证券日报网讯 9月3日晚间，博济医药发布公告称，近日，公司申报的"FCZR"获得国家药品监督管理局 核准签发的《药物临床试验批准通知书》。 （文章来源：证券日报） ...

Group 1 - Shengtun Mining plans to repurchase shares worth between 500 million and 600 million yuan, with a maximum repurchase price of 11.82 yuan per share, aimed at employee stock ownership plans or equity incentives [1] - Kangnbei received a drug registration certificate for Linggui Shugan Granules, which is derived from traditional Chinese medicine and is used for treating phlegm and dampness due to Yang deficiency [2] - Zhangjiang Hi-Tech intends to publicly transfer 100% equity and related debts of Shanghai Jixin Rui Construction Technology Co., Ltd. with a total price not less than 151 million yuan [3] Group 2 - Shankai Intelligent won a bid for a metering device procurement project worth 13.318 million yuan from Hohhot Water Supply Company [4] - Hason Co. plans to jointly establish a supply chain company with a registered capital of 10 million yuan, in which Hason will hold a 10% stake [5] - Pudong Construction's subsidiaries won multiple major projects with a total amount of 1.271 billion yuan [6] Group 3 - Jinling Pharmaceutical received approval for the Phase III clinical trial of Olaratogrel tablets, which are used for treating moderate to severe pain associated with endometriosis [8] - Menohua's subsidiary obtained a drug registration certificate for Mosapride Citrate Tablets, aimed at improving gastrointestinal symptoms [10] - Shapuaisi's major shareholder plans to reduce holdings by up to 2% of the company's shares due to personal financial needs [11] Group 4 - Changyuan Power reported an August electricity generation of 3.771 billion kWh, a year-on-year decrease of 6.03% [15][16] - Xibu Livestock's August fresh milk production increased by 4.8% month-on-month but decreased by 7.27% year-on-year [19] - Yong'an Pharmaceutical's actual controller and chairman had their detention lifted, allowing them to resume normal duties [20] Group 5 - Jinkai Intelligent's director resigned due to work adjustments [22] - Xinhua Medical received a Class II medical device registration for an endoscope cleaning workstation [23] - Haishi Science and Technology's innovative drug HSK47388 received approval for a new indication clinical trial [25] Group 6 - Baotai Co. plans to participate in a land use rights auction in Baoji City with a starting price of 57.34 million yuan [26] - Minfeng Special Paper received a government subsidy totaling 11.2 million yuan [27] - Jiuchang Bio obtained a medical device registration for a heparin-binding protein assay kit [29] Group 7 - Jingao Technology plans to repurchase shares worth between 200 million and 400 million yuan, with a maximum price of 17.36 yuan per share [31] - Youxunda won a bid for a metering equipment project from China Southern Power Grid worth approximately 161 million yuan [32] - Qianli Technology reported an August vehicle sales increase of 168.55% year-on-year [32] Group 8 - Guangzhou Port expects an August container throughput increase of 1.2% year-on-year [32] - Kexing Pharmaceutical's GB08 injection completed the first subject enrollment for Phase II clinical trials [33] - Wu Ming Pharmaceutical plans to transfer 98.9% of its subsidiary's shares to a newly established wholly-owned subsidiary [34] Group 9 - Shanghai Electric's acquisition of K-Electric Limited shares has not yet completed the transfer [35] - Fulai New Materials plans to raise no more than 710 million yuan through a private placement [36] - Huaren Health's drug registration application for a new type of potassium ion competitive acid blocker has been accepted [37]

人民财讯9月3日电，博济医药（300404）9月3日晚间公告，近日，公司申报的"FCZR"获得国家药监局 核准签发的《药物临床试验批准通知书》。FCZR拟定适应症为耳真菌病。 ...

Group 1 - The company Boji Pharmaceutical (300404.SZ) has received approval from the National Medical Products Administration for the clinical trial of its drug "FCZR" [1] - FCZR is a modified new drug of category 2.2/2.4, optimized based on known active ingredients, with significant clinical advantages, targeting the indication of ear fungal disease [1] - Ear fungal disease is a common infectious condition in otolaryngology, often recurring and difficult to cure, particularly prevalent in hot and humid seasons and regions [1] Group 2 - The formulation of FCZR offers advantages in fluidity and ease of administration, allowing for direct contact with lesions in the ear canal through ear drops, thus achieving localized therapeutic effects [1] - Currently, there are no similar drugs approved for sale in both domestic and international markets, and there are no related sales data available [1]

FCZR是在已知活性成份的基础上，对其剂型、处方工艺、给药途径、适应症等进行优化，且具有明显 临床优势的2.2/2.4类改良型新药，拟定适应症为耳真菌病。耳真菌病是耳鼻咽喉科门诊较常见的一类感 染性疾病，高温潮湿的季节和地区多见，常反复发作、不易根治。FCZR剂型具有流动性和给药操作便 利上的优势，滴耳给药可直接与耳道内各隐蔽角落的病灶接触，发挥局部给药局部起效的作用。目前国 内外尚无该类药品获批上市，亦无相关销售数据。 格隆汇9月3日丨博济医药(300404.SZ)公布，近日，博济医药科技股份有限公司申报的"FCZR"获得国家 药品监督管理局核准签发的《药物临床试验批准通知书》。 ...

博济医药公告，近日公司申报的"FCZR"获得国家药品监督管理局核准签发的《药物临床试验批准通知 书》。通知书编号为2025LP02257和2025LP02258，药品名称为FCZR，适应症为耳真菌病，注册分类为 化学药品2.2/2.4类。审批结论为同意开展临床试验。FCZR剂型具有流动性和给药操作便利上的优势， 目前国内外尚无该类药品获批上市。本次获得《药物临床试验批准通知书》是新药研发的阶段性成果， 不会对公司的经营业绩产生重大影响。 ...

FCZR是在已知活性成份的基础上，对其剂型、处方工艺、给药途径、适应症等进行优化，且具有明显 临床优势的2.2/2.4类改良型新药，拟定适应症为耳真菌病。耳真菌病是耳鼻咽喉科门诊较常见的一类感 染性疾病，高温潮湿的季节和地区多见，常反复发作、不易根治。FCZR剂型具有流动性和给药操作便 利上的优势，滴耳给药可直接与耳道内各隐蔽角落的病灶接触，发挥局部给药局部起效的作用。目前国 内外尚无该类药品获批上市，亦无相关销售数据。 智通财经APP讯，博济医药(300404.SZ)发布公告，近日，公司申报的"FCZR"获得国家药品监督管理局 核准签发的《药物临床试验批准通知书》。 ...

一、 药物基本情况 1、通知书编号：2025LP02257、2025LP02258（同药品不同规格） 2、药品名称：FCZR 证券代码：300404 证券简称：博济医药 公告编号：2025-071 博济医药科技股份有限公司 关于公司获得药物临床试验批准通知书的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假 记载、误导性陈述或重大遗漏。 近日，博济医药科技股份有限公司（以下简称"公司"）申报的"FCZR" 获得国家药品监督管理局核准签发的《药物临床试验批准通知书》。现将相关情 况公告如下： 根据我国药品注册相关法律法规要求，药品在取得药物临床批准后，须按照 批件内容进行研究工作并经国家药品监督管理局审批通过后方可上市。 1 3、适应症：耳真菌病 4、注册分类：化学药品 2.2/2.4 类 5、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， 2025 年 6 月 19 日受理的 FCZR 临床试验申请符合药品注册的有关要求，同意开 展临床试验。 二、 药物其他情况 FCZR 是在已知活性成份的基础上，对其剂型、处方工艺、给药途径、适应 症等进行优化，且具有明显临床优势的 ...

Financial Performance - The company's total revenue for the first half of 2025 was 361 million yuan, an increase of 5.88% year-on-year [1] - The net profit attributable to shareholders was 15.57 million yuan, a decrease of 48.33% year-on-year [1] - The gross profit margin was 30.65%, down 6.03% year-on-year, while the net profit margin was 4.86%, down 46.3% year-on-year [1] - The company reported a significant increase in operating cash flow per share, which rose by 342.15% to 0.06 yuan [1] Business Operations - Clinical research service revenue reached approximately 290 million yuan, a year-on-year increase of 6.78% [4] - The company signed new clinical research service contracts worth 752 million yuan, showing growth compared to the previous year [4] - The company is expanding its clinical business team and has seen a noticeable increase in the number of clinical projects it is bidding for [4] Market Position and Competition - The company is positioned as a leading CRO with strong履约能力 and rich experience, benefiting from the difficulties faced by smaller CROs in the market [5] - The industry is expected to see increased concentration as smaller CROs struggle with operations, layoffs, and even closures [5] Research and Development - The company has several ongoing self-developed projects, including traditional Chinese medicine and chemical drugs, with notable projects in various stages of development [6] - The company is actively seeking partners for its self-developed projects and aims to enhance its innovation capabilities [12] Future Outlook - The company aims to achieve a revenue target for 2025 based on the 2024 stock incentive plan and plans to control expenses while expanding business orders [9] - The company anticipates an increase in gross margins for its clinical CRO business due to rising prices driven by improved funding for innovative drug development [10] - The company has a significant amount of unrecognized revenue from signed contracts, estimated at approximately 3.195 billion yuan, with expected revenue recognition of about 480 million yuan in the second half of 2025 [14]

证券代码：300404 证券简称：博济医药 博济医药科技股份有限公司 投资者关系活动记录表 | | □特定对象调研 □分析师会议 | | --- | --- | | 投资者关系活 | □媒体采访 □业绩说明会 | | 动类别 | □新闻发布会 □路演活动 | | | □现场参观 | | | ■其他（投资者电话交流会） | | | 华创证券、兴业证券、招商证券、太平洋证券、东北证券、光大 | | 参与单位名称 | 证券、开源证券、银河证券、华安证券、华福证券、国泰海通、 | | 及人员姓名 | 西部利得、瑞丰基金、博远基金、富安达基金、瑞天投资、乾璐 | | | 投资、华宝基金、摩根资产、银河基金、长盛基金、招商基金等 | | 时间 | 年 月 日（星期三） 2025 8 27 | | 地点 | 广州 | | 上市公司接待 | 董事长、总经理：王廷春 | | 人员姓名 | 副总经理、董事会秘书：韦芳群 | | | 1、管理层介绍公司经营情况 2、交流互动环节： | | | 问题 1：请问目前公司临床 CRO 业务发展情况如何？订单价 | | | 格水平是否有所回暖？ | | 投资者关系活 动主要内容 | 答：2 ...