.47%, a decrease of 1.75 percentage points compared to the same period last year[41]. - The total amount of payable dividends at the end of the period is CNY 95,253,652.30, an increase from CNY 80,076,867.70 at the beginning of the period[47]. Industry Trends - The pharmaceutical manufacturing industry in China has shown a compound annual growth rate (CAGR) of 6.8% in revenue from 2019 to 2022, with profits increasing at a CAGR of 11.2%[143]. - The export delivery value of the pharmaceutical manufacturing industry in China increased by 22.3% CAGR from 2019 to 2022, indicating strong international demand[143]. - In 2022, China's chemical raw material drug industry revenue grew by 15.0%, reaching 531.9 billion RMB[162]. - China's raw material drug exports amounted to 51.786 billion USD in 2022, a year-on-year increase of 24.04%[162].

Financial Performance - The company's operating revenue for Q1 2023 was ¥302,135,926.13, representing a year-on-year increase of 38.07%[6] - The net profit attributable to shareholders of the listed company was ¥45,877,847.97, reflecting a growth of 12.30% compared to the same period last year[6] - Basic earnings per share for the period were ¥0.11, which is a 10.00% increase from the previous year[6] - Total revenue for Q1 2023 reached ¥302,135,926.13, a 38.0% increase from ¥218,833,057.33 in Q1 2022[46] - Operating profit for Q1 2023 was ¥58,973,162.21, compared to ¥53,425,178.89 in Q1 2022, reflecting a 10.0% increase[47] - Net profit for Q1 2023 was ¥45,710,870.38, an increase of 12.0% from ¥40,535,906.17 in Q1 2022[47] - The total comprehensive income attributable to the parent company owners rose to ¥45,666,820.85, compared to ¥40,575,787.80, indicating an increase of about 12.5%[1] - The total comprehensive income for the period reached ¥45,499,843.26, up from ¥40,259,023.99, marking an increase of about 13.5%[1] Cash Flow and Liquidity - The net cash flow from operating activities reached ¥79,859,097.31, showing a significant increase of 214.67% year-on-year[6] - The total cash inflow from operating activities amounted to ¥322,269,254.53, up from ¥256,057,499.13 in Q1 2022[9] - Cash outflow from operating activities was ¥242,410,157.22, compared to ¥230,678,487.89 in the same quarter last year[9] - The significant increase in cash flow is attributed to enhanced sales performance during the reporting period[2] - The net cash flow from operating activities surged by 214.67%, mainly due to an increase in cash received from sales of goods[2] - The company's cash and cash equivalents at the end of the first quarter of 2023 were approximately 382.24 million, compared to 417.75 million at the end of 2022, indicating a decrease of about 8.5%[37] - The net increase in cash and cash equivalents for the first quarter of 2023 was approximately 43.69 million, contrasting with a decrease of about 22.59 million in the same period of the previous year[37] Assets and Liabilities - As of March 31, 2023, the company's total current assets amounted to approximately 1.14 billion, an increase from 1.09 billion as of December 31, 2022, representing a growth of about 5.5%[31] - The company's total assets as of March 31, 2023, were approximately 2.11 billion, reflecting a year-over-year increase of 3.77% from 2.03 billion[38] - Total liabilities rose to ¥368,497,742.33, up from ¥348,684,087.93, indicating a 5.0% increase[46] - The company's total equity attributable to shareholders was approximately 1.73 billion, an increase of 3.4% from 1.68 billion at the end of the previous year[38] - The company's equity attributable to shareholders increased to ¥1,733,075,449.62 from ¥1,676,167,948.81, a growth of 3.4%[46] Operational Highlights - The company received government subsidies amounting to ¥2,865,008.34, which are closely related to its normal business operations[24] - The company reported a non-operating loss of ¥39,363.83 from the disposal of non-current assets[24] - The cash received from sales of goods and services was ¥283,108,059.34, compared to ¥220,963,775.27 in Q1 2022[9] - The company's inventory as of March 31, 2023, was approximately 440.81 million, slightly down from 444.94 million at the end of 2022, showing a decrease of about 0.5%[31] - The company had a total of 6,825 common shareholders at the end of the reporting period, with the largest shareholder holding 37.81% of the shares[40] Research and Development - Research and development expenses for Q1 2023 amounted to ¥25,717,254.75, a decrease of 20.0% from ¥32,181,663.57 in Q1 2022[47] - The company did not disclose any new product developments or market expansion strategies in the report[30] Shareholder Information - The net loss attributable to minority shareholders decreased to -¥166,977.59 from -¥316,763.81, showing an improvement of approximately 47.4%[1] - The company did not report any audit opinion type applicable for this period[3]

Financial Performance - In 2022, the company achieved operating revenue of CNY 1.008 billion, a year-on-year increase of 25.48%[36] - The net profit attributable to shareholders was CNY 211 million, reflecting a growth of 25.00% compared to the previous year[36] - The net profit attributable to the parent company after deducting non-recurring gains and losses was CNY 207 million, up 26.56% year-on-year[36] - The company's main business revenue for the current period is CNY 1,000,848,370.61, representing a year-on-year increase of 25.03% from CNY 800,459,806.62[80] - The total operating costs for the current period amount to CNY 487,676,482.77, which is a 19.34% increase compared to CNY 408,644,195.42 in the previous year[81] - The gross profit margin for the main business increased by 2.38 percentage points to 51.50% compared to the previous year[81] - The company achieved a total operating revenue of 1,008,076,473.51 RMB, representing a year-on-year increase of 25.48%[101] - The gross profit margin improved, with operating costs rising to 487,676,482.77 RMB, an increase of 19.34% compared to the previous year[101] - The company reported a total of 71,644,825.31 RMB in trade product revenue, which decreased by 11.30% compared to the previous year[89] - The revenue from trade products remained stable at ¥88,559,794.94, showing a slight decrease of 6.62%[105] Research and Development - The company invested CNY 117.26 million in R&D during the reporting period, representing a year-on-year increase of 69.09%[47] - There are currently 30 products in the R&D stage, including chemical APIs, peptide APIs, and oligonucleotide APIs[47] - The company has formed a strong R&D capability with six engineering technology innovation platforms, focusing on high-end pharmaceutical intermediates and APIs[57] - The company is developing multiple oligonucleotide API products to better serve clients and support their product launches[47] - The company has established long-term cooperative relationships with several domestic universities and research institutes to enhance its technological capabilities[57] - The company operates six R&D centers located in various regions, focusing on small molecule drugs, peptide drugs, and innovative drug development[125] - The company's R&D investment reached RMB 117.26 million, accounting for 11.63% of revenue, with a year-on-year growth of 69.09%[150] - R&D investment amounted to 6,882.46 million RMB, representing 12.08% of operating revenue and 5.52% of net assets[170] - The average R&D investment in the industry was 27,079.03 million RMB, with the company's R&D investment accounting for 11.63% of operating revenue and 7.00% of net assets[170] Product Development and Sales - The overall sales of cardiovascular products increased by 31.19% year-on-year, driven by the commercialization of key raw materials[66] - The sales of anti-tumor products surged by 248.42%, primarily due to the growth in sales of Abiraterone acetate and increased demand from both existing and new customers[66] - The company produced 22,444.93 kg of cardiovascular products, with sales increasing by 58.08% year-on-year[108] - The revenue from the oncology segment surged by 248.42% year-over-year, reaching 14,066.64 million RMB[123] - The female health product segment achieved revenue of CNY 194,403,869.14, marking a 17.35% increase due to new customer acquisition[83] - The respiratory system products' revenue remained stable at CNY 151,925,618.98, showing a slight decline of 0.91% year-on-year[83] - The gross margin for the female health segment was 75.03%, with a revenue increase of 17.35% compared to the previous year[123] - The gross margin for the anti-infection segment was 41.83%, with a year-over-year decrease of 5.61% in revenue[123] Market Expansion and Strategy - The company has established a U.S. business development team to accelerate market penetration and custom processing business[66] - The company is actively expanding its export of specialty APIs to meet CDMO business demands and broaden its formulation market[49] - The company has developed a complete sales system for APIs in the Americas, Europe, and Asia, establishing stable long-term partnerships with major pharmaceutical companies[58] - The company plans to expand its marketing network and strengthen relationships with existing customers while penetrating markets in Europe, America, and Asia[167] - The company aims to develop a high-quality technology platform covering six major fields, including respiratory, cardiovascular, and oncology[164] - The company is focusing on enhancing its market competitiveness and increasing the domestic market share in response to international trade risks[168] - The company has established a marketing center in Shanghai to unify product sales and expand market reach through various channels[152] Financial Position and Liabilities - Total assets increased by 18.09% year-on-year, reaching CNY 2.033 billion by the end of 2022[32] - As of the end of 2022, the company's total assets reached 2.033 billion yuan, an increase of 18.09% compared to the beginning of the year[61] - The company's total liabilities amounted to 349 million yuan, reflecting a growth of 63.37% from the start of the year[61] - The total equity attributable to the parent company was 1.676 billion yuan, up 11.28% year-on-year[61] - The company’s total liabilities included 39,984,808.44 RMB in employee compensation payables, reflecting a 32.30% increase due to personnel growth[99] Operational Challenges and Risks - The company faces risks related to environmental compliance, safety production, and potential regulatory changes in the pharmaceutical industry[190][192] - The company's financial expenses were impacted by exchange rate fluctuations, leading to changes in foreign exchange gains[80] - The total cash flow from financing activities was affected by the implementation of equity incentives during the period[80] - The overall increase in sales costs was primarily due to the expansion of sales scale, which necessitated higher expenditure[80] - The company reported a significant increase in cash outflows from financing activities, totaling 109,176,692.10 RMB, which is an increase of 108.01% compared to the previous year[97]

2022 年第三季度报告 单位：元 币种：人民币 证券代码：605116 证券简称：奥锐特 奥锐特药业股份有限公司 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 本报告期比 年初至报告期 | --- | --- | --- | --- | --- | |------------------------------------------------|----------------|---------------------------|----------------|-------------------------------| | 项 ...

公司代码：605116 公司简称：奥锐特 2022 年半年度报告 奥锐特药业股份有限公司 2022 年半年度报告 1 / 128 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、 公司全体董事出席董事会会议。 三、 本半年度报告未经审计。 四、 公司负责人彭志恩、主管会计工作负责人王袖玉及会计机构负责人（会计主管人员）王袖玉 声明：保证半年度报告中财务报告的真实、准确、完整。 五、 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 不适用 六、 前瞻性陈述的风险声明 √适用 □不适用 本报告中所涉及的公司未来计划、发展战略等前瞻性描述不构成公司对投资者的实质承诺， 敬请投资者注意投资风险。 七、 是否存在被控股股东及其关联方非经营性占用资金情况 否 八、 是否存在违反规定决策程序对外提供担保的情况？ 否 九、 是否存在半数以上董事无法保证公司所披露半年度报告的真实性、准确性和完整性 否 十、 重大风险提示 公司已在本报告中详细描述可能存在的风险，具 ...

2021 年年度报告 公司代码：605116 公司简称：奥锐特 奥锐特药业股份有限公司 2021 年年度报告 1 / 210 2021 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、 公司全体董事出席董事会会议。 三、 天健会计师事务所（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。 四、 公司负责人彭志恩、主管会计工作负责人王袖玉及会计机构负责人（会计主管人员）王袖玉 声明：保证年度报告中财务报告的真实、准确、完整。 五、 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2021年度利润分配预案为：公司拟以实施权益分派股权登记日登记的总股本为基数，向 全体股东每10股派发现金红利人民币1.30元（含税），以截至2021年12月31日公司总股本 401,000,000股计算，共计派发现金红利人民币52,130,000.00元（含税），2021年度公司不送红 股，不进行资本公积转增，剩余未分配利润全部结转以后年度分配。该预案业经公司第二届董事 会第 ...

2022 年第一季度报告 单位：元币种：人民币 证券代码：605116 证券简称：奥锐特 奥锐特药业股份有限公司 2022 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、准确性和完整性承担个别及连带责任。 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报表 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 | | 营业收入 | 218,833,057.33 | 变动幅度 (%) 17.45 | | 归属于上市 ...

2021 年第三季度报告 单位：元 币种：人民币 证券代码：605116 证券简称：奥锐特 奥锐特药业股份有限公司 2021 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、准确性和完整性承担个别及连带责任。 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 报表信息的真实、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 | --- | --- | --- | --- | --- | |-----------------------------|----------------|-------------------------------------------|----------------|----------------------------------------------- ...

公司代码：605116 公司简称：奥锐特 2021 年半年度报告 奥锐特药业股份有限公司 2021 年半年度报告 1 / 126 2021 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、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。 二、 公司全体董事出席董事会会议。 三、 本半年度报告未经审计。 四、 公司负责人彭志恩、主管会计工作负责人王袖玉及会计机构负责人（会计主管人员）王袖玉 声明：保证半年度报告中财务报告的真实、准确、完整。 五、 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 不适用 六、 前瞻性陈述的风险声明 √适用 □不适用 本报告中所涉及的公司未来计划、发展战略等前瞻性描述不构成公司对投资者的实质承诺， 敬请投资者注意投资风险。 七、 是否存在被控股股东及其关联方非经营性占用资金情况 否 八、 是否存在违反规定决策程序对外提供担保的情况？ 否 九、 是否存在半数以上董事无法保证公司所披露半年度报告的真实性、准确性和完整性 否 十、 重大风险提示 公司已在本报告中详细描述可能存在的风险，具体内容 ...