山东新华制药股份有限公司 关于子公司获得非那雄胺片药品注册证书的公告 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。 证券代码：000756 证券简称：新华制药 公告编号：2025-45 药品批准文号：国药准字H20255064 近日，山东新华制药股份有限公司之全资子公司山东淄博新达制药有限公司（以下简称 "新达制药"）收到国家药品监督管理局核准签发的非那雄胺片（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：非那雄胺片 剂型：片剂 规格：5mg 药品分类：处方药 注册分类：化学药品4类 申请人：山东淄博新达制药有限公司 申请事项：境内生产药品注册上市许可 受理号：CYHS2400153 通知书编号：2025S02419 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1月，新达制药向国家药品监督管理局CDE递交非那雄胺 ...

Core Viewpoint - Xinhua Pharmaceutical (000756.SZ) has received approval from the National Medical Products Administration for the registration of Finasteride tablets, which are indicated for the treatment and management of benign prostatic hyperplasia (BPH) [1] Group 1: Product Information - Finasteride tablets are used to treat and control benign prostatic hyperplasia (BPH) and to prevent urinary system events [1] - The medication reduces the risk of acute urinary retention and the need for transurethral resection of the prostate (TURP) and prostatectomy [1] - Finasteride tablets can shrink enlarged prostates, improve urinary flow, and alleviate symptoms associated with prostatic hyperplasia [1]

Core Viewpoint - Xinhua Pharmaceutical (000756.SZ) has received approval from the National Medical Products Administration for the registration of Finasteride tablets, which are indicated for the treatment and management of benign prostatic hyperplasia (BPH) [1] Company Summary - The company's wholly-owned subsidiary, Shandong Zibo Xinda Pharmaceutical Co., Ltd., is responsible for the newly approved Finasteride tablets [1] - Finasteride tablets are designed to reduce the risk of acute urinary retention and the need for surgical procedures such as transurethral resection of the prostate (TURP) and prostatectomy [1] Industry Summary - Finasteride tablets can help shrink enlarged prostates, improve urinary flow, and alleviate symptoms associated with benign prostatic hyperplasia [1]

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. announced that its wholly-owned subsidiary, Shandong Zibo Xinda Pharmaceutical Co., Ltd., has received the drug registration certificate for Finasteride tablets from the National Medical Products Administration, which is expected to enhance the company's product portfolio and explore new market opportunities [1] Group 1 - The drug registration certificate for Finasteride tablets was obtained on August 2025 [1] - The approval is seen as beneficial for the company to diversify its product range [1] - The move is aimed at expanding into new market sectors [1]

Core Viewpoint - Xinhua Pharmaceutical's subsidiary, Xinda Pharmaceutical, has received approval for Finasteride tablets, which are indicated for the treatment of benign prostatic hyperplasia (BPH) and prevention of urinary system events, enhancing the company's product portfolio and market opportunities [2] Group 1: Product Approval and Market Impact - Xinda Pharmaceutical has been granted a drug registration certificate for Finasteride tablets by the National Medical Products Administration [2] - The Finasteride tablets are classified as a Category B drug under the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog (2025) [2] - The estimated sales revenue for Finasteride tablets in Chinese public medical institutions is approximately RMB 1.45 billion in 2024 [2] Group 2: Strategic Implications - The approval of Finasteride tablets is expected to enrich the company's product line and explore new market segments [2] - The pharmaceutical sales business is subject to uncertainties due to potential changes in domestic pharmaceutical policies and market conditions [2]

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval for the registration of Finasteride tablets, which will enhance its product portfolio and open new market opportunities [1] Group 1 - The company's wholly-owned subsidiary, Shandong Zibo Xinda Pharmaceutical Co., Ltd., has obtained the drug registration certificate for Finasteride tablets from the National Medical Products Administration [1] - The registration certificate for Finasteride tablets was granted in August 2025, indicating a future product launch [1] - This development is expected to contribute positively to the company's growth by diversifying its product offerings [1]

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the registration of Finasteride tablets, which are used to treat benign prostatic hyperplasia (BPH) and prevent urinary system events [1] Company Summary - The company's wholly-owned subsidiary, Shandong Zibo Xinda Pharmaceutical Co., Ltd., is responsible for the newly approved Finasteride tablets [1] - Finasteride tablets are indicated for reducing the risk of acute urinary retention and the need for surgical procedures such as transurethral resection of the prostate (TURP) and prostatectomy [1] - The medication is designed to shrink enlarged prostates, improve urinary flow, and alleviate symptoms associated with prostatic hyperplasia [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 8 月 6 日 在 巨 潮 資 訊 網 （http://www.cninfo.com.cn）刊登的本公司《關於子公司獲得非那雄胺片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8月5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 ...

Market Overview - The Shanghai Composite Index closed at 3567.02 points, with a change of 0.20% [1] - The total trading volume of A-shares reached 932.32 billion yuan [1] Technical Analysis - A total of 45 A-shares experienced a death cross, where the 5-day moving average fell below the 10-day moving average [1] - Notable stocks with significant distance between their 5-day and 10-day moving averages include: - Sifang Jingchuang (300468) with a distance of -1.64% - Zhongyou Capital (000617) with a distance of -1.04% - Langxin Group (300682) with a distance of -0.94% [1] Individual Stock Performance - Sifang Jingchuang (300468) saw a decline of 1.58% with a trading turnover of 4.30% [1] - Zhongyou Capital (000617) decreased by 3.42% with a turnover of 1.28% [1] - Langxin Group (300682) fell by 1.37% with a turnover of 1.64% [1] - Other notable stocks include: - China Life Insurance (601319) increased by 0.37% [1] - Haosen Intelligent (688529) rose by 0.71% [1] - Donglai Technology (688129) increased by 1.25% [1] Additional Stock Movements - Stocks with minor declines include: - Huatai Wine Industry (000995) down by 1.31% [1] - Changyang Technology (688299) down by 0.22% [1] - Dream Jie's (002397) decline of 1.39% [1] - Stocks with slight increases include: - Matrix Technology (301299) up by 1.15% [2] - Lianxin Electronics (002036) down by 0.47% [2]

FF301 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8月4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 | A | | 於香港聯交所上市 (註1) | | 否 | | | --- | --- | --- | ...