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坎地沙坦酯氢氯噻嗪片(Ⅱ)
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北京福元医药股份有限公司关于坎地沙坦酯氢氯噻嗪片(Ⅱ)获得药品注册证书的公告
Core Viewpoint - Beijing Fuyuan Pharmaceutical Co., Ltd. has received the drug registration certificate for Candesartan Cilexetil and Hydrochlorothiazide Tablets (II), which will enhance the company's product line and market competitiveness [1][5]. Drug Registration Certificate Details - The drug is a combination of Candesartan Cilexetil (16mg) and Hydrochlorothiazide (12.5mg) and is indicated for adults with primary hypertension who do not achieve adequate blood pressure control with either drug alone [1][2]. R&D Investment - The total R&D investment for this drug has reached RMB 4.8441 million (unaudited) as of the announcement date [3]. Market Status of Similar Drugs - In 2024, the sales revenue of Candesartan Cilexetil and Hydrochlorothiazide combination in China was approximately RMB 153.76 million, with significant contributions from urban public hospitals and community health centers [4].
福元医药:关于坎地沙坦酯氢氯噻嗪片(Ⅱ)获得药品注册证书的公告
Core Viewpoint - Fuyuan Pharmaceutical has received approval from the National Medical Products Administration for the production of Candesartan Cilexetil and Hydrochlorothiazide Tablets, indicating a significant advancement in its product portfolio [1] Group 1 - The approved product is Candesartan Cilexetil and Hydrochlorothiazide Tablets, with each tablet containing 16mg of Candesartan Cilexetil and 12.5mg of Hydrochlorothiazide [1] - The product has been assigned the registration certificate number 2025S02994 [1] - This approval allows the company to commence production of the medication, potentially enhancing its market presence [1]
福元医药:坎地沙坦酯氢氯噻嗪片(Ⅱ)获得药品注册证书
Core Viewpoint - Fuyuan Pharmaceutical (601089) has received the drug registration certificate from the National Medical Products Administration for Candesartan Cilexetil and Hydrochlorothiazide Tablets, indicating a significant step in expanding its product portfolio in the hypertension treatment market [1] Group 1: Product Approval - The approved product is Candesartan Cilexetil and Hydrochlorothiazide Tablets, with each tablet containing 16mg of Candesartan Cilexetil and 12.5mg of Hydrochlorothiazide [1] - This medication is not intended for initial treatment of hypertension but is suitable for adults with primary hypertension who do not achieve effective blood pressure control with either Candesartan Cilexetil or Hydrochlorothiazide alone [1] - The drug can also serve as a replacement therapy for patients already on a combination of both medications at the same dosage [1]
福元医药(601089.SH):坎地沙坦酯氢氯噻嗪片(Ⅱ)获得药品注册证书
Ge Long Hui A P P· 2025-09-29 08:16
Core Viewpoint - Fuyuan Pharmaceutical (601089.SH) has received the drug registration certificate from the National Medical Products Administration for Candesartan Cilexetil and Hydrochlorothiazide Tablets, indicating a significant regulatory approval for the company’s product line [1] Group 1: Product Approval - The company has been granted a drug registration certificate for Candesartan Cilexetil and Hydrochlorothiazide Tablets, with a specification of 16mg of Candesartan Cilexetil and 12.5mg of Hydrochlorothiazide per tablet [1] - This medication is not intended for initial treatment of hypertension but is suitable for adults with primary hypertension whose blood pressure is not effectively controlled by either Candesartan Cilexetil or Hydrochlorothiazide alone, or as a replacement therapy at the same dosage for the combination of both drugs [1]
福元医药:坎地沙坦酯氢氯噻嗪片(Ⅱ)获注册证书
Xin Lang Cai Jing· 2025-09-29 08:09
Core Viewpoint - Beijing Fuyuan Pharmaceutical Co., Ltd. has received a drug registration certificate for Candesartan Cilexetil and Hydrochlorothiazide Tablets, which will enhance the company's product line and is expected to generate approximately 154 million yuan in sales in 2024 [1] Group 1: Product Approval - The drug is classified as a Class 3 chemical drug and is not suitable for initial treatment of hypertension but is intended for specific adult patients with primary hypertension [1] - The company submitted the application for approval in May 2024, and this approval is considered equivalent to passing the consistency evaluation [1] Group 2: Financial Implications - The total research and development investment for this drug amounted to 4.8441 million yuan [1] - The expected sales revenue for the compound preparation in 2024 is approximately 154 million yuan [1] Group 3: Market Considerations - The sales of the drug will be influenced by various factors, indicating potential uncertainties in the market [1]
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: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]