证券代码： 688177 证券简称：百奥泰 公告编号：2024-024 百奥泰生物制药股份有限公司 自愿披露关于托珠单抗注射液（施瑞立®） 获得药品注册证书的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 重要内容提示： 百奥泰生物制药股份有限公司（以下简称"百奥泰"或"公司"）于近日收到国 家药品监督管理局（以下简称"国家药监局"）核准签发的关于托珠单抗注射液（商 品名称：施瑞立®）的《药品注册证书》（证书编号：2024S00472）。该药品获批 新规格：200mg/10mL。 一、 《药品注册证书》基本情况 药品名称：托珠单抗注射液 注册分类：治疗用生物制品 药品注册标准编号：YHS00162024 药品批准文号：国药准字 S20240009 上市许可持有人：百奥泰生物制药股份有限公司 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，本品 符合药品注册的有关要求，批准注册，发给药品注册证书，生产工艺、质量标准、 说明书及标签按所附执行。 二、 药品相关情况 商品名称：施瑞立® 剂型：注射剂 规格：2 ...

Investment Rating - The report maintains a "Buy" rating for the company [2] Core Views - The company achieved strong revenue growth, with a total revenue of 705 million yuan in 2023, representing a year-on-year increase of 54.86%. The revenue for Q4 alone was 244 million yuan, showing a quarter-on-quarter growth of 67% [2][3] - The company has made significant progress in the overseas market for biosimilars, with two products receiving FDA approval. BAT1806 (Tocilizumab) was approved in September 2023, and BAT1706 (Bevacizumab) was approved in December 2023. Applications for marketing authorization have also been submitted to the EMA [3] - The company has a rich pipeline of innovative drugs, with multiple ADC products in clinical trials. BAT2094 (Batrifiban) is currently in the domestic listing application stage, while BAT4406F (CD20 antibody) is in a critical trial phase [4] Financial Summary - The company forecasts revenues of 1.396 billion yuan, 2.548 billion yuan, and 4.363 billion yuan for 2024, 2025, and 2026 respectively, with net profits projected at -22 million yuan, 571 million yuan, and 1.329 billion yuan for the same years [4][10] - The gross margin is expected to be 69.4% in 2024, 71.0% in 2025, and 72.7% in 2026, indicating a stable profitability outlook [10] - The company reported a total asset value of 2.287 billion yuan as of 2023, with a projected increase to 5.214 billion yuan by 2026 [10][19]

Financial Performance - The company reported a net loss attributable to shareholders of 85,867,423.14 CNY for the reporting period, a decrease compared to the previous year[18]. - Basic earnings per share for 2023 was -0.95 CNY, an improvement from -1.16 CNY in 2022[16]. - The weighted average return on net assets was -27.98%, a decrease of 1.97 percentage points from the previous year[16]. - The company’s net profit after deducting non-recurring gains and losses was -50,814,675.39 CNY, reflecting a significant loss reduction[18]. - The diluted earnings per share also stood at -0.95 CNY, consistent with the basic earnings per share[16]. - The company experienced a decrease in the weighted average return on net assets after deducting non-recurring gains and losses, which was -33.46%[17]. - The company’s operating revenue for 2023 was ¥704,794,652.84, representing a 54.86% increase compared to ¥455,131,950.13 in 2022[196]. - The net profit attributable to shareholders for 2023 was -¥394,531,428.45, an improvement from -¥480,398,851.59 in 2022[196]. - The adjusted net profit excluding non-recurring gains and losses for 2023 was -¥471,830,530.42, an improvement from -¥522,645,205.81 in 2022[196]. - The net cash flow from operating activities decreased by ¥48,053,035.12 compared to the previous year, primarily due to a smaller increase in cash received from sales compared to cash paid for operating activities[198]. - The total assets at the end of 2023 were ¥2,287,097,856.78, a 4.93% increase from ¥2,179,736,935.85 at the end of 2022[196]. - The net assets attributable to shareholders decreased by 24.55% to ¥1,212,715,420.61 at the end of 2023 from ¥1,607,255,215.08 at the end of 2022[196]. - In Q1 2023, the operating revenue was ¥154,927,728.15, while in Q2 2023, it was ¥159,738,745.66[199]. - The net profit attributable to shareholders in Q4 2023 was -¥12,351,191.33, showing a significant reduction in losses compared to earlier quarters[199]. - The net profit attributable to shareholders in Q3 2023 was -¥128,559,363.86, indicating ongoing challenges[199]. Research and Development - Research and development expenses accounted for 109.06% of operating revenue, a decrease of 26.37 percentage points compared to 2022[17]. - The total R&D investment for the year was approximately ¥768.64 million, representing a 24.70% increase compared to the previous year[175]. - The ratio of total R&D investment to operating income decreased by 26.37 percentage points to 109.06%[175]. - The company has submitted 94 patent applications and received 5 patents, with a total of 57 authorized patents and 213 pending applications as of December 31, 2023[85]. - The company has multiple products in clinical research and preclinical stages, indicating a robust pipeline for future growth[90]. - The company is developing multiple bispecific antibodies and multifunctional molecules targeting tumors and autoimmune diseases, with clinical studies for BAT7104 already underway in Australia and domestically[171]. - The company has developed several ADCC-enhanced antibody candidates that are currently in various clinical trial stages[157]. - The company has established a leading antibody drug technology platform, IDEAL, which is actively advancing multiple projects in clinical research[151]. - The company has a total of 213 pending patent applications, covering various regions including mainland China, Hong Kong, Macau, Taiwan, and international jurisdictions[172]. Product Development and Approvals - The company received FDA approval for two products during the reporting period: BAT1806 (Tocilizumab) in September 2023 and BAT1706 (Bevacizumab) in December 2023, marking significant milestones[41]. - BAT1806 is the first biosimilar Tocilizumab approved by the FDA and the first monoclonal antibody developed and produced by a Chinese company to receive FDA approval[41]. - BAT1806 (Tocilizumab) received approval from the National Medical Products Administration in January 2023 and from the FDA in September 2023, marking it as the first biosimilar of Tocilizumab approved in both China and the US[67]. - BAT1706 (Bevacizumab) has been commercialized in multiple global regions, including partnerships with BeiGene in China and Sandoz AG in the US and Europe[66]. - The company has established commercial production capabilities for Gelerit®, Pubeixi®, and Shilili® and has a robust GMP management system[44]. - The company has signed commercialization agreements for BAT2206 (Ustekinumab) and BAT1706 (Bevacizumab) in Brazil, Indonesia, Pakistan, and Afghanistan, expanding its global market presence[56]. - The company has established a comprehensive quality management system compliant with international standards, ensuring product quality throughout the lifecycle[106]. - The company has successfully launched three biosimilar products, including BAT1706 (Bevacizumab), which received FDA approval and is marketed as Avzivi® in the U.S.[149]. - BAT2506 (Golimumab) has completed global Phase III clinical trials and targets TNF-α for treating autoimmune diseases, with market potential due to existing treatment limitations[70]. - The company has established multiple licensing and commercialization agreements for BAT1706 (Bevacizumab) in various international markets, including the U.S., Europe, and emerging countries[135]. - The company has signed licensing agreements for BAT1806 with Biogen for exclusive rights outside of China, enhancing international market development[109]. Market Trends and Opportunities - The global pharmaceutical market grew from $1.3 trillion in 2018 to $1.5 trillion in 2022, with projections to reach $2.1 trillion by 2030[112]. - The Chinese biopharmaceutical market increased from ¥262.2 billion in 2018 to ¥421 billion in 2022, with a compound annual growth rate (CAGR) of 12.6%[116]. - The global autoimmune disease treatment market reached $132.3 billion in 2022 and is expected to grow to $176.7 billion by 2030[118]. - The global biopharmaceutical market is projected to grow from $263.1 billion in 2022 to $783.2 billion by 2030, with a compound annual growth rate (CAGR) of 12.4% from 2022 to 2026[141]. - The Chinese biopharmaceutical market is expected to grow from 1.6 trillion RMB in 2022 to 2.6 trillion RMB by 2030, with a CAGR of 7.8% from 2022 to 2026[141]. - The aging population in China, with over 29.7 million people aged 60 and above, is expected to drive the demand for biopharmaceuticals, providing stable market support[139]. - The global tumor immunotherapy market reached $50.2 billion in 2022 and is expected to grow to $203.5 billion by 2030, indicating a significant growth trajectory[145]. - The ADC drug market grew from $2 billion in 2018 to $7.9 billion in 2022, with a compound annual growth rate (CAGR) of 40.4%, projected to reach $64.7 billion by 2030[145]. - The Chinese ADC drug market was valued at 800 million RMB in 2022 and is expected to reach 66.2 billion RMB by 2030[145]. - The biopharmaceutical market's share of biologics in autoimmune disease treatment is projected to exceed 80% by 2030[118]. Corporate Governance and Compliance - The company’s financial report was prepared in accordance with international accounting standards and Chinese accounting standards[19]. - The company has ensured the accuracy and completeness of the annual report, with all board members present at the meeting[22]. - The company emphasizes a data integrity and traceability quality management approach to maintain high standards in drug production[106]. - The commercial department has optimized market promotion strategies, increasing reliance on external CSOs for market outreach[107]. - The company is committed to independent innovation while actively seeking external collaboration opportunities globally[84]. - The company plans to not distribute profits or increase share capital from capital reserves for the 2023 fiscal year, pending shareholder approval[185]. - The company has not yet achieved profitability since its listing[179]. - The company has not capitalized any R&D expenditures during the reporting period[175].

关于百奥泰生物制药股份有限公司 募集资金存放与使用情况 专项报告的鉴证报告 二○二三年度 关于百奥泰生物制药股份有限公司 2023年度募集资金存放与使用情况专项报告的鉴证报告 | | 目 录 | 页 次 | | --- | --- | --- | | 一、 | 2023 年度募集资金存放与实际使用情况专项报告的鉴证报 | 1-3 | | | 告 | | | 二、 | 百奥泰生物制药股份有限公司 2023 年度募集资金存放与 | 1-10 | | | 使用情况专项报告 | | 关于百奥泰生物制药股份有限公司2023年度募集资金存放 与使用情况专项报告的鉴证报告 信会师报字[2024]第ZC10208号 三、工作概述 我们按照《中国注册会计师其他鉴证业务准则第3101号——历史 财务信息审计或审阅以外的鉴证业务》的规定执行了鉴证业务。该准 则要求我们遵守职业道德规范，计划和实施鉴证工作，以对募集资金 专项报告是否在所有重大方面按照中国证券监督管理委员会《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 鉴证报告第 1页 鉴证报告第 1页 百奥泰生物制药股份有限公司全体股东： 我们接受委托，对后附的 ...

证券代码：688177 证券简称： 百奥泰 公告编号：2024-015 百奥泰生物制药股份有限公司 与关联方签署分布式屋顶光伏电站能源管理协议暨 关联交易的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 重要内容提示： 百奥泰生物制药股份有限公司（以下简称"百奥泰"或"公司"）拟与关联 方广州七喜电脑有限公司（以下简称"七喜电脑"）签署分布式屋顶光伏电站能源 管理协议，百奥泰将提供营销总部大楼的屋顶，由七喜电脑负责建设、运营光伏 发电系统项目（以下简称"项目"），百奥泰按当地电网同时段工商业电价的 85% 与七喜电脑结算，本项目预计投建总容量为 633.94KW（以实际安装为准）的光 伏发电系统，协议约定项目运营期限自建成并网之日起算二十年（以下称"运营 期限"），项目所发电能由百奥泰优先使用，剩余电能接入公共电网，电能的电费 收入由七喜电脑享有。七喜电脑自行负责项目的设计、政府许可或备案文件的办 理、设备采购、施工建设以及项目运维管理并承担由此发生的费用。 七喜电脑系百奥泰控股股东广州七喜集团有限公司的控股子公司， ...

百奥泰生物制药股份有限公司 内部控制审计报告 二〇二三年度 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、 2023 年度内部控制审计报告 1-2 内部控制审计报告 信会师报字[2024]第 ZC10207 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） 2023 年 12 月 31 日的财务报告内部控制的有效性。 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。 (此页无正文) 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，或对控制政策 和程序遵循的程度降低，根据内部控制审计结果推测未来内部控制的 有效性具 ...

证券代码：688177 证券简称：百奥泰 公告编号：2024-022 百奥泰生物制药股份有限公司 关于提请股东大会授权董事会以简易程序向特 定对象发行股票的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈 述或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 一、本次授权事项概述 根据《上市公司证券发行注册管理办法》《上海证券交易所上市公司证券发 行上市审核规则》《上海证券交易所上市公司证券发行与承销业务实施细则》等 相关规定，百奥泰生物制药股份有限公司（以下简称"公司"）于 2024 年 3 月 28 日召开第二届董事会第十四次会议，审议通过了《关于提请股东大会授权董事 会以简易程序向特定对象发行股票的议案》，同意公司董事会提请股东大会授权 董事会决定和办理向特定对象发行融资总额不超过人民币 3 亿元且不超过最近 一年末净资产 20%的股票，授权期限自公司 2023 年年度股东大会审议通过之日 起至公司 2024 年年度股东大会召开之日止。上述议案已经公司第二届董事会独 立董事第一次专门会议审议，独立董事全票同意议案内容并同意将该议案提交 公司董事会审议。本议案尚需提交 ...

证券代码： 688177 证券简称： 百奥泰 公告编号：2024-016 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 根据《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上市公司自律监管指引第 1 号——规范运作》和 《上海证券交易所科创板股票上市规则》等有关规定，百奥泰生物制药股份有限 公司（以下简称"百奥泰"或"公司"）董事会对 2023 年度募集资金存放与实际使 用情况专项报告说明如下： 一、 募集资金基本情况 （一）实际募集资金的金额及到账情况 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，本公司公 开发行人民币普通股 60,000,000 股，发行价格为人民币 32.76 元/股。募集资金总 额为人民币 1,965,600,000.00 元，募集资金净额为人民币 1,8 ...

证券代码： 688177 证券简称：百奥泰 公告编号：2024-021 邮箱：IR@bio-thera.com 联系地址：广州市黄埔区科学城科学大道 286 号七喜大厦 10 楼 特此公告。 百奥泰生物制药股份有限公司董事会 2024 年 3 月 29 日 百奥泰生物制药股份有限公司 关于聘任证券事务代表的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 百奥泰生物制药股份有限公司（以下简称 "公司"）于 2024 年 3 月 28 日召 开第二届董事会第十四次会议，审议通过了《关于聘任证券事务代表的议案》， 同意聘任宋姗珊女士（简历见附件）担任公司证券事务代表，协助董事会秘书开 展工作，任期自董事会审议通过之日起至第二届董事会届满之日止。 宋姗珊女士已取得上海证券交易所科创板董事会秘书资格证书，具备履行职 责所必须的专业知识、相关素质与工作经验，能够胜任相关岗位职责的要求，符 合《中华人民共和国公司法》《上海证券交易所科创板股票上市规则》等相关法 律法规的规定。 公司证券事务代表联系方式： 电话：020-322035 ...

中国国际金融股份有限公司 关于百奥泰生物制药股份有限公司 2024 年度日常关联交易预计的核查意见 一、日常关联交易基本情况 （一）日常关联交易履行的审议程序 公司于2024年3月28日召开第二届董事会第十四次会议、第二届监事会第十三次会 议审议通过了《关于公司2024年度日常关联交易预计的议案》，公司董事、监事一致审 议通过了该议案，审议程序符合《中华人民共和国公司法》《中华人民共和国证券法》 等法律法规以及《百奥泰生物制药股份有限公司章程》的有关规定。 公司于2024年3月28日召开第二届董事会独立董事第一次专门会议审议通过了《关 于公司2024年度日常关联交易预计的议案》，公司独立董事一致审议通过了该议案，并 形成以下意见：公司2024年度日常关联交易预计是基于公司正常经营业务所需，该关联 交易是公司正常经营、提高经济效益的市场化选择，符合公司实际经营需要；该关联交 易遵循了"公平、公正、公允"的原则，交易事项符合市场原则，决策程序合法，交易 定价公允合理，不会对公司的独立性产生不利影响，公司的主要业务不会因此类交易对 关联方形成依赖，不存在损害公司及其他股东利益，特别是中小股东利益情况。独立董 事同意 ...