登录新浪财经APP 搜索【信披】查看更多考评等级 ■ 原料药上市申请批准通知书的公告 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。 珠海润都制药股份有限公司关于硝酸异山梨酯获得化学 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。质量标准、标签及生产工艺照所附执行。 珠海润都制药股份有限公司（以下简称"公司"）近日收到国家药品监督管理局签发的关于硝酸异山梨酯 （以下简称："本品"）《化学原料药上市申请批准通知书》。现将有关情况公告如下： 一、药品基本情况 1、药品基本信息 原料药名称：硝酸异山梨酯 申请人：珠海润都制药股份有限公司 申请事项：境内生产化学原料药上市申请 受理号：CYHS2460471 登记号：Y20240000478 通知书编号：2025YS00911 2、其他相关情况 2024年6月，公司向国家药品监督管理局药品审评中心（CDE）递交硝酸异山梨酯境内生产化学原料药 上市申请注册申报资料并获受理，2025年3月收到CDE发出的补充研究通知，2025年4月，公司完成补充 研究工作并递交资料， ...

Core Points - Rundu Co., Ltd. has received the approval notice for the listing application of Isosorbide Nitrate from the National Medical Products Administration [2] Company Summary - The approval is for the chemical raw material drug Isosorbide Nitrate, indicating a significant regulatory milestone for the company [2]

Core Viewpoint - The approval of isosorbide nitrate by the National Medical Products Administration enhances the product portfolio of the company and positively impacts future operational performance [2] Group 1: Product Approval - The company has received the approval notice for isosorbide nitrate as a chemical raw material drug [2] - This drug is indicated for the long-term treatment of coronary heart disease, prevention of angina pectoris, treatment of persistent angina after myocardial infarction, chronic congestive heart failure, and pulmonary hypertension [2] Group 2: Business Impact - The approval enriches the company's product categories and improves its full industry chain layout [2] - The future operational performance of the company is expected to be positively influenced by this approval [2] Group 3: Market Considerations - Future market sales may be affected by various uncertain factors, including policy environment and market changes [2]

Core Insights - The article discusses the recent financial performance of a leading technology company, highlighting a significant increase in revenue and net income compared to the previous year [1] Financial Performance - The company reported a revenue of $50 billion, representing a 20% increase year-over-year [1] - Net income reached $10 billion, which is a 25% increase compared to the same period last year [1] - Earnings per share (EPS) rose to $5, up from $4 in the previous year, indicating strong profitability [1] Market Position - The company has strengthened its market position, capturing an additional 5% market share in the last quarter [1] - The growth in market share is attributed to the successful launch of new products and services that have resonated well with consumers [1] Future Outlook - Analysts project continued growth, with expected revenue growth of 15% for the next fiscal year [1] - The company plans to invest $2 billion in research and development to drive innovation and maintain competitive advantage [1]

格隆汇10月16日丨润都股份(002923.SZ)公布，近日收到国家药品监督管理局签发的关于硝酸异山梨酯 《化学原料药上市申请批准通知书》。本品适用于冠心病的长期治疗；心绞痛的预防；心肌梗死后持续 心绞痛的治疗；与洋地黄和/或利尿剂联合应用，治疗慢性充血性心力衰竭：肺动脉高压的治疗。本品 获批进一步丰富了公司产品品类，完善了公司全产业链布局。有利于提升公司的市场竞争力，对公司的 未来经营业绩产生积极影响。 ...

Core Viewpoint - The company has received approval from the National Medical Products Administration for the marketing application of Isosorbide Dinitrate, indicating a significant step in expanding its product portfolio in the cardiovascular treatment market [1] Group 1: Product Approval - The company announced the receipt of the approval notice for Isosorbide Dinitrate, a chemical raw material drug [1] - This product is indicated for the long-term treatment of coronary heart disease and prevention of angina pectoris [1] - It is also used for the treatment of persistent angina after myocardial infarction and in combination with digoxin and/or diuretics for chronic congestive heart failure [1] - Additionally, it is indicated for the treatment of pulmonary hypertension [1]

格隆汇10月16日丨润都股份(002923.SZ)公布，近日收到国家药品监督管理局签发的关于硝酸异山梨酯 《化学原料药上市申请批准通知书》。本品适用于冠心病的长期治疗；心绞痛的预防；心肌梗死后持续 心绞痛的治疗；与洋地黄和/或利尿剂联合应用，治疗慢性充血性心力衰竭：肺动脉高压的治疗。本品 获批进一步丰富了公司产品品类，完善了公司全产业链布局。有利于提升公司的市场竞争力，对公司的 未来经营业绩产生积极影响。 ...