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福元医药(601089) - 北京福元医药股份有限公司关于利丙双卡因乳膏获得药品注册证书的公告
2025-07-04 08:00
证券代码:601089 证券简称:福元医药 公告编号:临 2025-050 北京福元医药股份有限公司 关于利丙双卡因乳膏获得药品注册证书的公告 (二)浅层外科手术。例如:生殖器粘膜,在浅层外科手术或浸润 麻醉之前的腿部溃疡清洁/清创术。 福元药业于2023年12月26日获得申报受理通知书,并于近日获得国 家药监局批准。根据国家相关政策规定,本次获得《药品注册证书》 视同通过一致性评价。 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 公司福元药业有限公司(以下简称"福元药业")收到了国家药品监 督管理局(以下简称"国家药监局") 颁发的利丙双卡因乳膏(规格: 5g:利多卡因 125mg 与丙胺卡因 125mg,以下简称"该药品")《药 品注册证书》(证书编号:2025S02053)。现将相关情况公告如下: 药品名称 药品通用名称:利丙双卡因乳膏 英文名/拉丁名:Lidocaine and Prilocaine Cream 剂型 乳膏剂 注册分类 化学药品4类 规格 5 ...
福元医药(601089) - 北京福元医药股份有限公司关于盐酸贝尼地平片获得药品注册证书的公告
2025-07-04 08:00
证券代码:601089 证券简称:福元医药 公告编号:临 2025-051 北京福元医药股份有限公司 关于盐酸贝尼地平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")颁发的盐酸贝尼地平 片(规格:4mg,以下简称"该药品")《药品注册证书》(证书编号: 2025S02068),批准该药品生产。现将相关情况公告如下: 公司于 2024 年 4 月 29 日获得申报受理通知书,并于近日获得国 家药监局批准。根据国家相关政策规定,本次获得《药品注册证书》, 视同通过一致性评价。 截至本公告日,公司针对该药品累计研发投入为人民币 431.48 万元(未经审计)。 三、同类药品的市场状况 根据米内网数据显示,2024 年中国三大终端六大市场盐酸贝尼地 平片的销售额约为 10.07 亿元,其中城市公立医院和县级公立医院销 售额为 6.59 亿元,城市社区中心和乡镇卫生院销售额为 1.26 亿元, 城市实体药店和 ...
福元医药(601089) - 北京福元医药股份有限公司关于盐酸阿莫罗芬搽剂获得药品注册证书的公告
2025-07-04 08:00
证券代码:601089 证券简称:福元医药 公告编号:临 2025-049 北京福元医药股份有限公司 关于盐酸阿莫罗芬搽剂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 公司福元药业有限公司(以下简称"福元药业")收到了国家药品监 督管理局(以下简称"国家药监局") 颁发的盐酸阿莫罗芬搽剂(规格: 5%(2.5ml:125mg,按 C21H35NO 计),以下简称"该药品")《药品 注册证书》(证书编号:2025S01976)。现将相关情况公告如下: 药品名称 药品通用名称:盐酸阿莫罗芬搽剂 英文名/拉丁名:Amorolfine Hydrochloride Liniment 剂型 搽剂 注册分类 化学药品4类 规格 5%(2.5ml:125mg,按C21H35NO计) 药品批准文号 国药准字H20254685 药品注册标准编号 YBH14682025 处方药/非处方药 非处方药 申请事项 药品注册(境内生产) 一、药品注册证书主要内容 | 审批 ...
福元医药:盐酸阿莫罗芬搽剂获药品注册证书
news flash· 2025-07-04 07:45
Core Viewpoint - Fuyuan Pharmaceutical (601089) has received the drug registration certificate for Amorolfine Hydrochloride Solution from the National Medical Products Administration, indicating a significant advancement in its product portfolio aimed at treating fungal infections of nails [1] Company Summary - Fuyuan Pharmaceutical's wholly-owned subsidiary, Fuyuan Pharmaceutical Co., Ltd., has been granted the drug registration certificate for Amorolfine Hydrochloride Solution, which is intended for the treatment of nail infections caused by sensitive fungi [1] - The company received the acceptance notice for the application on January 2, 2024, and has recently obtained approval [1] - As of the announcement date, Fuyuan Pharmaceutical has invested a total of RMB 3.9783 million in the research and development of this drug [1] Industry Summary - According to data from Minet, the sales revenue of Amorolfine Hydrochloride Solution in China's three major terminal markets is estimated to be approximately RMB 456 million in 2024 [1]
福元医药:利丙双卡因乳膏获药品注册证书
news flash· 2025-07-04 07:45
Core Viewpoint - Fuyuan Pharmaceutical (601089) has received the drug registration certificate for Lidocaine and Prilocaine Cream from the National Medical Products Administration, indicating a significant milestone in its product development and market entry [1] Company Summary - Fuyuan Pharmaceutical's wholly-owned subsidiary, Fuyuan Pharmaceutical Co., Ltd., has been granted the drug registration certificate for Lidocaine and Prilocaine Cream, which is intended for local anesthesia of the skin [1] - The drug registration standard number is YBH15772025, with a specification of 5g containing 125mg of Lidocaine and 125mg of Prilocaine [1] - The total R&D investment for this drug by Fuyuan Pharmaceutical Co., Ltd. has reached RMB 5.3826 million [1] Industry Summary - According to data from Minet, the estimated sales revenue for Lidocaine and Prilocaine Cream in China's three major terminal markets is approximately RMB 615 million in 2024 [1]
7月1日晚间重要公告一览
Xi Niu Cai Jing· 2025-07-01 10:29
Group 1 - TaiLong Pharmaceutical plans to apply for the registration and issuance of super short-term financing bonds not exceeding 800 million yuan, with a maturity of no more than 270 days, for purposes including replacing bank loans and supplementing working capital [1] - GuoXin Technology won a bid for a 46 million yuan automotive airbag ignition driver chip project, indicating its growing presence in the automotive semiconductor market [1] - GuoMai Technology expects a net profit increase of 60.52% to 100.33% for the first half of 2025, with a projected net profit of 125 million to 156 million yuan [2] Group 2 - ChangAluminum's subsidiary signed a 165 million yuan contract for the customized construction of a clinical and industrial base for a vaccine project, highlighting its involvement in the biopharmaceutical sector [3] - ZhongSalt Chemical acquired exploration rights for natural soda ash in Inner Mongolia for 929,000 yuan, expanding its resource base [4] - Six Kingdom Chemical announced the resignation of its deputy general manager, which may impact its operational strategy [5][6] Group 3 - FuYuan Pharmaceutical received a drug registration certificate for Bisoprolol Amlodipine tablets, indicating its expansion in the hypertension treatment market [7][8] - GuanShi Technology's subsidiary received a government subsidy of 7 million yuan, which is 45.29% of its net profit for the previous year, enhancing its financial position [9] - XiZhong Technology plans to repurchase shares worth between 75 million and 150 million yuan, aimed at employee stock ownership plans or equity incentives [10] Group 4 - BeiLu Pharmaceutical's subsidiary received approval for the raw material drug Iopromide, which is used as a contrast agent for various imaging examinations [12] - HongHui New Materials obtained a patent for a water-based protective paint for hardware parts, enhancing its product portfolio [13] - BoJi Pharmaceutical's subsidiary received two patents related to high bioavailability formulations, indicating innovation in biopharmaceutical technology [14] Group 5 - ChengJian Development received a cash dividend of 23.625 million yuan from its investment in Huaneng Capital, contributing to its investment income [15] - JiuZhou Pharmaceutical's subsidiary received a drug registration certificate for Sildenafil Citrate orally disintegrating tablets, expanding its product offerings in the erectile dysfunction treatment market [16] - RuiAng Gene's subsidiary received a government subsidy of 176,290 yuan, supporting its operational activities [17] Group 6 - FengFan Technology plans to acquire 100% equity of a subsidiary for 48 million yuan, indicating strategic expansion in the renewable energy sector [18] - AoJing Medical's subsidiary received a medical device production license, allowing it to manufacture absorbable surgical dressings [19] - TaiLin Bio's subsidiary won land use rights for an industrial site, facilitating its high-performance filter project [20] Group 7 - KaiPu Bio received a patent for a method and device for analyzing genomic copy number variations, enhancing its capabilities in molecular diagnostics [21] - Shanghai KaiBao received a drug registration certificate for Phlegm-Heat Clearing Capsules, which can be used in the treatment of COVID-19 symptoms [23] - TuoJing Life received two patents for high uniformity streptavidin applications, improving its diagnostic product stability [25] Group 8 - AnKe Bio's AK2024 injection received approval for clinical trials, marking a significant advancement in cancer treatment [26] - HuanYuan Pharmaceutical expects a net profit of 142 million to 160 million yuan for the first half of 2025, reflecting substantial growth [27] - JinHongShun terminated a major asset restructuring plan due to a lack of consensus among parties involved, impacting its strategic direction [28] Group 9 - HeZhan Energy signed a 177 million yuan contract for the sale of steel-concrete tower structures, indicating strong demand in the renewable energy sector [29] - InSai Group's acquisition plan for an 80% stake in ZhiZheTongXing was accepted by the Shenzhen Stock Exchange, indicating growth in its consulting business [30] - JiuDian Pharmaceutical received a drug registration certificate for Zinc Granules, enhancing its product line in gastrointestinal treatments [32] Group 10 - GuoYao Modern plans to publicly transfer a 51% stake in its subsidiary to optimize resource allocation [34] - GuoYao Modern's subsidiary received a drug registration certificate for Perindopril Indapamide tablets, expanding its hypertension treatment portfolio [36] - ZhongGong International signed a 175 million yuan engineering consulting service contract, showcasing its capabilities in project management [38] Group 11 - China Railway won contracts worth approximately 5.343 billion yuan for overseas construction projects, indicating its strong international presence [39] - JunPu Intelligent signed a framework contract for humanoid robot sales worth about 28.25 million yuan, reflecting growth in the robotics sector [41] - Sinopec's chairman resigned due to age, which may lead to changes in corporate governance [42] Group 12 - JiuFeng Energy's controlling shareholder plans to reduce their stake by up to 0.71%, indicating potential changes in ownership structure [44] - Zhejiang Oriental's subsidiary plans to establish a 1.74 billion yuan equity investment fund, focusing on strategic emerging industries [46] - ChenGuang New Materials received a government subsidy of 26 million yuan, significantly impacting its financial performance [48]
福元医药(601089) - 北京福元医药股份有限公司关于盐酸贝尼地平片获得药品注册证书的公告
2025-07-01 08:00
证券代码:601089 证券简称:福元医药 公告编号:临 2025-048 北京福元医药股份有限公司 由协和发酵麒麟研制的盐酸贝尼地平片,最早于 1991 年 10 月获 日本批准上市,2004 年 3 月,经国家药品监督管理局批准,盐酸贝尼 地平片在国内获批上市,用于原发性高血压,心绞痛。 关于盐酸贝尼地平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")颁发的盐酸贝尼地平 片(规格:8mg)(以下简称"该药品")《药品注册证书》(证书编号: 2025S01906),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:盐酸贝尼地平片 英文名/拉丁名:Benidipine Hydrochloride Tablets 剂型 片剂 注册分类 化学药品4类 规格 8mg 药品批准文号 国药准字H20254631 药品注册标准编号 YBH13712025 申请事项 药品注册(境内生产) 审批结论 ...
福元医药(601089) - 北京福元医药股份有限公司关于比索洛尔氨氯地平片获得药品注册证书的公告
2025-07-01 08:00
| 一、药品注册证书主要内容 | | --- | | | 批准注册,发给药品注册证书。质量标准、说 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 | 北京福元医药股份有限公司 | 二、药品相关信息 由默克研制的比索洛尔氨氯地平片,最早于 2010 年 10 月通过互 认程序获批上市,参照成员国为匈牙利,2021 年 5 月,经国家药品监 督管理局批准,比索洛尔氨氯地平片在国内获批上市。本品作为高血 压治疗的替代疗法,用于目前同时服用与复方制剂剂量相同的单药且 血压控制良好的患者。 公司于 2024 年 2 月 26 日获得申报受理通知书,并于近日获得国 家药监局批准。根据国家相关政策规定,本次获得《药品注册证书》, 视同通过一致性评价。 证券代码:601089 证券简称:福元医药 公告编号:临 2025-047 北京福元医药股份有限公司 关于比索洛尔氨氯地平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、 ...
福元医药:盐酸贝尼地平片获药品注册证书
news flash· 2025-07-01 07:35
Core Viewpoint - The company has received the drug registration certificate for Benidipine Hydrochloride Tablets (8mg) from the National Medical Products Administration, which will enhance its product line and market competitiveness [1] Group 1: Drug Approval and Market Impact - The drug was first approved in Japan in 1991 and received domestic approval in 2004 for the treatment of primary hypertension and angina [1] - The company received the acceptance notice for the application on March 5, 2024, and has recently been granted approval [1] - The estimated sales revenue for Benidipine Hydrochloride Tablets in China's three major terminal markets is approximately 1.007 billion yuan in 2024 [1] Group 2: R&D Investment - The total research and development investment for this drug by the company amounts to 5.2737 million yuan [1]
医药生物行业周报:《2025年基本医保目录及商保创新药目录调整申报操作指南》出炉,继续看好创新药-20250701
Guoyuan Securities· 2025-07-01 05:53
Investment Rating - The report maintains a "Recommended" investment rating for the healthcare sector [7]. Core Insights - The healthcare sector has shown a mixed performance, with the Shenyin Wanguo Pharmaceutical Bio Index rising by 1.60% from June 23 to June 27, 2025, underperforming the CSI 300 Index by 0.35 percentage points [2][12]. - Year-to-date, the pharmaceutical sector has increased by 6.24%, outperforming the CSI 300 Index by 6.57 percentage points, ranking 11th among 31 sectors [2][14]. - As of June 27, 2025, the valuation of the pharmaceutical sector stands at 27.54 times (TTM overall method, excluding negative values), with a premium of 140.94% compared to the CSI 300 [2][17]. Summary by Sections 1. Market Performance - The pharmaceutical sector's performance from June 23 to June 27, 2025, was a 1.60% increase, ranking 23rd among 31 sectors [12]. - The year-to-date performance shows a 6.24% increase, ranking 11th among 31 sectors [14]. 2. Important Events - The National Healthcare Security Administration released the "2025 Basic Medical Insurance Directory and Commercial Insurance Innovative Drug Directory Adjustment Application Guidelines," marking a significant step for commercial health insurance in the multi-level medical security system [4][21]. 3. Industry Perspective - The inclusion of the commercial insurance innovative drug directory indicates an enhanced role for commercial insurance in the multi-level medical security system, providing greater opportunities for the industry [5][22]. - The report expresses optimism for innovative drugs, overseas expansion, and the clearing of procurement in specific segments, suggesting a focus on companies involved in these areas [22].