证券代码：300832 证券简称：新产业 公告编号：2023-086 深圳市新产业生物医学工程股份有限公司 关于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、准确和完整，没有虚假 记载、误导性陈述或重大遗漏。 近日，深圳市新产业生物医学工程股份有限公司（以下简称"公司"）收到 了国家药品监督管理局颁发的 2 项《医疗器械注册证》。具体情况如下： 肺炎衣原体（CP）被认为是世界常见的呼吸道传染病原体，可引起肺炎、 支气管炎、咽炎、鼻窦炎等急性呼吸道感染，并可能激发哮喘。CP 感染引起的 肺炎占社区获得性肺炎（指在医院外罹患的肺实质炎症, 是全球第六大死因）的 10%-20%。CP 感染主要临床表现为咽痛、声嘶、流涕等，也可出现发热、咳嗽， 其影像学表现多样化，且轻症者多不易显示，因临床症状和影像学特征不典型常 常导致忽略或误诊，须要结合实验室检测结果做出诊断。 目前，国内 CP 感染诊断主要依靠血清学抗体检测，CP 感染可诱导机体产 生特异性 IgM 和 IgG 血清抗体，临床上采用 CP IgM 抗体结合 IgG 抗体检测辅助 诊断急性感染和既往感染。IgM 抗体阳性提示近期感染；单 ...

证券代码：300832 证券简称：新产业 公告编号：2023-085 深圳市新产业生物医学工程股份有限公司 关于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、准确和完整，没有虚假 记载、误导性陈述或重大遗漏。 抗心磷脂抗体是抗磷脂综合征的特异性抗体，其升高也见于系统性红斑狼疮 等自身免疫疾病中，此次公司抗心磷脂抗体 IgG 测定试剂盒（磁微粒化学发光法） 在国内取得《医疗器械注册证》，进一步完善了公司自身免疫疾病产品套餐，其 与公司之前已获证的 aCL IgM、β2-GP1 IgM 和β2-GP1 IgG 组成了抗磷脂抗体 四项检测试剂菜单，有利于进一步提升公司在抗磷脂综合征、系统性红斑狼疮等 自身免疫疾病诊断方面的市场竞争力。 二、 对公司的影响及风险提示 截至目前，公司已先后取得 164 项化学发光试剂《医疗器械注册证》（共 234 个注册证）。以上试剂新产品医疗器械注册证的取得，丰富了公司化学发 光检测产品中"自免抗体"项目类别，将对公司发展具有正面影响，但对近期 的生产经营和业绩不会产生重大影响，敬请投资者给予关注并注意投资风险。 近日，深圳市新产业生物医学工程股份有限公司（ ...

深圳市新产业生物医学工程股份有限公司 投资者关系活动记录表 证券代码：300832 证券简称：新产业 编号：2023-008 深圳市新产业生物医学工程股份有限公司 投资者关系活动记录表 □特定对象调研 □分析师会议 □媒体采访 □业绩说明会 投资者关系 □新闻发布会 □路演活动 活动类别 现场参观 其他 线上交流、瑞银策略会、国联证券策略会、德邦证券 策略会、广发证券策略会、西南证券策略会、海通证券策略会、 野村证券策略会、安信证券策略会 参与单位名 称及人员姓 共计84 家机构，204名参会人员，详见附件《与会机构名单》。 名 时间 2023年8月26 日-9月28日 深圳市坪山区坑梓街道金沙社区锦绣东路23号新产业生物大厦 地点 等 董事长兼总经理 饶微 上市公司接 副总经理兼董事会秘书 张蕾 待人员姓名 投资者关系负责人 吕宇宁 投资者关系 除前期已披露的投资者关系活动交流内容外，无新增主要 活动主要内 ...

证券代码：300832 证券简称：新产业 公告编号：2023-084 深圳市新产业生物医学工程股份有限公司 关于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、准确和完整，没有虚 假记载、误导性陈述或重大遗漏。 近日，深圳市新产业生物医学工程股份有限公司（以下简称"公司"）收到 了 1 项国家药品监督管理局、4 项广东省药品监督管理局颁发的《医疗器械注册 证》。具体情况如下： | 序 | 产品名称 | 注册 | 注册证编号 | | | | 注册证有效期 | | | 适用范围 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 号 | | 分类 | | | | | | | | | | | Ⅱ型单纯疱疹 病毒 抗体 | | | | | | | | | 本试剂盒用于体外定性 | | | IgM | | 国械注准 | 2023 | 年 | 09 | 月 | 19 | 日至 | 检测人血清或血浆样本 | | 1 | 检测试剂盒（化 | Ⅲ类 | 20233401367 | 2028 | 年 | 09 | ...

证券代码：300832 证券简称：新产业 公告编号：2023-083 深圳市新产业生物医学工程股份有限公司 关于获得医疗器械注册证的公告 | 序 号 | 产品名称 | 注册 分类 | 注册证编号 | | | | 注册证有效期 | | | 适用范围 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | 肌酐测定试剂 | | 粤械注准 | 2023 | 年 | 09 | 月 | 08 | 日至 | 本试剂盒用于体外定量测 定人血清、血浆或尿液中 | | 5 | 盒（肌氨酸氧化 | Ⅱ类 | | | | | | | | 肌酐（Cr）的含量，临床 | | | 酶法）注 | | 20232401510 | 2028 | 年 | 09 | 月 | 07 | 日 | 上主要作为肾功能的评价 | | | | | | | | | | | | 指标之一。 | | | γ-谷氨酰基转 | | | | | | | | | 本试剂盒用于体外定量测 | | | 移酶测定试剂 | | 粤械注准 | 2023 | 年 | 09 | 月 | 08 | ...

证券代码：300832 证券简称：新产业 公告编号：2023-082 深圳市新产业生物医学工程股份有限公司 关于控股股东部分股份办理质押及解除质押的公告 本公司及董事会全体成员保证信息披露的内容真实、准确和完整，没有虚假 记载、误导性陈述或重大遗漏。 深圳市新产业生物医学工程股份有限公司（以下简称"公司"）于近日收到 公司控股股东西藏新产业投资管理有限公司（以下简称"西藏新产业"）的函告， 获悉其所持有的公司 1,210 万股股份办理了质押手续；另，西藏新产业已质押给 华泰证券股份有限公司的其所持有的公司 1,904 万股（含补充质押 270 万股）股 份办理了解除质押手续。具体事项如下： 二、 公司控股股东部分质押股份解除质押的基本情况 | 股东 名称 | 是否为控股股东 或第一大股东及 | 本次解除质 押股份数量 | 占其所持 股份比例 | 占公司总 股本比例 | 质押 起始日 | | 质押 解除日 | 质权人 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | 其一致行动人 | （万股） | | | | | | | | 西藏 | 是 ...

Financial Performance - In the first half of 2023, the company achieved operating revenue of 1.865 billion CNY, a year-on-year increase of 31.64% [3] - The net profit attributable to shareholders was 750 million CNY, reflecting a growth of 31.68% year-on-year [3] - The net cash flow from operating activities reached 527 million CNY, up by 20.30% compared to the previous year [3] Revenue Structure - Revenue from reagent products and instrument products accounted for 71% and 29% of total revenue, respectively [4] - Domestic and overseas market revenues were split at 65% and 35%, respectively [4] Domestic Market Overview - Domestic main business revenue grew by 31.56% year-on-year in the first half of 2023, with a significant second-quarter growth of 51.56% [4] - The company installed 806 chemiluminescence analyzers, with large machines making up 60.55% of installations [4] - Testing volume from tertiary hospitals contributed to 43% of the total domestic testing volume, an increase of 1.3 percentage points from 2022 [4] Overseas Market Overview - Overseas main business revenue increased by 31.55% year-on-year in the first half of 2023, with a second-quarter growth of 38.19% [4] - The company sold 2,271 chemiluminescence analyzers overseas, with mid-to-large machines accounting for 54.73% of sales, a rise of 20.28 percentage points year-on-year [4] - The company’s products are now present in 151 countries and regions, with eight wholly-owned subsidiaries established overseas [4] Industry Challenges and Responses - The company anticipates that recent anti-corruption measures in the pharmaceutical sector may delay procurement for large equipment but will have a limited impact on single machine installations [5] - To mitigate potential negative impacts from anti-corruption measures, the company is expanding its third-party testing business, which has significant growth potential in grassroots healthcare [5] - The company emphasizes compliance and integrity in its operations, aiming to foster a fair competitive environment [5] Product Development and Market Strategy - The company has developed a small molecule sandwich method for testing, which is expected to enhance its competitive edge in the market [7] - The company plans to expand this method to include thyroid and drug monitoring categories, aiming for simultaneous sales in domestic and international markets [7] - The company has been actively promoting its products overseas for over 13 years, leading to a rapid increase in sales and brand recognition [6]

Financial Performance - The company's operating revenue for the reporting period was ¥1,865,184,210.29, representing a year-on-year increase of 31.64% compared to ¥1,416,911,249.55[22]. - The net profit attributable to shareholders was ¥749,998,559.46, reflecting a growth of 31.68% from ¥569,577,003.52 in the same period last year[22]. - The net profit after deducting non-recurring gains and losses was ¥686,546,138.08, up 31.21% from ¥523,257,138.03[22]. - The company generated a net cash flow from operating activities of ¥526,542,485.46, which is a 20.30% increase from ¥437,690,320.85[22]. - The total assets at the end of the reporting period amounted to ¥7,251,576,463.86, marking a 3.38% increase from ¥7,014,554,339.23 at the end of the previous year[22]. - Total operating revenue for the reporting period was CNY 1.865 billion, a 31.64% increase compared to the previous year[58]. - Net profit attributable to shareholders reached CNY 750 million, marking a year-on-year growth of 31.68%[58]. Corporate Governance and Shareholder Matters - The company reported a plan not to distribute cash dividends, issue bonus shares, or increase capital from reserves[5]. - The company has confirmed that all commitments related to shareholding and transfer restrictions have been fulfilled as of the reporting date[157]. - The company plans to implement a share repurchase program, with a total amount not exceeding 5% of the total share capital in one year[161]. - The company will comply with all necessary legal and regulatory procedures before implementing the share repurchase, demonstrating diligence in governance[159]. - The company has reported a change in board members, with Li Xu being appointed as a director and audit committee member on April 27, 2023[131]. - The company has not implemented any employee stock ownership plans or other employee incentive measures[143]. Research and Development - The company has established four major technology platforms for product development in the in vitro diagnostics field, including nano-magnetic microspheres and fully automated diagnostic instruments[30]. - The company is committed to continuous research and development of new products to maintain competitiveness in the technology-intensive in vitro diagnostics industry[119]. - The company has received CE List A certification for its hepatitis B, C, and HIV detection products, marking it as the first domestic manufacturer to achieve this[71]. - The company has developed the MAGLUMI series of analyzers, with the MAGLUMI X8 achieving a testing speed of over 600 tests per hour, leading the field of fully automated chemiluminescence immunoassay[50]. - The company has 37 reagent projects under development that have obtained registration inspection reports and are in the review stage by the drug regulatory authority[61]. Market Presence and Competition - The company has a comprehensive list of subsidiaries across various countries, indicating a broad international presence[12]. - The company has expanded its product exports to 151 countries and regions across Asia, Europe, America, Africa, and Oceania[123]. - The company is facing increasing competition in the in vitro diagnostics industry, particularly from multinational corporations like Roche, Siemens, Beckman, and Abbott, which dominate the high-end market[122]. - The company acknowledges the risk of technological obsolescence if it fails to keep pace with industry advancements in product development[124]. Environmental and Social Responsibility - The company does not belong to the key pollutant discharge units and has not faced any environmental violations during the reporting period[145]. - The company has implemented a wastewater management system, including a 100m³ concentrated water recovery pool for recycling and reusing wastewater for toilet flushing and irrigation[151]. - The company actively participates in social responsibility initiatives, including donations to support poverty alleviation and rural revitalization projects[154]. - The company promotes a green philosophy in daily operations, encouraging energy conservation and paperless practices[153]. Risk Management - The management has emphasized the importance of risk factors and countermeasures in the report, urging investors to be cautious[4]. - The company is closely monitoring regulatory changes in the medical industry to adjust its operational strategies accordingly[118]. - The company has implemented internal controls and risk management measures for its foreign exchange hedging activities[113]. Investment and Financial Management - Research and development investment increased by 29.90% to ¥171,998,461.05, reflecting the company's commitment to innovation[80]. - The company has entrusted RMB 360,603.97 million in bank financial products, with an outstanding balance of RMB 290,959.06 million[110]. - The company has implemented strict cost control measures during project execution, resulting in significant fund savings[105]. Share Structure and Changes - The total number of shares decreased from 786,126,335 to 785,718,785, a reduction of 407,550 shares, representing a 0.0518% decrease in total share capital[189]. - The number of restricted shares before the change was 501,503,988, which accounted for 63.79% of total shares, and after the change, it decreased to 87,321,673, representing 11.11%[187]. - The company’s total shareholding structure shows a significant concentration of ownership among the top shareholders, with the largest shareholder holding over 50%[196].

深圳市新产业生物医学工程股份有限公司 2023 年半年度 募集资金存放与使用情况专项报告 证券代码：300832 证券简称：新产业 公告编号：2023-080 深圳市新产业生物医学工程股份有限公司 2023 年半年度募集资金存放与使用情况的专项报告 本公司及董事会全体成员保证信息披露内容的真实、准确、完整，没有虚 假记载、误导性陈述或重大遗漏。 一、 募集资金基本情况 经中国证券监督管理委员会《关于核准深圳市新产业生物医学工程股份有限公司首次公 开发行股票的批复》（证监许可[2020]738 号）核准，深圳市新产业生物医学工程股份有限公 司（下称"公司"或"本公司"）首次公开发行人民币普通股 4,120 万股，发行价格为 31.39 元/股，募集资金总额为人民币 1,293,268,000.00 元，扣除与发行有关的费用（不含税）人民 币 90,756,418.87 元，实际募集资金净额为人民币 1,202,511,581.13 元。 上述募集资金到位情况已由大华会计师事务所（特殊普通合伙）审验，并已于 2020 年 5 月 7 日出具"大华验字[2020]000192 号"《验资报告》（以下简称"《验资报告 ...

华泰联合证券有限责任公司 关于深圳市新产业生物医学工程股份有限公司 开展外汇套期保值业务的核查意见 华泰联合证券有限责任公司（以下简称"华泰联合证券"、"保荐机构"） 作为深圳市新产业生物医学工程股份有限公司（以下简称"新产业"、"公司"） 首次公开发行股票并在创业板上市持续督导阶段的保荐机构，根据《证券发行上 市保荐业务管理办法》《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13号——保荐业务》及《深圳证券交易所上市公司自 律监管指引第2号——创业板上市公司规范运作》等有关规定，对公司开展外汇 套期保值业务进行了审慎核查，并出具本核查意见： 一、开展外汇套期保值业务的目的 随着公司业务的快速发展，公司及子公司业务涉及美元、欧元等外币结算量 不断上升。当市场汇率出现较大波动时，汇兑损益对公司的经营业绩会造成一定 的影响。为了降低汇率波动对公司业绩的影响，增加公司财务对汇率波动风险的 管控，公司拟与银行等金融机构开展与日常经营需求紧密相关的外汇套期保值业 务，降低汇率波动风险。 二、外汇套期保值业务基本情况 （一）主要涉及币种及业务品种 公司拟开展的外汇套期保值业务的币种只限于从事 ...