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]

Core Viewpoint - The company has received approval from the National Medical Products Administration for the marketing application of fumaric acid volnorelin, which is primarily used for treating gastroesophageal reflux disease [1] Group 1 - The drug fumaric acid volnorelin has been approved for marketing, indicating a significant milestone for the company [1] - This approval may enhance the company's product portfolio and potentially increase revenue from the treatment of gastroesophageal reflux disease [1]

Core Viewpoint - Xinhua Pharmaceutical (000756.SZ) has received approval from the National Medical Products Administration for the marketing application of fumaric acid volnorasone, which is primarily used for treating gastroesophageal reflux disease [1] Group 1 - The approval signifies a regulatory milestone for the company, potentially enhancing its product portfolio in the pharmaceutical market [1] - Fumaric acid volnorasone is specifically indicated for gastroesophageal reflux disease, indicating a targeted therapeutic application [1]

Core Viewpoint - Xinhua Pharmaceutical (000756) has received approval from the National Medical Products Administration for the marketing application of Fumaric Acid Venlafaxine, which is primarily used for gastroesophageal reflux disease [1] Group 1 - The approval notification for Fumaric Acid Venlafaxine marks a significant milestone for the company in expanding its product portfolio [1] - The drug is specifically indicated for the treatment of reflux esophagitis, addressing a common gastrointestinal condition [1]

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the marketing application of Fumaric Acid Venlafaxine, which is primarily used for gastroesophageal reflux disease and is included in the 2025 National Basic Medical Insurance Drug List as a Class B drug [1] Company Summary - The company has announced the receipt of the approval notice for Fumaric Acid Venlafaxine, indicating a significant development in its product portfolio [1] - This approval may enhance the company's market position in the pharmaceutical industry, particularly in the treatment of gastroesophageal reflux disease [1] Industry Summary - The inclusion of Fumaric Acid Venlafaxine in the National Basic Medical Insurance Drug List suggests a growing recognition of the drug's importance in treating specific medical conditions [1] - The approval aligns with industry trends towards expanding access to essential medications through insurance coverage [1]

Core Viewpoint - Shandong Xinhua Pharmaceutical has received approval from the National Medical Products Administration for the marketing of fumaric acid volnorex, indicating a significant advancement in its product portfolio and potential revenue growth in the pharmaceutical market [1] Company Summary - Shandong Xinhua Pharmaceutical submitted the registration application for fumaric acid volnorex in March 2024, which was accepted by the National Medical Products Administration [1] - The company received the approval notice for the chemical raw material drug in November 2025, allowing it to commence production [1] Industry Summary - Fumaric acid volnorex is primarily used for treating 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 sales revenue for fumaric acid volnorex-related formulations in Chinese public medical institutions is projected to be approximately RMB 825 million in 2024 [1]

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the marketing application of Fumaric Acid Venlafaxine, indicating a significant advancement in its product portfolio and potential revenue growth in the pharmaceutical market [1] Company Summary - Shandong Xinhua Pharmaceutical submitted the registration application for Fumaric Acid Venlafaxine in March 2024, which was accepted by the National Medical Products Administration [1] - The company received the approval notice for the chemical raw material drug in November 2025, allowing it to commence production [1] Industry Summary - Fumaric Acid Venlafaxine is primarily used for treating 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 Venlafaxine-related formulations in Chinese public medical institutions is approximately RMB 825 million 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。 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 18 日 在 巨 潮 資 訊 網 （http://www.cninfo.com.cn）刊登的本公司《關於獲得富馬酸伏諾拉生化學原料藥上市申請批 准通知書的公告》,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17日 於本公告日期，本公司董事會之成員如下： 執行董事： 賀同慶先生（董事長） 徐文輝先生 侯 寧先生 山东新华制药股份有限公司 关于获得富马酸伏诺 ...

Core Viewpoint - Xinhua Pharmaceutical's stock has shown a modest increase in recent trading sessions, with a year-to-date rise of 5.05%, despite a decline over the past 60 days [1][2]. Group 1: Stock Performance - On November 7, Xinhua Pharmaceutical's stock rose by 2.33%, reaching 16.24 CNY per share, with a trading volume of 1.20 billion CNY and a turnover rate of 1.52% [1]. - The stock has experienced a net inflow of 620.05 thousand CNY from major funds, with significant buying activity from large orders [1]. - Year-to-date, the stock has appeared on the "Dragon and Tiger List" once, with a net purchase of 15.67 million CNY on January 6 [1]. Group 2: Financial Performance - For the period from January to September 2025, Xinhua Pharmaceutical reported a revenue of 6.763 billion CNY, reflecting a year-on-year growth of 0.42%, while the net profit attributable to shareholders decreased by 25.53% to 256 million CNY [2]. - Cumulative cash dividends since the A-share listing amount to 1.17 billion CNY, with 495 million CNY distributed over the past three years [3]. Group 3: Shareholder Information - As of September 30, 2025, the number of shareholders decreased by 7.60% to 70,700, with an average of 0 circulating shares per person [2]. - The top ten circulating shareholders include Hong Kong Central Clearing Limited and several ETFs, all of which have seen a reduction in their holdings compared to the previous period [3].