| 投资者关系 | □特定对象调研 □分析师会议 □媒体采访 □新闻发布会 | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | 活动类别 | √业绩说明会 □路演活动 □电话会议 | | | □现场参观 | | | | | | □其他： | | | | | | | | 时间 | 2024 年 4 月 日 15:00-17:00 | 15 | | | | | | | 地点 | 上证路演中心（网址：http://roadshow.sseinfo.com/） | | | | | | | | 接待人员 | 董事长、总经理：LI SHENGFENG（李胜峰）先生 董事、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 | | | | | | | | | 公司于 2024 4 月 15 日 在上证路演中心（网 | | 年 | 15:00-17:00 | | | | | | 址：http://roadshow.sseinfo.com/） ...

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 首次公开发行股票并在科创板上市之持续督导保荐总结报告书 经中国证券监督管理委员会（以下简称"中国证监会"）《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）核准并 经上海证券交易所同意，百奥泰生物制药股份有限公司（以下简称"百奥泰"或 "公司"或"上市公司"）获准公开发行人民币普通股 6,000 万股，募集资金总额 为人民币 196,560.00 万元。 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"）作为公 司首次公开发行股票并在科创板上市的保荐机构，根据《上海证券交易所科创板股 票上市规则》的相关规定，中金公司的持续督导期间为 2020 年 2 月 21 日至 2023 年 12 月 31 日。截至 2023 年 12 月 31 日，前述持续督导期限已届满。 截至 2023 年 12 月 31 日，公司首次公开发行的募集资金尚未使用完毕，中金 公司将对其募集资金使用情况继续履行持续督导义务。 中金公司根据《证券发行上市保荐业务管理办法》、《上海证券交易所上市公 司自律监管指引第 11 号 ...

中国国际金融股份有限公司 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"）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》和《上海 证券交易所上市公司自律监管指引第 11 号——持续督导》等相关规定对百奥泰生 物制药股份有限公司（以下简称"百奥泰"、"公司"或"上市公司"）进行持续督 导，并出具本持续督导跟踪报告。 关于百奥泰生物制药股份有限公司 一、持续督导工作情况 2023 年度持续督导跟踪报告 | 序号 | 工作内容 | 持续督导情况 | | --- | --- | --- | | 1 | 建立健全并有效执行持续督导工作制度，并针 | 保荐机构已建立健全并有效执行了持续 | | | 对具体的持续督导工作制定相应的工作计划 | 督导制度，并制定了相应的工作计划 | | 2 | 根据中国证监会相关规定，在持续督导工作开 | 保荐机构已与百奥泰签订《保荐协议》， | | | 始前，与上市公司或相关当事人签署持续督导 | 已明确双方在持续督导期间的权利和义 | | | 协议，明确双方在持续督导期间的权利义务， | 务，并已报上海证券交易所备案 | | | 并报上海证券交易 ...

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 （六）现场检查手段： 1、对公司高级管理人员等有关人员进行访谈； 2023 年度持续督导工作现场检查报告 上海证券交易所： 经中国证券监督管理委员会（以下简称"中国证监会"）《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，百奥泰生物制药股份有限公司（以下简称"百奥泰"或"公司"或"上 市公司"）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。 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 百奥泰首次公开发行股票并持续督导的保荐机构，负责对百奥泰的持续督导工作。 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》 《上海证券交易所上市公司自律监管指引第11号——持续督导》《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》等有关法律、法规的规定， 本着审慎和勤勉尽责的原则，对公司2023年度的规范运作情况进行 ...

证券代码：688177 证券简称：百奥泰 百奥泰生物制药股份有限公司 2023年年度股东大会会议资料 2024 年 4 月 18 日 | 2023 年年度股东大会会议须知 | 2 | | | | --- | --- | --- | --- | | 年年度股东大会会议议程 2023 | 5 | | | | 2023 年年度股东大会议案 | 7 | | | | 议案一：关于公司 2023 | 年年度报告及摘要的议案 | 8 | | | 议案二：关于公司 2023 | 年度董事会工作报告的议案 | 9 | | | 议案三：关于公司 2023 | 年度监事会工作报告的议案 | 10 | | | 议案四：关于公司 2023 | 年度财务决算报告的议案 | 11 | | | 议案五：关于公司 2023 | 年度利润分配方案的议案 | 12 | | | 议案六：关于公司 2024 | 年度董事、监事和高级管理人员薪酬方案的议案 | 13 | | | 议案七：关于续聘 2024 | 年度会计师事务所的议案 | | 14 | | 议案八：关于向金融机构申请授信额度的议案 | | 18 | | | 议案九：关于提请股东大会授权董 ...

券 研 告 司 究 究 证券研究报告 ▌ 盈利预测 ▌ 风险提示 | --- | --- | --- | --- | --- | |----------------------|-------------------------|--------|-------|-------| | 预测指标 | 2023A 2024E 2025E 2026E | | | | | 主营收入（百万元） | 705 | 1,137 | 1,581 | 2,212 | | 增长率（%） | 54.9% | 61.3% | 39.1% | 40.0% | | 归母净利润（百万元） | -395 | -144 | 192 | 639 | | 增长率（%） | 233.0% | | | | | 摊薄每股收益（元） | -0.95 | -0.35 | 0.46 | 1.54 | | ROE （%） | -32.5% | -13.4% | 15.3% | 34.7% | 请阅读最后一页重要免责声明 2 | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | |------- ...

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].