Workflow
Rundu Pharma(002923)
icon
Search documents
润都股份:关于缬沙坦氨氯地平片(I)获得药品注册证书的公告
Zheng Quan Ri Bao· 2025-09-29 10:50
Core Viewpoint - The company, Rundu Co., has received a drug registration certificate from the National Medical Products Administration for its product, Valsartan Amlodipine Tablets (I) [2] Company Summary - Rundu Co. announced the receipt of the drug registration certificate on the evening of September 29 [2] - The registered drug is Valsartan Amlodipine Tablets (I), indicating a new product introduction in the pharmaceutical market [2] Industry Summary - The approval of Valsartan Amlodipine Tablets (I) reflects ongoing regulatory support for new drug registrations in the pharmaceutical industry [2] - This development may enhance the competitive landscape within the cardiovascular drug segment [2]
9月29日晚间重要公告一览
Xi Niu Cai Jing· 2025-09-29 10:45
Group 1 - Yinglian Co., Ltd. expects a net profit increase of 1531.13% to 1672.97% year-on-year for the first three quarters of 2025, with projected revenue of 1.63 billion to 1.65 billion yuan, a growth of 9.49% to 10.83% [1] - Meixin Sheng plans to reduce its shareholding by no more than 1% through centralized bidding and block trading [1] - Huayin Technology signed two sales contracts totaling 402 million yuan, with one contract for special functional materials and another for research project materials [3] Group 2 - Shen Highways reported a total toll revenue of 114 million yuan for August [5] - Dash Smart signed a contract worth 113 million yuan for a smart hospital project [7] - Tianbang Food received an administrative regulatory measure decision from the China Securities Regulatory Commission for failing to disclose information in a timely manner [8] Group 3 - Fashilong plans to invest 250 million yuan to establish a wholly-owned subsidiary focused on AI applications and cloud computing [10] - Junpu Intelligent received a government subsidy of 20 million yuan, accounting for 243.97% of its audited net profit for 2024 [11] - Longyun Co. plans to apply for a bank credit limit of 32 million yuan [12] Group 4 - Yifan Pharmaceutical's subsidiary received acceptance for a drug registration application for a medication used to lower phenylalanine levels in patients [12] - Rundu Co. received a drug registration certificate for a hypertension medication [13] - Huahai Qingke elected a new employee director and appointed a new vice president [17] Group 5 - Wanyi Technology received a government subsidy of 173,000 yuan [19] - Haizheng Pharmaceutical's tacrolimus capsules passed the consistency evaluation for generic drugs [20] - Pulaike's new veterinary vaccine received registration certification [22] Group 6 - Boguang New Materials signed a major sales contract estimated at 4.3 billion to 5 billion yuan for nickel powder products [41] - Electric Soul Network announced plans for shareholders to reduce their holdings by up to 1.63% [42] - Jin Haitong's shareholders plan to reduce their holdings by up to 3% [44]
润都股份:缬沙坦氨氯地平片(I)获得药品注册证书
Zhi Tong Cai Jing· 2025-09-29 08:03
Core Viewpoint - The company, Rundu Co., Ltd. (002923.SZ), has received a drug registration certificate from the National Medical Products Administration for Valsartan Amlodipine Tablets, which is indicated for the treatment of primary hypertension in patients whose blood pressure is not adequately controlled with monotherapy [1] Group 1 - The drug Valsartan Amlodipine Tablets is specifically designed for patients with primary hypertension [1] - The approval signifies a potential expansion in the company's product offerings in the hypertension treatment market [1]
润都股份(002923.SZ):缬沙坦氨氯地平片(I)获得药品注册证书
智通财经网· 2025-09-29 08:02
Group 1 - The core point of the article is that Rundu Co., Ltd. has received a drug registration certificate from the National Medical Products Administration for Valsartan Amlodipine Tablets, which are indicated for the treatment of primary hypertension [1] Group 2 - The drug is intended for patients whose blood pressure cannot be adequately controlled with monotherapy [1]
润都股份:产品“缬沙坦氨氯地平片(I)”取得注册证
Mei Ri Jing Ji Xin Wen· 2025-09-29 08:01
Group 1 - The core point of the article is that Rundu Co., Ltd. has received a drug registration certificate from the National Medical Products Administration for its product "Valsartan Amlodipine Tablets (I)" [1] - As of the first half of 2025, the revenue composition of Rundu Co., Ltd. is as follows: 56.18% from chemical drug formulation manufacturing, 42.61% from active pharmaceutical ingredient manufacturing, and 1.2% from other businesses [1] - The current market capitalization of Rundu Co., Ltd. is 4.2 billion yuan [1] Group 2 - The article mentions a competitive scenario where Nongfu Spring's green bottle launch has negatively impacted the market share of Yibao, which has dropped nearly 5 percentage points [1]
润都股份(002923) - 关于缬沙坦氨氯地平片(I)获得药品注册证书的公告
2025-09-29 08:00
证券代码:002923 证券简称:润都股份 公告编号:2025-045 珠海润都制药股份有限公司 关于缬沙坦氨氯地平片(I)获得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。 珠海润都制药股份有限公司(以下简称"公司"或"本公司")近日收到国 家药品监督管理局签发的《药品注册证书》。现将有关情况公告如下: 一、药品基本情况 药品名称:缬沙坦氨氯地平片(I)(以下简称"本品") 剂型:片剂 申请事项:药品注册(境内生产) 规格:每片含缬沙坦80mg,苯磺酸氨氯地平5mg(按C₂₀H₂₅ClN₂O₅计) 注册分类:化学药品 4 类 受理号:CYHS2400118 证书编号:2025S02990 药品批准文号:国药准字 H20255570 药品注册标准编号:YBH24072025 本品未来市场销售情况可能受到行业政策变动、招标采购、市场环境变化等 因素影响,存在不确定性,敬请广大投资者谨慎决策,注意防范投资风险。 特此公告。 珠海润都制药股份有限公司 董事会 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 ...
润都股份:缬沙坦氨氯地平片(I)获药品注册证书
Xin Lang Cai Jing· 2025-09-29 07:50
Core Viewpoint - The company has received a drug registration certificate from the National Medical Products Administration for Valsartan Amlodipine Tablets, which will enhance its product offerings in the antihypertensive market [1] Group 1: Drug Registration Details - The drug is named Valsartan Amlodipine Tablets (I) and is in tablet form, with each tablet containing 80mg of Valsartan and 5mg of Amlodipine [1] - The approval number for the drug is Guo Yao Zhun Zi H20255570, classified as a Class 4 chemical drug [1] Group 2: Indication and Market Impact - The drug is indicated for the treatment of primary hypertension, specifically for patients whose blood pressure cannot be adequately controlled with monotherapy [1] - The acquisition of this drug registration certificate will further enrich the company's antihypertensive product line and enhance its market competitiveness in the hypertension sector [1]
珠海润都制药股份有限公司关于盐酸伐昔洛韦片获得药品补充申请批准通知书的公告
珠海润都制药股份有限公司 关于盐酸伐昔洛韦片获得药品补充申请批准通知书的公告 登录新浪财经APP 搜索【信披】查看更多考评等级 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(以下简称"公司"或"本公司")近日收到国家药品监督管理局签发的《药品 补充申请批准通知书》。现将有关情况公告如下: 一、药品基本情况 药品名称:盐酸伐昔洛韦片(以下简称"本品") 剂型:片剂 药品注册标准编号:YBH25122025 审批结论:根据《中华人民共和国药品管理法》、《国务院关于改革药品医疗器械审评审批制度的意 见》(国发〔2015〕44号)和《关于仿制药质量和疗效一致性评价工作有关事项的公告》(2017年第 100号)的规定,经审查,本品通过仿制药质量和疗效一致性评价。同意增加规格0.5g(按C??H??N?O? 计),发给药品批准文号。 二、药品的适应症 申请内容:仿制药质量和疗效一致性评价 规格:0.5g(按C??H??N?O?计) 包装规格:30片/瓶 注册分类:化学药品 受理号:CYHB2450554 通知书编号:2025B04393 药 ...
润都股份:关于盐酸伐昔洛韦片获得药品补充申请批准通知书的公告
Zheng Quan Ri Bao· 2025-09-25 14:08
(文章来源:证券日报) 证券日报网讯 9月25日晚间,润都股份发布公告称,公司近日收到国家药品监督管理局签发的《药品补 充申请批准通知书》。药品名称:盐酸伐昔洛韦片。 ...
翰宇药业:拟定增不超9.68亿元用于司美格鲁肽研发等;平煤股份:控股股东拟实施战略重组丨公告精选
Group 1: Investment and Fundraising - Hanyu Pharmaceutical plans to raise no more than 968 million yuan for the development of semaglutide and other projects [1] - Ganfeng Lithium intends to introduce investors for a capital increase of up to 2.5 billion yuan [9] Group 2: Strategic Restructuring - Pingmei Shenma Holdings is undergoing a strategic restructuring as directed by the Henan provincial government, which will not affect the company's operations significantly [2][8] - Shennong Holdings is also involved in a strategic restructuring with no change in control or significant impact on operations [7][8] Group 3: Clinical Trials and Approvals - XinNuoWei's subsidiary received approval for clinical trials of a drug for treating mild Alzheimer's disease, marking a significant milestone in the development of biosimilar drugs [3] - Tainkang's subsidiary has received approval for clinical trials of CKBA cream for rosacea, a first-class innovative drug in China [4] - Baili Tianheng's drug, iza-bren, has been included in the list of breakthrough therapies, indicating its potential in treating advanced urinary tract cancer [5] Group 4: Contracts and Projects - Zhongyou Engineering signed an EPC contract worth 2.524 billion USD for a seawater pipeline project in Iraq, expected to positively impact future revenues [6]