证券代码：688177 证券简称：百奥泰 公告编号：2024-031 百奥泰生物制药股份有限公司 关于与 STADA 就 BAT2506（戈利木单抗）注射液 签署授权许可与商业化协议的公告 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。 重要内容提示: 协议内容摘要： 百奥泰生物制药股份有限公司（以下简称"百奥泰"或"公司"）与 STADA Arzneimittel AG （以下简称"STADA"）签署授权许可与商业化协议，将公司的 BAT2506（戈利木单抗）注射液在欧盟、英国、瑞士以及其他部分欧洲国家市 场的独占的产品商业化权益有偿许可给 STADA（以下简称"协议"或"本协议"）。 交易标的名称：BAT2506（戈利木单抗）注射液在欧盟、英国、瑞士以及其 他部分欧洲国家市场的独占的产品商业化权益。 交易金额：首付款及里程碑款总金额最高至 1.575 亿美元，其中包括 1,000 万美元首付款、累计不超过 1.475 亿美元里程碑付款，以及净销售额的两位数百 分比作为收入分成。 协议生效条件：经双方签订盖章并经百奥泰董 ...

证券代码：688177 证券简称：百奥泰 公告编号：2024-028 百奥泰生物制药股份有限公司 自愿披露关于 BAT1308 联合 BAT8006 获得药物临床试验批准通知书的公告 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《药物临床试验批准通 知书》，公司在研药品 BAT1308 联合 BAT8006 治疗晚期实体瘤的临床试验申请 获得批准。 根据《Clinical Development Success Rates2011-2020》公布的数据，通常情况 下对于抗肿瘤药物，一般 I/II 期临床研究阶段持续约 2 年时间，I 期完成进入 II 期的比率约 48.8%，II 期完成进入 III 期的比率约 24.6%，考虑到临床研究周期 长、投入大，过程中不可预测因素较多，临床试验、审评和审批的结果以及时间 都具有一定的不确定性，容易受到一些不确定性因素的影响，敬请广大投资者 ...

证券代码： 688177 证券简称： 百奥泰 公告编号：2024-027 申请事项：境内生产药品注册上市许可 百奥泰生物制药股份有限公司 关于 BAT2206（乌司奴单抗）注射液 上市许可申请获得受理的公告 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"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"）核准签发的关于公司在研药品 乌司奴单抗注射液（以下简称"BAT2206"）药品上市许可申请的《受理通知 书》。 BAT2206经审评审批通过后可获发药品批准证书并可投入生产、销售，因 为审评审批的办结时间无法预估，所以本次获得药品上市许可申请受理通知书 对公司近期业绩不会产生影响。 一、 《受理通知书》基本情况 药品名称：乌司奴单抗注射液、乌司奴单抗注射液（静脉输注） 剂型：注射剂 规格：45mg/0.5mL，90mg/1.0mL，130mg/26mL 受理号：CXSS2400046，CXSS2400047，CXSS2400048 审批结论：根据《中华人民共和 ...

Financial Performance - The company's operating revenue for Q1 2024 was RMB 161,591,937.51, representing a year-on-year increase of 4.30%[26] - The net profit attributable to shareholders of the listed company for Q1 2024 was a loss of RMB 118,958,055.48[26] - The net profit attributable to shareholders after deducting non-recurring gains and losses was a loss of RMB 122,773,183.58[26] - The basic and diluted earnings per share for Q1 2024 were both -0.29 RMB[26] - The weighted average return on net assets for Q1 2024 was -10.32%[26] - Total operating revenue for Q1 2024 was $161.59 million, an increase of 4.3% compared to $154.93 million in Q1 2023[41] - Net profit for Q1 2024 was a loss of $118.96 million, an improvement from a loss of $142.58 million in Q1 2023[42] - Basic and diluted earnings per share for Q1 2024 were both -0.29, compared to -0.34 in Q1 2023[44] - The company's net loss for the period was CNY -119,035,070.61, an improvement from CNY -143,294,729.60 in the previous period[55] - The company reported a net loss of CNY 118,895,169.25 for Q1 2024, an improvement from a net loss of CNY 140,205,070.68 in Q1 2023[82] Shareholder Information - The total number of ordinary shareholders at the end of the reporting period was 7,352[17] - The largest shareholder, Guangzhou Qixi Group Co., Ltd., held 38.64% of the shares, totaling 159,990,270 shares[17] - Therabio International Limited, the second-largest shareholder, held 11.39% of the shares, totaling 47,177,729 shares[17] - The company has not reported any significant changes in the top 10 shareholders due to margin trading or securities lending[21] Cash Flow and Liquidity - The net cash flow from operating activities for Q1 2024 was a negative RMB 64,803,155.03[26] - Net cash flow from operating activities increased due to higher cash received from sales of goods and services[28] - Cash and cash equivalents increased to ¥341,977,265.74 from ¥163,986,759.82, reflecting improved liquidity[36] - Cash and cash equivalents at the end of Q1 2024 totaled $295.74 million, down from $357.78 million at the end of Q1 2023[48] - The net cash flow from financing activities in Q1 2024 was $74.15 million, a decrease from $248.69 million in Q1 2023[48] - Cash inflow from operating activities for Q1 2024 was $220,047,817.51, an increase of 18.3% compared to $186,026,836.36 in Q1 2023[85] - Net cash flow from operating activities for Q1 2024 was -$64,845,661.88, an improvement from -$145,550,657.10 in Q1 2023[85] Research and Development - Total R&D investment amounted to ¥171,622,215.16, a decrease of 25.71%[27] - R&D investment as a percentage of operating revenue decreased by 42.90 percentage points to 106.21%[27] - Research and development expenses were $171.62 million in Q1 2024, down 25.7% from $231.02 million in Q1 2023[41] - Research and development expenses for Q1 2024 were CNY 173,059,632.30, down from CNY 233,112,801.12 in Q1 2023, a decrease of approximately 25.8%[82] - The company plans to continue focusing on R&D and market expansion strategies in the upcoming quarters[41] Assets and Liabilities - Total assets at the end of the reporting period were ¥2,259,221,078.96, down 1.22% from the previous year[27] - Total assets as of Q1 2024 were $2.26 billion, a slight decrease from $2.29 billion in Q1 2023[52] - Total liabilities increased to CNY 1,164,943,634.68, up from CNY 1,073,907,031.98, representing a growth of approximately 8.1%[53] - The total owner's equity decreased to CNY 1,095,160,786.70 from CNY 1,214,195,857.31, reflecting a decline of about 9.8%[53] - The company's retained earnings showed a negative balance of CNY -2,351,443,995.19, worsening from CNY -2,232,408,924.58[53] - The total assets decreased slightly to CNY 2,259,221,078.96 from CNY 2,287,097,856.78, a decline of about 1.2%[64] - Total liabilities and shareholders' equity as of March 31, 2024, were CNY 2,260,104,421.38, a slight decrease from CNY 2,288,102,889.29 at the end of 2023[76] Operational Efficiency - Total operating costs decreased to $284.40 million in Q1 2024 from $323.39 million in Q1 2023, representing a reduction of 12.1%[41] - The company reported a decrease in sales expenses to $49.93 million in Q1 2024 from $41.04 million in Q1 2023[41] - Cash outflow for purchasing fixed assets and intangible assets in Q1 2024 was $43,235,271.99, a decrease of 53.1% from $92,098,312.72 in Q1 2023[85]

证券代码： 688177 证券简称： 百奥泰 公告编号：2024-026 百奥泰生物制药股份有限公司 自愿披露关于 TOFIDENCE（托珠单抗注射液）获 欧洲药品管理局人用药品委员会积极意见的公告 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"百奥泰"或"公司"）的合作伙伴 Biogen International GmbH（以下简称"Biogen"）于近日收到了欧洲药品管理局 （以下简称"欧洲EMA"）的通知， TOFIDENCE（BAT1806，托珠单抗注射液） 获得欧洲EMA人用药品委员会（以下简称"CHMP"）积极意见。CHMP建议欧 盟委员会批准TOFIDENCE上市，用于治疗类风湿性关节炎、多关节型幼年特发 性关节炎、全身型幼年特发性关节炎和COVID-19。 现将相关情况公告如下： 一、 药品相关情况 药品名称：托珠单抗注射液 考虑到医药产品具有高科技、高风险、高附加值的特点，药品的前期研发 以及产品从研制、临床试验报批到投产的周期长，易受到技术、审批、政策等 多方面 ...

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 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 ...

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 ...