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 ...

证券代码：688177 证券简称：百奥泰 公告编号：2024-023 百奥泰生物制药股份有限公司 关于参加 2023 年度生物制品专场 集体业绩说明会的公告 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： 投资者可于 2024 年 4 月 12 日（星期五）16:00 前登录上证路演中心网站 首页点击"提问预征集"栏目或通过公司邮箱 IR@bio-thera.com 进行提问。公司将 在说明会上对投资者普遍关注的、有代表性的问题逐条进行回答。 一、 说明会类型 三、 参会人员 公司董事长兼总经理 LI SHENGFENG（李胜峰）先生、董事会秘书鱼丹女 士、财务总监占先红女士、独立董事 HENRY WEI（魏亨利）先生（如有特殊情 况，参会人员将可能进行调整）。 四、 投资者参加方式 （一）欢迎投资者于 2024 年 4 月 15 日（星期一）15:00-17:00 登陆上海证 券交易所上证路演中心（http://roadshow.sseinfo.com），在线参与本次说明会。 （二）投资者可于 2024 ...

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 ...

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 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 易的核查意见 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"上市公司"或"公司"） 首次公开发行股票并在科创板上市项目的保荐机构，根据《证券发行上市保荐业 务管理办法》《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）》及《上海证券交易所上市公司自律监管指引第 11 号——持续督导》 等有关规定，对百奥泰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 易事项进行了核查，具体核查情况如下： 一、关联交易概述 为充分利用百奥泰建筑物屋顶，降低公司运营成本，百奥泰拟与广州七喜电 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， 百奥泰将提供建筑物屋顶共计2,000平方米，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用电电价的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 ...

证券代码：688177 证券简称：百奥泰 公告编号：2024-011 百奥泰生物制药股份有限公司 第二届董事会第十四次会议决议的公告 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。 二、董事会会议审议情况 经与会董事充分讨论，本次会议以记名投票方式审议通过了如下议案： （一）审议通过《关于公司 2023 年年度报告及摘要的议案》 本议案已经董事会审计委员会全体委员审议通过并提交董事会审议。经审 议，董事会认为公司 2023 年年度报告的编制和审议程序符合相关法律法规及 《公司章程》等内部规章制度的规定；公司 2023 年年度报告的内容与格式符合 相关规定，公允地反映了公司 2023 年度的财务状况和经营成果等事项；年度报 告编制过程中，未发现公司参与年度报告编制和审议的人员有违反保密规定的 行为；董事会全体成员保证公司 2023 年年度报告披露的信息真实、准确、完整， 不存在任何虚假记载、误导性陈述或重大遗漏，并对其内容的真实性、准确性 和完整性依法承担法律责任。 具 体 内 容 详 见 公 司 于 2024 年 3 月 ...

证券代码：688177 证券简称：百奥泰 公告编号：2024-012 百奥泰生物制药股份有限公司 第二届监事会第十三次会议决议的公告 本公司监事会及全体监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、准确性和完整性承担个别及连带责任。 一、 监事会会议召开情况 百奥泰生物制药股份有限公司（以下简称"公司"）第二届监事会第十三次会 议（以下简称"本次会议"）于 2024 年 3 月 28 日在公司会议室以现场方式召开， 本次会议通知及相关材料已于 2024 年 3 月 18 日以书面方式送达公司全体监事。 本次会议由监事会主席吴晓云召集并主持，会议应出席监事 3 人，实际出席监事 3 人。会议的召集、召开和表决程序符合《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、行政法规、规范性文件及《百奥泰生 物制药股份有限公司章程》（以下简称"《公司章程》"）的有关规定。 二、 监事会会议审议情况 经与会监事充分讨论，本次会议以记名投票方式审议通过了如下议案： (一) 审议通过《关于公司 2023 年年度报告及摘要的议案》 经审议，监事会认为公司 2023 年 ...

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 2023 年度募集资金存放与使用情况的专项核查报告 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"发行人"或"公司"） 持续督导的保荐机构，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》《证券发行上市保荐业务管理办法》《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》《上海证券交易所科创板股票上 市规则》《上海证券交易所上市公司自律监管指引第 11 号——持续督导》等相关 法律、法规和规范性文件的规定，中金公司及其指定保荐代表人对 2023 年度募 集资金存放与使用情况进行了专项核查，核查情况与意见如下： 一、募集资金基本情况 （一）实际募集资金金额、资金到位情况 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 ...

证券代码：688177 证券简称：百奥泰 公告编号：2024-013 百奥泰生物制药股份有限公司 关于召开 2023 年年度股东大会的通知 本公司董事会及全体董事保证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： 一、 召开会议的基本情况 （一） 股东大会类型和届次 （四） 现场会议召开的日期、时间和地点 召开日期时间：2024 年 4 月 18 日 14 点 30 分 召开地点：广州市黄埔区永和经济开发区摇田河大街 155 号 E 栋 5K702 会 议室 （五） 网络投票的系统、起止日期和投票时间。 网络投票系统：上海证券交易所股东大会网络投票系统 网络投票起止时间：自 2024 年 4 月 18 日 至 2024 年 4 月 18 日 2023 年年度股东大会 （二） 股东大会召集人：董事会 （三） 投票方式：本次股东大会所采用的表决方式是现场投票和网络投票相结 合的方式 （六） 融资融券、转融通、约定购回业务账户和沪股通投资者的投票程序 涉及融资融券、转融通业务、约定购回业务相关账户以及沪股通投资者的 投票，应按照《上海证券交 ...