FF301 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: 2025年10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: 2025年11月3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 | ...

新华制药公告，近日收到国家药品监督管理局核准签发的阿仑膦酸钠口服溶液《药品注册证书》。该药 品适用于治疗绝经后妇女的骨质疏松症，以预防髋部和脊柱骨折（椎骨压缩性骨折）和男性骨质疏松以 增加骨量。2024年阿仑膦酸钠在包括中国公立医院、公立基层医疗机构、零售药店在内的三大终端销售 额达人民币7.2亿元。 ...

人民财讯10月31日电，新华制药（000756）10月31日公告，近日，公司收到国家药品监督管理局核准签 发的阿仑膦酸钠口服溶液《药品注册证书》。阿仑膦酸钠口服溶液适用于治疗绝经后妇女的骨质疏松 症，以预防髋部和脊柱骨折(椎骨压缩性骨折)和男性骨质疏松以增加骨量。根据有关统计数据，2024年 阿仑膦酸钠在包括中国公立医院、公立基层医疗机构、零售药店在内的三大终端销售额达7.2亿元。 ...

Core Viewpoint - Xinhua Pharmaceutical (000756.SZ) has received the drug registration certificate for Alendronate Sodium Oral Solution from the National Medical Products Administration, indicating a significant advancement in its product offerings for osteoporosis treatment [1] Company Summary - The approval of Alendronate Sodium Oral Solution is aimed at treating osteoporosis in postmenopausal women and preventing hip and spinal fractures, as well as increasing bone mass in men with osteoporosis [1]

证券代码：000756 证券简称：新华制药 公告编号：2025-65 山东新华制药股份有限公司 关于获得《药品注册证书》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阿仑膦酸钠口服溶液（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：阿仑膦酸钠口服溶液 剂型：口服溶液剂 规格：75ml:70mg（按C4H13NO7P2计） 药品分类：处方药 受理号：CYHS2401018、CYHB2402066 药品批准文号：国药准字 H20255791 证书编号：2025S03243 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。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。 二、其他相关信息 2024年4月，山东朗诺制药有限公司（以下简称"山东朗诺"）向国家药品监督管理局药 品审评中心（ ...

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the registration of Alendronate Sodium Oral Solution, which is indicated for the treatment of osteoporosis in postmenopausal women and men, aimed at preventing hip and vertebral fractures [1] Company Summary - The newly approved Alendronate Sodium Oral Solution is designed to increase bone mass and prevent fractures in specific patient populations [1] - The projected sales revenue for Alendronate Sodium in 2024 across major distribution channels, including public hospitals, grassroots medical institutions, and retail pharmacies, is estimated to reach RMB 720 million [1]

据悉，阿仑膦酸钠口服溶液适用于治疗绝经后妇女的骨质疏松症，以预防髋部和嵴柱骨折(椎骨压缩性 骨折)和男性骨质疏松以增加骨量。根据有关统计数据，2024年阿仑膦酸钠在包括中国公立医院、公立 基层医疗机构、零售药店在内的叁大终端销售额达人民币7.2亿元。 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收到国家药品 监督管理局核准签发的阿仑膦酸钠口服溶液《药品注册证书》。 ...

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 1 日 在 巨 潮 資 訊 網 （http://www.cninfo.com.cn）刊登的本公司《關於獲得〈藥品註冊證書〉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 2025年10月31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 ...

Core Viewpoint - Xinhua Pharmaceutical's stock price has shown a slight increase of 2.65% year-to-date, but has experienced a decline over the past 60 days, indicating potential volatility in its market performance [1][2]. Company Overview - Xinhua Pharmaceutical, established on November 20, 1998, and listed on August 6, 1997, is located in Zibo, Shandong Province. The company specializes in the development, manufacturing, and sales of chemical raw materials, pharmaceutical preparations, and other products [1]. - The company's main business revenue composition includes: 44.36% from tablets, injections, and capsules; 32.11% from raw materials for antipyretic and analgesic drugs; and 23.53% from pharmaceutical intermediates and others [1]. Financial Performance - For the period from January to September 2025, Xinhua Pharmaceutical achieved an operating income of 6.763 billion yuan, representing a year-on-year growth of 0.42%. However, the net profit attributable to shareholders decreased by 25.53% to 256 million yuan [2]. - The company has distributed a total of 1.17 billion yuan in dividends since its A-share listing, with 495 million yuan distributed over the past three years [3]. Shareholder Information - As of September 30, 2025, the number of shareholders for Xinhua Pharmaceutical was 70,700, a decrease of 7.60% from the previous period. The average circulating shares per person remained at 0 shares [2]. - The top ten circulating shareholders include Hong Kong Central Clearing Limited, which holds 3.1337 million shares, a decrease of 275,600 shares from the previous period [3].

Core Insights - Xinhua Pharmaceutical, established in 1998 and listed in 1997, is a significant player in the raw material pharmaceutical industry in China, particularly in the field of analgesics, with a full industry chain advantage [1] Group 1: Business Performance - In Q3 2025, Xinhua Pharmaceutical reported a revenue of 6.763 billion, ranking third among 47 companies in the industry, with the top competitor, Puluo Pharmaceutical, generating 7.764 billion [2] - The net profit for the same period was 267 million, placing Xinhua ninth in the industry, while the leading company, Zhejiang Pharmaceutical, achieved a net profit of 867 million [2] Group 2: Financial Ratios - As of Q3 2025, Xinhua Pharmaceutical's debt-to-asset ratio was 40.72%, down from 42.25% year-on-year, which is higher than the industry average of 27.75% [3] - The gross profit margin for Q3 2025 was 19.17%, a decrease from 23.50% year-on-year, and below the industry average of 35.38% [3] Group 3: Executive Compensation - The chairman, He Tongqing, received a salary of 1.8981 million in 2024, an increase of 285,300 from 2023 [4] - The general manager, Xu Wenhui, earned 1.8081 million in 2024, up by 286,700 from the previous year [4] Group 4: Shareholder Information - As of June 30, 2025, the number of A-share shareholders decreased by 2.48% to 76,500, while the average number of shares held per shareholder increased by 10.89% to 6,442.22 [5] - By September 30, 2025, major shareholders included Hong Kong Central Clearing Limited and various ETFs, with notable decreases in their holdings [5]