证券代码：688108 证券简称：赛诺医疗 公告编号：2023-009 赛诺医疗科学技术股份有限公司 关于参加 2022 年度医疗器械专场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： （http://roadshow.sseinfo.com/） 投资者可于 2023 年 4 月 27 日(星期四)17:00 前通过公司邮箱（ir@sinomed.com）、 投资者关系电话（010-80482240）、传真等方式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。 赛诺医疗科学技术股份有限公司（以下简称"赛诺医疗"或"公司"）将于2023年 4月27日发布公司2022年年度报告，为便于广大投资者更及时全面深入地了解公司2022 年度的经营成果、财务状况和发展理念，公司计划于2023年04月28日参加上海证券交易 所主办的2022年度医疗器械专场集体业绩说明会，就投资者关心的问题进行线上交流。 一、 说明会类型 本次业绩说明会将以视频和网络互动形式 ...

证券代码：688108 证券简称：赛诺医疗 赛诺医疗科学技术股份有限公司 投资者关系活动记录表 编号：2022-001 | --- | --- | --- | --- | --- | |----------------|--------------------------------------------|-------------------------------------------------------------------------------------------------|-------|-------| | | | | | | | | | □特定对象调研 □分析师会议 | | | | 投资者关系 | | □媒体采访 业绩说明会 | | | | 活动类别 | | □新闻发布会 □路演活动 | | | | | □现场参观 | | | | | | □其他 | | | | | 参与单位名称 | 网上投资者 | | | | | 及人员姓名 | | | | | | | 时 间 2022 年 5 月 16 | 日 9:00-10:00 | | | | 接待人员姓名 | 地 点 上证路演中心 | ...

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。 重要内容提示： 2022 年第三季度报告 证券代码：688108 证券简称：赛诺医疗 赛诺医疗科学技术股份有限公司 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。 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 | | | 本报告期比上 | | 年初至报告期末 | | --- | --- | --- | --- | --- | | 项目 | 本报告期 | 年同期增减变 | 年初至报告期末 | 比上年同期增减 | | | | 动幅度(%) | | 变动幅度(%) | | 营业收入 | 55,624,497.05 | 30.88 | 165,927,252.95 | 36.98 | ...

Financial Performance - The company's operating revenue for the first half of 2022 was ¥110,302,755.90, representing a 40.28% increase compared to ¥78,633,119.10 in the same period last year[17]. - The net profit attributable to shareholders of the listed company was -¥71,234,762.46, an improvement of 12.64% from -¥81,542,212.35 in the previous year[17]. - The net profit attributable to shareholders after deducting non-recurring gains and losses was -¥73,614,639.21, showing an 11.63% improvement from -¥83,299,852.62 year-on-year[17]. - The net cash flow from operating activities was -¥48,485,199.62, which is a decline of 95.43% compared to -¥24,809,916.71 in the same period last year[17]. - The net assets attributable to shareholders at the end of the reporting period were ¥859,100,349.51, a decrease of 7.41% from ¥927,836,465.08 at the end of the previous year[17]. - Total assets at the end of the reporting period were ¥1,065,252,701.61, down 3.43% from ¥1,103,085,987.51 at the end of the previous year[17]. - Basic earnings per share for the reporting period is -0.17 yuan, an improvement of 15% compared to -0.20 yuan in the same period last year[18]. - Operating revenue increased by 40.28% year-on-year, reaching 45.7045 million yuan, primarily driven by a 57.59% increase in coronary and other business revenues[18]. - Net profit attributable to shareholders grew by 12.64% year-on-year, influenced by the significant increase in operating revenue and a 20.07% rise in total operating costs[19]. - The weighted average return on equity decreased by 0.07 percentage points to -7.98% compared to the same period last year[21]. Research and Development - Research and development expenses accounted for 97.00% of operating revenue, a decrease of 12.35 percentage points from 109.35% in the previous year[18]. - The company achieved a cumulative R&D investment of 107 million yuan in the first half of 2022, an increase of 24.44% year-on-year, representing 97% of the operating revenue for the same period[39]. - The company has developed 8 key technologies and 29 product pipelines, with 5 new invention patents and 16 other intellectual property rights granted during the reporting period[40]. - The company filed for a total of 9 new intellectual property applications during the reporting period, bringing the cumulative total to 449 applications[54]. - The company has increased its R&D personnel to 177, representing 26.26% of the total workforce, up from 125 and 23.95% in the same period last year[82]. - Total compensation for R&D personnel reached 2,570.7 million, compared to 1,723.79 million in the previous year, reflecting a significant increase in investment in talent[82]. - The average salary for R&D personnel rose to 14.52 million from 13.79 million year-on-year[82]. Product Development and Innovation - The company continues to focus on expanding its product offerings and enhancing its market presence in the medical device sector, supported by favorable government policies[27]. - Sino Medical focuses on high-end interventional medical device R&D, production, and sales, covering key areas such as cardiovascular, neurovascular, and structural heart disease interventions[28]. - The company’s product pipeline includes advanced devices for coronary, neurovascular, and structural heart disease interventions, leveraging existing core technologies[30]. - The new generation coronary drug-eluting stent HT Supreme, approved in December 2020, is the only domestic product with a 5.0mm large specification and has received CE certification and FDA acceptance[34]. - The NOVA intracranial drug-eluting stent, launched in July 2021, is the world's first specifically designed for intracranial artery stenosis treatment, enhancing patient safety and reducing the risk of re-stenosis[36]. - The company’s negative pressure suction pump, approved in April 2022, is designed to improve surgical efficiency and is compatible with various suction devices[37]. - The company is developing a retractable, dual-stent, self-locking intervention mitral valve replacement technology, with over 30 patents granted globally[47]. - The company’s coated mesh stent, the only one of its kind in China, is expected to start clinical enrollment by the end of 2022[46]. - The company has developed a new intracranial drug balloon system, which is expected to have a significant development space and broad market prospects[72]. Market Outlook and Strategy - The coronary intervention market in China is the most mature segment, with significant room for import substitution and rapid growth driven by local manufacturers and increased market penetration[28]. - The neurovascular intervention market in China is still in its early stages, with foreign manufacturers holding a significant market share, indicating substantial potential for domestic product innovation[28]. - The company is focused on expanding its market presence through new product launches and technological advancements[62]. - The company aims to maintain a leading position in the international market through continuous innovation and patent acquisition[60]. - The market outlook for the new products is optimistic, with expectations of substantial growth post-launch[61]. - The company anticipates a market growth rate of 8.7% annually for stroke incidence in China, driven by an increasing prevalence of chronic diseases[72]. - The company is committed to improving patient outcomes through advanced medical technologies and innovative treatment solutions[71]. Risks and Challenges - The company faces risks related to the failure of new product development or delays in registration, particularly in high-risk medical devices, which could affect revenue and profitability growth[106]. - The company is at risk of talent loss if it cannot provide competitive compensation and a conducive work environment, which is critical for its development in a technology-driven industry[107]. - The company is exposed to risks from important raw material supply disruptions, as the required materials are sourced from a limited number of global suppliers[112]. - The company’s ability to maintain or improve product competitiveness is challenged by increasing competition in the cardiovascular intervention market[110]. - The company’s financial situation may be adversely affected by the inability to recover accounts receivable, particularly with aging receivables[119]. - The company is subject to risks from macroeconomic factors, including trade tensions and currency fluctuations, which could impact its overseas operations and overall performance[122]. Corporate Governance and Compliance - The company has committed to not engaging in any business that competes substantially with its operations, either directly or indirectly, through subsidiaries or controlled entities[162]. - The company has established a legal framework for its commitments, ensuring they are binding and enforceable[161]. - The company will distribute cash dividends of no less than 10% of the distributable profits achieved in the current year after reserving the statutory surplus and discretionary surplus funds[171]. - The company will ensure compliance with relevant laws and regulations regarding share reduction and will disclose reduction plans in advance[172]. - The company has no significant litigation or arbitration matters during the reporting period[187]. - The credit status of the company and its controlling shareholder is good, with no records of violations or significant tax offenses in the last three years[187].

Financial Performance - Sino Medical reported no cash dividends for 2021 due to significant adverse impacts from the centralized procurement policy for coronary stents, prioritizing future development funding needs[5]. - The company's operating revenue for 2021 was CNY 194,356,081.09, a decrease of 40.64% compared to the previous year[21]. - The net profit attributable to shareholders was CNY -130,765,690.12, representing a decline of 681.36% year-on-year[23]. - The cash flow from operating activities was CNY -60,133,405.36, down 185.28% from the previous year, primarily due to reduced revenue[23]. - Basic and diluted earnings per share were both CNY -0.32, a decrease of 740% compared to the previous year[22]. - The weighted average return on equity was -13.08%, a decrease of 15.15 percentage points year-on-year[22]. - The net profit after deducting non-recurring gains and losses was CNY -134,507,245.16, a decrease of 1,317.29% year-on-year[23]. - The company experienced a significant decline in main business income due to the implementation of centralized procurement policies for coronary stents, leading to a substantial drop in product prices[23]. - The company's main business revenue decreased by 40.51% year-on-year, primarily due to a 69.42% decline in stent product revenue, with sales volume dropping by 78.05%[160]. - The overall gross profit margin decreased by 6.08 percentage points, attributed to lower sales prices and reduced production scale due to the impact of centralized procurement policies[162]. Research and Development - The company is focused on product research and development, particularly in the area of biodegradable drug-coated coronary stent systems[5]. - Research and development expenses accounted for 95.37% of operating revenue, an increase of 46.75 percentage points from the previous year[22]. - The company invested CNY 185 million in R&D during the reporting period, an increase of 16.44% year-on-year, representing 95.37% of the 2021 revenue, up 46.75 percentage points from the previous year[36]. - The company added 16 new invention patents during the reporting period, with a total of 199 invention patents authorized and exclusive licenses globally[38]. - The company’s R&D personnel increased by 79.41% year-on-year, totaling 183 individuals by the end of the reporting period[36]. - The company has developed 8 key technologies and 18 product pipelines, with 16 new invention patents and 55 other intellectual property rights granted during the reporting period[71]. - The company is advancing the development of a unique thorn balloon that combines micro-cutting technology with balloon dilation, aimed at enhancing pre-dilation effects and treatment outcomes in coronary interventions[75]. - The company has established a complete independent core technology system in the cardiovascular and cerebrovascular intervention treatment fields, focusing on breakthroughs in key technologies and products[117]. Market Environment and Challenges - The company faced a challenging external operating environment, which was detailed in the risk factors section of the report[4]. - The national volume-based procurement policy initiated in October 2020 has altered the competitive landscape, impacting the company's market share due to its products not qualifying for the procurement[64]. - The company is focused on expanding its market presence in the coronary stent sector, despite facing challenges from national procurement policies[64]. - The domestic coronary intervention market is relatively mature, with significant room for domestic product substitution, driven by increased penetration of local manufacturers[62]. - The company faces risks related to new product development failures or delays, which could impact revenue and profitability growth[133][142]. - The company’s ability to maintain or improve market competitiveness is challenged by the ongoing centralized procurement policies and intense market competition[136][137]. - The company is exposed to risks from national procurement policies that could lead to significant price reductions for its products[146]. Governance and Compliance - The annual report includes a standard unqualified audit opinion from the accounting firm, ensuring the accuracy and completeness of the financial statements[5]. - The board of directors approved a profit distribution plan that reflects the company's current operational situation and future funding requirements for product development and market promotion[5]. - The board of directors consists of all members present at the meeting, affirming governance and decision-making processes[5]. - The company has not reported any non-operating fund occupation by controlling shareholders or related parties, ensuring financial integrity[7]. Product Development and Innovation - The new generation drug-eluting stent system HT Supreme received EU approval and is undergoing clinical research in collaboration with National University of Ireland, Galway, involving 2,540 participants across six European countries[39]. - The company received regulatory approval for the world's first drug-eluting stent specifically designed for intracranial artery stenosis treatment, establishing a leading position in the ischemic neurology field[42]. - The company reported a significant breakthrough in the design of the Accufit interventional mitral valve replacement system, with improved survival rates and heart function recovery during animal trials[44]. - The company is developing a retractable, dual-stent, self-locking intervention mitral valve replacement technology, with multiple patents granted globally[78]. - The company’s NOVA intracranial drug-eluting stent system, the first of its kind for treating intracranial artery stenosis, received regulatory approval in July 2021, showing significant advantages in vascular healing and reducing restenosis compared to bare stents[77]. - The company has completed clinical trials for its new drug-eluting stent technology, which is expected to enhance treatment efficacy[26]. Human Resources - The company added 206 employees during the reporting period, a 43.19% increase year-over-year, including 81 new R&D personnel, reflecting a 79.41% growth in R&D staff[46]. - The number of R&D personnel increased by 81, a year-on-year growth of 79.41%, with master's degree and above personnel increasing by 13, a growth of 65%[116]. - Total compensation for R&D personnel reached 40.18 million RMB, compared to 27.40 million RMB in the previous period, with average compensation decreasing to 21.96 thousand RMB from 26.86 thousand RMB[118]. - The company emphasizes the importance of building a talent pool through internal training and high-level talent recruitment to support its rapid development[198]. Investment and Financial Strategy - The company invested $4 million to acquire an 18.2% stake in eLum Technologies, enhancing its innovation and R&D capabilities in the neurovascular intervention sector[45]. - The company plans to increase R&D and innovation efforts, aiming to enrich its product pipeline and accelerate the speed of new product launches[129]. - The company aims to balance domestic market risks by actively expanding into overseas markets, particularly for the HT Supreme stent in the US and Japan over the next two years[70]. - The company has invested RMB 10.50 million in working capital, exceeding the planned amount of RMB 10 million[194].

Financial Performance - Sino Medical reported no cash dividends for 2021 due to significant adverse impacts from the centralized procurement policy for coronary stents, prioritizing future development needs[5]. - The company faced a challenging external operating environment, which affected its financial performance and strategic planning[5]. - The company's operating revenue for 2021 was CNY 194,356,081.09, a decrease of 40.64% compared to the previous year[21]. - The net profit attributable to shareholders was CNY -130,765,690.12, representing a decline of 681.36% year-over-year[21]. - The cash flow from operating activities was CNY -60,133,405.36, down 185.28% from the previous year, primarily due to reduced revenue[23]. - Basic and diluted earnings per share were both CNY -0.32, a decrease of 740% compared to the previous year[22]. - The weighted average return on equity was -13.08%, a decrease of 15.15 percentage points year-over-year[22]. - The total assets at the end of 2021 were CNY 1,103,085,987.51, a decrease of 9.40% compared to the end of 2020[21]. - The net assets attributable to shareholders decreased by 13.92% to CNY 927,836,465.08 at the end of 2021[21]. - The company experienced a significant decline in sales due to the implementation of centralized procurement policies for coronary stents, leading to a sharp drop in product prices[23]. - In 2021, the company achieved a revenue of CNY 194 million, a decrease of 40.64% year-on-year, and a net profit attributable to shareholders of CNY -131 million, a decline of 681.36%[35]. - The company’s main business revenue decreased by 40.51%, with stent product revenue dropping by 69.42% due to significant price reductions from national centralized procurement policies, resulting in a sales volume decline of 78.05%[160]. - The overall gross profit margin decreased by 6.08 percentage points compared to the previous year, primarily due to lower sales prices and reduced production scale effects[162]. Research and Development - Sino Medical has not achieved profitability since its listing, indicating ongoing investment in product development and market expansion[4]. - The company is focused on the development of new products and technologies to enhance its market position[5]. - Research and development expenses accounted for 95.37% of operating revenue, an increase of 46.75 percentage points from the previous year[22]. - The company invested CNY 185 million in R&D during the reporting period, an increase of 16.44% year-on-year, representing 95.37% of the 2021 revenue, up 46.75 percentage points from the previous year[36]. - The company added 16 new invention patents during the reporting period, with a total of 199 invention patents authorized and exclusive licenses globally[38]. - The company is actively expanding its product categories and improving production quality and efficiency through lean manufacturing and smart manufacturing initiatives[35]. - Continuous R&D investment has led to the development of multiple key technologies and a robust product pipeline, ensuring sustained revenue growth[56]. - The company has established a comprehensive operational system covering product R&D, manufacturing, and sales, with a focus on high-end interventional medical devices[55]. - The company has developed 8 key technologies and 18 product pipelines, with 16 new invention patents and 55 other intellectual property rights granted during the reporting period[71]. - The company has established five technical platforms to support the development and production of neuro-interventional products, enhancing its capabilities in this field[76]. - The company has a multi-disciplinary R&D team with over 180 members, ensuring a strong foundation for continuous innovation[118]. Market Dynamics - The company is positioned to leverage the growing demand for interventional medical devices amid an aging population and increasing health awareness in China[59]. - The interventional medical device industry in China is supported by government policies aimed at promoting high-end medical device development, indicating a strategic national focus[59]. - The coronary intervention market is relatively mature, with significant potential for domestic product substitution, driven by increased competition and market penetration of local manufacturers[62]. - The national volume-based procurement policy initiated in 2020 has altered the competitive landscape of the coronary stent market, impacting the company's market share[64]. - The domestic neurointerventional market is still largely dominated by foreign brands, with low domestic replacement rates, indicating significant growth potential for local products[66]. - The grassroots medical market is expected to be a major growth point for medical device sales, with over 950,000 grassroots medical institutions in China as of November 2018[68]. - The market for neurointerventional products is largely dominated by foreign brands, indicating significant potential for domestic alternatives[106]. Regulatory and Compliance - The audit report issued by Lixin Accounting Firm confirmed the accuracy and completeness of the financial statements[5]. - The company is committed to maintaining long-term shareholder interests while navigating a complex regulatory landscape[5]. - There were no instances of non-operational fund occupation by controlling shareholders or related parties reported[7]. - The company has not violated decision-making procedures regarding external guarantees[7]. - The company is closely monitoring regulatory changes in the medical device industry to adapt its business strategies accordingly[148]. Operational Risks - The company has outlined various operational risks and corresponding mitigation strategies in its annual report[4]. - The company faces risks related to new product development failures or delays, which could impact revenue and profitability growth[132]. - The company is exposed to market competition risks, particularly in the neuro intervention sector, where foreign companies currently dominate the market[136]. - The company is at risk of talent loss if it cannot provide competitive compensation and a conducive work environment for its skilled workforce[133]. - The company faces potential impairment risks related to development expenditures and intangible assets if new products do not achieve effective sales post-launch[143]. Strategic Investments - The company made a strategic investment of 4 million USD in eLum Technologies, acquiring an 18.2% stake to enhance its innovation and R&D capabilities in the neurology sector[190]. - The company plans to accelerate its international market expansion, with an increasing proportion of overseas revenue as it seeks CE certification for its new generation HT Supreme drug-eluting stent[197]. - The company intends to broaden its product line through self-research and strategic partnerships, including acquisitions in the cardiovascular and neurovascular fields[198]. - The company plans to launch 30 research centers by April 2023 to enhance its product development capabilities in the neuro-interventional field[22].

2022 年第一季度报告 证券代码：688108 证券简称：赛诺医疗 赛诺医疗科学技术股份有限公司 2022 年第一季度报告 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。 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 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 1 / 18 单位：元 币种：人民币 项目 本报告期 本报告期比上年同期增减变动幅度(%) 营业收入 59,092,563.59 113.27 归属于上市公司股东的 净利润 -29,398,472.91 28.81 归属于上市公司股东的 扣除非经常性损益的净 利润 -30,555,065.49 27.68 经营活动产生的现金流 量净额 -43,690,458.86 -30.55 基本每股收益 ...

2021 年第三季度报告 证券代码：688108 证券简称：赛诺医疗 赛诺医疗科学技术股份有限公司 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 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 单位：元 币种：人民币 | 项目 | 本报告期 | 本报告期比上 年同期增减变 | 年初至报告期末 | 年初至报告期 末比上年同期 | | --- | --- | --- | --- | --- | | | | 动幅度(%) | | 增减变动幅度 | | | | | | (%) | | 营业收入 | 42,499,145.99 | -56.93 | 121,132,265.09 | -55. ...

Financial Performance - The company's operating revenue for the first half of 2021 was ¥78,633,119.10, a decrease of 55.44% compared to ¥176,446,024.58 in the same period last year[18]. - The net profit attributable to shareholders of the listed company was -¥81,542,212.35, representing a decline of 360.02% from a profit of ¥31,360,544.71 in the previous year[18]. - The net profit attributable to shareholders after deducting non-recurring gains and losses was -¥83,299,852.62, down 395.45% from ¥28,194,339.52 in the same period last year[18]. - The net cash flow from operating activities was -¥24,809,916.71, a decrease of 161.50% compared to ¥40,344,143.30 in the previous year[18]. - Basic earnings per share decreased to -0.20 CNY, a decline of 350.00% compared to the same period last year[19]. - The weighted average return on net assets was -7.91%, a decrease of 10.72 percentage points compared to the same period last year[22]. - The company achieved total revenue of 78.63 million yuan and a net loss attributable to shareholders of 81.54 million yuan in the reporting period[32]. - Revenue for the first half of 2021 was CNY 78.63 million, a decrease of 55.44% year-over-year, with a net loss of CNY 81.54 million, down 360.02% year-over-year[67]. Research and Development - Research and development expenses accounted for 109.35% of operating revenue, an increase of 71.13 percentage points year-on-year[19]. - Research and development investment totaled approximately 85.98 million yuan, representing a 27.51% increase year-over-year, and accounted for 109.35% of the company's revenue in the first half of 2021[36]. - The company has developed 8 key technologies and 18 product pipelines, with 8 new invention patents authorized during the reporting period[36]. - The company is focusing on continuous technological innovation and evidence-based medical research to meet clinical needs and achieve sustainable commercial development[31]. - The company has applied for 11 new invention patents and obtained 8 patents in the first half of 2021, with a total of 345 applications and 196 granted patents[43]. Market and Product Development - The domestic market for coronary intervention has largely completed import substitution, with a trend towards cost control and standardization of channels expected to benefit high-quality stent products[30]. - The new generation pre-dilation and post-dilation balloon project in the coronary field is progressing as planned, with product performance significantly improved, especially in delivery performance, expected to launch in 2022 in China[39]. - The NOVA intracranial drug-eluting stent system, the world's first specifically designed for intracranial artery stenosis, received regulatory approval in July 2021, showing significant advantages in vascular healing and reducing restenosis compared to bare stents[40]. - The company is expanding its product layout in the neuro-interventional field with multiple new products progressing as planned[40]. - The company is focused on advancing its innovative products to meet the growing demand in the cardiovascular and neurovascular sectors, with a strong emphasis on research and development[52]. Risks and Challenges - The company has detailed various risks and countermeasures in the report, which investors should review[4]. - The report includes a forward-looking statement risk declaration, indicating that future plans and strategies do not constitute a substantive commitment to investors[6]. - The implementation of centralized procurement policies has led to a risk of significant declines in sales revenue and net profit, with potential losses if hospitals continue to primarily use selected products[75]. - The company faces risks related to new product development failures or registration delays due to high technical barriers and significant R&D investment in the medical device industry[73]. - The company is exposed to risks of talent loss if it cannot provide competitive compensation and a conducive work environment, which could adversely affect its operational capabilities[74]. Environmental and Compliance - The company does not belong to industries classified as heavily polluting by the state, and its emissions are monitored regularly, with results meeting compliance standards[105]. - The company has installed waste gas treatment facilities and conducts annual monitoring of wastewater and emissions, all of which are compliant[105]. - There were no administrative penalties related to environmental issues during the reporting period[106]. - The company is actively involved in ensuring compliance with environmental responsibilities and has not disclosed any adverse changes in its environmental information[106]. Shareholder and Capital Management - The company will distribute at least 10% of the distributable profits as cash dividends after reserving the statutory surplus and discretionary surplus[119]. - The company will prioritize cash dividends when conditions allow, and may also consider stock dividends and capital reserve transfers[119]. - The company has a commitment from major shareholders and management regarding the handling of funds and transactions, ensuring fair and reasonable pricing[108]. - The company has a lock-up period for shares held by core technical personnel, lasting 12 months from the date of listing[109]. - The company has not proposed any profit distribution or capital reserve transfer plans for the current period[102].

Financial Performance - The company's operating revenue for the first half of 2021 was ¥78,633,119.10, a decrease of 55.44% compared to ¥176,446,024.58 in the same period last year[18]. - The net profit attributable to shareholders of the listed company was -¥81,542,212.35, representing a decline of 360.02% from a profit of ¥31,360,544.71 in the previous year[18]. - The net profit attributable to shareholders after deducting non-recurring gains and losses was -¥83,299,852.62, down 395.45% from ¥28,194,339.52 in the same period last year[18]. - The net cash flow from operating activities was -¥24,809,916.71, a decrease of 161.50% compared to ¥40,344,143.30 in the previous year[18]. - The net assets attributable to shareholders at the end of the reporting period were ¥977,818,391.57, a decrease of 9.28% from ¥1,077,867,456.52 at the end of the previous year[18]. - Total assets at the end of the reporting period were ¥1,151,673,493.03, down 5.41% from ¥1,217,497,750.16 at the end of the previous year[18]. - Basic earnings per share for the reporting period was -0.20 CNY, a decrease of 350.00% compared to the same period last year[19]. - The weighted average return on net assets was -7.91%, a decrease of 10.72 percentage points compared to the same period last year[22]. - The diluted earnings per share was also -0.20 CNY, reflecting a 350.00% decline year-on-year[21]. - The company achieved total revenue of 78.63 million yuan and a net loss attributable to shareholders of 81.54 million yuan in the reporting period[32]. Research and Development - Research and development expenses accounted for 109.35% of operating revenue, an increase of 71.13 percentage points year-on-year[19]. - Research and development investment reached approximately 85.98 million yuan, a year-on-year increase of 27.51%, accounting for 109.35% of total revenue in the first half of 2021[36]. - The company has developed 8 key technologies and 18 product pipelines, with 8 new invention patents authorized during the reporting period[36]. - The company applied for 11 new invention patents and obtained 8 patents in the first half of 2021, with a total of 345 applications and 196 granted patents to date[43]. - The company is focusing on innovative research and development to drive sustainable commercial growth in the rapidly developing medical device industry[31]. Product Development and Innovation - The new generation drug-eluting stent HT Supreme is the first in the world to be guided by healing and has been submitted for PMA registration in the US, with the first four modules completed[37]. - The Neuro RX intracranial balloon dilation catheter was the first to be approved in China using rapid exchange technology, enhancing treatment for symptomatic intracranial atherosclerotic stenosis[34]. - The company plans to expand its product offerings in the coronary field to meet diverse market demands amid centralized procurement policies[38]. - The company’s magnesium alloy fully biodegradable drug-eluting stent system has made significant progress in material research, with ongoing animal experiments[38]. - The new generation pre-dilation and post-dilation balloon project in the coronary field is progressing as planned, with product performance significantly improved, especially in delivery performance, expected to launch in 2022 in China[39]. - The NOVA intracranial drug-eluting stent system, the world's first specifically designed for intracranial artery stenosis, received regulatory approval in July 2021, demonstrating significant advantages over existing bare stents in vascular healing and reducing restenosis[40]. Market Challenges and Strategies - The national procurement policy for coronary stents initiated in October 2020 is expected to significantly impact the company's operations and market strategy[71]. - The procurement price of coronary stents has significantly decreased, with domestic products averaging a drop of over 92% compared to 2019, resulting in an average price of around 700 RMB[72]. - The company's revenue from coronary stents has been severely impacted, leading to a substantial decline in overall profitability, with a reported revenue of 78.63 million RMB for the first half of 2021, a year-on-year decrease of 55.44%[80]. - The implementation of national centralized procurement policies has led to a risk of significant declines in sales revenue and net profit, with potential for continued market share loss if institutions favor selected products[75]. - The ongoing global pandemic continues to pose risks to the company's business operations, particularly in overseas markets[79]. Financial Position and Investments - The company reported a total of 90,902,330 shares held by Tianjin Weixin Sunshine Enterprise Management Consulting Limited, representing 22.17% of the total shares[146]. - The company has a total of ¥10,000 million allocated for working capital, with ¥5,618.28 million utilized in the current year[94]. - The company completed a capital increase of $4 million to eLum Technologies, Inc., enhancing its investment portfolio[90]. - The company plans to invest a total of ¥30,690.19 million across several projects, including ¥14,430.76 million for high-end interventional therapy equipment upgrades and ¥2,267.58 million for R&D center construction[94]. - The company has registered 2 trademarks and filed 11 invention patents, showcasing its strong R&D capabilities[92]. Corporate Governance and Compliance - The company has undergone a change in its board and management structure, electing new members to the second board and supervisory committee[101]. - The company commits to not engaging in any business that competes substantially with Sino Medical, either directly or indirectly, through joint ventures or other means[111]. - The company will ensure compliance with all relevant laws and regulations regarding share repurchases and reductions[125]. - The company has committed to reducing carbon emissions, although specific measures and their effectiveness were not disclosed[106]. - The company has a commitment to fair and reasonable pricing in transactions with related parties, ensuring compliance with disclosure obligations[109].