Core Viewpoint - Xinhua Pharmaceutical's stock has shown fluctuations with a recent increase of 2.07%, reflecting a total market capitalization of 11.21 billion yuan, while facing net outflows of major funds [1][2]. Group 1: Stock Performance - As of October 20, Xinhua Pharmaceutical's stock price reached 16.25 yuan per share, with a trading volume of 1.30 billion yuan and a turnover rate of 1.65% [1]. - Year-to-date, the stock has increased by 5.11%, with a 3.90% rise over the last five trading days, but a decline of 5.63% over the past 60 days [1]. - The company has appeared on the "Dragon and Tiger List" once this year, with a net purchase of 15.67 million yuan on January 6 [1]. Group 2: Financial Performance - For the first half of 2025, Xinhua Pharmaceutical reported a revenue of 4.639 billion yuan, a year-on-year decrease of 1.98%, and a net profit attributable to shareholders of 224 million yuan, down 15.69% year-on-year [2]. - Cumulative cash dividends since the A-share listing amount to 1.17 billion yuan, with 495 million yuan distributed over the last three years [3]. Group 3: Shareholder Information - As of June 30, 2025, the number of shareholders decreased to 76,500, with an average of 6,442 circulating shares per person [2]. - Major shareholders include Hong Kong Central Clearing Limited, which increased its holdings by 1.066 million shares, and several ETFs that also increased their positions [3].

Core Viewpoint - Xinhua Pharmaceutical (000756.SZ) has received approval from the National Medical Products Administration for the marketing of Fumarate Bisoprolol Tablets, which are indicated for hypertension, coronary heart disease (angina), and chronic stable heart failure with reduced left ventricular systolic function (ejection fraction ≤ 35%) [1] Summary by Category Product Approval - The approval includes the issuance of a Drug Registration Certificate for Fumarate Bisoprolol Tablets [1] - The product is intended for use under medical supervision alongside ACE inhibitors, diuretics, and selectively used cardiac glycosides [1] Indications - Fumarate Bisoprolol Tablets are indicated for the treatment of: - Hypertension - Coronary heart disease (angina) - Chronic stable heart failure with reduced left ventricular systolic function (ejection fraction ≤ 35%) [1]

Core Viewpoint - Xinhua Pharmaceutical (000756.SZ) has received approval from the National Medical Products Administration for the registration certificate of Fumarate Bisoprolol Tablets, indicating a significant advancement in its product portfolio [1] Group 1: Product Approval - The Fumarate Bisoprolol Tablets are indicated for the treatment of hypertension and coronary heart disease (angina) [1] - The product is also indicated for chronic stable heart failure with reduced left ventricular systolic function (ejection fraction ≤ 35%) [1] - The use of this medication requires adherence to medical advice, including the use of ACE inhibitors, diuretics, and selectively using cardiac glycosides [1]

Core Viewpoint - Xinhua Pharmaceutical (000756.SZ) has received the drug registration certificate for Fumarate Bisoprolol Tablets from the National Medical Products Administration, indicating a significant advancement in its product portfolio [1] Group 1: Product Approval - The approval is for Fumarate Bisoprolol Tablets, which are indicated for hypertension and coronary heart disease (angina) [1] - The product is also indicated for chronic stable heart failure with reduced left ventricular systolic function (ejection fraction ≤ 35%) [1] Group 2: Treatment Guidelines - The use of Fumarate Bisoprolol Tablets should be accompanied by ACE inhibitors, diuretics, and selectively used cardiac glycosides as per medical advice [1]

Core Viewpoint - The announcement indicates that Xinhua Pharmaceutical has received approval from the National Medical Products Administration for the registration of Fumarate Bisoprolol tablets, which are indicated for hypertension, coronary heart disease (angina), and chronic stable heart failure with reduced left ventricular systolic function (ejection fraction ≤ 35%) [1] Group 1 - The approved drug, Fumarate Bisoprolol, targets specific cardiovascular conditions [1] - The estimated sales revenue for Fumarate Bisoprolol tablets in Chinese public medical institutions is approximately RMB 1.228 billion in 2024 [1]

证券代码：000756 证券简称：新华制药 公告编号：2025-59 山东新华制药股份有限公司 关于获得富马酸比索洛尔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。 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比索洛尔片（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：富马酸比索洛尔片 剂型：片剂 规格：5mg；2.5mg 药品分类：处方药 注册分类：化学药品4类 申请人：山东新华制药股份有限公司 申请事项：药品注册（境内生产） 受理号：CYHS2400705、CYHS2400706 药品批准文号：国药准字H20255640；国药准字H20255641 证书编号：2025S03071；2025S03072 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 2 ...

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received the drug registration certificate for Fumarate Bisoprolol Tablets from the National Medical Products Administration, enhancing its cardiovascular product line and providing more options for clinical medication [1]. Group 1 - The company has been approved for the registration of Fumarate Bisoprolol Tablets [1]. - This approval enriches the company's cardiovascular product offerings [1]. - The new product provides additional choices for clinical medication [1].

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the registration of Fumaric Acid Bisoprolol Tablets, indicating a significant advancement in its product portfolio and potential market impact [1] Group 1: Product Approval and Registration - The company has been granted a drug registration certificate for Fumaric Acid Bisoprolol Tablets, confirming compliance with the relevant drug registration requirements [1] - The registration process included submission of application materials to the Center for Drug Evaluation (CDE) in February 2024, with approval granted in October 2025 [1] Group 2: Indications and Usage - Fumaric Acid Bisoprolol Tablets are indicated for hypertension, coronary heart disease (angina), and chronic stable heart failure with reduced left ventricular systolic function (ejection fraction ≤ 35%) [1] - The use of this medication should be accompanied by ACE inhibitors, diuretics, and selectively used cardiac glycosides as per medical advice [1] Group 3: Market Potential - The drug is classified as a Category A product in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog (2024 edition) [1] - Estimated sales for Fumaric Acid Bisoprolol Tablets in Chinese public medical institutions are projected to be approximately RMB 1.228 billion in 2024 [1]

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the registration certificate of Fumaric Acid Bisoprolol Tablets, enhancing its cardiovascular product line and providing more options for clinical medication [1] Company Summary - The approval of Fumaric Acid Bisoprolol Tablets enriches the company's cardiovascular product offerings [1] - This development indicates the company's commitment to expanding its portfolio in the cardiovascular sector [1] Industry Summary - The approval reflects ongoing regulatory support for new pharmaceutical products in the cardiovascular market [1] - The introduction of new medications can lead to increased competition and innovation within the cardiovascular treatment landscape [1]

山東新華製藥股份有限公司 Shandong Xinhua Pharmaceutical Company Limited 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。 （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 10 月 14 日 在 巨 潮 資 訊 網 （http://www.cninfo.com.cn）刊登的本公司《關於獲得富馬酸比索洛爾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10月13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 ...