格隆汇11月25日丨山东新华制药股份(00719.HK)公布，近日，公司收到国家药品监督管理局核准签发的 利丙双卡因乳膏(以下简称"本品")《药品注册证书》。 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。 利丙双卡因乳膏是利多卡因和丙胺卡因的复方制剂，用于下列情况的皮肤局部麻醉：1.针穿刺，例如： 置入导管或采血；2.浅层外科手术，例如：生殖器粘膜，在浅层外科手术或浸润麻醉之前；腿部溃疡清 洁/清创术。 相关事件 山东新华制药股份(00719.HK)：获得利丙双卡因乳膏药品注册证书 山东新华制药股份(00719.HK)：获得 富马酸伏诺拉生化学原料药上市申请批准通知书 ...

利丙双卡因乳膏是利多卡因和丙胺卡因的复方制剂，用于下列情况的皮肤局部麻醉：1.针穿刺，例如： 置入导管或采血;2.浅层外科手术，例如：生殖器粘膜，在浅层外科手术或浸润麻醉之前;腿部溃疡清洁/ 清创术。 根据相关统计数据，2024年中国公立医疗机构利丙双卡因乳膏销售额约为人民币6.15亿元。 智通财经APP讯，山东新华制药股份(00719)发布公告，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利丙双卡因乳膏(以下简称"本品")《药品注册 证书》。 2024年2月，新华制药向国家药品监督管理局药品审评中心(CDE)递交利丙双卡因乳膏境内生产药品上 市许可注册申报资料并获受理，2025年11月获得《药品注册证书》，审评结论为批准注册。 ...

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 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 2025 年 11 月 26 日 在 巨 潮 資 訊 網 （http://www.cninfo.com.cn）刊登的本公司《關於獲得利丙雙卡因乳膏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 2025年11月25日 於本公告日期，本公司董事會之成員如下： 非執行董事： 徐 列先生 張成勇先生 1 证券代码：000756 证券简称：新华制药 公告编号：2025-67 山东新 ...

Core Viewpoint - Xinhua Pharmaceutical (SZ000756) experienced a trading halt with a price of 17.16 yuan, marking a 10% increase and a total market capitalization of 11.837 billion yuan, driven by recent drug approvals, innovation in drug development, and improved cash flow [1] Group 1: Company Developments - Xinhua Pharmaceutical has recently obtained registration certificates for several drugs, including Fumaric Acid Vorinostat, Alendronate Sodium, and Fumaric Acid Bisoprolol, enhancing its product line in cardiovascular and digestive system treatments [1] - The company received clinical trial approval for its first-class innovative drug LXH-1211 tablets, indicating significant progress in its drug development efforts, which lays a foundation for long-term growth [1] - The net cash flow from operating activities for Q3 2025 increased by 26.65% year-on-year, reflecting improved financial management and boosting market confidence in the company [1] Group 2: Industry Context - The pharmaceutical industry remains a focal point for market attention, with innovative drug development being a critical direction for industry growth [1] - Companies within the pharmaceutical sector that have made research breakthroughs have seen active stock performance, suggesting that Xinhua Pharmaceutical's recent innovations may attract market investment [1] - Technical indicators suggest that the stock price may break through key resistance levels, potentially drawing in more investors and contributing to the stock's trading halt [1]

消息面上，11月24日，据中国国家药品监督管理局(NMPA)官网最新显示，山东新华制药股份有限公司 按注册分类4类申报的利丙双卡因乳膏获批上市，视同过评。公开资料显示，利丙双卡因乳膏是利丙双 卡因乳膏是利多卡因和丙胺卡因的复合制剂，主要用于正常完整皮肤的局部麻醉和生殖器粘膜浅表手术 和浸润麻醉的预处理，与传统麻醉药物相比具有便利、安全性高和无依赖性等优点。 山东新华制药股份(00719)涨超4%，截至发稿，涨4.14%，报7.05港元，成交额1935.58万港元。 ...

智通财经APP获悉，山东新华制药股份(00719)涨超4%，截至发稿，涨4.14%，报7.05港元，成交额 1935.58万港元。 消息面上，11月24日，据中国国家药品监督管理局(NMPA)官网最新显示，山东新华制药股份有限公司 按注册分类4类申报的利丙双卡因乳膏获批上市，视同过评。公开资料显示，利丙双卡因乳膏是利丙双 卡因乳膏是利多卡因和丙胺卡因的复合制剂，主要用于正常完整皮肤的局部麻醉和生殖器粘膜浅表手术 和浸润麻醉的预处理，与传统麻醉药物相比具有便利、安全性高和无依赖性等优点。 ...

Core Viewpoint - Xinhua Pharmaceutical (000756) has received approval from the National Medical Products Administration for the marketing application of fumaric acid volnorelin, which is primarily used for gastroesophageal reflux disease and is classified as a Category B drug in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog (2025) [1] Group 1 - The approval of fumaric acid volnorelin will enhance the company's product line [1] - This new product is expected to improve the company's overall competitiveness in the pharmaceutical market [1]

Core Viewpoint - The approval of fumaric acid volnorasone as a chemical raw material drug by the National Medical Products Administration enhances the company's product line and overall competitiveness in the pharmaceutical market [1][2]. Group 1: Product Approval - The company received the approval notice for fumaric acid volnorasone, with the notification number 2025YS00988 [1]. - The application for the domestic production of fumaric acid volnorasone was submitted in March 2024 and was accepted by the National Medical Products Administration [1]. - The approval for production was granted in November 2025, confirming the product's evaluation conclusion as approved [1]. Group 2: Market Potential - Fumaric acid volnorasone is primarily used for gastroesophageal reflux disease and is classified as a Category B drug in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog (2025) [1]. - The estimated sales revenue for fumaric acid volnorasone-related formulations in Chinese public medical institutions is approximately RMB 825 million in 2024 [1]. Group 3: Competitive Advantage - The approval of this product will further enrich the company's product line, thereby enhancing its comprehensive competitiveness in the pharmaceutical industry [2].

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。 证券代码：000756 证券简称：新华制药 公告编号：2025-66 山东新华制药股份有限公司 关于获得富马酸伏诺拉生化学原料药上市申请批准通知书的公告 近日，山东新华制药股份有限公司（"新华制药"或"本公司"）收到国家药品监督管理局 核准签发的富马酸伏诺拉生（"本品"）《化学原料药上市申请批准通知书》。现将相关情况公告 如下： 一、基本情况 原料药名称：富马酸伏诺拉生 注册分类：化学药品 申请人：山东新华制药股份有限公司 申请事项：境内生产化学原料药上市申请 受理号：CYHS2460214 登记号：Y20230001353 通知书编号：2025YS00988 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，批准生产本品。质量标准、包装标签及生产工艺照所附执行。 二、其他相关信息 2024 年 3 月，新华制药向国家药品监督管理局 CDE 递交富马酸伏诺拉生境内生产化学原料 药上市申请注册申报资料并获受理，2025 年 11 月获得《化学原料药上市申请批准通知书》，审 ...

Core Viewpoint - The approval of fumaric acid volnorasone by the National Medical Products Administration enhances the company's product line and competitiveness, with potential sales in public medical institutions projected at approximately 825 million yuan in 2024 [1] Group 1: Product Approval - The company has received approval for fumaric acid volnorasone, which is primarily used for reflux esophagitis [1] - The application for market registration was submitted in March 2024 and has been accepted [1] Group 2: Market Potential - The product is classified as a Category B item in the medical insurance catalog, indicating its relevance in the healthcare market [1] - The estimated sales revenue for related formulations in Chinese public medical institutions is around 825 million yuan in 2024 [1] Group 3: Competitive Landscape - The approval is expected to enrich the company's product portfolio, thereby enhancing its competitive position in the pharmaceutical market [1] - However, the sales of the drug may be influenced by various factors, including policies and market conditions, leading to uncertainties [1]