注射用盐酸罗沙替丁醋酸酯
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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
Core Viewpoint - Company Huahai Pharmaceutical has received approval from the National Medical Products Administration for the registration of two new drugs, indicating a positive development in its product pipeline and potential revenue growth [1] Group 1: Drug Approvals - The company has obtained the drug registration certificate for Candesartan Cilexetil and Hydrochlorothiazide Tablets (II), which is indicated for the treatment of hypertension in adults who do not respond adequately to monotherapy [1] - The injection of Rosatadine Hydrochloride Acetate is approved for low-risk patients with upper gastrointestinal bleeding caused by conditions such as peptic ulcers and acute stress ulcers [1] - Both drugs are classified as chemical drugs of category 3, which allows them to be considered as having passed the consistency evaluation according to national policies [1]
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
Core Viewpoint - Huahai Pharmaceutical has received approval from the National Medical Products Administration for the registration of two new drugs, which will enhance its product line and market competitiveness [1] Group 1: Regulatory Approval - The company has obtained the drug registration certificates for Candesartan Cilexetil and Rosatadine Acetate Injection from the National Medical Products Administration [1] - These drugs are classified as Category 3 chemical drugs, which are considered to have passed the consistency evaluation according to national policies [1] Group 2: Business Impact - The approval of these new drugs will enrich the company's product portfolio [1] - This development is expected to positively impact the company's operational growth and market competitiveness [1]
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
Core Viewpoint - Huahai Pharmaceutical has received approval from the National Medical Products Administration for the registration of two new drugs, which will enhance its product line and market competitiveness [1] Group 1: Regulatory Approval - The company has obtained the drug registration certificates for Candesartan Cilexetil and Rosatadine Hydrochloride Injection from the National Medical Products Administration [1] - These drugs are classified as Category 3 chemical drugs, which are considered to have passed the consistency evaluation according to national policies [1] Group 2: Business Impact - The approval of these new drugs will enrich the company's product portfolio [1] - This development is expected to positively impact the company's operational growth and market competitiveness [1]
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
Core Viewpoint - Huahai Pharmaceutical has received approval from the National Medical Products Administration for the registration of two drugs: Candesartan Cilexetil and Hydrochlorothiazide Tablets (II) and Injectable Ranitidine Hydrochloride Acetate, indicating a significant advancement in its product portfolio and potential revenue growth in the domestic market [1] Group 1: Product Approvals - The company has obtained a drug registration certificate for Candesartan Cilexetil and Hydrochlorothiazide Tablets (II), which is used for treating hypertension, with an estimated domestic market sales amount of approximately 149 million yuan [1] - The Injectable Ranitidine Hydrochloride Acetate is indicated for low-risk patients with upper gastrointestinal bleeding, with an estimated domestic market sales amount of around 1.18 billion yuan [1] Group 2: R&D Investment - The company has invested approximately 11.28 million yuan in the research and development of Candesartan Cilexetil and Hydrochlorothiazide Tablets (II) [1] - For the Injectable Ranitidine Hydrochloride Acetate, the company has invested about 4.31 million yuan in its research and development [1]
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
Core Viewpoint - Huahai Pharmaceutical (600521.SH) has received approval from the National Medical Products Administration for the drug registration certificates of Candesartan Cilexetil and Hydrochlorothiazide Tablets (II) and Injectable Ranitidine Acetate, indicating a significant advancement in its product portfolio for hypertension treatment [1] Group 1: Product Approval - The company has obtained the drug registration certificate for Candesartan Cilexetil and Hydrochlorothiazide Tablets (II), which is intended for the treatment of hypertension [1] - This product is not suitable for initial treatment of hypertension but is applicable for adults with primary hypertension whose blood pressure cannot be effectively controlled by either Candesartan Cilexetil or Hydrochlorothiazide alone, or as a replacement therapy for the combination of both drugs at the same dosage [1]
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
Shang Hai Zheng Quan Bao· 2025-04-22 21:10
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
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2025-04-20 23:57
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]