证券代码：000756 证券简称：新华制药 公告编号：2025-72 山东新华制药股份有限公司 关于获得间苯三酚注射液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（以下简称"新华制药"或"本公司"）收到国家药品监督管理 局核准签发的间苯三酚注射液（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 受理号：CYHS2402195 药品批准文号：国药准字H20256347 证书编号：2025S03880 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。 药品名称：间苯三酚注射液 剂型：注射剂 规格：4ml：40mg（按C6H6O3·2H2O计） 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） 二、其他相关信息 2024年7月，新华制药向国家药品监督管理局药 ...

Core Viewpoint - The approval of Valsartan capsules by the National Medical Products Administration is a significant milestone for the company, enhancing its cardiovascular product line and competitive position in the market [1] Group 1: Product Approval - The company has received the drug registration certificate for Valsartan capsules (80mg), classified as a prescription drug and a Class 4 chemical drug [1] - The drug is indicated for the treatment of mild to moderate primary hypertension and is included in the Class A medical insurance category [1] Group 2: Market Potential - The sales revenue for Valsartan capsules in Chinese public medical institutions is estimated to be approximately 1.82 billion yuan in 2024 [1] - The company submitted the application for market approval in September 2024, which was accepted, and the approval is expected by December 2025 [1] Group 3: Competitive Advantage - The approval of Valsartan capsules will enrich the company's product line for cardiovascular diseases, thereby enhancing its competitiveness in the pharmaceutical market [1] - However, the sales of the drug may be influenced by various factors such as policies and market conditions, indicating potential uncertainties [1]

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the registration certificate of its injection product, Benzyl Alcohol Injection, which is intended for treating acute spasmodic pain caused by digestive system and biliary dysfunction, as well as acute spasmodic pain in the urinary tract, bladder, and kidney, and gynecological spasmodic pain [1] Company Summary - The company has announced the approval of Benzyl Alcohol Injection, which expands its product offerings in the pharmaceutical market [1] - This product is specifically designed to address various types of acute spasmodic pain, indicating a focus on pain management solutions [1] Industry Summary - The approval of new pharmaceutical products like Benzyl Alcohol Injection reflects ongoing developments in the healthcare sector, particularly in pain management therapies [1] - The market for treatments addressing acute spasmodic pain is significant, highlighting potential growth opportunities for companies in this segment [1]

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the registration of Valsartan capsules, which will enhance the company's cardiovascular disease treatment product line and improve its overall competitiveness [1] Group 1 - The company has been granted a drug registration certificate for Valsartan capsules, which is expected to be effective from December 2025 [1] - The approval of Valsartan capsules is part of the company's strategy to diversify its product offerings in the cardiovascular disease sector [1] - This development is anticipated to strengthen the company's market position and competitive edge in the pharmaceutical industry [1]

Group 1 - The core point of the article is that Shandong Xinhua Pharmaceutical has received approval from the National Medical Products Administration for the registration of its injection product, Isopropylphenol [1] - The product is indicated for the treatment of acute spasmodic pain caused by digestive system and biliary dysfunction, as well as acute spasmodic pain in the urinary tract, bladder, and kidney, and gynecological spasmodic pain [1] - The product is classified as a Category B drug in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog (2025) [1] Group 2 - In July 2024, the company submitted the registration application for the domestic production of Isopropylphenol injection, which was accepted by the National Medical Products Administration [1] - The product received its registration certificate in December 2025, with the review conclusion being approval for registration [1] - The estimated sales revenue for Isopropylphenol injection in Chinese public medical institutions is approximately RMB 900 million in 2024 [1]

Group 1 - The core point of the article is that Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the registration certificate of Valsartan capsules, which are used to treat mild to moderate primary hypertension [1] Group 2 - The approval signifies a regulatory milestone for the company, potentially enhancing its product portfolio in the cardiovascular medication market [1] - Valsartan is a well-known medication in the treatment of hypertension, indicating a strategic move by the company to address a significant health issue [1] - The introduction of Valsartan capsules may lead to increased revenue opportunities for the company in the pharmaceutical sector [1]

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the registration of its Isopropylphenol Injection, marking a significant milestone for the company in expanding its product offerings in the pharmaceutical market [1] Group 1: Product Approval and Registration - The company submitted the registration application for Isopropylphenol Injection to the Center for Drug Evaluation (CDE) in July 2024, which was accepted [1] - The product received its registration certificate in December 2025, with the evaluation conclusion being approval for registration [1] Group 2: Product Indications - Isopropylphenol Injection is indicated for the treatment of acute spasmodic pain caused by digestive system and biliary dysfunction, acute spasmodic urethral, bladder, and renal colic, as well as gynecological spasmodic pain [1] Group 3: Market Potential - The product 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 Isopropylphenol Injection in Chinese public medical institutions is approximately RMB 900 million in 2024 [1]

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received the drug registration certificate for Valsartan capsules from the National Medical Products Administration, which is expected to enhance the company's product portfolio for cardiovascular disease treatment and improve its overall competitiveness [1]. Group 1 - The drug registration certificate for Valsartan capsules was approved and issued on December 2025 [1]. - The approval of Valsartan capsules will enrich the company's product line for treating cardiovascular diseases [1]. - This development is anticipated to strengthen the company's comprehensive competitiveness in the pharmaceutical industry [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 12 月 30 日 在 巨 潮 資 訊 網 （http://www.cninfo.com.cn）刊登的本公司《關於獲得間苯三酚注射液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12月29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 ...

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 12 月 30 日 在 巨 潮 資 訊 網 （http://www.cninfo.com.cn）刊登的本公司《關於獲得缬沙坦膠囊藥品註冊證書的公告》,茲載列有 關文檔之中文版，以供參閱。 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 | | 徐文輝先生 | | 朱建偉先生 | | 侯 | 寧先生 | 凌沛學先生 | | ...