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]

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]

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]

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。 ...

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]

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]

Group 1: Clinical Research Organization (CRO) Business Development - In the first half of 2025, the company's clinical research service revenue was approximately CNY 290 million, representing a 6.78% decrease compared to the same period last year [2] - The new clinical research service contract amount was CNY 752 million, indicating growth in market demand for clinical CRO services [2] - The company is expanding its clinical business team and expects clinical business prices to rise due to improved financing conditions [2] Group 2: Market Competition and Industry Trends - Many small CRO companies are facing operational difficulties, leading to layoffs and even closures, which is expected to increase industry concentration [3] - The company, being a well-established CRO, has strong performance capabilities and competitive advantages [3] Group 3: Research and Development Progress - The company has several self-developed projects, including a Class 1 innovative drug for chronic heart failure and various traditional Chinese medicine projects [4] - In the first half of 2025, new signed orders amounted to CNY 870 million, with over 50% from chemical drugs and over 20% from traditional Chinese medicine [4] Group 4: Future Business Plans and Financial Projections - The company plans to increase clinical staff in the second half of 2025, but not on a large scale [5] - The company aims to achieve revenue targets based on the 2024 stock incentive plan and expects to confirm approximately CNY 480 million in revenue in the second half of 2025 [7][11] - The gross margin for clinical CRO services is expected to increase due to higher quality demands and improved funding for innovative drug development [8] Group 5: Collaboration and Mergers - The company is open to mergers and acquisitions, particularly in the fields of vaccines and blood products, while focusing on its core business [12] - The company is actively seeking partners for its self-developed projects, including the "Runnor9591" project [6] Group 6: Regulatory and Operational Efficiency - The execution cycle for clinical projects varies, with significant improvements in efficiency and quality compared to previous years [10] - The company anticipates a decrease in expense ratios as revenue grows, with stable personnel levels [11]

Investment Rating - The report maintains a "Buy" rating for the company, indicating a positive outlook for future performance [6]. Core Insights - The company's clinical business shows stable growth, with a revenue of 290 million yuan in H1 2025, reflecting a year-over-year increase of 6.78%. However, the gross margin for this segment has slightly declined [2]. - The non-clinical business performance is mixed, with preclinical research services experiencing a revenue decrease of 2.21% year-over-year, while other consulting services saw a significant increase of 31.79% [3]. - The company has made progress in its self-developed projects, including innovative traditional Chinese medicine and chemical drug candidates, which could enhance profitability if successfully licensed [3]. - The operating cash flow has significantly improved, reaching 21.25 million yuan in H1 2025, a substantial increase of 343.46% compared to the previous year [4]. Summary by Sections Financial Performance - The company reported a total revenue of 361 million yuan for H1 2025, a year-over-year increase of 5.88%. However, the net profit attributable to shareholders decreased by 48.33% to 15.57 million yuan [1]. - The gross margin for clinical services was 30.6%, showing a slight decline of 0.6 percentage points year-over-year [2]. Business Segments - Clinical research services generated 290 million yuan in revenue, with a new contract amount of 752 million yuan, indicating slight growth from the previous year [2]. - Preclinical research services generated 40.87 million yuan, while other consulting services brought in 23.49 million yuan, marking a significant increase [3]. Cash Flow and Operational Efficiency - The net cash flow from operating activities reached 21.25 million yuan, a notable increase from 4.79 million yuan in the same period last year, reflecting improved cash collection efficiency [4]. Profit Forecast and Valuation - The profit forecast for 2025-2026 has been revised downwards, with net profit estimates of 45 million yuan and 66 million yuan respectively. The current stock price corresponds to a P/E ratio of 98 for 2025 [4].