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华海药业:获得坎地沙坦酯氢氯噻嗪片(Ⅱ)和注射用盐酸罗沙替丁醋酸酯药品注册证书
Xin Lang Cai Jing· 2025-09-16 09:32
华海药业9月16日晚间公告,公司近日收到国家药品监督管理局核准签发的坎地沙坦酯氢氯噻嗪片 (Ⅱ)和注射用盐酸罗沙替丁醋酸酯的《药品注册证书》。坎地沙坦酯氢氯噻嗪片(Ⅱ)用于治疗高血 压。本品不适用于高血压的初始治疗,本品适用于单用坎地沙坦酯或氢氯噻嗪不能有效控制血压的成年 人原发性高血压,或两药联合用药同剂量的替代治疗。注射用盐酸罗沙替丁醋酸酯用于上消化道出血 (由消化性溃疡、急性应激性溃疡、出血性胃炎等引起)的低危患者。根据国家相关政策,公司坎地沙 坦酯氢氯噻嗪片(Ⅱ)和注射用盐酸罗沙替丁醋酸酯按化学药品3类批准生产可视同通过一致性评价。 ...
华海药业:两款产品获得药品注册证书
Zhi Tong Cai Jing· 2025-09-16 09:21
根据国家相关政策,公司坎地沙坦酯氢氯噻嗪片(Ⅱ)和注射用盐酸罗沙替丁醋酸酯按化学药品3类批准 生产可视同通过一致性评价。本次坎地沙坦酯氢氯噻嗪片(Ⅱ)和注射用盐酸罗沙替丁醋酸酯获得国家药 监局的《药品注册证书》,进一步丰富了公司的产品线,有助于提升公司产品的市场竞争力,对公司的 经营发展具有一定积极的作用。 智通财经APP讯,华海药业(600521.SH)发布公告,公司于近日收到国家药品监督管理局(以下简称"国家 药监局")核准签发的坎地沙坦酯氢氯噻嗪片(Ⅱ)和注射用盐酸罗沙替丁醋酸酯的《药品注册证书》。 ...
华海药业(600521.SH):两款产品获得药品注册证书
智通财经网· 2025-09-16 09:20
智通财经APP讯,华海药业(600521.SH)发布公告,公司于近日收到国家药品监督管理局(以下简称"国家 药监局")核准签发的坎地沙坦酯氢氯噻嗪片(Ⅱ)和注射用盐酸罗沙替丁醋酸酯的《药品注册证书》。 根据国家相关政策,公司坎地沙坦酯氢氯噻嗪片(Ⅱ)和注射用盐酸罗沙替丁醋酸酯按化学药品3类批准 生产可视同通过一致性评价。本次坎地沙坦酯氢氯噻嗪片(Ⅱ)和注射用盐酸罗沙替丁醋酸酯获得国家药 监局的《药品注册证书》,进一步丰富了公司的产品线,有助于提升公司产品的市场竞争力,对公司的 经营发展具有一定积极的作用。 ...
华海药业:坎地沙坦酯氢氯噻嗪片和注射用盐酸罗沙替丁醋酸酯获批
Xin Lang Cai Jing· 2025-09-16 09:16
华海药业公告,近日收到国家药监局核准签发的坎地沙坦酯氢氯噻嗪片(Ⅱ)和注射用盐酸罗沙替丁醋 酸酯的《药品注册证书》。坎地沙坦酯氢氯噻嗪片(Ⅱ)用于治疗高血压,国内市场销售金额约1.49亿 元。注射用盐酸罗沙替丁醋酸酯用于上消化道出血(由消化性溃疡、急性应激性溃疡、出血性胃炎等引 起)的低危患者,国内市场销售金额约11.8亿元。公司在坎地沙坦酯氢氯噻嗪片研发项目上已投入约 1128万元,在注射用盐酸罗沙替丁醋酸酯研发项目上已投入约431万元。 ...
华海药业(600521.SH):获得药品注册证书
Ge Long Hui A P P· 2025-09-16 09:16
格隆汇9月16日丨华海药业(600521.SH)公布,公司于近日收到国家药品监督管理局核准签发的坎地沙坦 酯氢氯噻嗪片(Ⅱ)和注射用盐酸罗沙替丁醋酸酯的《药品注册证书》,坎地沙坦酯氢氯噻嗪片(Ⅱ)用于 治疗高血压。本品不适用于高血压的初始治疗,本品适用于单用坎地沙坦酯或氢氯噻嗪不能有效控制血 压的成年人原发性高血压,或两药联合用药同剂量的替代治疗。 ...
吉林省西点药业科技发展股份有限公司2025年第一季度报告
Core Viewpoint - The company, Jilin Xidian Pharmaceutical Technology Development Co., Ltd., has released its annual report for 2024, highlighting its financial performance, business operations, and future development plans. The report indicates a focus on the research, production, and sales of chemical raw materials and formulations, particularly in the fields of iron supplementation and psychiatric medications [1][5]. Company Overview - The company primarily engages in the research, production, and sales of chemical raw materials and formulations, with a strong emphasis on iron supplementation, treatment of circulatory disorders, and psychiatric medications [5]. - As of the end of the reporting period, the company holds 25 registered formulation varieties (32 specifications) and 16 registered raw material drug approvals, focusing on anti-anemia, circulatory disorder treatments, and psychiatric medications [5]. Financial Highlights - The company has received a standard unqualified audit opinion from Rongcheng Accounting Firm for the financial report of the reporting period [3]. - The board of directors approved a profit distribution plan, proposing a cash dividend of 2.60 yuan per 10 shares (including tax), with no stock bonus or capital reserve transfer [4][9]. Shareholder Information - The company has no preferred shareholders and has disclosed the shareholding structure, including the top 10 shareholders [7][8]. Recent Developments - The company has received several approvals for new drug applications, including sodium hyaluronate eye drops and other formulations, indicating ongoing product development and regulatory compliance [8][65]. - The company has also obtained a patent for the application of rhizoma smilacis in preparing drugs for treating lymphatic reflux disorders [10][67]. Governance and Compliance - The company’s board and supervisory committee have ensured that the annual report and its summary are accurate and complete, with no misleading statements or omissions [11][18]. - The company has appointed Rongcheng Accounting Firm as its auditor for the year 2025, following a thorough review of the firm’s qualifications and capabilities [42][56].
武汉海特生物制药股份有限公司
Group 1 - The biopharmaceutical industry is a rapidly growing strategic emerging industry globally, with significant government support and innovation driving its development [5][7] - The global biopharmaceutical market grew from $261.1 billion in 2018 to $363.8 billion in 2022, with a compound annual growth rate (CAGR) of 8.6%, and is expected to reach $783.2 billion by 2030, with a CAGR of approximately 10.1% from 2022 to 2030 [5] - In China, the biopharmaceutical market is projected to grow from $45.2 billion in 2019 to $66.5 billion in 2023, with a CAGR of 10.13%, and is expected to reach $162.8 billion by 2030, with a CAGR of approximately 13.64% from 2023 to 2030 [7] Group 2 - The company specializes in the production and sales of biopharmaceuticals, including the first commercialized nerve growth factor product, Jinlujie, which has been widely used in clinical applications for nerve injury repair [15][16] - The company’s subsidiary, Tianjin Hankan, is a well-known CRO-CDMO integrated service provider, offering a comprehensive range of drug development services from research to clinical trials and production [11][22] - The company has developed over 200 products for more than 600 enterprises, with significant achievements in the development of generic drugs and innovative drugs [12][11] Group 3 - The company has received various accolades, including being recognized as a "National Specialized and New 'Little Giant' Enterprise" and ranking among the top 50 innovative enterprises in the pharmaceutical industry [13] - The company’s product pipeline includes innovative drugs such as injection of Epinavamine, a targeted anti-tumor drug, and other pharmaceutical products that address various medical needs [17][18][20] - The company has made significant advancements in drug registration, with several products receiving approval from the National Medical Products Administration [37]