证券代码：601089 证券简称：福元医药 公告编号：临 2025-066 北京福元医药股份有限公司 关于地屈孕酮片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"）全资子 公司浙江爱生药业有限公司（以下简称"浙江爱生"）收到了国家药 品监督管理局（以下简称"国家药监局"）颁发的地屈孕酮片（规格： 10mg）（以下简称"该药品"）《药品注册证书》（证书编号：2025S03127）， 批准该药品生产。现将相关情况公告如下： 二、药品相关信息 地 屈 孕 酮 是 一 种 口 服 可 吸 收的 合 成 孕 激 素 ， 原 研 厂 家 为 Solvay Pharmaceuticals（现已被雅培收购），最早于 1961 年 7 月在 葡萄牙获批上市。2002 年 12 月，经国家药品监督管理局批准，地屈 孕酮片在国内上市，用于治疗内源性孕酮不足引起的疾病和辅助生殖 技术中的黄体支持。 浙江爱生于 2024 年 6 月 20 日获得申报受理通知书，并于近日获 得国 ...

Core Viewpoint - Fuyuan Pharmaceutical's subsidiary, Zhejiang Aisheng Pharmaceutical Co., Ltd., has received a drug registration certificate for Dydrogesterone tablets (10mg) from the National Medical Products Administration of China [1] Company Summary - The drug Dydrogesterone is an orally absorbable synthetic progestogen, originally developed by Solvay Pharmaceuticals, which has since been acquired by Abbott [1] - Dydrogesterone was first approved for sale in Portugal in July 1961 and was subsequently approved for the Chinese market in December 2002 [1] - The medication is used to treat conditions caused by endogenous progesterone deficiency and for luteal support in assisted reproductive technology [1]

Core Viewpoint - The company has received approval for the production of Dydrogesterone tablets (10mg) from the National Medical Products Administration, indicating a significant regulatory milestone for the company [1] Group 1: Company Information - The full subsidiary of the company, Zhejiang Aisheng Pharmaceutical Co., Ltd., is responsible for the production of Dydrogesterone tablets [1] - Dydrogesterone is classified as an orally absorbable synthetic progestogen, which may expand the company's product offerings in the hormonal therapy market [1]

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].

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]