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]

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].

Company Performance - Boji Pharmaceutical (SZ 300404) reported a revenue of approximately 361 million yuan for the first half of 2025, representing a year-on-year increase of 5.88% [1] - The net profit attributable to shareholders was approximately 15.57 million yuan, showing a year-on-year decrease of 48.33% [1] - Basic earnings per share were 0.0407 yuan, which is a year-on-year decrease of 48.42% [1] Industry Insights - The pet industry is experiencing significant growth, with a market size of 300 billion yuan, leading to a surge in stock prices for related companies [1]

Core Viewpoint - The legal opinion issued by Beijing Kangda Law Firm confirms the validity and compliance of the stock incentive plan of Boji Pharmaceutical Technology Co., Ltd, particularly regarding the cancellation of certain restricted stocks [1][12]. Group 1: Legal Compliance and Verification - The law firm conducted thorough verification and confirmed that all provided documents and statements from Boji Pharmaceutical were authentic and accurate [2][3]. - The legal opinion is strictly focused on legal issues related to the incentive plan and does not cover accounting, financial, or auditing matters [2][3]. Group 2: Stock Incentive Plan Details - The company approved the 2023 restricted stock incentive plan, granting a total of 2,968,000 shares to 47 eligible participants, with the first grant date set for April 26, 2023 [3][4]. - The first category of restricted stocks was granted at a price of 5.47 CNY per share, while the second category was granted at 8.75 CNY per share [3][4]. - Adjustments were made to the grant prices following the annual profit distribution, reducing the first category price to 5.46 CNY and the second category price to 8.74 CNY [4][7]. Group 3: Cancellation of Restricted Stocks - The company decided to cancel 140,600 shares of the second category of restricted stocks due to certain participants failing to meet performance criteria or leaving the company [5][10]. - An additional 300,000 shares from the reserved portion of the second category were also rendered invalid due to not being granted within the stipulated timeframe [5][10]. - The legal opinion asserts that the cancellation of these stocks has received the necessary approvals and complies with relevant regulations [11][12].

证券代码：300404 证券简称：博济医药 公告编号：2025-070 博济医药科技股份有限公司 关于召开 2025 年第一次临时股东大会的通知 根据《博济医药科技股份有限公司章程》（以下简称"《公司章程》"）的有 关规定，经博济医药科技股份有限公司（以下简称"公司"或"本公司"）第 五届董事会第十六次会议审议通过，决议于 2025 年 9 月 12 日以现场投票与网 络投票相结合的方式召开公司 2025 年第一次临时股东大会，现将本次股东大会 有关事项通知如下： 一、 本次股东大会召开的基本情况 六次会议审议通过，召集程序符合有关法律、行政法规、部门规章、规范性文 件和《公司章程》的规定。 （1）现场会议召开时间：2025 年 9 月 12 日（星期五）下午 14:30。 （2）网络投票时间：2025 年 9 月 12 日。其中，通过深圳证券交易所交易 系统进行网络投票的具体时间为：2025 年 9 月 12 日上午 9:15-9:25，9:30-11:30， 下午 13:00-15:00；通过深圳证券交易所互联网投票系统投票的具体时间为：2025 年 9 月 12 日 9:15-15:00。 （1）现场投 ...

证券代码：300404 证券简称：博济医药 公告编号：2025-069 博济医药科技股份有限公司 关于作废部分限制性股票的公告 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。 博济医药科技股份有限公司（以下简称"公司"）于 2025 年 8 月 25 日召开 第五届董事会第十六次会议和第五届监事会第十五次会议，审议通过了《关于作 废部分限制性股票的议案》，根据公司《2023 年限制性股票激励计划（草案）》 等有关规定，鉴于公司部分激励对象因个人原因离职导致其不再具备激励资格， 同意公司作废其已授予但尚未归属的 2023 年第二类限制性股票 12,000 股。现将 有关情况公告如下： 一、公司 2023 年限制性股票激励计划概述及已履行的相关程序 1、2023 年 3 月 17 日，公司第四届董事会第二十五次会议审议通过了《关 于公司<2023 年限制性股票激励计划（草案）>及其摘要的议案》《关于公司<20 23 年限制性股票激励计划实施考核管理办法>的议案》《关于提请股东大会授权 董事会办理 2023 年限制性股票激励计划相关事宜的议案》等议案。同日，公司 第 ...