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上海市锦天城(北京)律师事务所 关于赛诺医疗科学技术股份有限公司 2024 年第一次临时股东大会之 法 律 意 见 书 天城 律师事务 所 年 ALLBRIGHT LAW OFFICES 北京市 东城区 东长安街1号 东方广场C1座6层(100738) 6/F,Office Tower C1,Oriental Plaza,No.1 East Chang An Avenue,Beijing 100738,PRC Tel: +86 10 8523 0688 Fax: +86 10 8523 0699 www.allbrightlaw.com 法律意见书 上海市锦天城（北京）律师事务所 关于赛诺医疗科学技术股份有限公司 2024 年第一次临时股东大会之 根据《中华人民共和国证券法》(以下简称"《证券法》")、《中华人民共 和国公司法》(以下简称"《公司法》")和中国证券监督管理委员会《上市公 司股东大会规则》(以下简称"《股东大会规则》")等法律、行政法规、规章 和规范性文件的要求以及《赛诺医疗科学技术股份有限公司章程》(以下简称"《公 司章程》"),上海市锦天城(北京)律师事务所(以下简称"本所")接受赛诺 医疗 ...

证券代码：688108 证券简称：赛诺医疗 公告编号：2024-045 赛诺医疗科学技术股份有限公司 关于第三届董事会第三次会议决议的公告 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。 一、董事会会议召开情况 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"）第三届董 事会第三次会议通知于 2024 年 8 月 8 日以书面等方式送达各位董事和监事。会议于 2024 年 8 月 19 日以现场和通讯相结合的方式在北京市海淀区高梁桥斜街 59 号中坤 大厦 7 层公司会议室召开。本次会议应出席董事 9 人，实际出席董事 9 人。本次会议 为定期会议，由董事长孙箭华先生召集并主持，公司监事、部分高管列席了本次会议。 本次会议的召开符合《中华人民共和国公司法》等有关法律、法规、规范性文件及《公 司章程》《董事会议事规则》等的规定，会议召开程序合法有效。 二、董事会会议审议情况 经与会董事认真讨论，审议并通过如下事项： 2、审议通过"关于赛诺医疗科学技术股份有限公司 2024 年半年度募集资金存放 与实际使用情况专项 ...

证券代码：688108 证券简称：赛诺医疗 公告编号：2024-046 赛诺医疗科学技术股份有限公司 关于第三届监事会第三次会议决议的公告 本公司监事会及全体监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。 一、监事会会议召开情况 二、监事会会议审议情况 经与会监事认真讨论，审议并通过如下事项： 1、审议通过"关于赛诺医疗科学技术股份有限公司 2024 年半年度报告及其摘要 的议案" 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"）第三届监 事会第三次会议通知于 2024 年 8 月 8 日以书面送达等方式通知各位监事。会议于 2024 年 8 月 19 日在北京市海淀区高梁桥斜街 59 号中坤大厦 7 层公司会议室以现场和通讯 相结合的方式召开。本次会议应出席监事 3 人，实际出席监事 3 人。本次会议为定期 会议，由监事会主席于长春先生召集并主持，公司部分高管列席了本次会议。本次会议 的召开符合《中华人民共和国公司法》等有关法律、法规、规范性文件及《公司章程》 《监事会议事规则》等的规定，会议召开程序合法有效。 经与会监事审 ...

Company Information - The company's registered address is No. 5, Fourth Avenue, Tianjin Development Zone, TEDA Biomedical Research Building, Block B, 2nd Floor[9] - The company's legal representative is Sun Jianhua[9] - The company's website is http://www.sinomed.com[9] - The company's stock is listed on the Shanghai Stock Exchange's STAR Market under the ticker symbol 688108[13] - The company's stock abbreviation is Sino Medical[13] - The company's board secretary is Huang Kai, and the securities affairs representative is Zhang Xidan[10] - The company's contact email for investor relations is ir@sinomed.com[10] - The company's contact phone number is 010-82163261[10] - The company's contact fax number is 010-82162787[10] - The company's office address is No. 5, Fourth Avenue, Tianjin Development Zone, TEDA Biomedical Research Building, Block A, 3rd Floor[9] Financial Performance - Revenue for the reporting period reached RMB 213,692,262.55, a year-on-year increase of 32.49%[14] - Net profit attributable to shareholders of the listed company was RMB 7,662,008.81, a year-on-year increase of 125.88%[16] - Revenue from coronary intervention business increased by 70.77% year-on-year, driven by the second round of national centralized procurement of coronary stents[16] - Revenue from neurointervention business increased by 2.74% year-on-year, influenced by price and sales volume changes in neurointervention balloon products[16] - R&D investment accounted for 43.16% of revenue, a decrease of 6.69 percentage points year-on-year[17] - Net cash flow from operating activities was RMB 13,002,580.28, a year-on-year decrease of 16.72%[16] - Total assets increased by 11.04% compared to the end of the previous year, reaching RMB 1,316,769,024.79[14] - Non-recurring gains and losses amounted to RMB 20,255,319.85, including government subsidies of RMB 5,817,325.90[18][19] - Basic earnings per share were RMB 0.02, a year-on-year increase of 128.57%[17] - Weighted average return on equity was 0.92%, an increase of 4.46 percentage points year-on-year[17] Product Portfolio - The company's main products include coronary stents, coronary balloons, neuro stents, and neuro balloons, with several products leading both domestically and internationally[25] - The company's HT Supreme coronary drug-eluting stent system is the first healing-oriented coronary drug stent system globally and the first in China to undergo pre-market clinical studies in China, the US, Japan, and Europe[25] - The company's Neuro RX intracranial balloon dilatation catheter is the first in China to adopt rapid exchange technology and has been approved by the National Medical Products Administration[25] - The company's NOVA intracranial drug-eluting stent system is the first globally for treating intracranial arterial stenosis and the first healing-oriented intracranial stent[25] - The company's products have been used in nearly 2 million cases and are available in over 3,000 hospitals in China, Southeast Asia, Europe, and South America[24] Global Operations - The company has established subsidiaries in Beijing, Suzhou, Hong Kong, the US, Japan, the Netherlands, and France, with an international-level R&D, production, and operation system[24] - The company focuses on cardiovascular, cerebrovascular, and structural heart disease intervention treatment fields[24] - The company's products are registered in multiple countries and regions, including China, Thailand, Brazil, Indonesia, Kazakhstan, Europe, Singapore, Turkey, India, the UK, Taiwan, Bangladesh, Malaysia, South Korea, Hong Kong, Egypt, Belarus, and Mexico[26] - The company's NC Thonic® non-compliant PTCA balloon dilatation catheter is used for post-PCI stent expansion and is registered in China, Thailand, Indonesia, Brazil, Taiwan, and Singapore[26] - The company's BuMA biodegradable drug-coated coronary stent system is registered in China, Thailand, Brazil, Indonesia, Kazakhstan, Europe, Singapore, and Turkey[26] R&D and Innovation - The company's core technology in vascular drug-eluting implant design, based on the "healing window period" theory, has been applied to products like the BuMA series drug-eluting stents, NOVA intracranial stents, and HT series drug-eluting stent systems[31] - The company has developed a timed drug release technology and LPN spray process platform, which synchronizes drug release with vascular smooth muscle cell proliferation cycles[32] - The company has a complete vascular and non-vascular stent design and manufacturing platform, covering all processes from design to loading[33] - The company has established a comprehensive balloon catheter and delivery system process platform, crucial for clinical performance[33] - The company is developing a new generation of magnesium alloy biodegradable stents with a wall thickness controlled below 120 microns, ensuring mechanical support for 3 to 6 months and complete degradation within 1 year[33] - The company's interventional mitral valve replacement system uses nickel-titanium memory alloy and bovine pericardium, with a positioning device for precise placement[33] - The company has built an automated and intelligent manufacturing platform, including automated image collection, defect recognition, and material transfer[34] - The company has a full set of imported tube extrusion equipment, capable of producing single-layer, double-layer, and multi-cavity tubes for various product performance needs[34] - The company has a complete catheter design and precision processing platform, equipped with various catheter braiding machines to respond to clinical demands[34] Financial Details - Total R&D investment (including capitalized and expensed) reached 92.2267 million yuan, accounting for 43.16% of total revenue[35] - The company has 22 products in the coronary, neuro, and structural heart disease intervention fields, with 50 registrations obtained in 21 countries and regions globally[36] - 7 new invention patents were applied for, and 9 were granted in the first half of the year, bringing the total number of invention patents to 150 globally[36] - The company's clinical research results were published in 2 international core journals, with a cumulative total of 36 papers published (22 in international core journals)[36] - The company's neurovascular subsidiary, Sinomed Neurovita, obtained a medical device registration certificate for its delivery catheter, and the balloon guide catheter received registration acceptance[38] - The company's intracranial self-expanding drug stent received innovative device approval and completed registration acceptance, being the world's first of its kind[39] - The company is developing a globally patented retractable, self-locking interventional mitral valve replacement technology, with multiple patents granted worldwide[40] - Capitalized R&D investment decreased by 14.36% to 23.9618 million yuan, mainly due to reduced clinical trial and material costs as some projects reached key milestones[42] - The BuMA Supreme biodegradable drug-coated coronary stent system - PIONEER II project has received market approval, with a cumulative investment of 71.9712 million yuan[43] - Precision tube extrusion technology has achieved a production capacity of millions, accelerating the development of self-developed products and ensuring the supply of mass-produced products[44] - The non-compliant balloon dilatation catheter (II) has obtained registration certification, with future growth estimated to maintain a compound growth rate of around 15%[44] - The semi-compliant balloon dilatation catheter has obtained registration certification, with future growth estimated to maintain a compound growth rate of around 15%[44] - The HT Supreme II has obtained registration certification, with future growth estimated to maintain a compound growth rate of around 15%[44] - The extension catheter has obtained registration certification, with PCI surgeries in China growing at an annual rate of 10% to 20%, and the number of PCI surgeries expected to reach 250 by 2025[44] - The Accufit interventional mitral valve replacement system has entered the long-term animal experiment stage, with a market potential of over 10 million severe MR patients in China[45] - The intracranial aspiration catheter has submitted design optimization and registration changes, with a market share of 70-80% in thrombectomy surgeries[45] - The Nova drug-eluting stent system is in the clinical enrollment stage, with a potential market of 70-80 thousand ischemic stroke patients annually in China[45] - The intracranial drug balloon system is undergoing product design optimization, with a potential market for small vessels and in-stent restenosis cases[46] - The intracranial self-expanding drug stent system has received innovative approval and registration application acceptance, with a potential market of 70-80 thousand ischemic stroke patients annually in China[46] Risks and Challenges - The company faces risks of new product R&D failure or delayed registration, which could impact revenue and profitability[60] - Potential loss of key scientific and technical talent could adversely affect the company's continuous operation[61] - The company's products are subject to risks from centralized procurement policies, which may lead to fluctuations in sales volume and pricing[63] - Intense competition in the cardiovascular and neurovascular intervention markets could weaken the company's market position and profitability[64] - Uncertainty in the launch of new products due to strict regulatory oversight could delay commercialization and impact revenue[65] - Risks associated with the supply of critical raw materials, which could disrupt production if supply is interrupted[66] - The company's neurovascular intervention products face risks of R&D failure or inability to achieve expected sales targets[67] - The company's performance turned from profit to loss in 2024 due to the impact of centralized procurement and high R&D expenses[69] Shareholder and Equity Information - The company's total shares increased from 410,000,000 to 413,456,000 due to the issuance of 3,456,000 new shares[140] - The company completed the registration of 3,456,000 unrestricted shares from the second vesting period of the 2022 restricted stock incentive plan, which became tradable on June 27, 2024[141] - As of the reporting period, the total number of ordinary shareholders was 10,834[141] - Shareholder Guo Yanchao holds a total of 22,649,343 shares, including 12,399,343 shares through a regular securities account and 10,250,000 shares through a margin account[142] - Shareholder Huang Songlang holds a total of 10,050,000 shares, all through a margin account[142] - Shareholder Wang Ning holds a total of 4,979,733 shares, all through a margin account[142] - Tianjin Weixin Sunshine Enterprise Management Consulting Co., Ltd. holds 71,859,417 shares, representing 17.38% of the total shares[143] - The China Bank Co., Ltd. - Guotai Jiangyuan Advantage Select Flexible Allocation Mixed Securities Investment Fund holds 12,628,045 shares, representing 3.05% of the total shares[143] - Tianjin Sunshine Guangye Enterprise Management Partnership holds 10,628,155 shares, representing 2.57% of the total shares[143] - The total number of shares held by the top 10 shareholders is 162,958,708, accounting for 39.41% of the total shares[149] - The largest shareholder, Tianjin Weixin Sunshine Enterprise Management Consulting Co., Ltd., holds 71,859,417 shares, representing 17.38% of the total shares[149] - The second-largest shareholder, Guo Yanchao, holds 22,649,343 shares, accounting for 5.48% of the total shares[149] - The third-largest shareholder, China Bank Co., Ltd. - Guotai Jiangyuan Advantage Select Flexible Allocation Hybrid Securities Investment Fund, holds 12,628,045 shares, representing 3.05% of the total shares[149] - The fourth-largest shareholder, Tianjin Sunshine Guangye Enterprise Management Partnership (Limited Partnership), holds 10,628,155 shares, accounting for 2.57% of the total shares[149] - The fifth-largest shareholder, Huang Songlang, holds 10,050,000 shares, representing 2.43% of the total shares[149] - The sixth-largest shareholder, Tianjin Sunshine Deye Enterprise Management Partnership (Limited Partnership), holds 8,208,381 shares, accounting for 1.99% of the total shares[149] - The seventh-largest shareholder, China Construction Bank Co., Ltd. - Guotai Medical and Health Stock Securities Investment Fund, holds 7,909,831 shares, representing 1.91% of the total shares[149] - The eighth-largest shareholder, China Bank Co., Ltd. - Guotai Zhiyuan Advantage Hybrid Securities Investment Fund, holds 7,642,724 shares, accounting for 1.85% of the total shares[149] - The ninth-largest shareholder, Tianjin Sunshine Yongye Enterprise Management Partnership (Limited Partnership), holds 6,403,079 shares, representing 1.55% of the total shares[149] - The company completed the transfer of 20,500,000 shares at a price of 9.784 yuan per share to Guo Yanchao, with the transfer registered on January 19, 2024[152] Cash Flow and Financial Position - The company's monetary funds increased to 232,967,228.24 yuan as of June 30, 2024, up from 188,640,045.22 yuan at the end of 2023[156] - Accounts receivable rose to 23,309,703.48 yuan as of June 30, 2024, compared to 8,936,220.19 yuan at the end of 2023[156] - Inventory increased to 123,823,611.18 yuan as of June 30, 2024, from 118,220,173.59 yuan at the end of 2023[156] - Total assets grew to 1,316,769,024.79 yuan as of June 30, 2024, up from 1,185,821,379.98 yuan at the end of 2023[157] - Short-term borrowings increased to 63,055,736.10 yuan as of June 30, 2024, compared to 53,554,648.62 yuan at the end of 2023[157] - Accounts payable decreased to 23,217,668.84 yuan as of June 30, 2024, from 28,170,465.48 yuan at the end of 2023[157] - Long-term loans increased to 59,300,000.00 yuan as of June 30, 2024, up from 50,300,000.00 yuan at the end of 2023[157] - The company's total liabilities increased to 171,422,574.73 yuan as of June 30, 2024, compared to 151,272,495.57 yuan at the end of 2023[157] - The company's total non-current liabilities increased to 171,407,337.86 yuan as of June 30, 2024, up from 130,220,448.24 yuan at the end of 2023[157] - Total revenue for the first half of 2024 reached 213,692,262.55 RMB, an increase from 161,285,944.35 RMB in the same period of 2023[162] - Total operating costs for the first half of 2024 were 238,544,415.05 RMB, compared to 203,874,673.63 RMB in the first half of 2023[162] - Total assets as of June 30, 2024, amounted to 1,451,911,970.97 RMB, up from 1,339,305,239.98 RMB at the end of 2023[161] - Total liabilities as of June 30, 2024, were 310,167,325.59 RMB, compared to 240,066,782.01 RMB at the end of 2023[161] - Total equity as of June 30, 2024, stood at 1,141,744,645.38 RMB, up from 1,099,238,457.97 RMB at the end of 2023[161] - Long-term equity investments increased to 638,971,339.75 RMB as of June 30, 2024, from 457,149,318.53 RMB at the end of 2023[160] - Development expenditure rose to 287,523,300.75 RMB as of June 30, 2024, compared to 273,538,721.28 RMB at the end of 2023[160] - Total non-current liabilities as of June 30, 2024, were 176,552,239.37 RMB, up from 137,843,698.94 RMB at the end of 2023[161] - Total current liabilities as of June 30, 2024, were 133,615,086.22 RMB, compared to 102,223,083.07 RMB at the end of 2023[160] - Total owner's equity as of June 30, 2024, was 913,769,096.29 RMB, up from 861,649,791.13 RMB at the end of 2023[158] - Sales expenses increased to 37,006,450.01 RMB, up from 31,514,848.96 RMB in the previous period[163] - R&D expenses rose to 68,264,921.24 RMB, compared to 52,417,509.01 RMB in the prior period[163] - Net profit for the period was 9,774,478.68 RMB, a significant improvement from a net loss of -32,195,883.38 RMB in the previous year[163] - Revenue for the parent company increased to 162,087,758.30 RMB, up from 112,694,732.52 RMB in the same period last year[165] - Parent company's net profit reached 19,791,804.69 RMB, compared to a net loss of -7,699,793.59 RMB in the previous year[166] - Basic earnings per share for the parent company improved to 0.05 RMB, up from -0.02 RMB in the prior period[166] - Total comprehensive income for the parent company was 19,791,804.69 RMB, compared to -7,699,793.59 RMB in the previous year[166] - Interest expenses for the parent company increased to 2,423,568.33 RMB, up from 1,130,151.28 RMB in the prior period[165] - Other income for the parent company decreased to 2,716,338.29 RMB, down from 4,423,801.37 RMB in the previous year[165] - Credit impairment loss for the parent company was -1,911

证券代码：688108 证券简称：赛诺医疗 公告编号：2024-048 赛诺医疗科学技术股份有限公司 关于召开 2024 年半年度业绩说明会的公告 重要内容提示： 一、说明会类型 赛诺医疗科学技术股份股份有限公司（以下简称"赛诺医疗"或"公司"） 于 2024 年 8 月 20 日在上海证券交易所网站（http://www.sse.com.cn）上披露 了《赛诺医疗科学技术股份有限公司 2024 年半年度报告》及其摘要。 为加强与投资者的深入交流，便于广大投资者更全面深入地了解公司，在上 海证券交易所的支持下，公司计划于 2024 年 8 月 26 日上午 10:00-11:00 在上证 路演中心（网址：https://roadshow.sseinfo.com/）以网络文字互动问答的方 式举行赛诺医疗 2024 年半年度业绩说明会，与广大投资者进行充分交流，解答 投资者普遍关注的问题。 二、说明会召开的时间、地点 1、会议召开时间：2024 年 8 月 26 日 10:00-11:00 会议召开时间：2024 年 8 月 26 日 10:00-11:00 会议召开地点：上海证券交易所上证路演中心 （网址：ht ...

证券代码：688108 证券简称：赛诺医疗 公告编号：2024-049 赛诺医疗科学技术股份有限公司 2024 年第一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 （一） 股东大会召开的时间：2024 年 8 月 19 日 （二） 股东大会召开的地点：北京市海淀区高梁桥斜街 59 号中坤大厦 701-707，公司会议室 二、 议案审议情况 （一） 非累积投票议案 1、 议案名称：赛议案诺医疗科学技术股份关于变更注册资本修改经营范围并修改《赛诺医疗 科学技术股份有限公司章程》的议案 审议结果：通过 表决情况： （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 | 72 | | --- | --- | | 普通股股东人数 | 72 | | 2、出席会议的股东所持有的表决权数量 | 103,654,008 | | 普通股股东所持有表决权数量 | 103 ...

证券代码：688108 证券简称：赛诺医疗 公告编号：2024-047 （一）实际募集资金金额、资金到账时间 经中国证券监督管理委员会 2019 年 9 月 27 日证监许可[2019] 1794 号文核准， 本公司向社会公开发行人民币普通股 50,000,000 股，每股面值人民币 1.00 元，每股 发行价格为人民币 6.99 元，募集资金总额为人民币 349,500,000.00 元，由主承销商 中信证券扣除保荐承销费 29,680,000.00 元后，将剩余募集资金 319,820,000.00 元汇 入公司开立的募集资金专用账户。扣除公司后期为发行股份所支付的其他发行费用 12,053,400.00 元 ， 扣 除 公 司 应 转 出 的 先 期 以 自 有 资 金 垫 付 其 他 发 行 费 用 3,416,018.23 元，加上应归还募集资金账户的发行费用进项税 2,551,270.23 元，实 际募集资金净额为 306,901,852.00 元，其中计入股本 50,000,000.00 元，资本溢价 256,901,852.00 元计入资本公积，新增股本占新增注册资本的 100%。上述资金于 ...

证券代码：688108 证券简称：赛诺医疗 公告编号：2024-044 赛诺医疗科学技术股份有限公司关于 公司产品在摩洛哥获得注册证的自愿性披露公告 产品名称：NC Rockstar 非顺应性冠状动脉球囊扩张导管 结构及组成型：该产品由 TIP 头、球囊保护鞘、球囊、球囊内管、Marker、球囊外 管、金属导管、护套、接头、洞口和金属导管的两个标记组成。产品经环氧乙烷灭菌， 一次性使用，货架有效期 3 年。 适用范围：该产品适用于为动脉粥样硬化患者改善心肌灌注而针对自体冠状动脉或 搭桥狭窄部位所进行的球囊导管扩张。该产品还适用于球囊扩张支架（裸金属和药物洗 脱支架）的递送后扩张。 2、HT Supreme™药物洗脱支架系统 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： 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"）于 2024 年向 摩洛哥药物和药品部门（以下简称"DMP"）递交了 NC Rockstar 非顺应性冠状动脉球囊 扩张导管和 HT Supreme™药物洗脱支架系统的注册申报资 ...

各位投资人早上好 欢迎介入动物医药诸葛广团队的系列培训 我是医药研究员刘乐童那我来介绍下塞诺伊了这家器械公司公司主营业务呢 是做神经介入及灌卖介入的器械产品的主要的看点呢 第一个就是它有两款这个颅内支架的单品将于今年年底到明年年初获批上市 他们的销售峰值分别是十几亿元这样的一个量级那第二点就是公司的外卖产品系列这边有这个新一代的改良外卖支架产品以及公司独家技术的一款全能新品都是光脚进入了国家集采并且在进入集采后带来了快速放量也将有助助力公司的业绩在今年实现扭亏为盈 同时呢HT系列的这个贯卖产品有望于今年年底是拿到FDA的获批并且在海外上市之后带来贯卖业务板块的一个新的增量展开来说公司在这个神经介入板块布局也是较早的这两年是进入了产品的收获期神经介入的医疗器械市场整体的市场空间增速较快 市场规模近150亿元过去的复合增速是20亿%公司在缺血出血和通路的这三大领域都是有所布局的产品界较为丰富大家现在最为关注的两款产品第一个这个是鲁内自捧药物支架是用于缺血型脑突冻的也就是鲁内动脉中央硬化狭窄这个市场潜力还是较大的然而市场 格局还是较好的当前目前的这个竞争产品只有三款分别是这个威创和史赛克的两款裸支架以及赛诺他自己在 ...