Staidson BioPharm(300204)

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舒泰神:投资者关系活动记录表(2023年度业绩网上说明会)
2024-04-17 10:29
证券代码:300204 证券简称:舒泰神 舒泰神(北京)生物制药股份有限公司 投资者关系活动记录表 编号:2024-001 | | □特定对象调研 □分析师会议 □媒体采访 ■业绩说明会 | | --- | --- | | 投资者关系活动 类别 | | | | □新闻发布会 □路演活动 | | | □现场参观 | | | □其他 | | 参与单位名称 | 参与公司 2023 年年度网上业绩说明会的投资者 | | 时间 | 2024 年 04 月 17 日 15:00-17:00 | | 地点 | "全景网"平台线上进行 | | 上市公司接待人 | 董事长周志文先生 | | | 独立董事赵利先生 | | 员姓名 | 总经理王超先生 | | | 董事会秘书、副总经理于茂荣先生 公司于 2024 年 04 月 17 日(星期三)下午 15:00-17:00 | | | 在全景网举办了 2023 年年度业绩说明会,本次业绩说明会采 | | | 用网络远程方式举行,业绩说明会的主要问答情况如下: | | | 1.问:预计未来三年,会有新药获批上市吗? | | 投资者关系活动 | 答:您好,(1)目前公司生物药中有多个产 ...
舒泰神:北京市康达律师事务所关于舒泰神(北京)生物制药股份有限公司2023年年度股东大会的法律意见书
2024-04-16 10:19
康达股会字【2024】第 0147 号 致:舒泰神(北京)生物制药股份有限公司 北京市朝阳区建外大街丁 12 号英皇集团中心 8、9、11 层 8/9/11/F, Emperor Group Centre, No.12D, Jianwai Avenue, Chaoyang District, Beijing, 100022, P.R.China 电话/Tel.:010-50867666 传真/Fax:010-56916450 网址/Website:www.kangdalawyers.com 北京 西安 深 圳 海口 上海 广 州 杭州 沈阳 南 京 天津 菏泽 成 都 苏州 呼和浩特 香 港 武汉 郑州 长 沙 厦门 重庆 合肥 宁 波 济南 北京市康达律师事务所 关于舒泰神(北京)生物制药股份有限公司 2023 年年度股东大会的法律意见书 根据《中华人民共和国公司法》(以下简称"《公司法》")、《上市公司股东大 会规则》(以下简称"《规则》")、《深圳证券交易所上市公司股东大会网络投票实 施细则》(以下简称"《实施细则》")、《舒泰神(北京)生物制药股份有限公司章 程》(以下简称"《公司章程》")及舒泰神( ...
舒泰神:2023年年度股东大会决议公告
2024-04-16 10:19
证券代码:300204 证券简称:舒泰神 公告编号:2024-13-01 舒泰神(北京)生物制药股份有限公司 2023 年年度股东大会决议公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整,没有虚假 记载、误导性陈述或重大遗漏。 特别提示: 1、本次股东大会无增加、变更、否决提案的情况,本次股东大会不涉及变 更前次股东大会决议。 2、本次股东大会以现场投票、网络投票相结合的方式召开。 3、为尊重中小投资者利益,提高中小投资者对公司股东大会决议事项的参 与度,本次股东大会对中小投资者的表决进行单独计票,中小投资者是指除上市 公司董事、监事、高级管理人员以及单独或者合计持有公司5%以上股份的股东 以外的其他股东。 一、会议召开和出席情况 1、会议通知情况 舒泰神(北京)生物制药股份有限公司(以下简称"公司")召开 2023 年年 度股东大会的通知于 2024 年 03 月 26 日在证监会指定信息披露网站(巨潮资讯 网)公告。 2、召开和出席情况 公司 2023 年年度股东大会于 2024 年 04 月 16 日下午 14:00 在北京市经济技 术开发区经海二路 36 号公司会议室召开。 本次股东大会 ...
舒泰神:关于STSP-0902滴眼液(用于治疗神经营养性角膜炎)申报新药临床试验申请获得受理的公告
2024-04-12 10:25
证券代码:300204 证券简称:舒泰神 公告编号:2024-12-02 舒泰神(北京)生物制药股份有限公司 关于 STSP-0902 滴眼液(用于治疗神经营养性角膜炎) 申报新药临床试验申请获得受理的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整,没有虚假 记载、误导性陈述或重大遗漏。 近日,舒泰神(北京)生物制药股份有限公司(以下简称"舒泰神"或"公 司")收到了国家药品监督管理局行政许可文书《受理通知书》,国家药品监督管 理局同意受理舒泰神提交的关于 STSP-0902 滴眼液用于治疗神经营养性角膜炎 的临床试验申请。现将有关情况公告如下: 一、受理通知书主要内容 1、药品名称:STSP-0902 滴眼液 2、申请事项:境内生产药品注册临床试验 3、受理号:CXSL2400224、CXSL2400225、CXSL2400226 4、结论:根据《中华人民共和国行政许可法》第三十二条的规定,经审查, 决定予以受理。受理号:CXSL2400224、CXSL2400225、CXSL2400226。 二、其他相关情况 神经营养性角膜炎(neurotrophic keratitis,NK)也称为神经 ...
舒泰神:关于STSP-0902注射液(用于治疗少弱精子症)申报新药临床试验申请获得受理的公告
2024-04-12 10:25
证券代码:300204 证券简称:舒泰神 公告编号:2024-12-01 舒泰神(北京)生物制药股份有限公司 关于 STSP-0902 注射液(用于治疗少弱精子症) 申报新药临床试验申请获得受理的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整,没有虚假 记载、误导性陈述或重大遗漏。 近日,舒泰神(北京)生物制药股份有限公司(以下简称"舒泰神"或"公 司")收到了国家药品监督管理局行政许可文书《受理通知书》,国家药品监督管 理局同意受理舒泰神提交的关于 STSP-0902 注射液用于治疗少弱精子症的临床 试验申请。现将有关情况公告如下: 一、受理通知书主要内容 调节作用,还能明显提高精子活力和活率,促进精子生成。 STSP-0902 是舒泰神自主研发的对特定位点进行定向改造的重组人神经生 长因子 Fc 融合蛋白,能够结合并激活 TrkA 受体通路,发挥生物学效应,临床 前实验数据显示,STSP-0902 可促进神经生长、精原细胞和睾丸支持细胞增殖, 提高少弱精子症小鼠模型的精子数量和精子活力,减少精子畸形率,改善睾丸生 精小管变性/萎缩。同时,与野生型人神经生长因子相比,STSP-0902 在临 ...
舒泰神:关于召开2023年年度股东大会的提示性公告
2024-04-11 08:46
证券代码:300204 证券简称:舒泰神 公告编号:2024-11-01 舒泰神(北京)生物制药股份有限公司 关于召开 2023 年年度股东大会的提示性公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整,没有虚假记 载、误导性陈述或重大遗漏。 舒泰神(北京)生物制药股份有限公司(以下简称"公司")第五届董事会第 二十三次会议审议通过了《关于提请召开公司2023年年度股东大会的议案》,本次 股东大会将于2024年04月16日采用现场表决与网络投票相结合的方式召开。《关于 召开2023年年度股东大会的通知》已于2024年03月26日刊登于中国证监会指定的创 业板信息披露网站。现将会议有关事项提示如下: 一、召开会议的基本情况 1、股东大会届次:2023年年度股东大会。 2、股东大会召集人:舒泰神(北京)生物制药股份有限公司董事会。 3、会议召开的合法、合规性:公司第五届董事会第二十三次会议审议通过了《关 于提请召开公司2023年年度股东大会的议案》,决定召开股东大会,召集程序符合 有关法律、行政法规、部门规章、规范性文件和公司章程的规定。 4、会议召开日期和时间: (1)现场会议召开时间为:2024年 ...
舒泰神:关于持股5%以上股东减持计划期限届满未减持股份的公告
2024-04-08 10:32
证券代码:300204 证券简称:舒泰神 公告编号:2024-10-01 舒泰神(北京)生物制药股份有限公司 关于持股 5%以上股东减持计划期限届满未减持股份的公告 持股 5%以上股东香塘集团有限公司保证向本公司提供的信息内容真实、准 确、完整,没有虚假记载、误导性陈述或重大遗漏。 本公司及董事会全体成员保证信息披露内容的真实、准确和完整,没有虚假 记载、误导性陈述或重大遗漏。 舒泰神(北京)生物制药股份有限公司(以下简称"公司"或"舒泰神") 于 2023 年 12 月 15 日披露了《关于持股 5%以上股东减持股份的预披露公告》(公 告编号 2023-62-01)。公司持股 5%以上股东香塘集团有限公司(以下简称"香塘 集团")因自身资金需求,计划在公告披露之日起 15 个交易日后的 3 个月内,即 2024 年 01 月 09 日至 2024 年 04 月 08 日期间(窗口期不减持),通过证券交易 所集中竞价交易方式减持公司股份合计不超过 477.77 万股,占公司目前有表决 权总股本的 1%。若计划减持期间公司有送股、配股、资本公积金转增股本等股 份变动事项,则对上述股份减持数量进行相应调整。 2、 ...
舒泰神(300204) - 2023 Q4 - 年度财报
2024-03-25 16:00
Financial Performance - The company achieved a sales revenue of 364 million yuan, a decrease of 33.66% compared to the same period last year[4]. - The company reported a net profit of negative value for the reporting period, indicating ongoing performance pressure[4]. - The company's operating revenue for 2023 was ¥364,175,426.91, a decrease of 33.66% compared to ¥548,988,617.75 in 2022[31]. - The net profit attributable to shareholders for 2023 was -¥398,892,799.55, representing a decline of 102.48% from -¥197,008,085.75 in the previous year[31]. - The cash flow from operating activities for 2023 was -¥228,319,173.72, which is a 30.02% increase in negative cash flow compared to -¥175,602,342.50 in 2022[32]. - The basic earnings per share for 2023 was -¥0.84, a decrease of 104.88% from -¥0.41 in 2022[32]. - Total assets at the end of 2023 were ¥1,332,220,277.68, down 20.19% from ¥1,669,315,254.73 at the end of 2022[32]. - The net assets attributable to shareholders decreased by 24.61% to ¥1,020,667,878.29 in 2023 from ¥1,353,862,783.16 in 2022[32]. - The company reported a quarterly revenue of ¥105,087,074.35 in Q3 2023, with a net profit of -¥31,538,972.33 for the same quarter[34]. - The weighted average return on equity for 2023 was -33.72%, a decline from -13.60% in 2022[32]. - The company has indicated uncertainty regarding its ability to continue as a going concern due to negative net profits over the past three years[32]. Research and Development - Research and development expenses amounted to 412 million yuan, an increase of 13.63% year-on-year[4]. - The company continues to focus on innovative drug development, particularly in the field of biopharmaceuticals, maintaining a high level of R&D investment[4]. - The company plans to control R&D spending in the near future due to the ongoing progress of its research projects[6]. - The company has made significant progress in its R&D efforts, with multiple products entering various clinical trial phases, including STSA-1002 and STSA-1005, which have completed Phase I clinical trials[50]. - The company aims to address unmet clinical needs, focusing on therapeutic drugs for infectious diseases, autoimmune diseases, and neurological disorders[49]. - The company is focusing on innovative drug development in areas such as autoimmune diseases, infectious diseases, and neurological disorders, with multiple projects in clinical trials[61]. - The company has established a comprehensive drug development system and collaborates with third-party institutions to enhance product development and technology transfer[64]. - The company is actively communicating with the CDE to clarify the research and market application paths for its products, ensuring compliance with regulatory standards[50]. - The company has several key R&D projects in clinical trial stages, including BDB-001 and STSA-1002, aimed at addressing severe medical conditions[90]. Market and Competitive Landscape - The company is navigating a competitive landscape in the innovative biopharmaceutical industry, emphasizing the importance of clinical efficiency and commercialization capabilities[6]. - The company is committed to a strategy of innovation-driven development, focusing on achieving clinical treatment value[6]. - The biopharmaceutical industry is a strategic emerging industry in China, driven by increasing healthcare demands due to rising living standards and an aging population[42]. - The pharmaceutical industry is characterized as a weakly cyclical sector, with strong demand driven by public health needs and minimal seasonal variations[42]. - The company recognizes the significant market demand driven by China's aging population, indicating a larger growth potential for the domestic pharmaceutical industry[126]. Governance and Management - The company held four shareholder meetings during the reporting period, including the first extraordinary meeting of 2023 and the annual meeting for 2022, all in compliance with relevant regulations[147]. - The board of directors consists of seven members, including three independent directors, and all directors actively participated in training to enhance their responsibilities[138]. - The company has established four specialized committees within the board, with independent directors holding a majority in each committee, ensuring professional decision-making[138]. - The company emphasizes investor relations management, providing multiple communication channels for investors, including a dedicated hotline and email[141]. - The controlling shareholder has not interfered with the company's decision-making or operations, ensuring the company's independent business capabilities[137]. - All directors attended the board meetings with a 100% attendance rate, demonstrating their commitment to governance[145]. - The company has maintained a transparent information disclosure process, with the chairman as the primary responsible person for disclosures[141]. - The company respects the rights of stakeholders and actively engages in social responsibility initiatives[142]. - The company has not bypassed shareholder meetings for any significant matters, ensuring compliance with governance standards[136]. - The independent directors have actively participated in meetings and provided objective opinions on company operations, safeguarding the interests of minority shareholders[146]. Future Plans and Investments - The company plans to focus resources on advancing clinical-stage R&D projects, following adjustments to early-stage R&D teams[91]. - The company plans to enhance its marketing capabilities and explore new business models to improve sales and profitability of existing products[124]. - The company aims to accelerate the progress of its R&D projects, focusing on advancing pipeline projects currently in Phase I and II/III clinical trials to the next stage in 2024[124]. - The company plans to invest 15,000 million RMB in the construction of a pilot production workshop for protein drugs, later adjusted to 10,000 million RMB[108]. - The company is considering strategic acquisitions to enhance its product portfolio, with a budget of 500 million RMB allocated for potential deals[182]. - The company plans to increase its marketing budget by 30% to support new product launches and market penetration strategies[182]. - The company aims to achieve a revenue growth target of 15% for the next fiscal year, reflecting its optimistic outlook on market demand[176]. Human Resources - The company has a diverse and highly qualified R&D team, with 122 researchers, of which 69.67% hold master's degrees and 20.49% hold doctoral degrees[65]. - The number of R&D personnel decreased by 53.44% from 262 in 2022 to 122 in 2023, with the proportion of R&D personnel in total staff dropping from 32.63% to 21.98%[91]. - The company acknowledges the challenge of attracting and retaining high-quality talent, which is crucial for its growth in the technology-intensive biopharmaceutical sector[128]. - The company plans to enhance its human resources management system and develop a talent cultivation framework to address the risk of talent shortages[128]. Investment and Funding - The total amount of raised funds was RMB 87,675 million, with a net amount of RMB 83,159.285 million after deducting underwriting fees[103]. - As of December 31, 2023, the actual use of raised funds was RMB 8,905.28 million, with a cumulative usage of RMB 104,161.201 million, leaving a balance of RMB 7.065 million[103]. - The company has committed to invest RMB 20,388 million in the pharmaceutical production base project, with a completion rate of 92.14% as of December 31, 2023[105]. - The company has allocated RMB 4,500 million for the acquisition of Beijing Novartis Medical Technology Co., with a completion rate of 100%[106]. - The company has achieved a cumulative investment of RMB 57,449 million in various projects, with a significant portion directed towards enhancing production capabilities[105]. Compliance and Risk Management - The company is committed to optimizing its governance capabilities while ensuring compliance with regulatory standards[170]. - The company reported a significant focus on internal control systems, confirming no major defects in financial reporting controls as of the evaluation report date[166]. - The company has not reported any major changes in the feasibility of the projects after adjustments[116]. - The company has disclosed that there are no violations in the management and disclosure of raised funds[113]. - The company faces risks related to the lengthy and costly process of drug development, which may hinder project progress and affect financial performance if new drugs do not meet market needs[127].
舒泰神:董事会对独董独立性评估的专项意见
2024-03-25 08:48
因此,公司独立董事满足独立董事的任职要求,不存在影响独立性的情形, 符合《上市公司独立董事管理办法》、《深圳证券交易所上市公司自律监管指引第 2 号——创业板上市公司规范运作》中对独立董事独立性的相关规定。 舒泰神(北京)生物制药股份有限公司 2024 年 03 月 24 日 根据《上市公司独立董事管理办法》、《深圳证券交易所上市公司自律监管指 引第 2 号——创业板上市公司规范运作》等相关规定要求,舒泰神(北京)生物 制药股份有限公司(以下简称"公司")董事会就公司在任独立董事孙英、赵利、 赵家俊的独立性情况进行评估并出具如下专项意见: 经核查独立董事的任职经历以及相关自查文件,上述人员未在公司担任除独 立董事外的其他职务,并与公司及主要股东、实际控制人不存在直接或者间接利 害关系,或者其他可能影响其进行独立客观判断关系。 舒泰神(北京)生物制药股份有限公司 关于独立董事独立性情况的专项报告 董事会 ...
舒泰神:关于举行2023年度业绩网上说明会的公告
2024-03-25 08:48
证券代码:300204 证券简称:舒泰神 公告编号:2024-09-03 舒泰神(北京)生物制药股份有限公司 关于举行 2023 年度业绩网上说明会的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整,没有虚假 记载、误导性陈述或重大遗漏。 舒泰神(北京)生物制药股份有限公司(以下简称"公司")已于 2024 年 03 月 26 日披露了公司 2023 年年度报告。为便于广大投资者更深入、全面地了解公 司发展战略、生产经营等情况,公司定于 2024 年 04 月 17 日(星期三)下午 15:00-17:00 举办 2023 年度业绩说明会,本次年度业绩说明会将采用网络远程的 方式举行,投资者可登录全景网"投资者关系互动平台"(http://rs.p5w.net)参与 本次年度业绩说明会。 为充分尊重投资者、提升交流的针对性,现就公司 2023 年度业绩说明会提 前向投资者公开征集问题,广泛听取投资者的意见和建议。投资者可于 2024 年 04 月 17 日(星期三)17:00 前访问 http://ir.p5w.net/zj/,或扫描下方二维码,进 入问题征集专题页面。公司将在 2023 年度业 ...