证券代码：000756 证券简称：新华制药 公告编号：2025-54 山东新华制药股份有限公司 关于子公司获得熊去氧胆酸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。 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熊去氧胆酸胶囊（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：熊去氧胆酸胶囊 剂型：胶囊剂 2024年1月，新达制药向国家药品监督管理局药品审评中心（CDE）递交熊去氧胆酸胶囊上 市许可申报资料并获受理，2025年9月获得《药品注册证书》，审评结论为：批准注册。 规格：250mg 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：药品注册（境内生产） 受理号：CYHS2400384 药品批准文号：国药准字H20255344 证书编号：2025S02741 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 ...

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枸橼酸西地那非口崩片（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 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。 证券代码：000756 证券简称：新华制药 公告编号：2025-55 山东新华制药股份有限公司 关于获得枸橼酸西地那非口崩片药品注册证书的公告 枸橼酸西地那非口崩片用于治疗勃起功能障碍。根据相关统计数据，2024年中国公立医 疗机构西地那非相关制剂销售额约为人民币52亿元。 三、对上市公司的影响及风险提示 新华制药的枸橼酸西地那非口崩片于2025年9月取得药品注册证书，有利于本公司开拓 新的市场领域，提高市场竞争力。 因药品销售业务易受到国内医药行业政策变动、招标采购、市场环境变化等因素影响， 存 ...

Core Viewpoint - Xinhua Pharmaceutical (000756.SZ) announced that its wholly-owned subsidiary, Shandong Zibo Xinda Pharmaceutical Co., Ltd., has received the drug registration certificate for Ursodeoxycholic Acid Capsules from the National Medical Products Administration, indicating a significant regulatory approval for a new treatment option [1] Group 1 - The approved drug is indicated for the treatment of cholesterol gallstones, specifically those that are X-ray penetrable and require normal gallbladder contraction function [1] - The drug is also used for cholestatic liver diseases, such as primary biliary cirrhosis [1] - Additionally, it is indicated for the treatment of bile reflux gastritis [1]

Group 1 - The core point of the article is that Xinhua Pharmaceutical has received approval from the National Medical Products Administration for the registration of its Sildenafil Citrate Orally Disintegrating Tablets, which are used to treat erectile dysfunction [1] - The approval of Sildenafil Citrate Orally Disintegrating Tablets is expected to help the company explore new market areas and enhance its market competitiveness [1]

Group 1 - The core point of the article is that Xinhua Pharmaceutical (000756.SZ) announced that its wholly-owned subsidiary, Shandong Zibo Xinda Pharmaceutical Co., Ltd., received the drug registration certificate for Ursodeoxycholic Acid Capsules from the National Medical Products Administration [1] - The drug is indicated for the treatment of cholesterol gallstones (which must be X-ray penetrable stones and the gallbladder must have normal contraction function) [1] - It is also used for cholestatic liver diseases (such as primary biliary cirrhosis) and bile reflux gastritis [1]

Group 1 - The core point of the article is that Xinhua Pharmaceutical has received approval for the registration of Ursodeoxycholic Acid Capsules from the National Medical Products Administration [1] - Xinhua Pharmaceutical's revenue composition for the first half of 2025 is as follows: 44.36% from chemical drug formulation manufacturing, 32.11% from chemical raw material manufacturing, and 23.53% from pharmaceutical intermediates and others [1] - As of the report, Xinhua Pharmaceutical has a market capitalization of 11.6 billion yuan [1]

Core Viewpoint - Xinhua Pharmaceutical's subsidiary, Xinda Pharmaceutical, has received the drug registration certificate for Ursodeoxycholic Acid Capsules from the National Medical Products Administration, indicating a significant development in its product portfolio [1] Company Summary - Xinda Pharmaceutical, a wholly-owned subsidiary of Xinhua Pharmaceutical, has been approved for Ursodeoxycholic Acid Capsules, which are used to treat cholesterol gallstones, cholestatic liver disease, and bile reflux gastritis [1] - The drug is classified as a Class A item in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog for 2024, enhancing its market accessibility [1] Industry Summary - The estimated sales revenue for Ursodeoxycholic Acid in Chinese public medical institutions is approximately 2.155 billion yuan in 2024, indicating a substantial market opportunity for the newly approved drug [1] - Xinda Pharmaceutical submitted the application for marketing authorization in January 2024 and received approval in September 2025, reflecting the regulatory timeline for new drug approvals in the industry [1]

Group 1 - The company announced that its wholly-owned subsidiary, Shandong Zibo Xinda Pharmaceutical Co., Ltd., has received the drug registration certificate for Ursodeoxycholic Acid Capsules from the National Medical Products Administration [1] - The drug is indicated for the treatment of cholesterol gallstones, cholestatic liver disease, and bile reflux gastritis [1] - The estimated sales revenue for Ursodeoxycholic Acid in Chinese public medical institutions is approximately RMB 2.155 billion in 2024 [1]

Core Viewpoint - Shandong Xinhua Pharmaceutical's subsidiary, Shandong Zibo Xinda Pharmaceutical, has received approval for Ursodeoxycholic Acid Capsules from the National Medical Products Administration, enhancing the company's product offerings in the digestive system medication sector [1] Group 1: Regulatory Approval - The company submitted the application for Ursodeoxycholic Acid Capsules to the Center for Drug Evaluation in January 2024, which was accepted [1] - The product received its registration certificate in September 2025, with the evaluation conclusion being approval for registration [1] Group 2: Product Indications - Ursodeoxycholic Acid Capsules are indicated for the treatment of cholesterol gallstones, cholestatic liver diseases, and bile reflux gastritis [1] Group 3: Market Potential - The product is classified as a Category A drug in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog for 2024 [1] - The estimated sales revenue for Ursodeoxycholic Acid in Chinese public medical institutions is approximately RMB 2.155 billion in 2024 [1] Group 4: Strategic Impact - The approval of Ursodeoxycholic Acid Capsules is expected to enrich the company's product variety in digestive system medications and enhance its overall competitiveness [1]

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the registration of Sildenafil Citrate Orally Disintegrating Tablets, which is expected to enhance the company's market competitiveness and open new market opportunities [1]. Company Summary - The company submitted the registration application for Sildenafil Citrate Orally Disintegrating Tablets to the Center for Drug Evaluation (CDE) in April 2024, and the application was accepted [1]. - The drug received its registration certificate in September 2025, with the evaluation conclusion being approval for registration [1]. - The product is indicated for the treatment of erectile dysfunction, a market that generated approximately RMB 5.2 billion in sales for related formulations in public medical institutions in China in 2024 [1]. Industry Summary - The approval of Sildenafil Citrate Orally Disintegrating Tablets is expected to contribute positively to the market landscape for erectile dysfunction treatments in China [1]. - The significant sales figure of RMB 5.2 billion in 2024 indicates a robust demand for erectile dysfunction medications within the public healthcare sector [1].