证券代码：000756 证券简称：新华制药 公告编号：2026-19 山东新华制药股份有限公司 关于获得《药品补充申请批准通知书》等相关情况的公告 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（以下简称"新华制药"或"本公司"）收到国家药品监督 管理局核准签发的人工牛黄甲硝唑胶囊（以下简称"本品"）《药品补充申请批准通知书》，批准本 品上市许可持有人转让补充申请。现将相关情况公告如下： 一、基本情况 药品名称：人工牛黄甲硝唑胶囊 剂型：胶囊剂 申请事项：上市许可持有人变更申请 受理号：CYHB2600473 原药品批准文号：国药准字H22026771 通知书编号：2026B02018 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，本品此次申请事项符合 药品注册的有关要求，同意按照《药品上市后变更管理办法（试行）》相关规定，批准本品上市许 可持有人变更。 二、其他相关信息 2023年9月，新华制药与吉林省中晟制药有限公司（以下简称"中晟制药"）签订了本品的生产 技术及持有人转让合同，合同约定：中晟制药将拟取得的人 ...

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the transfer of the marketing authorization of artificial bile acid metronidazole capsules, indicating compliance with post-marketing change management requirements [1] Group 1: Company Developments - The company submitted a supplementary application for the change of marketing authorization holder in March 2026, which has now been approved [1] - The approval allows the transfer of the marketing authorization holder for the product, which is used for treating acute pericoronitis, local alveolar abscess, pulpitis, and apical periodontitis [1] Group 2: Market Insights - The sales revenue of artificial bile acid metronidazole capsules in Chinese public medical institutions is projected to be approximately RMB 579 million in 2024 [1]

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the transfer of the marketing authorization of artificial bile acid metronidazole capsules [1] Group 1 - The product in question is referred to as "artificial bile acid metronidazole capsules" [1] - The approval allows for the transfer of the supplementary application for the marketing authorization holder [1] - The application complies with the relevant requirements for drug registration as per the Drug Administration Law of the People's Republic of China [1]

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the transfer of the marketing authorization of artificial bile acid metronidazole capsules, indicating compliance with post-marketing change management requirements [1] Group 1: Company Developments - The company submitted a supplementary application for the change of marketing authorization holder in March 2026, which has now been approved [1] - The approval allows the company to transfer the marketing authorization for the product, which is indicated for acute pericoronitis, local alveolar abscess, pulpitis, and apical periodontitis [1] Group 2: Market Insights - The sales revenue of artificial bile acid metronidazole capsules in Chinese public medical institutions is projected to be approximately RMB 579 million in 2024 [1]

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2026年3月31日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 山東新華製藥股份有限公司 呈交日期: 2026年4月1日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | H | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 00719 | 說明 | H股 | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 195,000,000 | RMB | | 1 RMB | | 195,000,000 | | 增加 / 減少 (-) | | | | | | RMB | | | | 本月底結存 | | | 195,000,000 | RMB | | 1 RMB | | 195,000,000 | | 2. 股份分類 | 普通股 | 股份類別 | A | | 於香 ...

Group 1 - The core point of the article is the resignation of Xu Lie from his position as a director and member of the Strategic Development Committee of Xinhua Pharmaceutical due to age reasons [1] - Xu Lie's resignation will not affect the minimum number of board members required by law, ensuring the normal operation of the company's board [1] - The resignation is effective immediately upon delivery to the board, and Xu Lie will not hold any position in the company after his resignation [1]

Group 1 - The core point of the article is the resignation of Xu Lie from the board of directors and the strategic development committee of Shandong Xinhua Pharmaceutical Co., Ltd. due to age reasons, effective March 31, 2026 [1] - Xu Lie will not hold any position in the company after his resignation [1] Group 2 - The article also mentions a separate investigation into the performance of an AI stock trading tool, with reports of significant gains and losses among users, highlighting the volatility and risks associated with such investment strategies [1]

证券代码：000756 证券简称：新华制药 公告编号：2026-18 截止本公告披露日，徐列先生持有公司 A 股 503,150 股，其辞职后将继续按照相关法律、 法规及规范性文件的有关规定管理其所持股份。 董事会谨此对徐列先生在任职期间为公司所做出的贡献表示衷心感谢。 特此公告。 山东新华制药股份有限公司董事会 关于董事辞职的公告 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"）董事会于 2026 年 3 月 31 日收到公司董事徐列先 生提交的书面辞职报告。徐列先生因年龄原因申请辞去公司董事及战略发展委员会委员职务， 辞职后不在公司担任任何职务。 根据《公司法》及《公司章程》等有关规定，徐列先生辞去董事职务未导致公司董事会 成员人数低于法定最低人数，不会影响公司董事会正常工作，其辞职报告自送达董事会之日 起生效。截止本公告披露日，徐列先生不存在应当履行而未履行的承诺事项，其辞职不会影 响公司正常的生产经营活动，其在任职期间与公司董事会并无意见分歧，也没有任何相关的 事项需提请公司股东注意。 山东新华制药股份有限公司 2 ...

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. announced the resignation of non-executive director Mr. Xu Lie due to reaching retirement age, effective March 31, 2026, after which he will hold no positions within the company [1] Group 1 - Mr. Xu Lie's resignation includes his role as a member of the Board Development Strategy Committee [1]

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. announced the resignation of non-executive director Mr. Xu Lie due to reaching retirement age, effective March 31, 2026, after which he will hold no positions within the company [1] Group 1 - Mr. Xu Lie's resignation includes his role on the Board Development Strategy Committee [1] - The effective date of the resignation is set for March 31, 2026 [1] - Post-resignation, Mr. Xu will not hold any position or role within the company [1]