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]

吡格列酮二甲双胍片(15mg/850mg)的原研企业是武田药品工业株式会社，2005年8月获美国批准上市。 目前，原研厂家的吡格列酮二甲双胍片尚未在中国上市。本品适用于在饮食控制和运动的基础上，用于 目前使用盐酸吡格列酮和盐酸二甲双胍联合治疗的2型糖尿病患者或单用盐酸二甲双胍治疗后血糖控制 不佳的2型糖尿病患者。 福元医药（601089）(601089.SH)发布公告，近日，公司收到了国家药品监督管理局(以下简称"国家药监 局")颁发的吡格列酮二甲双胍片(15mg/850mg)(规格：每片含盐酸吡格列酮15mg(以C H N O S计)和盐酸 二甲双胍850mg)(以下简称"该药品")《药品注册证书》(证书编号：2025S02764)，批准该药品生产。 ...

证券代码：601089 证券简称：福元医药 公告编号：临 2025-064 北京福元医药股份有限公司 关于吡格列酮二甲双胍片（15mg/850mg）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"）颁发的吡格列酮二 甲双胍片（15mg/850mg）（规格：每片含盐酸吡格列酮 15mg（以 C₁₉H₂₀N₂O₃S 计）和盐酸二甲双胍 850mg）（以下简称"该药品"） 《药品注册证书》（证书编号：2025S02764），批准该药品生产。现 将相关情况公告如下： | | 药品通用名称：吡格列酮二甲双胍片 | | --- | --- | | 药品名称 | （15mg/850mg） | | | 英文名/拉丁名：Pioglitazone Hydrochloride and | | | Metformin Hydrochloride Tablets（15mg/850mg） | | 剂型 | 片剂 | | 注册分类 ...

福元医药公告，近日，公司收到了国家药品监督管理局颁发的吡格列酮二甲双胍片（15mg/850mg） （规格：每片含盐酸吡格列酮15mg（以C₁₉H₂₀N₂O₃S计）和盐酸二甲双胍850mg）《药品注册证书》 （证书编号：2025S02764），批准该药品生产。 ...

Group 1 - The core point of the article is that Fuyuan Pharmaceutical has received the drug registration certificate for Arolol hydrochloride tablets (10mg) from the National Medical Products Administration, allowing the company to commence production of this medication [2] Group 2 - The approval of Arolol hydrochloride tablets signifies a potential expansion in Fuyuan Pharmaceutical's product offerings, which may enhance its market position in the pharmaceutical industry [2] - This development reflects the ongoing regulatory support for new drug approvals in the pharmaceutical sector, indicating a favorable environment for innovation and growth [2]