证券代码：300110 证券简称：华仁药业 公告编号：2024-053 华仁药业股份有限公司 关于全资子公司取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。 近日，华仁药业股份有限公司（以下简称"公司"）全资子公司青岛华仁医 疗用品有限公司收到山东省药品监督管理局核准签发的"一次性使用无菌手术包" 的《医疗器械注册证》，现将相关情况公告如下： 一、医疗器械基本情况 1、注册人名称：青岛华仁医疗用品有限公司 2、注册人住所：青岛市崂山区株洲路 187 号 3、生产地址：青岛市崂山区株洲路 187 号无菌医疗器械车间楼 4、产品名称：一次性使用无菌手术包 5、产品型号：HRSA、HRSC、HRSD、HRSE、HRSF、HRSG、HRSH、HRSI、 HRSJ 6、适用范围：适用于医疗机构临床手术使用 7、注册证编号：鲁械注准 20242140880 8、注册分类：Ⅱ类 9、批准日期：2024 年 09 月 20 日 10、有效期至：2029 年 09 月 19 日 二、医疗器械相关情况 公司本次获得二类医疗器械注册证的一次性使用无菌手术包适 ...

证券代码：300110 证券简称：华仁药业 公告编号：2024-052 华仁药业股份有限公司 | 本次变动是否存在违反 | | | | --- | --- | --- | | 《证券法》《上市公司收 | | | | 购管理办法》等法律、行 | 否 是  | | | 政法规、部门规章、规范 | | | | 性文件和本所业务规则 | | | | 等规定的情况 | | | | 5.被限制表决权的股份情况 | | | | 按照《证券法》第六十三 | | | | 条的规定，是否存在不得 | 是 否  | | | 行使表决权的股份 | | | | 6.表决权让渡的进一步说 | 不适用 | | | 明 | | | | 7.30%以上股东增持股份 | 不适用 | | | 的进一步说明 | | | | 8.备查文件 | 红塔创新《关于减持华仁药业股份比例超过 | 1%的告知函》 | 信息披露义务人：红塔创新投资股份有限公司 2024 年 9 月 20 日 股东红塔创新投资股份有限公司保证向本公司提供的信息内容真实、准确、 完整，没有虚假记载、误导性陈述或重大遗漏。本公司及董事会全体成员保证 公告内容与信息披露义务人提供 ...

证券代码：300110 证券简称：华仁药业 公告编号：2024-051 华仁药业股份有限公司 关于公司及子公司涉及重大诉讼的公告 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。 重要内容提示： 1、案件所处诉讼阶段：法院已受理，尚未开庭审理； 2、公司及子公司所处的当事人地位：公司及全资子公司西安曲江华仁药业有 限公司为被告，公司全资子公司安徽恒星制药有限公司为第三人； 3、涉案金额：人民币 284,288,000 元； 4、对上市公司损益产生的影响：目前由于案件尚未开庭审理，对公司本期利 润及期后利润的影响尚存在不确定性。 因股权转让纠纷，华仁药业股份有限公司（以下简称"华仁药业"或"公司"）及 全资子公司西安曲江华仁药业有限公司（以下简称"曲江华仁"）、全资子公司安徽 恒星制药有限公司（以下简称"安徽恒星"）于近日收到西安市中级人民法院送达的 《传票》（案号：（2024）陕 01 民初 302 号）及《民事起诉状》，现将具体情况 公告如下： 一、本次诉讼的基本情况 （一）受理机构：西安市中级人民法院 （二）受理地点：陕西省西安市 （三）诉讼各方当事人 原告 ...

证券代码：300110 证券简称：华仁药业 公告编号：2024-050 华仁药业股份有限公司 关于全资子公司盐酸罂粟碱原料药获得上市申请批准通知书 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。 近日，华仁药业股份有限公司（以下简称"公司"）全资子公司安徽恒星制药有 限公司（以下简称"安徽恒星制药"）收到国家药品监督管理局核准签发的"盐酸罂 粟碱原料药"《化学原料药上市申请批准通知书》（通知书编号：2024YS00938）。 现将相关情况公告如下： 一、原料药登记信息 1．通用名称：盐酸罂粟碱 2．英文名/拉丁名：Papaverine Hydrochloride 3．化学原料药注册标准编号：YBY71132024 4．包装规格：5kg/袋 5．申请事项：境内生产化学原料药上市申请 6．审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，本 品符合药品注册的有关要求，批准注册。质量标准、标签及生产工艺照所附执行。 7．生产企业 名称∶安徽恒星制药有限公司 地址∶合肥市包河工业区纬五路 15 号 二、药品的其他情况 盐酸罂粟碱适用于治疗脑、心及外 ...

Financial Performance - The company reported a revenue of RMB 500 million for the first half of 2024, representing a year-on-year increase of 15%[7]. - The net profit attributable to shareholders was RMB 80 million, up 20% compared to the same period last year[7]. - The company's operating revenue for the reporting period was ¥771,461,220.59, a decrease of 6.95% compared to ¥829,046,309.50 in the same period last year[13]. - The net profit attributable to shareholders was ¥73,213,045.80, down 11.02% from ¥82,281,868.89 year-on-year[13]. - The basic earnings per share decreased to ¥0.0619, reflecting an 11.06% decline from ¥0.0696 in the previous year[13]. - The total assets at the end of the reporting period were ¥4,978,902,617.01, a decrease of 3.62% from ¥5,165,697,057.91 at the end of the previous year[13]. - The net assets attributable to shareholders increased by 1.80% to ¥2,742,478,303.30 from ¥2,694,091,730.12 at the end of the previous year[13]. - The company achieved a total drug sales volume of 369 million bottles (bags/sticks), representing a year-on-year growth of 17.95%[26]. - The revenue from self-produced pharmaceuticals was 695 million yuan, an increase of 5.26% year-on-year[19]. - The company’s important subsidiaries contributed to net profits of 41.34 million yuan, 28.26 million yuan, 8.82 million yuan, and 12.69 million yuan respectively during the reporting period[27]. Market Expansion and Strategy - The company plans to expand its market presence in Southeast Asia, targeting a 10% market share by the end of 2025[7]. - The company is exploring potential acquisitions in the biotechnology sector to enhance its product portfolio[7]. - The company has expanded its business areas from large-volume infusions and nephrology to respiratory and narcotic fields, enhancing its product range[18]. - The company is actively expanding its market presence and enhancing core product and customer development amidst ongoing healthcare reforms and competitive pressures[19]. - The company has successfully entered over 30 provinces and cities across the country, with its "Ren" brand recognized as a famous Chinese trademark[18]. Research and Development - Research and development expenses increased by 25% to RMB 50 million, focusing on new drug formulations and delivery systems[7]. - The company has enriched its R&D pipeline, focusing on nephrology, respiratory, and anesthesiology fields, with 2 new approved products during the reporting period[19]. - The company is advancing its integrated development strategy of "raw materials + formulations + packaging materials" to enhance its product capabilities[19]. - The company has obtained 28 Class II medical device registration certificates by the end of the reporting period, with 5 new registrations during the period[22]. - The company holds a total of 542 authorized patents, with 33 new patents granted during the reporting period, including 1 invention patent, 30 utility model patents, and 2 design patents[24]. Compliance and Risk Management - The management highlighted potential risks related to regulatory changes and supply chain disruptions, with strategies in place to mitigate these risks[7]. - The company faces risks from industry policy changes, with an emphasis on adapting to national medical reform policies to maintain market share[51]. - The company is focusing on compliance and risk management, improving contract management and internal processes to ensure healthy development[27]. - The company strictly adheres to various environmental protection laws and standards, ensuring compliance with discharge limits[58]. - The company has established emergency response plans for environmental incidents and regularly updates them[60]. Environmental and Social Responsibility - The company invested a total of 1.2341 million yuan in environmental protection measures in the first half of 2024, including 657,000 yuan for new environmental facilities[61]. - The company has implemented a comprehensive environmental protection management system, with no environmental pollution incidents reported since its establishment[65]. - The company actively engages in social responsibility initiatives, including community support and employee welfare programs[66]. - The company emphasizes sustainable development and has established various environmental management protocols to enhance ecological awareness among employees[65]. Financial Management and Capital Structure - The company has no plans to distribute cash dividends or issue bonus shares for this fiscal year[2]. - The company reported a net cash flow from operating activities of approximately 161.31 million yuan, an increase of 28.38% compared to the previous year[39]. - The net cash flow from investing activities decreased by 73.90% to -19,691,576.09 CNY due to a reduction in equity transfer payments compared to the previous period[40]. - The net cash flow from financing activities decreased by 439.21% to -261,771,062.01 CNY primarily due to an increase in bank loan repayments at the end of the reporting period[40]. - The company has not undergone any changes in its controlling shareholder or actual controller during the reporting period[98]. Shareholder Information - The annual shareholders' meeting had an investor participation rate of 41.18% on May 16, 2024[55]. - The company distributed cash dividends totaling 24.8265 million yuan to all shareholders during the reporting period[67]. - The total number of ordinary shareholders at the end of the reporting period was 46,453[93]. - The number of shareholders holding more than 5% of ordinary shares includes Xi'an Qujiang Tian Shou Health Investment Partnership with 20.00% and Huaren Century Group Co., Ltd. with 7.90%[93]. Industry Overview - The pharmaceutical industry in China generated a main business revenue of CNY 3.36 trillion in 2022, with a compound annual growth rate (CAGR) of 6.49% over the past five years[28]. - The medical device market in China reached CNY 98.3 billion in 2022, growing by 10.35% year-on-year, and has increased 18.37 times since 2007, with an average CAGR of 19.95%[29]. - The pharmaceutical packaging industry in China is projected to reach a market size of approximately CNY 153.7 billion in 2023, with an expected increase to CNY 163.4 billion in 2024[29]. - The consistency evaluation policy for generic drugs is driving a structural adjustment in the industry, favoring companies that can meet quality standards[28]. Accounting and Financial Reporting - The company adheres to the Chinese Accounting Standards, ensuring that the financial reports accurately reflect its financial position and performance as of June 30, 2024[133]. - The financial statements are prepared based on the going concern assumption, indicating the company has the ability to continue operations for at least 12 months from the reporting date[131]. - The company recognizes revenue when customers obtain control of related goods, which occurs when all contract conditions are met[190]. - The company measures expected credit losses based on whether credit risk has significantly increased since initial recognition, using a general or simplified approach[154]. - The company recognizes lease assets primarily as buildings and measures them at the present value of lease payments, excluding short-term and low-value leases[197].

华仁药业股份有限公司 2024年半年度非经营性资金占用及其他关联资金往来情况汇总表 编制单位：华仁药业股份有限公司 金额单位：人民币万元 | 非经营性资 | 资金占用方名称 | 占用方与上市公司的 | 上市公司核算 | 2024年初往来 | 2024年1-6月往来累计发 | 2024年1-6月往来资金 | 2024年1-6月偿还 | 2024年6月末往 | 占用形成原因 | 占用性质 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 金占用 | | 关联关系 | 的会计科目 | 资金余额 | 生金额（不含利息） | 的利息（如有） | 累计发生额 | 来资金余额 | | | | 现大股东及 | | | | | | | | | | | | 其附属企业 | | | | | | | | | | | | 小 计 | —— | —— | —— | - | | - | - | - | - —— | —— | | 前大股东及 | | | | | | | | | | | | 其附属企业 | | | | | | | | | | | | ...

证券代码：300110 证券简称：华仁药业 公告编号：2024-044 华仁药业股份有限公司 关于全资子公司取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。 近日，华仁药业股份有限公司（以下简称"公司"）全资子公司青岛华仁医疗用 品有限公司收到山东省药品监督管理局核准签发的"一次性使用腹膜透析导管"的 《医疗器械注册证》，现将相关情况公告如下： 一、医疗器械基本情况 1、注册人名称：青岛华仁医疗用品有限公司 2、注册人住所：青岛市崂山区株洲路 187 号 7、注册证编号：鲁械注准 20242100815 8、注册分类：Ⅱ类 9、批准日期：2024 年 08 月 20 日 10、有效期至：2029 年 08 月 19 日 二、医疗器械相关情况 公司本次获得二类医疗器械注册证的一次性使用腹膜透析导管用于对肾功能 衰竭患者进行腹膜透析建立治疗通路。产品包含 6 个型号规格，能够满足多样化 临床使用需求。目前国内拥有一次性使用腹膜透析导管同类上市产品的企业共 3 家（数据来源：国家药品监督管理局网站）。 三、对公司的影响及风险提示 3、生产地址 ...

证券代码：300110 证券简称：华仁药业 公告编号：2024-043 华仁药业股份有限公司 关于全资子公司己酮可可碱原料药获得上市申请批准通知书 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。 近日，华仁药业股份有限公司（以下简称"公司"）全资子公司安徽恒星制药有 限公司（以下简称"安徽恒星制药"）收到国家药品监督管理局核准签发的"己酮可 可碱原料药"《化学原料药上市申请批准通知书》（通知书编号：2023YS00826）。 现将相关情况公告如下： 一、原料药登记信息 1．通用名称：己酮可可碱 6．审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，本 品符合药品注册的有关要求，批准本品注册申请。生产工艺、质量标准和包装标签 照所附执行。 公司将积极推进上述药品的生产及销售，但药品未来销售情况及对公司未来 业绩的影响受医药行业政策变动、国家集采、市场环境变化等影响，具有不确定性。 敬请广大投资者谨慎决策，注意投资风险。 四、备查文件 7．生产企业 名称∶安徽恒星制药有限公司 地址∶合肥市包河工业区纬五路 15 号 二、药品的其他情况 己酮可可 ...

证券代码：300110 证券简称：华仁药业 公告编号：2024-042 华仁药业股份有限公司 关于全资子公司己酮可可碱注射液取得药品注册证书的 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。 近日，华仁药业股份有限公司（以下简称"公司"）全资子公司安徽恒星制药 有限公司（以下简称"安徽恒星制药"）收到国家药品监督管理局核准签发的"己 酮可可碱注射液"的《药品注册证书》，具体情况公告如下： 一、药品基本情况 1．药品名称 4．规格：5ml：0.1g 5．注册分类：化学药品 3 类 6．药品注册标准编号：YBH16392024 7．药品有效期：24 个月 8．包装规格：5 支/盒 9．处方药/非处方药：处方药 10．审批结论 11．上市许可持有人 地址：合肥市包河工业区纬五路 15 号 12．生产企业 药品通用名称：己酮可可碱注射液 英文名/拉丁名：Pentoxifylline Injection 2．剂型：注射剂 3．申请事项：药品注册（境内生产） 根据《中华人民共和国药品管理法》及有关规定，经审查，本品符合药品注 册的有关要求，批准注册，发给药品注册证书 ...

证券代码：300110 证券简称：华仁药业 公告编号：2024-041 华仁药业股份有限公司 关于持股 5%以上股东减持计划预披露的公告 5、减持期间：自本减持计划公告之日起十五个交易日后的三个月内（即 2024年8月22日至2024年11月21日）。 6、价格区间：视市场情况确定。 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。 华仁药业股份有限公司（以下简称"华仁药业"或"公司"）于近日收到持股5% 以上股东红塔创新投资股份有限公司（以下简称"红塔创新"）《关于减持华仁药 业股份计划的告知函》，红塔创新计划自减持计划公告之日起十五个交易日后的 三个月内（即2024年8月22日至2024年11月21日）通过集中竞价交易方式减持不 超过公司总股本1%的股份，即不超过11,800,000股。现将具体情况公告如下： 一、减持主体的基本情况 1、减持主体的名称：红塔创新投资股份有限公司。 2、减持主体持有股份的总数量、占公司总股本的比例：截至本公告披露日， 红塔创新持有公司股份 91,263,000 股，占公司总股本的 7.72%。 二、本次减持计划的主要内容 1、 ...