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新华制药(000756) - 关于子公司获得克拉霉素干混悬剂《药品注册证书》的公告
2025-08-26 11:29
证券代码:000756 证券简称:新华制药 公告编号:2025-52 山东新华制药股份有限公司 关于子公司获得克拉霉素干混悬剂《药品注册证书》的公告 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,发给药品注册证书。质量标准、说明书、标签及生产工艺照所附执行。 药品生产企业应当符合药品生产质量管理规范要求方可生产销售。 本公司及董事会全体成员保证信息披露内容的真实、准确和完整,没有虚假记载、误导性 陈述或重大遗漏。 近日,山东新华制药股份有限公司之全资子公司山东淄博新达制药有限公司(以下简称"新 达制药")收到国家药品监督管理局核准签发的克拉霉素干混悬剂(以下简称"本品")《药品注 册证书》,批准本品注册。现将相关情况公告如下: 一、基本情况 二、其他相关信息 2023 年 12 月,新达制药向国家药品监督管理局药品审评中心(CDE)递交克拉霉素干混悬 剂上市许可申报资料并获受理,2025 年 8 月获得《药品注册证书》,审评结论为:批准注册。 本品用于治疗对克拉霉素敏感的病原体所引起的感染,包括: 1.上呼吸道感染:鼻咽部(扁 1 药品名称:克拉霉素干混 ...
新华制药(000756) - 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
2025-08-26 11:29
2025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 | 上市公司名称:山东新华制药股份有限公司 | | | | | | | | | 单位:万元 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 非经营性资金占用 | 资金占用方名称 | 占用方与上市公司的关联关系 | 上市公司核算的会计科目 | 2025年初占用资金余额 | 2025年半年度 2025年半年度占用累计发生 占用资金的利 金额(不含利息) 息 | 2025年半年度偿还累计发生 金额 | 2025年6月末占用资金余额 | 占用形成原因 | 占用性质 | | 现大股东及其附属企业 | | | | | | | | | | | 小计 | | | | | | | | | | | 前大股东及其附属企业 | | | | | | | | | | | 小计 总计 | | | | | | | | | | | 其它关联资金往来 | 资金往来方名称 | 往来方与上市公司的关联关系 | 上市公司核算的会计科目 | 2025年初往来资金余额 | 2025年半年度 2025年半年度往来 ...
新华制药(000756) - 关于修订《公司章程》及相关议事规则的公告
2025-08-26 11:29
证券代码:000756 证券简称:新华制药 公告编号:2025-49 山东新华制药股份有限公司 关于修订《公司章程》及相关议事规则的公告 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。 山东新华制药股份有限公司("公司")于 2025 年 8 月 26 日召开第十一届董事会第八次 会议,审议通过了《关于修订<公司章程>及相关议事规则的议案》,该议案尚需提交股东大 会审议通过后方可生效。现将具体内容说明如下: 根据《中华人民共和国公司法》《中华人民共和国证券法》《上市公司章程指引》等有关 法律法规、深圳证券交易所和香港联合交易所有限公司的相关规定,结合公司实际情况和经 营发展需要,公司拟不再设置监事会及监事岗位,原监事会的职权由审核委员会行使,并对 《公司章程》及相关议事规则部分条款进行了修订,《监事会议事规则》同时废止。 另外,由于行政管理机构企业登记管理审批系统对经营范围的分类规则进行了调整,即: 原经营范围按"生产/批发/零售+具体产品"分类,现登记系统按"经营行为+产品"模式拆 分归类,为匹配新系统规则,需对经营范围表述进行调整。 具体修订情况请见附件。 ...
新华制药(000756) - 半年报监事会决议公告
2025-08-26 11:26
证券代码:000756 证券简称:新华制药 公告编号:2025-47 山东新华制药股份有限公司 第十一届监事会第八次会议决议公告 山东新华制药股份有限公司("本公司")第十一届监事会第八次会议通知于二零二五年八月十 二日以电邮形式发出,会议于二零二五年八月二十六日在山东省淄博市高新区鲁泰大道 1 号公司会 议室召开,应到会监事 5 名,实际到会监事 5 名。会议由本公司监事会主席刘承通主持。会议的召 开符合有关法律、法规、规章和公司章程的规定。 本公司全体监事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。 本公司第十一届监事会第八次会议记录。 特此公告。 山东新华制药股份有限公司监事会 2025 年 8 月 26 日 1 会议审议并通过了以下议案: 一、审议通过本公司 2025 年度半年度报告 经审核,监事会认为董事会编制和审议本公司 2025 年半年度报告的程序符合法律、行政法规 及中国证监会的规定,报告内容真实、准确、完整地反映了本公司的实际情况,不存在任何虚假记 载、误导性陈述或者重大遗漏。 5 名监事赞成本议案,0 票反对,0 票弃权。 备查文件 ...
新华制药(000756) - 半年报董事会决议公告
2025-08-26 11:24
证券代码:000756 证券简称:新华制药 公告编号:2025-46 二、审议通过关于修订《公司章程》及相关议事规则的议案(《关于修订〈公司章程〉及相关 议事规则的公告》见同日发布于巨潮资讯网公告)。 本议案尚需提交公司股东大会审议。 9 名董事赞成本议案,0 票反对,0 票弃权。 山东新华制药股份有限公司 第十一届董事会第八次会议决议公告 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。 山东新华制药股份有限公司("本公司")第十一届董事会第八次会议通知于二零二五年八月 十二日以电邮形式发出,会议于二零二五年八月二十六日在山东省淄博市高新区鲁泰大道 1 号公 司会议室召开,应到会董事 9 名,实际参会董事 9 名。监事会成员和非董事的副总经理列席了会 议。会议由董事长贺同庆主持。会议的召开符合有关法律、法规、规章和公司章程的规定。 会议主要审议并通过了以下议案: 一、审议通过本公司 2025 年半年度报告及业绩公告(2025 年半年度报告及其摘要见同日发布 于巨潮资讯网公告)。 9 名董事赞成本议案,0 票反对,0 票弃权。 上述议案经公司股东大会审议通过后, ...
新华制药:公司及子公司获得药品注册证书
Core Viewpoint - Recently, Xinhua Pharmaceutical (000756) announced the approval of several drug registration certificates by the National Medical Products Administration, indicating a positive development for the company's product portfolio [1] Group 1 - Xinhua Pharmaceutical received the drug registration certificate for Sacubitril/Valsartan Sodium Tablets and Minoxidil Lotion [1] - The wholly-owned subsidiary, Xinda Pharmaceutical, received the drug registration certificate for Clarithromycin Dry Suspension [1]
新华制药:上半年净利润同比下降15.69%
南财智讯8月26日电,新华制药发布2025年半年度报告,报告期实现营业收入46.39亿元,同比下降 1.98%;归属上市公司股东的净利润2.24亿元,同比下降15.69%;扣除非经常性损益后的归属于上市公 司股东的净利润2.11亿元,同比下降15.44%;基本每股收益0.32元。 ...
新华制药:获得米诺地尔搽剂《药品注册证书》
Xin Lang Cai Jing· 2025-08-26 10:41
Core Viewpoint - Xinhua Pharmaceutical has received approval from the National Medical Products Administration for the Minoxidil topical solution, which is intended for the treatment of male pattern baldness and alopecia areata [1] Group 1: Product Approval - The approval of Minoxidil topical solution enhances the product portfolio of Xinhua Pharmaceutical [1] - This product is expected to contribute to the company's competitiveness in the market [1] Group 2: Market Potential - The estimated sales revenue for Minoxidil in Chinese public medical institutions is approximately RMB 2.36 billion in 2024 [1] - The approval aligns with the growing demand for treatments related to hair loss in the healthcare sector [1]
新华制药:2025年上半年净利润2.24亿元,同比下降15.69%
Xin Lang Cai Jing· 2025-08-26 10:41
新华制药公告,2025年上半年营业收入46.39亿元,同比下降1.98%。净利润2.24亿元,同比下降 15.69%。公司计划不派发现金红利,不送红股,不以公积金转增股本。 ...
新华制药(000756) - 2025 Q2 - 季度财报
2025-08-26 10:40
Financial Performance - The company's operating revenue for the reporting period was approximately CNY 4.64 billion, a decrease of 1.98% compared to the same period last year[12]. - Total profit for the period was CNY 263.53 million, reflecting a decline of 13.13% year-over-year[12]. - Net profit attributable to shareholders was CNY 223.76 million, down 15.69% from the previous year[12]. - The net profit after deducting non-recurring gains and losses was CNY 210.86 million, a decrease of 15.44% year-over-year[12]. - The company reported a basic earnings per share of CNY 0.32, down 17.95% from the same period last year[12]. - Operating profit for the current period is RMB 264.25 million, down 13.06% from RMB 307.57 million in the previous period[118]. - Total comprehensive income for the current period is RMB 245.71 million, compared to RMB 300.09 million in the previous period, reflecting a decrease of 18.14%[118]. Cash Flow and Liquidity - The net cash flow from operating activities increased significantly by 202.49%, reaching CNY 234.13 million[12]. - The company's cash flow from operating activities demonstrates the company's ability to generate cash from its core business operations, which is crucial for future growth[120]. - The net cash flow from operating activities for the current period is RMB 234,132,352.73, an increase of 40.3% compared to RMB 77,401,054.87 in the previous period[120]. - The ending balance of cash and cash equivalents is RMB 1,163,830,264.02, up from RMB 850,921,699.35 in the previous period[120]. - The company's liquidity ratios showed a current ratio of 126.64% and a quick ratio of 87.66% as of June 30, 2025[67]. Shareholder Information - As of June 30, 2025, the total number of shareholders is 76,508, including 40 H-share shareholders and 76,468 A-share shareholders[20]. - The top three shareholders hold the following shares: 204,864,092 shares (29.70%) by Hualu Holdings Group Co., Ltd., 193,314,037 shares (28.03%) by Hong Kong Central Clearing (Agent) Co., Ltd., and 37,091,988 shares (5.38%) by Hualu Investment Development Co., Ltd.[21]. - The company plans not to distribute dividends for the first half of 2025[8]. - The board of directors has proposed not to distribute dividends for the first half of 2025, maintaining the previous year's dividend of RMB 0.025 per share[76]. Assets and Liabilities - Total assets at the end of the reporting period amounted to CNY 9.24 billion, an increase of 2.42% compared to the end of the previous year[12]. - The company's total liabilities rose to CNY 3.87 billion, marking a 1.86% increase from the previous year[12]. - The asset-liability ratio stood at 41.92%, indicating a stable financial structure[71]. - Total current assets reached RMB 3,992,086,651.00, an increase of 22.5% from RMB 3,726,840,162.91 at the end of the previous year[114]. Research and Development - Research and development investment decreased by 12.56% to approximately ¥202.78 million from ¥231.91 million in the previous year[56]. - The company has over 100 products in the research and development pipeline, supported by multiple R&D platforms[74]. - The company aims to secure over 10 new product approvals for APIs and formulations in the second half of the year[44]. Employee Information - The company reported a total of 7,159 employees, with 2,043 holding a university degree or higher[33][34]. - The company conducted 38 training sessions in the first half of 2025, with 2,281 participants, enhancing training effectiveness[35]. - The number of shares held by directors and senior management increased to 2,870,150 shares as of June 30, 2025, from 2,055,050 shares on January 1, 2025[26]. Market and Product Development - A total of 10 new formulation products were launched in the first half of the year, with 19 products and 25 specifications winning national procurement bids[38]. - The company plans to develop three key markets in South America and two potential markets in the Middle East and Africa, focusing on specialty APIs like L-DOPA and fish oil series[43]. - The company achieved export revenue of $152.475 million, indicating exposure to foreign exchange risk[72]. Corporate Governance and Compliance - The company has adhered to corporate governance codes and has not deviated from the rules set by the Hong Kong Stock Exchange[108]. - The audit committee has reviewed the financial accounting principles and methods for the six months ending June 30, 2025, and has agreed with the disclosures made[109]. - There were no significant lawsuits or arbitration matters during the reporting period[4]. Financial Management and Accounting - The company's financial statements are prepared in accordance with the accounting standards issued by the Ministry of Finance and relevant regulations[136]. - The group recognizes significant bad debt provisions for receivables exceeding RMB 5 million[139]. - The group assesses credit risk for receivables based on aging, nature of the receivables, and historical collection data, grouping them by similar credit risk characteristics[178].