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百奥泰:百奥泰监事会关于公司2023年度向特定对象发行A股股票相关事项的书面审核意见
2023-12-01 09:54
2、 本次发行的定价方式公平、公允,符合相关法律法规的规定,不存在 损害公司及全体股东特别是中小股东利益的情形。 百奥泰生物制药股份有限公司监事会 关于公司 2023年度向特定对象发行 A 股股票相关事项的书 面审核意见 根据《中华人民共和国公司法》(以下简称"《公司法》")、《中华人民 共和国证券法》(以下简称"《证券法》")、《上市公司证券发行注册管理办 法》(以下简称"《管理办法》")、《上海证券交易所科创板股票上市规则》 《上市公司治理准则》等法律、法规及规范性文件以及《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,百奥泰生物制药股 份有限公司(以下简称"公司")监事会在全面了解和审核公司 2023年度向特定 对象发行 A 股股票(以下简称"本次发行")的相关文件后,发表书面审核意见 如下: 1、本次发行的发行方案、发行预案符合《公司法》《证券法》《管理办 法》等相关法律、法规及规范性文件的规定,本次发行方案切实可行,符合公 司的实际情况和全体股东的利益,不存在损害公司及全体股东特别是中小股东 利益的情形。 监事会 ンの23年 3、 根据公司编制的《百奥泰生物制药股份有限公 ...
百奥泰:百奥泰关于本次募集资金投向属于科技创新领域的说明(修订稿)
2023-12-01 09:54
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 Bio-Thera Solutions, Ltd. (广州高新技术产业开发区科学城开源大道11号A6栋第五层) 关于本次募集资金投向属于 科技创新领域的说明(修订稿) $$\Xi=0\Xi\Xi\#+-\Xi$$ 百奥泰生物制药股份有限公司 关于本次募集资金投向属于科技创新领域的说明(修订稿) 百奥泰生物制药股份有限公司 关于本次募集资金投向属于科技创新领域的说明 一、公司的主营业务 公司是一家以创新药和生物类似药研发为核心的创新型生物制药企业,秉承 "创新只为生命"的理念,坚持创新驱动发展战略,致力于开发新一代创新药和 生物类似药,用于治疗肿瘤、自身免疫性疾病、心血管疾病以及其它危及人类生 命或健康的重大疾病。 医药行业是国民经济支柱性行业之一,是关系国计民生的重要产业,是战略 性新兴产业的重点发展领域,是"健康中国"建设的重要基础,创新药属于医药 行业中的战略新兴部分。长期以来我国药品以仿制药为主,为提升我国药品的创 新能力,降低对国外药品的依赖,近年来我国颁布多项政策,支持并鼓励创新药 的研发工作。公司专注于创新药的研究,迎合国家战略 ...
百奥泰(688177) - 百奥泰2023年11月投资者活动记录表
2023-11-16 10:42
Group 1: Product Development and Approval - Bevacizumab and tocilizumab have completed on-site inspections by the FDA and EMA, with tocilizumab (brand name: TOFIDENCE) receiving FDA approval in September 2023, marking it as the first monoclonal antibody drug developed and produced by a Chinese company to gain FDA approval [2] - BAT2506 (golimumab) is currently in global Phase III clinical trials, with patient enrollment expected to be completed in 2023. The company plans to pursue commercialization through global and regional partnerships, having already established cooperation with Pharmapark LLC for the drug in Russia and other CIS countries [2][3] Group 2: Global Market Strategy - The company recognizes the necessity of entering the global biopharmaceutical market, particularly in Europe and the U.S., which hold a significant share of the market. It will analyze trial data and market conditions while maintaining effective communication with global regulatory agencies [3] - The company is actively exploring opportunities for global commercialization of its innovative drugs, with a focus on maintaining compliance with international regulations [3] Group 3: Innovative Drug Pipeline - BAT2094 (batifiban) is a peptide β3 integrin receptor inhibitor for perioperative antithrombotic therapy, with a marketing authorization application submitted to the National Medical Products Administration [3] - BAT5906 is a monoclonal antibody designed for treating retinal diseases, currently in Phase III clinical trials for wet age-related macular degeneration (wAMD) [3] - BAT4406F is a next-generation glyco-optimized fully human anti-CD20 antibody, also in Phase III clinical trials for neuromyelitis optica spectrum disorders [3] Group 4: Technology Platforms - The company has established seven leading core technology platforms covering the entire drug development and production process, including antibody library and display technology, antibody structure and engineering design, and ADC technology [3] - The new ADC platform features three main characteristics: fully human or humanized monoclonal antibodies, PEG-modified cleavable linkers with strong stability and low off-target toxicity, and potent payloads with strong membrane permeability [3] Group 5: Financial Planning and Risks - The company adjusts R&D expenses based on product development progress and is exploring other financing channels as needed. Currently, there are no financial constraints affecting R&D and operations [4] - Investors are advised to be aware of investment risks related to industry forecasts and company development strategies, as these do not constitute commitments or guarantees from the company [4]
百奥泰(688177) - 百奥泰投资者关系活动记录表(2023年11月10日)
2023-11-13 08:46
百奥泰生物制药股份有限公司 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 投资者关系活动记录表 □特定对象调研□分析师会议□媒体采访□新闻发布会√业绩说明会 投资者关系活 动类别 路演活动√现场参观√电话会议□其他: 3W fund、AIHC Capital、Point72、润晖投资、淡水泉、易方达、中欧基 金、景顺长城基金、兴全基金、交银施罗德、华宝基金、华安基金、南 方基金、天弘基金、中国人寿泰康、阳光资产、东方红资管、红杉、中 参与单位名称 信建投、诺德基金、嘉实基金、千宜投资、招商基金、鹏扬基金、光证 资管、宁银理财、润晖投资、长城基金、国调基金、广东粤科金融、广 州产业投资、广州国聚创业、江西大成等。 时间 2023年11月10日 地点 公司会议室 董事长、总经理:李胜峰 ...
百奥泰:百奥泰关于召开2023年第三季度业绩说明会的公告
2023-11-13 08:16
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、准确性和完整性承担法律责任。 重要内容提示: 会议召开时间:2023 年 12 月 6 日(星期三)上午 09:00-10:00 会 议 召 开 地 点 : 上 海 证 券 交 易 所 上 证 路 演 中 心 ( 网 址 : https://roadshow.sseinfo.com/) 会议召开方式:上证路演中心网络互动 证券代码:688177 证券简称:百奥泰 公告编号:2023-060 百奥泰生物制药股份有限公司 关于召开 2023 年第三季度业绩说明会的公告 本次投资者说明会以网络互动形式召开,公司将针对 2023 年度第三季度的 经营成果及财务指标的具体情况与投资者进行互动交流和沟通,在信息披露允许 的范围内就投资者普遍关注的问题进行回答。 (二)会议召开地点:上证路演中心(https://roadshow.sseinfo.com/) (三)会议召开方式:上证路演中心网络互动 三、参加人员 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。(如有特殊情况 ...
百奥泰(688177) - 2023 Q3 - 季度财报
2023-10-26 16:00
Financial Performance - Total revenue for Q3 2023 was ¥146,383,740.09, a decrease of 4.19% compared to the same period last year[5]. - Net profit attributable to shareholders for Q3 2023 was -¥128,559,363.86, with a year-to-date net profit of -¥382,180,237.12[5]. - Basic and diluted earnings per share for Q3 2023 were both -¥0.31[9]. - The net profit for the third quarter of 2023 was -382,180,237.12 CNY, compared to -255,621,854.06 CNY in the same period of 2022, representing a year-over-year decline of approximately 49.4%[42]. - The company reported a total comprehensive income of -382,127,705.49 CNY for the third quarter, compared to -255,446,268.88 CNY in the previous year, indicating a decline of approximately 49.5%[45]. - The company reported a net profit of ¥461,050,213.90 for the first three quarters of 2023, compared to ¥381,785,964.28 in the same period of 2022, reflecting a growth of about 20.9%[36]. - Operating revenue for the first three quarters of 2023 reached CNY 461,050,213.90, a 21% increase compared to CNY 381,785,964.28 in the same period of 2022[66]. Research and Development - R&D expenses for Q3 2023 amounted to ¥190,027,538.46, an increase of 22.07% year-over-year, representing 129.81% of total revenue[9]. - The net profit attributable to shareholders for the year-to-date period decreased primarily due to increased R&D expenses compared to the previous year[15]. - The company is currently in the clinical research phase with multiple projects in Phase III clinical trials, leading to increased clinical trial and technical service costs[15]. - Research and development expenses surged to ¥609,935,344.48 from ¥422,090,457.76, a significant increase of approximately 44.5%[39]. - The company has indicated plans for market expansion and new product development, although specific details were not disclosed in the report[66]. Assets and Liabilities - Total assets as of the end of Q3 2023 were ¥2,333,501,593.23, reflecting a 7.05% increase from the end of the previous year[9]. - Total assets increased to ¥2,333,501,593.23, up from ¥2,179,736,935.85, representing a growth of approximately 7.0% year-over-year[34]. - Total liabilities increased to ¥1,108,374,083.64 from ¥572,481,720.77, marking an increase of around 93.5%[36]. - The company's total equity decreased to ¥1,225,127,509.59 from ¥1,607,255,215.08, a decline of approximately 23.7%[36]. - The company's equity decreased to CNY 1,226,100,255.71 from CNY 1,608,908,360.07, a decline of about 24%[59]. Cash Flow - Cash flow from operating activities for the year-to-date period was -¥358,146,180.10[9]. - The net cash flow from operating activities for the third quarter was -358,146,180.10 CNY, worsening from -266,574,644.11 CNY year-over-year[48]. - The net cash flow from operating activities for the first three quarters of 2023 was -¥358,448,480.50, compared to -¥266,915,083.43 in the first three quarters of 2022, indicating a worsening of approximately 34%[70]. - The total cash and cash equivalents at the end of the third quarter of 2023 amounted to ¥322,084,174.24, a significant increase from ¥153,525,975.32 at the end of the same period in 2022[71]. - The company generated 1,548,000,000.00 CNY from investment activities in the first nine months of 2023, down from 3,073,000,000.00 CNY in the same period of 2022[48]. - The net cash flow from investment activities for the first three quarters of 2023 was ¥140,077,438.28, a significant improvement from -¥379,822,726.81 in the first three quarters of 2022[71]. - The cash inflow from financing activities in the first three quarters of 2023 was ¥427,468,514.00, with a net cash flow of ¥396,822,894.07, compared to a net outflow of -¥32,422,859.82 in the same period of 2022[71]. Shareholder Information - The company reported a total of 8,376 common shareholders at the end of the reporting period[16]. - The top shareholder, Guangzhou Qixi Group Co., Ltd., holds 159,471,170 shares, representing 38.51% of the total shares outstanding[19]. - Therabio International Limited, another significant shareholder, owns 47,177,729 shares, accounting for 11.39% of the total shares[19]. - The company has engaged in securities lending, with 519,100 shares lent out, which is 0.13% of the total share capital[26]. Market and Strategic Focus - The company is exploring market expansion opportunities, as indicated by the involvement of various investment partnerships and funds[22]. - The report indicates that there are no new product launches or technological developments mentioned in the current quarter[29]. - There are no significant mergers or acquisitions reported in the current quarter[29].
百奥泰:上海市方达(广州)律师事务所关于百奥泰生物制药股份有限公司2023年第一次临时股东大会的法律意见书
2023-10-09 09:40
FANGDA PARTNERS 上海 Shanghai·北京 Beijing·深圳 Shenzhen·广州 Guangzhou·香港 Hong Kong http://www.fangdalaw.com 中国广东省广州市珠江新城 电子邮件 E-mail: email@fangdalaw.com 珠江东路 6 号 广州周大福金融中心 66 楼 电 话 Tel.: 86-20-3225-3888 邮政编码:510623 传 真 Fax: 86-20-3225-3899 66F, Guangzhou CTF Finance Centre, No.6 Zhujiang East Road, Zhujiang New Town Guangzhou 510623, PRC 上海市方达(广州)律师事务所 关于百奥泰生物制药股份有限公司 2023 年第一次临时股东大会的法律意见书 致:百奥泰生物制药股份有限公司 上海市方达(广州)律师事务所(以下简称"本所")是具有中华人民共和 国法律执业资格的律师事务所。根据相关法律顾问协议,本所指派律师出席百奥 泰生物制药股份有限公司(以下简称"百奥泰"或"公司")2023 年第一次临 ...
百奥泰:百奥泰2023年第一次临时股东大会决议公告
2023-10-09 09:40
证券代码:688177 证券简称:百奥泰 公告编号:2023-059 百奥泰生物制药股份有限公司 2023 年第一次临时股东大会决议公告 | 1、出席会议的股东和代理人人数 | 21 | | --- | --- | | 普通股股东人数 | 21 | | 2、出席会议的股东所持有的表决权数量 | 313,794,960 | | 普通股股东所持有表决权数量 | 313,794,960 | | 3、出席会议的股东所持有表决权数量占公司表决权数量的 | 75.7812 | | 比例(%) | | | 普通股股东所持有表决权数量占公司表决权数量的比例(%) | 75.7812 | (四) 表决方式是否符合《公司法》及公司章程的规定,大会主持情况等。 本次会议由公司董事会召集,董事长李胜峰先生主持。本次会议的召集、召 开程序、出席会议人员的资格、表决程序和表决结果符合《中华人民共和国公司 法》、《中华人民共和国证券法》等法律、法规和规范性文件以及《百奥泰生物制 药股份有限公司章程》的规定。 (五) 公司董事、监事和董事会秘书的出席情况 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 ...
百奥泰:百奥泰关于BAT1806(托珠单抗)注射液获得美国FDA上市批准的公告
2023-10-08 07:54
百奥泰生物制药股份有限公司 关于 BAT1806(托珠单抗)注射液 获得美国 FDA 上市批准的公告 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")于近日收到了美国食品药品监督 管理局(以下简称"美国FDA")签发的关于BAT1806(托珠单抗)注射液(美国 商品名称:TOFIDENCE)上市批准的通知,现将相关情况公告如下: 一、 药品相关情况 (一) 药品名称:托珠单抗注射液 (二) 商品名称:TOFIDENCE (三) 适应症:中到重度类风湿性关节炎、多关节型幼年特发性关节炎、全 身型幼年特发性关节炎。 证券代码: 688177 证券简称: 百奥泰 公告编号:2023-058 BAT1806(托珠单抗)注射液是百奥泰根据国家药品监督管理局、美国FDA、 欧洲药品管理局(EMA)(以下简称"欧洲EMA")生物类似药相关指导原则开发 的托珠单抗注射液。BAT1806(托珠单 ...
百奥泰:百奥泰2023年第一次临时股东大会会议资料
2023-09-21 07:38
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年第一次临时股东大会会议资料 2023 年 10 月 目录 | 2023 | 年第一次临时股东大会会议须知 2 | | | --- | --- | --- | | 2023 | 年第一次临时股东大会会议议程 5 | | | 2023 | 年第一次临时股东大会议案 7 | | | | 议案一:与关联方签署分布式屋顶光伏电站能源管理协议的议案 | 8 | | | 议案二:关于修订《独立董事工作制度》的议案 | 10 | | 2023 | 年第一次临时股东大会议案附件 11 | | | | 附件一:百奥泰生物制药股份有限公司独立董事工作制度 | 12 | 1 百奥泰生物制药股份有限公司 2023 年第一次临时股东大会 百奥泰生物制药股份有限公司 2023 年第一次临时股东大会会议须知 为了维护全体股东的合法权益,确保股东大会的正常秩序和议事效率,保证 大会的顺利进行,根据《中华人民共和国公司法》、《中华人民共和国证券法》、 《上市公司股东大会规则》以及《百奥泰生物制药股份有限公司章程》、《百奥 泰生物制药股份有限公司股东大会议事规则》等相 ...