Core Viewpoint - Xinhua Pharmaceutical (000756.SZ) has received the drug registration certificate for Valsartan capsules from the National Medical Products Administration, indicating a significant step in its product portfolio aimed at treating mild to moderate primary hypertension [1] Group 1 - The approval of Valsartan capsules is a regulatory milestone for Xinhua Pharmaceutical, enhancing its position in the hypertension treatment market [1] - Valsartan is specifically indicated for the treatment of mild to moderate primary hypertension, which addresses a substantial patient population [1]

Core Viewpoint - Xinhua Pharmaceutical's oseltamivir phosphate dry suspension has been approved for market launch by the National Medical Products Administration, marking a significant milestone for the company in the oral antiviral market for influenza [1][2]. Group 1: Product Approval and Market Impact - Oseltamivir phosphate is a selective neuraminidase inhibitor effective against both influenza A and B viruses, suitable for treatment and prevention in adults and children aged 2 weeks and older [1]. - The product is recognized as the first approved oral antiviral drug for influenza in China, filling a gap in the company's product line and enhancing its strategic positioning in the antiviral treatment sector [2]. - The estimated sales revenue for oseltamivir phosphate formulations in Chinese public medical institutions is approximately RMB 5.9 billion for 2024 [1]. Group 2: Clinical Significance and Usage - The dry suspension formulation is expected to become a primary treatment option for pediatric influenza due to its lower gastrointestinal side effects and ease of administration for young children [2]. - The product's design allows for precise dosage control, making it a flexible and convenient choice for influenza prevention and treatment in children [2].

Group 1 - Core viewpoint: XinHua Pharmaceutical has received the drug registration certificate for Valsartan capsules from the National Medical Products Administration [1] - Company market capitalization: As of the report, XinHua Pharmaceutical's market value is 10.8 billion yuan [2]

Core Viewpoint - The company has received approval from the National Medical Products Administration for the registration of Valsartan capsules, which will enhance its cardiovascular product portfolio and overall competitiveness [1] Group 1: Product Approval - The company announced that it has obtained the drug registration certificate for Valsartan capsules, a prescription medication classified as a chemical drug of category 4, with a specification of 80mg [1] - The approval is significant as it allows the company to offer a treatment for mild to moderate primary hypertension [1] Group 2: Market Impact - The registration certificate for Valsartan capsules was granted in December 2025, indicating a future opportunity for the company to expand its product offerings [1] - The sales of the drug may be influenced by various factors such as domestic pharmaceutical policy changes, tender procurement, and market environment fluctuations, which introduces a level of uncertainty [1]

Core Viewpoint - Xinhua Pharmaceutical (000756.SZ) has received approval from the National Medical Products Administration for the injection of phenobarbital, which is intended 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] Company Summary - Xinhua Pharmaceutical has obtained the drug registration certificate for the injection of phenobarbital, indicating a significant regulatory milestone for the company [1]

Core Viewpoint - Xinhua Pharmaceutical (000756) has received approval from the National Medical Products Administration for the registration certificates of Valsartan capsules and Isosorbide Injection, indicating a significant advancement in its product offerings and potential market expansion [1] Group 1: Product Approvals - Valsartan capsules are indicated for the treatment of mild to moderate primary hypertension [1] - Isosorbide Injection is used for treating acute spasmodic pain caused by digestive system and biliary dysfunction, acute spasmodic urethral, bladder, and renal colic, as well as gynecological spasmodic pain [1]

证券代码：000756 证券简称：新华制药 公告编号：2025-71 山东新华制药股份有限公司 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缬沙坦胶囊（以下简称"本品"）《药品注册证书》。现将相关情况 公告如下： 关于获得缬沙坦胶囊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。 一、基本情况 药品名称：缬沙坦胶囊 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9月，新华制药向国家药品监督管理局药品审评中心（CDE）递交缬沙坦胶囊上市 许可申报资料并获受理，2025年12月获得《药品注册证书》，审评结论为：批准注册。 本品用于治疗轻、中度原发性高血压。 剂型：胶囊剂 规格：80mg 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：境内生产药品注册 ...

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]