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]

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]

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]

关于坎地沙坦酯氢氯噻嗪片（Ⅱ）获得药品注册证书 的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、 误导性陈述或者重大遗漏，并对其内容的真实性、准确性和完整性承 担法律责任。 近日，北京福元医药股份有限公司（以下简称"公司"）收到了 国家药品监督管理局（以下简称"国家药监局"）颁发的坎地沙坦酯 氢氯噻嗪片（Ⅱ）（规格：每片含坎地沙坦酯 16mg 与氢氯噻嗪 12.5mg） （以下简称"该药品"）《药品注册证书》（证书编号：2025S02994）， 批准该药品生产。现将相关情况公告如下： 药品名称 药品通用名称：坎地沙坦酯氢氯噻嗪片（Ⅱ） 英文名/拉丁名：Candesartan Cilexetil and Hydrochlorothiazide Tablets（Ⅱ） 剂型 片剂 注册分类 化学药品3类 规格 每片含坎地沙坦酯16mg与氢氯噻嗪12.5mg 药品批准文号 国药准字H20255574 药品注册标准编号 YBH23802025 处方药/非处方药 处方药 一、药品注册证书主要内容 | 申请事项 | 药品注册（境内生产） | | --- | --- | | 审批结论 | 根据《中华人民共和国 ...

Core Viewpoint - Fuyuan Pharmaceutical (601089.SH) has received a drug registration certificate from the National Medical Products Administration for Candesartan Cilexetil and Hydrochlorothiazide Tablets, allowing the production of this combination medication [1] Group 1: Product Approval - The drug Candesartan Cilexetil and Hydrochlorothiazide is a combination of an angiotensin II receptor inhibitor and a diuretic, approved for production in China [1] - The product is indicated for adults with primary hypertension who do not achieve effective blood pressure control with either Candesartan Cilexetil or Hydrochlorothiazide alone, or as a substitute for the combination therapy at the same dosage [1] Group 2: Historical Context - The drug was co-developed by Takeda and AstraZeneca, first launched in Sweden in June 1998, and received FDA approval in the United States in September 2000 [1] - Currently, the original manufacturer’s version of Candesartan Cilexetil and Hydrochlorothiazide Tablets is not available in the Chinese market [1]

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]

Core Viewpoint - The company FuYuan Pharmaceutical (601089.SH) has received a drug registration certificate from the National Medical Products Administration for its product, Candesartan Cilexetil and Hydrochlorothiazide Tablets, indicating approval for production [1] Group 1: Product Details - The approved product is a combination formulation containing 16mg of Candesartan Cilexetil and 12.5mg of Hydrochlorothiazide per tablet [1] - This formulation is a combination of an angiotensin II receptor inhibitor (Candesartan Cilexetil) and a diuretic (Hydrochlorothiazide) [1] - The original developers of this drug are Takeda and AstraZeneca, with the product first launched in Sweden in June 1998 and receiving FDA approval in the United States in September 2000 [1] Group 2: Market Context - The original manufacturer’s version of Candesartan Cilexetil and Hydrochlorothiazide Tablets has not yet been launched in China [1] - The product 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, or as a substitute treatment at the same dosage for the combination of both drugs [1]

Core Viewpoint - The innovative pharmaceutical concept stocks continue to decline, with significant drops observed in several companies [1] Company Summary - Borui Pharmaceutical has seen a decline of over 8% [1] - Tibet Pharmaceutical has dropped by more than 7% [1] - Fuyuan Pharmaceutical, Zhendong Pharmaceutical, and Maiwei Biotechnology have also experienced declines [1]

Core Viewpoint - Fuyuan Pharmaceutical has received a drug registration certificate from the National Medical Products Administration for its product "Pioglitazone Metformin Tablets," allowing the company to commence production [1] Company Summary - Fuyuan Pharmaceutical's revenue composition for the year 2024 is as follows: 93.12% from pharmaceutical preparations, 6.46% from medical devices, 0.36% from other businesses, and 0.06% from other sources [1] - As of the report date, Fuyuan Pharmaceutical has a market capitalization of 11.2 billion yuan [1]

Core Viewpoint - The company Fu Yuan Pharmaceutical (601089.SH) has received a drug registration certificate from the National Medical Products Administration for its product, Pioglitazone Metformin Tablets (15mg/850mg), allowing for its production [1] Group 1: Product Approval - The National Medical Products Administration has issued a drug registration certificate for Pioglitazone Metformin Tablets (15mg/850mg) [1] - The product is indicated for type 2 diabetes patients who have inadequate blood sugar control with Metformin alone or those currently using a combination of Pioglitazone and Metformin [1] Group 2: Market Context - The original manufacturer of the drug is Takeda Pharmaceutical Company, which received approval for the product in the United States in August 2005 [1] - The original manufacturer's version of Pioglitazone Metformin Tablets has not yet been launched in China [1]