事件：2025 年4 月9 日，公司发布2024 年年度报告：全年实现营业收入7.43 亿元，同比增长5.44%，主 要为阿达木单抗销量持续增长；研发费用7.78 亿元，同比增长1.17%；销售费用率31.71%，同比增长 7.73%。 阿达木单抗持续增长，托珠单抗新增境外业务。 分产品看，自免业务持续稳健增长，肿瘤业务收入有所下降。 自身免疫药物：2024 年实现销售收入6.02 亿元，同比增长22.83%，毛利率为78.63%，主要为阿达木单 抗销量持续增长，公司自营团队与国内超过1500 家处方医院及超过1500 家药店已达成合作。同时，托 珠单抗新增境外供货业务，但境外合作商尚处于拓展初期，增额相对较小，毛利相对较低。 抗肿瘤药物：2024 年实现销售收入1.33 亿元，同比下降36.29%，毛利率为26.09%，主要为抗肿瘤药物 较高毛利率的授权许可收入减少，导致抗肿瘤药物整体毛利率降低。 多个品种达成对外授权，进一步拓宽海外市场 公司五款产品BAT1308、BAT3306、BAT5906、BAT4406F 和BAT8006处于III 期临床研究或关键注册临 床研究阶段，其中BAT5906 已完成w ...

Revenue and Profit - The total operating revenue of Baiotai (688177) in 2024 was 743 million yuan, a year-on-year increase of 5.44% compared to 705 million yuan in 2023 [1] - However, the net profit attributable to shareholders decreased from -395 million yuan in 2023 to -510 million yuan in 2024, a decline of 29.34% [1] - The non-recurring net profit also worsened, dropping from -472 million yuan in 2023 to -556 million yuan in 2024, a decrease of 17.76% [1] Quarterly Data - The performance in the fourth quarter of 2024 was particularly weak, with total operating revenue of 162 million yuan, a year-on-year decline of 33.65% [2] - The net profit attributable to shareholders for the fourth quarter was -145 million yuan, a staggering decline of 1073.85% [2] - The non-recurring net profit for the fourth quarter was -151 million yuan, down 189.16% year-on-year [2] Costs and Expenses - In 2024, the proportion of the three expenses (financial, selling, and administrative expenses) to total revenue significantly increased from 29.47% in 2023 to 38.48% in 2024, an increase of 30.59% [3] - Selling expenses rose by 39.42% year-on-year, primarily due to increased marketing costs [3] - Administrative expenses increased by 5.24% year-on-year, mainly due to higher employee compensation [3] - Financial expenses surged by 156.17% year-on-year, largely due to increased bank loan interest costs [3] Profitability - The gross profit margin was 69.11%, a decrease of 4.77 percentage points compared to 2023 [4] - The net profit margin was -68.67%, a reduction of 22.67 percentage points from the previous year [4] - This indicates a low added value of products or services after deducting all costs [4] Cash Flow and Debt Situation - Despite a year-on-year increase of 76.72% in cash and cash equivalents, reaching 290 million yuan, the company still needs to monitor its cash flow situation [5] - The net cash flow from operating activities was -0.13 yuan per share, an improvement from -1.11 yuan per share in 2023, but still negative [5] - Interest-bearing liabilities increased from 483 million yuan in 2023 to 629 million yuan in 2024, a rise of 30.24%, with an interest-bearing asset-liability ratio reaching 28.5% [5] Summary - Overall, Baiotai's financial performance in 2024 was poor, particularly in terms of profit and cash flow [6] - The company needs to closely monitor its cash flow and debt situation to ensure sustainable development in the future [6]

| | 和 | | | | | | | --- | --- | --- | --- | --- | --- | --- | | 601228 | 广州港 | 0.1280 | 96443.07 | -10.63 | 1407293.13 | 6.66 | | 301488 | 豪恩汽 | 1.1000 | 10091.18 | -11.15 | 140893.71 | 17.25 | | | 电 | | | | | | | 001324 | 长青科 | 0.4361 | 6018.00 | -16.41 | 46042.71 | -13.16 | | | 技 | | | | | | | 002535 | 林州重 | 0.1189 | 9534.40 | -18.47 | 168353.14 | -8.38 | | | 机 | | | | | | | 002075 | 沙钢股 | 0.0700 | 16258.29 | -27.75 | 1441626.09 | -7.69 | | | 份 | | | | | | | 002860 | 星帅尔 | 0.4700 | 14369.40 | -29.03 | 207 ...

Core Viewpoint - The company focuses on the development of innovative drugs and biosimilars, with a strong emphasis on oncology, autoimmune diseases, cardiovascular diseases, and ophthalmology, aiming to enhance patient health and expand its market presence globally [3][25]. Company Overview - The company is a biopharmaceutical enterprise dedicated to the research, development, production, and sales of innovative drugs and biosimilars, with a complete independent system for R&D, procurement, production, and commercialization [17]. - The company has four products approved for market in China: Gelerit (Adalimumab), Pubexi (Bevacizumab), Shireli (Tocilizumab), and Betanin (Citrulline Valproate) [21][39]. Product Pipeline - The company has developed several biosimilars, including Gelerit, which is the first approved biosimilar of Adalimumab in China, and has been included in the national medical insurance directory [4][38]. - The company’s product BAT1706 (Bevacizumab) has received approvals from NMPA, FDA, EMA, and ANVISA, making it the first and only domestically developed biosimilar of Bevacizumab to achieve such approvals [5][6][39]. - BAT1806 (Tocilizumab) is the first domestically developed biosimilar of Tocilizumab to receive FDA approval, marking a significant milestone for the company [8][39]. - The company has multiple products in clinical trials, including BAT2206 (Ustekinumab), BAT2506 (Golimumab), and BAT2306 (Secukinumab), with applications submitted to various regulatory bodies [12][13][14]. Industry Overview - The pharmaceutical manufacturing industry is a critical sector for national health, technological innovation, and economic development, with a focus on innovative drug development as a strategic priority [26]. - The global pharmaceutical market has shown stable growth, with the market size increasing from $1,324.5 billion in 2019 to $1,472.3 billion in 2023, and projected to reach $1,766.7 billion by 2026 [28]. - The oncology drug market has seen significant growth, with the global market size increasing from $143.5 billion in 2019 to $228.9 billion in 2023, and expected to reach $419.8 billion by 2030 [29][30]. - The autoimmune disease treatment market is also expanding rapidly, with the global market size projected to grow from $132.3 billion in 2022 to $176.7 billion by 2030 [31]. Market Dynamics - The aging population and increasing healthcare awareness are driving demand for pharmaceutical products, particularly in oncology and autoimmune disease treatments [27][31]. - The company is positioned to benefit from the growing demand for biosimilars and innovative drugs, especially as key patents for several blockbuster drugs are set to expire in the coming years [40].

Core Insights - The company reported a total revenue of 743 million yuan in 2024, representing a year-on-year growth of 5.44%, but the net profit attributable to shareholders was a loss of 510 million yuan, an increase in loss of 29.34% compared to the previous year [1] - Despite progress in innovative drug research and global market expansion, the company faces significant challenges due to ongoing losses and high R&D costs [1][5] Group 1: Innovative Drug Development - The company continued to advance its innovative drug development in 2024, achieving several milestones, including the approval of its first national Class 1 innovative drug, Beta Ning® (Citrulline Bevacizumab Injection), by NMPA for acute coronary syndrome patients [4] - BAT1706 (Bevacizumab) and BAT1806 (Tocilizumab) received marketing approvals from EMA and ANVISA, respectively, allowing for sales in the US, Europe, and Brazil [4] - However, the commercialization process for these innovative drugs remains slow, with BAT1806 generating only 1.1 million USD in revenue in the US market in 2024 [4] Group 2: Global Market Expansion - The company actively expanded its global market presence in 2024, entering into licensing agreements with several international firms, such as Macter International Limited for BAT1706 in Pakistan and Afghanistan, and STADA Arzneimittel AG for BAT2506 (Golimumab) in the EU, UK, and Switzerland [4] - These partnerships are expected to enhance the company's global product coverage, although their short-term revenue contribution is limited [4] Group 3: Financial Performance - The company's gross profit for 2024 was 514 million yuan, reflecting a year-on-year increase of 0.59%, but the net loss attributable to shareholders widened to 510 million yuan [5] - High R&D expenditures and commercialization costs are the primary reasons for the ongoing losses [5] Group 4: Production Capacity and Cost Pressure - The company continued to upgrade its production lines in 2024, with the Yonghe Phase II expansion project achieving a total production capacity of 66,500 liters, enhancing production capabilities [6] - The company has also obtained GMP certification from major global regulatory bodies, including NMPA, FDA, and EMA, ensuring access to key pharmaceutical markets [6] - However, the ongoing upgrades and GMP certification efforts have resulted in significant cost pressures, with a non-deductible net profit loss of 556 million yuan in 2024, an increase of 17.76% year-on-year [6]

4月8日晚间，百奥泰(688177)发布2024年年报。据公告，公司于报告期内实现营业收入7.43亿元，同比 微增，但由于营业成本及销售费用增长，公司于报告期录得亏损，净利润为-5.1亿元。 报告期内，公司研发项目也在稳步推进。其中，BAT2206（乌司奴单抗）向NMPA、FDA、EMA递交的 上市申请均获得受理；BAT2306（司库奇尤单抗）的上市申请已于2025年1月获得NMPA受理； BAT2506（戈利木单抗）的上市申请已分别于2025年1月和3月获得EMA和NMPA受理；BAT5906已完成 湿性老年黄斑变性（wAMD）临床III期受试者入组；BAT3306（帕博利珠单抗）在晚期非鳞状非小细胞 肺癌患者中开展的I/III期临床研究顺利推进；BAT2406（度普利尤单抗）的临床试验申请于8月获得 NMPA许可，成为中国首个获批的度普利尤单抗生物类似药临床试验。 目前，百奥泰已构建出包括噬菌体展示全人源抗体库、酵母展示库、抗体结构设计平台、ADCC改造平 台、ADC技术平台、双特异与多功能抗体在内的六大平台，确保了公司可持续的创新能力，以及完整 的创新药研发能力。通过充分应用自身的核心技术，公司获得多项 ...

中国国际金融股份有限公司（以下简称"中金公司"或"保荐机构"）作为 百奥泰生物制药股份有限公司（以下简称"百奥泰"或"公司"）首次公开发行 股票并在科创板上市的保荐机构，根据《证券发行上市保荐业务管理办法》《上 市公司监管指引第 2 号——上市公司募集资金管理和使用的监管要求》《上海证 券交易所科创板股票上市规则》《科创板上市公司持续监管办法（试行）》和《上 海证券交易所科创板上市公司自律监管指引第 1 号——规范运作》等有关规定， 对百奥泰部分募投项目子项目变更及金额调整事项进行了核查，具体核查情况如 下： 一、募集资金基本情况 经上海证券交易所科创板上市委员会2019年11月20日审核同意，并经中国证 券监督管理委员会2020年1月14日《关于同意百奥泰生物制药股份有限公司首次 公开发行股票注册的批复》（证监许可[2020]92号）注册同意，公司公开发行人 民币普通股6,000万股，发行价格为人民币32.76元/股。募集资金总额为人民币 196,560.00万元，扣除发行费用后，募集资金净额为人民币187,619.98万元。以上 募集资金到位情况已经由安永华明会计师事务所（特殊普通合伙）审验并于2020 ...

关于百奥泰生物制药股份有限公司 2024 年度营业收入扣除情况表 的鉴证报告 百奥泰生物制药股份有限公司全体股东： 我们审计了百奥泰生物制药股份有限公司(以下简称"百奥泰公 司")2024 年度的财务报表，包括 2024 年 12 月 31 日的合并及母公司 资产负债表、2024 年度合并及母公司利润表、合并及母公司现金流量 表、合并及母公司所有者权益变动表和相关财务报表附注，并于 2025 年 4 月 8 日出具了报告号为信会师报字[2025]第 ZC10237 号的无保留 意见审计报告。 在对上述财务报表执行审计的基础上，我们接受委托，对后附的 百奥泰公司2024年度营业收入扣除情况表（以下简称"营业收入扣除 情况表"）执行了合理保证的鉴证业务。 一、管理层的责任 百奥泰公司管理层的责任是按照《上海证券交易所科创板股票上 市规则》和上海证券交易所《科创板上市公司自律监管指南第9号— —财务类退市指标：营业收入扣除》的相关规定编制营业收入扣除情 况表，确保营业收入扣除情况表真实、准确、完整，不存在虚假记载、 误导性陈述或重大遗漏。 关于百奥泰生物制药股份有限公司2024年度 营业收入扣除情况表的鉴证报告 | ...

百奥泰生物制药股份有限公司 信会师报字[2025]第 ZC10238 号 百奥泰生物制药股份有限公司全体股东： 按照《企业内部控制审计指引》及中国注册会计师执业准则的相 关要求，我们审计了百奥泰生物制药股份有限公司（以下简称百奥泰） 2024 年 12 月 31 日的财务报告内部控制的有效性。 百奥泰生物制药股份有限公司 内部控制审计报告 | 目 | 录 | 页 | 次 | | --- | --- | --- | --- | | 一、 | 年度内部控制审计报告 | 2024 | 1-2 | 内部控制审计报告 内部控制审计报告 二〇二四年度 一、企业对内部控制的责任 按照《企业内部控制基本规范》、《企业内部控制应用指引》、《企 业内部控制评价指引》的规定，建立健全和有效实施内部控制，并评 价其有效性是百奥泰董事会的责任。 二、注册会计师的责任 我们的责任是在实施审计工作的基础上，对财务报告内部控制的 有效性发表审计意见，并对注意到的非财务报告内部控制的重大缺陷 进行披露。 三、内部控制的固有局限性 内部控制具有固有局限性，存在不能防止和发现错报的可能性。 此外，由于情况的变化可能导致内部控制变得不恰当，或对控制 ...

百奥泰生物制药股份有限公司 章 程 二〇二五年四月 | 第一章 | 总则 1 | | --- | --- | | 第二章 | 经营宗旨和范围 2 | | 第三章 | 股份 2 | | 第一节 | 股份发行 2 | | 第二节 | 股份增减和回购 4 | | 第三节 | 股份转让 5 | | 第四章 | 股东和股东会 6 | | 第一节 | 股东 6 | | 第二节 | 控股股东和实际控制人 9 | | 第三节 | 股东会的一般规定 10 | | 第四节 | 股东会的召集 12 | | 第五节 | 股东会的提案与通知 14 | | 第六节 | 股东会的召开 15 | | 第七节 | 股东会的表决和决议 18 | | 第五章 | 董事和董事会 23 | | 第一节 | 董事的一般规定 23 | | 第二节 | 董事会 26 | | 第三节 | 独立董事 31 | | 第四节 | 董事会专门委员会 34 | | 第六章 | 高级管理人员 36 | | 第七章 | 财务会计制度、利润分配和审计 38 | | 第一节 | 财务会计制度 38 | | 第二节 | 内部审计 43 | | 第三节 | 会计师事务所的聘任 4 ...