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"）颁发的联苯苄唑溶液（规格：1%(10毫 升：0.1克)，以下简称"该药品"）《药品注册证书》(证书编号：2025S02274)，批准该药品生产。现将 相关情况公告如下： 一、药品注册证书主要内容 ■ 二、药品相关信息 该药品用于下列皮肤真菌病的治疗： 证券代码：601089 证券简称：福元医药 公告编号：临2025-052 北京福元医药股份有限公司 关于联苯苄唑溶液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。 福元药业于2024年1月12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。 特此公告。 北京福元医药股份有限公司董事会 2025年7月30日 截至本公告日，福元药业针对该药品累计研发投入为人民币304.96万元(未经审计)。 三、同类药品的市场状况 米内网数据显示，2024年 ...

证券代码：601089 证券简称：福元医药 公告编号：临 2025-052 一、药品注册证书主要内容 药品通用名称：联苯苄唑溶液 药品名称 | | 英文名/拉丁名：Bifonazole Solution | | --- | --- | | 剂型 | 涂剂 | | 注册分类 | 化学药品3类 | | 规格 | 1%（10毫升：0.1克） | | 药品批准文号 | 国药准字H20254937 | | 药品注册标准编号 | YBH12812025 | | 处方药/非处方药 | 非处方药 | | 申请事项 | 药品注册（境内生产） | | | 根据《中华人民共和国药品管理法》及有关规 | 审批结论 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 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。 关于联苯苄唑溶液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 ...

Group 1 - The core point of the article is that Fuyuan Pharmaceutical has received a drug registration certificate from the National Medical Products Administration for its product, Lianbenbengzhuo Solution, which allows for its production [2]. Group 2 - Fuyuan Pharmaceutical's subsidiary, Fuyuan Pharmaceutical Co., Ltd., is responsible for the production of Lianbenbengzhuo Solution [2]. - The approval of the drug registration certificate signifies a regulatory milestone for the company, potentially enhancing its product portfolio [2].

Core Viewpoint - Fuyuan Pharmaceutical (601089.SH) has received a drug registration certificate from the National Medical Products Administration for its product, a 1% solution of bifonazole, which is approved for production [1]. Group 1: Product Approval - Fuyuan Pharmaceutical's wholly-owned subsidiary, Fuyuan Pharmaceutical Co., Ltd., has been granted a drug registration certificate for bifonazole solution (specification: 1% (10ml: 0.1g)) [1]. - The drug is indicated for the treatment of various skin fungal diseases, including tinea (foot, body, and groin), candidiasis (interdigital maceration, intertrigo, and cutaneous candidiasis), and vitiligo [1].

福元医药(601089.SH)公告称，公司全资子公司福元药业收到国家药监局颁发的联苯苄唑溶液《药品注 册证书》，批准该药品生产。该药品用于皮肤真菌病的治疗，包括白癣、念珠菌症和癜风。福元药业于 2024年1月12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。米内网数据显示，2024年中国三大终端六大市场联苯苄唑溶 液销售额约为3.75亿元。 ...

Investment Rating - The report does not explicitly state an investment rating for the skin disease drug industry Core Insights - The skin disease drug industry focuses on treating various skin conditions, with a strong market demand driven by increasing patient needs and innovative treatment methods [5][6] - The market size for skin disease drugs is projected to grow from 2.076 billion RMB in 2019 to 2.575 billion RMB in 2023, with a compound annual growth rate (CAGR) of 5.54%. It is expected to reach 3.551 billion RMB by 2028, with a CAGR of 6.32% [9][10] - The industry has evolved from the use of natural substances to synthetic drugs and innovative biopharmaceuticals, with significant advancements in drug formulations and delivery systems [8] Market Background - The skin disease drug industry is characterized by high regulatory barriers and significant policy impacts, but the growing patient demand is driving market expansion [5] - The prevalence of skin diseases in China is high, with estimates indicating that 40%-70% of the population is affected, leading to a strong treatment willingness and a growing market for topical medications [13] Market Status - The market supply is constrained by the complexity of developing topical formulations, with only five new topical drugs approved in the last five years compared to 80 oral formulations [11] - The demand for skin disease treatments is increasing due to rising incidence rates and the convenience of topical medications, which patients can self-administer [13] Market Competition - The competitive landscape features a tiered structure, with leading companies like Huabang Pharmaceutical and ZhiYuan Pharmaceutical dominating the market [18][19] - The online sales channel for skin disease drugs has grown significantly, with its share increasing from 9.0% in 2019 to 22.9% in 2023, reflecting a CAGR of 24.3% [18] Development Trends - Technological innovations, particularly in biopharmaceuticals and AI-driven drug development, are expected to be key growth drivers in the industry [32] - Local companies are likely to strengthen their market positions through channel advantages and innovation, while foreign companies may deepen their local presence through partnerships [33] - Policy changes and capital investments are anticipated to accelerate industry upgrades, enhancing the accessibility of innovative drugs [34]