香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責，對其準確性或完整性亦不發表任何 聲明，並明確表示概不就因本公告全部或任何部分內容而產生或因倚賴該等內容而引致之任何損失承擔任何責任。 山東新華製藥股份有限公司 Shandong Xinhua Pharmaceutical Company Limited （於中華人民共和國註冊成立之股份有限公司） （股份代碼：00719） 海外監管公告 山 東 新 華 製 藥 股 份 有 限 公 司 （ 「 本 公 司 」 ） 將 於 2026 年 3 月 5 日 在 巨 潮 資 訊 網 （http://www.cninfo.com.cn）刊登的本公司《關於獲得恩他卡朋片藥品註冊證書的公告》,茲載列有 關文檔之中文版，以供參閱。 承董事會命 山東新華製藥股份有限公司 賀同慶 董事長 中國 淄博 2026年3月4日 於本公告日期，本公司董事會之成員如下： | 執行董事： | 獨立非執行董事： | | --- | --- | | 賀同慶先生（董事長） | 潘廣成先生 | | 徐文輝先生 | 朱建偉先生 | | 侯 寧先生 | 凌沛學先生 | | | 張菁菁女士 ...

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責，對其準確性或完整性亦不發表任何 聲明，並明確表示概不就因本公告全部或任何部分內容而產生或因倚賴該等內容而引致之任何損失承擔任何責任。 （於中華人民共和國註冊成立之股份有限公司） （股份代碼：00719） 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第13.10B條作出。 山 東 新 華 製 藥 股 份 有 限 公 司 （ 「 本 公 司 」 ） 將 於 2026 年 3 月 5 日 在 巨 潮 資 訊 網 （http://www.cninfo.com.cn）刊登的本公司《關於子公司獲得沙格列汀二甲雙胍緩釋片藥品註冊證 書的公告》,茲載列有關文檔之中文版，以供參閱。 山東新華製藥股份有限公司 Shandong Xinhua Pharmaceutical Company Limited 山东新华制药股份有限公司 承董事會命 山東新華製藥股份有限公司 賀同慶 董事長 中國 淄博 2026年3月4日 於本公告日期，本公司董事會之成員如下： | 執行董事： | 獨立非執行董事： | | --- | --- | | 賀同慶先生（董事長 ...

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2月28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3月2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 (-) | | | 0 | | | | RMB | | 0 | | 本月底結存 | | | 195,000,000 | RMB | | | 1 RMB | | 195,000,000 | | 2. 股份分類 | ...

Core Viewpoint - The annual "Spring Research Symposium" of Shandong Xinhua Pharmaceutical Co., Ltd. reflects the company's commitment to research and development, showcasing both its enduring principles and its adaptation to changing times [1][4][9]. Group 1: Consistency in Leadership and Culture - The core participants in the symposium have remained consistent over the years, highlighting the importance of research personnel in the company's strategic discussions [3]. - The management's focus on "listening" to researchers has been a constant theme, emphasizing respect for scientific inquiry and the importance of feedback in the R&D process [4][6]. Group 2: Evolution of Research Focus - The topics discussed at the symposium have evolved significantly over the past three years, reflecting changes in the pharmaceutical industry and the company's strategic priorities [5][9]. - In 2024, the focus was on "breakthrough" and "foundation," with the company celebrating the achievement of 25 production approvals and 18 new product launches [6]. - By 2025, the emphasis shifted to "speed" and "collaboration," as the company secured 36 registration approvals and aimed for faster product development and cross-departmental cooperation [6][8]. - In 2026, discussions centered around "AI technology empowerment," "innovation," and "R&D," indicating a shift towards more advanced and integrated approaches in research [6][8]. Group 3: Strategic Directions for 2026 - The company plans to accelerate its R&D efforts towards high-value areas, focusing on innovative drugs and high-barrier sectors to secure future growth [8]. - There is a strong emphasis on creating a synergistic ecosystem between R&D, production, and market needs, aiming for efficient conversion of research outcomes into marketable products [8]. - The management aims to foster a self-driven research culture by enhancing career development pathways and creating an environment that values innovation and tolerates failure [8][10].

证券日报网讯 2月10日，新华制药在互动平台回答投资者提问时表示，公司始终致力于心无旁骛发展医 药主业，努力为各利益相关方创造更多回报。 （文章来源：证券日报） ...

Core Viewpoint - Xinhua Pharmaceutical (000756.SZ) has received approval from the National Medical Products Administration for the registration certificate of Glucosamine Sulfate Capsules, which are primarily used for the treatment of primary and secondary osteoarthritis [1] Company Summary - Xinhua Pharmaceutical has successfully obtained the necessary regulatory approval for its Glucosamine Sulfate Capsules, indicating a significant step in expanding its product offerings in the pharmaceutical market [1]

Core Viewpoint - Xinhua Pharmaceutical has received approval from the National Medical Products Administration for the registration of glucosamine sulfate capsule, which is classified as a Class 4 chemical drug and a Class A non-prescription drug, aimed at treating primary and secondary osteoarthritis [1] Group 1 - The glucosamine sulfate capsule is available in specifications of 0.25g or 0.314g [1] - The drug has been included in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug List (2025) as a Category B product [1]

Core Viewpoint - Xinhua Pharmaceutical (000756.SZ) has received approval from the National Medical Products Administration for the registration certificate of Glucosamine Sulfate Capsules, which are primarily used for the treatment of primary and secondary osteoarthritis [1] Group 1 - The approval signifies a regulatory milestone for the company, enhancing its product portfolio in the pharmaceutical market [1] - Glucosamine Sulfate Capsules are aimed at addressing a significant medical need in the treatment of osteoarthritis, a common joint disorder [1]

Core Viewpoint - Xinhua Pharmaceutical (000756.SZ) has received approval from the National Medical Products Administration for the registration certificate of Glucosamine Sulfate Capsules, which are primarily used for the treatment of primary and secondary osteoarthritis [1] Company Summary - The approval of Glucosamine Sulfate Capsules marks a significant milestone for Xinhua Pharmaceutical, enhancing its product portfolio in the orthopedic treatment sector [1] - The clinical application of this product targets a growing market for osteoarthritis treatments, indicating potential revenue growth for the company [1] Industry Summary - The approval aligns with the increasing demand for effective treatments for osteoarthritis, a condition affecting a large segment of the population [1] - The pharmaceutical industry is witnessing a trend towards the development of specialized medications for chronic conditions, which may lead to increased competition and innovation in the market [1]

证券代码：000756 证券简称：新华制药 公告编号：2026-04 山东新华制药股份有限公司 关于获得硫酸氨基葡萄糖胶囊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 局核准签发的硫酸氨基葡萄糖胶囊（以下简称"本品"）《药品注册证书》。现将相关情况公告如下： 一、基本情况 药品名称：硫酸氨基葡萄糖胶囊 剂型：胶囊剂 规格：0.25g（按硫酸氨基葡萄糖计）或0.314g（按硫酸氨基葡萄糖氯化钠计） 药品分类：非处方药 注册分类：化学药品4类 申请人：山东新华制药股份有限公司 申请事项：药品注册（境内生产） 受理号：CYHS2402615 药品批准文号：国药准字H20263303 证书编号：2026S00360 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。同意本品按（甲类）非处方药管理。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 ...