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博济医药:关于公司获得药物临床试验批准通知书的公告
Zheng Quan Ri Bao· 2025-09-03 11:55
Core Viewpoint - Boji Pharmaceutical has received approval from the National Medical Products Administration for its clinical trial application of "FCZR" [2] Group 1 - The company announced the approval of its clinical trial for "FCZR" on the evening of September 3 [2] - The approval is a significant step for the company's research and development efforts in the pharmaceutical sector [2]
9月3日晚间重要公告一览
Xi Niu Cai Jing· 2025-09-03 10:18
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]
博济医药:FCZR获得药物临床试验批准通知书
Zheng Quan Shi Bao Wang· 2025-09-03 08:09
Core Viewpoint - Boji Pharmaceutical (300404) has received approval from the National Medical Products Administration for its clinical trial application for "FCZR," which is intended for the treatment of ear fungal disease [1] Company Summary - Boji Pharmaceutical announced on September 3 that it has obtained the clinical trial approval notice for "FCZR" from the National Medical Products Administration [1] - The proposed indication for FCZR is ear fungal disease [1]
博济医药:“FCZR”获得药物临床试验批准通知书
Zhi Tong Cai Jing· 2025-09-03 08:06
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]
博济医药(300404.SZ):FCZR获得药物临床试验批准通知书
Ge Long Hui A P P· 2025-09-03 08:04
Core Viewpoint - Boji Pharmaceutical has received approval from the National Medical Products Administration for its clinical trial of the new drug "FCZR," which targets ear fungal infections and offers significant clinical advantages over existing treatments [1] Company Summary - Boji Pharmaceutical (300404.SZ) has announced the approval of its drug "FCZR" for clinical trials, indicating progress in its product development pipeline [1] - The drug is classified as a modified new drug of category 2.2/2.4, optimized for formulation, prescription process, administration route, and indications [1] Industry Summary - Ear fungal disease is a common infectious condition in otolaryngology, particularly prevalent in hot and humid seasons and regions, often recurring and difficult to cure [1] - Currently, there are no approved drugs for this condition in both domestic and international markets, highlighting a potential market opportunity for FCZR [1]
博济医药:获得药物临床试验批准通知书
Xin Lang Cai Jing· 2025-09-03 08:04
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。 ...
博济医药(300404.SZ):“FCZR”获得药物临床试验批准通知书
智通财经网· 2025-09-03 08:04
Core Viewpoint - The company Boji Pharmaceutical has received approval from the National Medical Products Administration for its clinical trial of the new drug "FCZR," which targets ear fungal infections and offers significant clinical advantages [1] Company Summary - Boji Pharmaceutical (300404.SZ) announced the approval of its clinical trial for "FCZR" [1] - FCZR is classified as a modified new drug of category 2.2/2.4, optimized in formulation, prescription process, administration route, and indications [1] - The intended indication for FCZR is ear fungal disease, a common infectious condition in otolaryngology, particularly prevalent in hot and humid seasons and regions [1] Industry Summary - Ear fungal disease is a frequently occurring infection that is often recurrent and difficult to cure [1] - 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 enabling localized treatment [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]