Core Viewpoint - The announcement indicates that the company's subsidiary has received approval for the production of Ibuprofen granules, which are included in the national medical insurance drug list for 2025, suggesting a significant market opportunity in the pharmaceutical sector [1] Company Summary - The company, through its wholly-owned subsidiary Shandong Zibo Xinda Pharmaceutical Co., Ltd., has obtained the drug registration certificate for Ibuprofen granules from the National Medical Products Administration [1] - The approval of Ibuprofen granules positions the company to capitalize on the growing demand for this medication in the Chinese market [1] Industry Summary - Ibuprofen granules are classified as a Category B drug in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug List for 2025 [1] - The estimated sales revenue for Ibuprofen-related formulations in Chinese public medical institutions is approximately RMB 4.4 billion in 2024, indicating a substantial market size and potential for growth [1]

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for its ibuprofen granules, indicating a significant development in its product portfolio and potential market expansion [1] Group 1: Company Announcement - The company's wholly-owned subsidiary, Shandong Zibo Xinda Pharmaceutical Co., Ltd., has been granted a drug registration certificate for ibuprofen granules [1] - The approved product is intended for the relief of mild to moderate pain, including headaches, joint pain, migraines, toothaches, muscle pain, neuralgia, dysmenorrhea, and fever caused by common colds or influenza [1]

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval for the registration of Ibuprofen Granules from the National Medical Products Administration, indicating a significant advancement in its product portfolio and potential market impact [1] Group 1: Company Developments - The company's wholly-owned subsidiary, Shandong Zibo Xinda Pharmaceutical Co., Ltd., has successfully obtained the drug registration certificate for Ibuprofen Granules [1] - The registration application for Ibuprofen Granules was submitted to the Center for Drug Evaluation (CDE) in December 2023 and was accepted, leading to the approval in March 2026 [1] Group 2: Product Information - Ibuprofen Granules are indicated for the relief of mild to moderate pain, including headaches, joint pain, migraines, toothaches, muscle pain, neuralgia, and dysmenorrhea, as well as for fever caused by common colds or influenza [1] - The product is classified as a Category B drug in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog (2025 edition) [1] Group 3: Market Insights - The sales revenue for ibuprofen-related formulations in Chinese public medical institutions is projected to be approximately RMB 4.4 billion in 2024 [1]

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。 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 24 日 在 巨 潮 資 訊 網 （http://www.cninfo.com.cn）刊登的本公司《關於子公司獲得布洛芬顆粒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23日 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） 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 ...

证券代码：000756 证券简称：新华制药 公告编号：2026-07 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 理局核准签发的依折麦布片（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： 药品分类：处方药 申请人：山东新华制药股份有限公司 申请事项：上市许可持有人变更申请 受理号：CYHB2600297 原药品批准文号：国药准字H20249171 通知书编号：2026B01495 一、基本情况 药品名称：依折麦布片 剂型：片剂 规格：10mg 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5月，新华制药与北京阳光诺和药物研究股份有限公司（以下简称"阳光诺和"）签订了 本 ...

Core Viewpoint - Xinhua Pharmaceutical (000756.SZ) has received approval from the National Medical Products Administration for the transfer of the supplementary application for Ezetimibe Tablets, enhancing its product portfolio and competitiveness in the market [1] Group 1: Regulatory Approval - The National Medical Products Administration issued a supplementary application approval notice for Ezetimibe Tablets, allowing the transfer of the marketing authorization holder [1] - The supplementary application for the change of the marketing authorization holder was submitted in February 2026 and accepted, with approval granted in March 2026 [1] Group 2: Product Indications - Ezetimibe Tablets are indicated for the adjunctive treatment of primary hypercholesterolemia, homozygous familial hypercholesterolemia, and sitosterolemia (or plant sterolosis) beyond dietary control [1] Group 3: Strategic Implications - The approval of Ezetimibe Tablets is expected to enrich the company's formulation product series and improve its competitive position in the pharmaceutical market [1]

Group 1 - The company Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the transfer of the marketing authorization holder (MAH) for Ezetimibe tablets [1] - In May 2023, the company signed a contract with Beijing Sunshine Nuohua Pharmaceutical Research Co., Ltd. for the transfer of production technology and MAH rights for Ezetimibe tablets, which includes production, sales, and marketing rights [1] - The transaction does not require approval from the company's board of directors or shareholders and does not constitute a related party transaction or a major asset restructuring as per relevant regulations [1] Group 2 - Ezetimibe tablets are indicated for the treatment of primary hypercholesterolemia, homozygous familial hypercholesterolemia, and sitosterolemia [2] - The estimated sales revenue for Ezetimibe tablets in Chinese public medical institutions is approximately RMB 810 million in 2024 [2]

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the transfer of the marketing authorization holder (MAH) for Ezetimibe tablets, indicating a strategic move to enhance its product portfolio and market presence [1]. Group 1: Company Actions - The company signed a contract with Beijing Sunshine Nuohua Pharmaceutical Research Co., Ltd. in May 2023 for the transfer of production technology and MAH rights for Ezetimibe tablets, which includes production, sales, and marketing rights [1]. - The transfer fee will be paid in stages by Xinhua Pharmaceutical to Sunshine Nuohua as per the contract [1]. - The transaction does not require approval from the company's board or shareholders, and it does not constitute a related party transaction or a major asset restructuring as per relevant regulations [1]. Group 2: Regulatory Approvals - Xinhua Pharmaceutical submitted a supplementary application for the change of the marketing authorization holder to the National Medical Products Administration in February 2026, which was accepted [1]. - The approval notification for the MAH transfer was received in March 2026, confirming that the application meets the requirements for post-marketing changes [1]. Group 3: Market Potential - Ezetimibe tablets are indicated for the treatment of primary hypercholesterolemia, homozygous familial hypercholesterolemia, and sitosterolemia [2]. - The projected sales revenue for Ezetimibe tablets in Chinese public medical institutions is approximately RMB 810 million in 2024 [2].

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） 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 17 日 在 巨 潮 資 訊 網 （http://www.cninfo.com.cn）刊登的本公司《關於獲得﹤藥品補充申請批准通知書﹥等相關情況的 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16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 ...

格隆汇3月13日丨山东新华制药股份(00719.HK)宣布，公司将于2026年3月27日(星期五)上午九时在中华 人民共和国(「中国」)山东省淄博市高新区鲁泰大道1号本公司会议室召开董事会会议，会议内容如 下：1、审议及批准公司及其附属公司截至2025年12月31日止经审计的年度业绩；2、审议宣派末期股息 事宜(如有)；及3、任何其他事宜，如适用。 ...