证券之星消息，9月4日化学制药板块较上一交易日下跌2.93%，南新制药领跌。当日上证指数报收于 3765.88，下跌1.25%。深证成指报收于12118.7，下跌2.83%。化学制药板块个股涨跌见下表： | 代码 | 名称 | 收盘价 | 涨跌幅 | 成交量(手) | 成交额(元) | | | --- | --- | --- | --- | --- | --- | --- | | 870656 | 海景药业 | 21.20 | 9.67% | 5.56万 | | 1.13亿 | | 688356 | 键凯科技 | 99.80 | 7.60% | 4.44万 | | 4.55 Z | | 6801089 | 福元医药 | 27.13 | 6.98% | 38.49万 | | 10.55 Z | | 301075 | 多瑞医药 | 40.87 | 5.88% | 6.56万 | | 2.68亿 | | 002365 | 永安药业 | 18.98 | 5.33% | 39.70万 | | 7.52亿 | | 000908 | ST景峰 | 5.78 | 5.09% | 10.14万 | 5846.85万 | | | ...

Core Viewpoint - Beijing Fuyuan Pharmaceutical Co., Ltd. has received the drug registration certificate for Amlodipine Besilate and Benazepril Hydrochloride Capsules, which will enhance the company's product line and market competitiveness [1][2]. Drug Registration Certificate Details - The drug is classified as a Class 3 chemical drug and is prescribed for patients whose blood pressure is not adequately controlled by Amlodipine or Benazepril alone [1]. - The drug's specifications include 5mg of Amlodipine Besilate and 10mg of Benazepril Hydrochloride per capsule [1]. - The registration certificate number is 2025S02582, and the drug is categorized as a prescription medication [1]. Market Information - The total sales of Amlodipine Besilate and Benazepril Hydrochloride Capsules in China for 2024 are estimated to be approximately 1.12 billion yuan, with sales in urban public hospitals and county-level public hospitals accounting for 727 million yuan [1]. - Sales from urban community centers and township health clinics are projected to be 167 million yuan, while urban pharmacies and online pharmacies are expected to generate 226 million yuan [1]. Company Impact - The approval of the drug registration certificate is expected to enrich the company's product portfolio and improve its market competitiveness [2].

证券代码：601089 证券简称：福元医药 公告编号：临 2025-062 北京福元医药股份有限公司 关于氨氯地平贝那普利胶囊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"）颁发的氨氯地平贝 那普利胶囊（规格：每粒含苯磺酸氨氯地平 5mg（按 C₂₀H₂₅ClN₂O₅计） 与盐酸贝那普利 10mg）（以下简称"该药品"）《药品注册证书》（证 书编号：2025S02582），批准该药品生产。现将相关情况公告如下： | | 根据《中华人民共和国药品管理法》及有关规 定，经审查，本品符合药品注册的有关要求， | | --- | --- | | | 批准注册，发给药品注册证书。质量标准、说 | | 审批结论 | 明书、标签及生产工艺照所附执行。药品生产 | | | 企业应当符合药品生产质量管理规范要求方可 | | | 生产销售。 | | 上市许可持有人 | 北京福元医药股份有限公司 | | 生产企业 | 北京 ...

Core Viewpoint - Fuyuan Pharmaceutical (601089.SH) has received the drug registration certificate from the National Medical Products Administration for Amlodipine Benazepril Capsules, indicating a significant milestone for the company in the hypertension treatment market [1]. Group 1: Product Approval - The National Medical Products Administration has issued a drug registration certificate for Amlodipine Benazepril Capsules, which contain 5mg of Amlodipine and 10mg of Benazepril per capsule [1]. - This product is intended for patients whose blood pressure is not adequately controlled by either Amlodipine or Benazepril alone, or for those who are switching from separate Amlodipine and Benazepril tablets [1]. Group 2: Market Context - Amlodipine Benazepril was originally developed by Novartis and was first approved in the United States in March 1995 [1]. - The original manufacturer’s version of Amlodipine Benazepril has not yet been launched in China, presenting a potential market opportunity for Fuyuan Pharmaceutical [1].

Core Viewpoint - The company has received a drug registration certificate from the National Medical Products Administration for Amlodipine Benazepril Capsules, indicating approval for production and use in hypertension treatment [1] Group 1: Drug Approval Details - The approved drug contains Amlodipine (5mg) and Benazepril (10mg) per capsule and is intended for patients whose blood pressure is not adequately controlled by either Amlodipine or Benazepril alone [1] - The drug was originally developed by Novartis and was first approved in the United States in March 1995 [1] - The company received the application acceptance notice on March 21, 2024, and has now obtained the drug registration certificate, which is considered equivalent to passing the consistency evaluation according to national policies [1]

Core Viewpoint - Fuyuan Pharmaceutical (601089.SH) has received the drug registration certificate from the National Medical Products Administration for Amlodipine Benazepril Capsules, indicating a significant step in expanding its product portfolio in the hypertension treatment market [1]. Group 1: Product Approval - The National Medical Products Administration has issued a drug registration certificate for Amlodipine Benazepril Capsules, with the certificate number 2025S02582, allowing the company to commence production [1]. - The capsules contain 5mg of Amlodipine and 10mg of Benazepril, and are intended for patients whose blood pressure is not adequately controlled by either Amlodipine or Benazepril alone [1]. Group 2: Market Context - Amlodipine Benazepril Capsules were originally developed by Novartis and were first approved for sale in the United States in March 1995 [1]. - The original manufacturer’s version of Amlodipine Benazepril Capsules has not yet been launched in China, presenting a potential market opportunity for the company [1].

Core Viewpoint - Beijing Fuyuan Pharmaceutical Co., Ltd. has received the drug registration certificate for Levothyroxine Sodium Tablets, which will enhance the company's product line and market competitiveness [1][3]. Group 1: Drug Registration Details - The drug is named Levothyroxine Sodium Tablets, with a specification of 100μg [1]. - The drug is classified as a prescription drug and falls under the category of chemical drugs [1]. - The registration certificate was issued by the National Medical Products Administration, confirming that the drug meets the necessary registration requirements [1]. Group 2: Drug Development and Market Information - Levothyroxine Sodium Tablets were developed by Merck and were first approved for sale in France in June 1980 [2]. - The drug was approved for sale in China in July 1997 for various therapeutic uses, including treatment of non-toxic goiter and hypothyroidism [2]. - As of the announcement date, the company has invested a total of RMB 7.57 million in the research and development of this drug [2]. Group 3: Market Status of Similar Drugs - According to data from Minet, the sales revenue of Levothyroxine Sodium Tablets in China for 2024 is approximately RMB 1.14631 billion [2]. - The sales distribution includes RMB 758.17 million from urban public hospitals and county-level public hospitals, RMB 109.20 million from urban community centers and township health centers, and RMB 279.94 million from urban pharmacies and online pharmacies [2].

Core Viewpoint - The announcement indicates that Fuyuan Pharmaceutical has received the drug registration certificate for Levothyroxine Sodium Tablets, allowing the company to commence production of the drug [1] Company Summary - Fuyuan Pharmaceutical has been granted a drug registration certificate by the National Medical Products Administration for Levothyroxine Sodium Tablets, with a specification of 100μg [1]

Company Summary - Fuyuan Pharmaceutical received the drug registration certificate for Levothyroxine Sodium Tablets from the National Medical Products Administration, allowing the production of this medication [1] - For the fiscal year 2024, Fuyuan Pharmaceutical's revenue composition 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] - The current market capitalization of Fuyuan Pharmaceutical is 12.4 billion yuan [1] Industry Summary - The pet industry is experiencing significant growth, with a market size of 300 billion yuan, leading to a surge in stock prices for related companies [1]

证券代码：601089 证券简称：福元医药 公告编号：临 2025-061 北京福元医药股份有限公司 关于左甲状腺素钠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"）收到了 国家药品监督管理局（以下简称"国家药监局"）颁发的左甲状腺素 钠片（规格：100μg（以左甲状腺素钠计））（以下简称"该药品"） 《药品注册证书》（证书编号：2025S02491），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：左甲状腺素钠片 英文名/拉丁名：Levothyroxine Sodium Tablets 剂型 片剂 注册分类 化学药品4类 规格 100μg（以左甲状腺素钠计） 药品批准文号 国药准字H20255126 药品注册标准编号 YBH19432025 处方药/非处方药 处方药 申请事项 药品注册（境内生产） 审批结论 根据《中华人民共和国药品管理法》及有关规 定，经审查，本品符合药品注册的有关要求， 一、药品注册证书主要内容 | | 批准注 ...