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》。 ...