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 ...

Market Performance - On November 13, the Shandong state-owned enterprise reform sector rose by 1.17%, with Furi Shares leading the gains [1] - The Shanghai Composite Index closed at 4029.5, up 0.73%, while the Shenzhen Component Index closed at 13476.52, up 1.78% [1] Top Gainers in Shandong State-Owned Enterprises - Key stocks in the Shandong state-owned enterprise reform sector included: - Qirui Shares (002083) closed at 10.51, up 10.05% with a trading volume of 182,000 shares and a turnover of 191 million yuan [1] - Shida Shenghua (603026) closed at 91.38, up 10.00% with a trading volume of 72,400 shares and a turnover of 655 million yuan [1] - Jiga Development (600807) closed at 3.88, up 9.92% with a trading volume of 561,900 shares and a turnover of 216 million yuan [1] Market Capital Flow - The Shandong state-owned enterprise reform sector experienced a net outflow of 132 million yuan from institutional investors, while retail investors saw a net inflow of 138 million yuan [2] - The top stocks by net inflow from retail investors included: - Qirui Shares (002083) with a net inflow of 64.38 million yuan, accounting for 33.65% of its trading volume [3] - ST Chenming (000488) with a net inflow of 38.29 million yuan, accounting for 29.70% of its trading volume [3] Notable Decliners - Some stocks in the sector faced declines, including: - Shandong High-speed (600350) closed at 9.37, down 1.99% with a trading volume of 97,100 shares and a turnover of 9.13 million yuan [2] - Shandong High-tech (000803) closed at 8.50, down 2.52% with a trading volume of 1,180,500 shares and a turnover of 1.06 billion yuan [2]

Core Viewpoint - The A-share market has seen a significant rise in flu-related stocks due to a noticeable increase in flu activity across China, with most provinces entering the flu epidemic period [1] Group 1: Stock Performance - Hendi Pharmaceutical has increased by over 14%, while Hualan Biological has risen by 11% [1] - Other notable performers include Peking University Pharmaceutical with a 10% increase, and Jinshi Yao with a rise of over 7% [1] - Several companies, including Teva Pharmaceutical, Erkang Pharmaceutical, and others, have also shown gains of over 5% [1] Group 2: Market Context - Recent data from the China CDC indicates that flu virus cases have surpassed other respiratory viruses, marking a significant shift in the current flu season [1] - Since mid-October, sales of related medications, such as Oseltamivir, have increased, with production running continuously [1]

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].

Group 1 - The stock price of Xinhua Pharmaceutical (000756) closed at 15.91 yuan on November 4, 2025, down 0.25% with a turnover rate of 1.96% and a trading volume of 96,400 shares, amounting to a total transaction value of 153 million yuan [1] - The company has a diverse product range including raw materials, formulations, and pharmaceutical intermediates, with the sales volume of the winning products from the national medical procurement policy being relatively small [2] - After winning bids under the national medical procurement policy, the gross margin of the winning products has decreased, but the company can mitigate this impact through economies of scale, refined management, and expanding market share [2] Group 2 - On November 4, the net inflow of main funds was 23.77 million yuan, accounting for 15.57% of the total transaction value, while retail investors experienced a net outflow of 14.34 million yuan, representing 9.39% of the total transaction value [3] - The implementation of the procurement policy has led to an improvement in the payment settlement cycle for the company as the National Healthcare Security Administration gradually expands the direct settlement range of medical insurance funds with pharmaceutical companies [2]

Core Viewpoint - The company, XinHua Pharmaceutical, has indicated that it operates with a diverse range of products including raw materials, formulations, and pharmaceutical intermediates, with a relatively small proportion of sales coming from awarded products [1] Group 1: Impact of National Drug Procurement Policy - The gross margin of awarded products has decreased following the implementation of the national drug procurement policy [1] - The company aims to mitigate the impact of this margin decline through scale effects, refined management, and expanding market share [1] Group 2: Improvement in Payment Settlement - The implementation of the national procurement policy has led to an improvement in the payment settlement cycle for the company, as the National Healthcare Security Administration gradually expands the direct settlement range of medical insurance funds with pharmaceutical companies [1]

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]