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圣诺生物:成都圣诺生物科技股份有限公司监事会对募集说明书真实性、准确性、完整性的审核意见
2023-10-17 09:54
经审核,公司监事会认为:公司编制的《募集说明书》符合法律法规和中国 证券监督管理委员会、上海证券交易所的相关规定,《募集说明书》的内容真实、 准确、完整,不存在虚假记载、误导性陈述或者重大遗漏。 成都圣诺生物科技股份有限公司(以下简称"公司")监事会根据《中华人 民共和国公司法》《中华人民共和国证券法》《上市公司证券发行注册管理办法》 《公开发行证券的公司信息披露内容与格式准则第 61 号——上市公司向特定对 象发行证券募集说明书和发行情况报告书》等法律、法规和规范性文件的要求, 认真审核了公司编制的《成都圣诺生物科技股份有限公司以简易程序向特定对象 发行股票募集说明书》(以下简称《募集说明书》)。 成都圣诺生物科技股份有限公司监事会 对募集说明书真实性、准确性、完整性的审核意见 成都圣诺生物科技股份有限公司 监事会 1 2023 年 10 月 17 日 ...
圣诺生物(688117) - 成都圣诺生物科技股份有限公司投资者关系活动记录表
2023-09-27 02:04
Group 1: Company Overview - Chengdu Saintno Biological Technology Co., Ltd. was established in July 2001 and is recognized as a high-tech enterprise in Sichuan Province [1] - The company specializes in providing CDMO services for peptide drugs, establishing a comprehensive R&D pipeline and full industry chain platform in the domestic peptide drug field [1] - The company has accumulated a high reputation, providing pharmaceutical research services for over 40 projects, with 1 product approved for commercialization and 19 peptide innovative drugs entering clinical trials [1] Group 2: Financial Performance - In the first half of the year, the company's net profit increased; however, the net profit attributable to shareholders of the listed company, excluding non-recurring gains and losses, decreased by 38.18% to 9.2579 million yuan [2] - The decline was primarily due to an increase in financial expenses from a new loan of 150 million yuan, along with rising management costs and expenses related to the disposal of non-recoverable organic solvents and packaging [2] Group 3: Market Position and Strategy - The company is one of the most powerful peptide R&D and production enterprises in China, focusing on developing peptide generic drugs with significant market potential [2] - The company has a range of active pharmaceutical ingredients (APIs) including Enfuvirtide, Bivalirudin, and Liraglutide, among others, and is continuously selecting peptide generic drugs for development based on market opportunities [3] Group 4: Technological Advancements - The company has developed long-chain peptide conjugation technology, which enhances coupling efficiency and product quality, allowing for large-scale automated production of long-chain peptide drugs [4] - The PEGylation technology used for drugs like Exenatide has extended the half-life by over 50 times, reducing the dosing frequency to once a week, significantly improving patient convenience [4] Group 5: Regulatory and Competitive Landscape - The successful consistency evaluation of Cabergoline injection reflects the company's comprehensive strength in R&D, production, and quality management, positively impacting future product competitiveness and operational performance [4]
圣诺生物:关于持股5%以上股东权益变动超过1%的提示性公告
2023-09-21 10:18
证券代码:688117 证券简称:圣诺生物 公告编号:2023-056 成都圣诺生物科技股份有限公司 关于持股 5%以上股东权益变动超过 1%的提示性公告 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: 本次权益变动后,成都圣诺生物科技股份有限公司(以下简称"公司") 股东乐普(北京)医疗器械股份有限公司(以下简称"信息披露义务人"或"乐 普医疗")持有公司的股份数量为 6,161,445 股,占公司总股本的比例由 8.1000% 减少至 5.5013%。 本次权益变动未触及要约收购,不会导致公司控股股东、实际控制人发 生变化,不会对公司治理结构及持续经营产生影响。 公司于近日收到公司股东乐普医疗出具的书面通知,现将其有关权益变动情 况公告如下: 一、本次权益变动基本情况 (一)信息披露义务人基本情况 (5)主要股东:中国船舶重工集团公司第七二五研究所(洛阳船舶材料研 究所)持有其 12.98% 股份,蒲忠杰持有其 12.13% 股份, WP MEDICAL TECHNOLOGIES,INC 持有其 6.5 ...
圣诺生物:关于自愿披露卡贝缩宫素注射液通过注射剂仿制药质量和疗效一致性评价的公告
2023-09-06 09:36
证券代码:688117 证券简称:圣诺生物 公告编号:2023-053 成都圣诺生物科技股份有限公司 关于自愿披露卡贝缩宫素注射液通过注射剂 仿制药质量和疗效一致性评价的公告 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。 成都圣诺生物科技股份有限公司(以下简称"公司")全资子公司成都圣诺 生物制药有限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") 核准签发的关于卡贝缩宫素注射液的《药品补充申请批准通知书》,现将相关情 况公告如下: 一、药品基本情况 药品名称:卡贝缩宫素注射液/Carbetocin Injection 剂型:注射剂 规格:1ml:100µg 注册分类:化学药品 原药品批准文号:国药准字 H20163001 上市许可持有人:成都圣诺生物制药有限公司 1 防子宫收缩乏力和产后出血,于 1984 年在我国上市,目前卡贝缩宫素注射液进 入我国医保乙类目录。公司卡贝缩宫素注射液系国内首仿品种,2019 年国内市 场份额超过 20%,仅次于辉凌制药的原研产品。 三、对公司的影响 卡贝缩宫素注射液通过注射剂 ...
圣诺生物:民生证券股份有限公司关于成都圣诺生物科技股份有限公司2023年半年度持续督导跟踪报告
2023-09-01 09:48
民生证券股份有限公司 | 序号 | 工作情况 | 持续督导情况 | | --- | --- | --- | | | 建立健全并有效执行持续督导工作制 | 保荐机构已建立健全并有效执行了持续督 | | 1 | 度,并针对具体的持续督导工作制定相 | 导制度,并制定了相应的工作计划。 | | | 应的工作计划。 | | | | 根据中国证监会相关规定,在持续督导 | | | | 工作开始前,与上市公司或相关当事人 | 保荐机构已与公司签订《保荐协议》,该协 | | 2 | 签署持续督导协议,明确双方在持续督 | 议明确了双方在持续督导期间的权利和义 | | | 导期间的权利义务,并报上海证券交易 | 务,并报上海证券交易所备案。 | | | 所备案。 | | | | 通过日常沟通、定期回访、现场检查、 | 保荐机构通过日常沟通、定期或不定期回 | | 3 | | 访、现场办公及走访等方式,对公司开展持 | | | 尽职调查等方式开展持续督导工作。 | 续督导工作。 | | | 持续督导期间,按照有关规定对上市公 | | | | 司违法违规事项公开发表声明的,应于 | 本持续督导期间,公司未发生按有关规定需 | | ...
圣诺生物:成都圣诺生物科技股份有限公司独立董事关于第四届董事会第十次会议相关事项的独立意见
2023-08-28 08:56
成都圣诺生物科技股份有限公司独立董事 关于第四届董事会第十次会议相关事项的独立意见 根据《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 法规以及《成都圣诺生物科技股份有限公司章程》《独立董事制度》等公司制度 的规定,我们作为成都圣诺生物科技股份有限公司(以下简称"公司")的独立 董事,本着对公司及全体股东负责的态度,基于审慎独立判断的立场,认真审阅 了公司第四届董事会第十次会议的相关议案,现发表独立意见如下: 一、《关于公司向兴业银行股份有限公司成都分行申请 15,000 万元人民币 最高综合授信额度及接受关联方担保的议案》的独立意见 经核查,同意公司向兴业银行股份有限公司成都分行申请总额度不超过人民 币 15,000 万元的综合授信,授信期限一年,最终授信额度以银行实际审批的授 信额度为准,该授信额度在授信期限内可循环使用。本次向银行申请授信额度是 根据公司经营计划及融资需求,满足日常经营和业务顺利开展而进行的,不会对 公司经营、财务状况产生不利影响,不存在损害公司或其他股东、特别是中小股 东利益的情形,符合《上海证券交易所科创板股票上市规则》《上海证券交易所 科创板上市公司自律监管指引第 ...
圣诺生物(688117) - 2023 Q2 - 季度财报
2023-08-17 16:00
Financial Performance - The company reported a total revenue of 500 million CNY for the first half of 2023, representing a 20% increase compared to the same period last year[1]. - The company expects a revenue guidance of 1.2 billion CNY for the full year 2023, which would mark a 25% year-over-year growth[1]. - The company reported a revenue of RMB 1.5 billion for the first half of 2023, representing a 20% increase year-over-year[12]. - The company expects a revenue guidance of RMB 3 billion for the full year 2023, indicating a projected growth of 25% compared to 2022[12]. - The company's operating revenue for the first half of 2023 was ¥173,833,824.96, representing a 3.78% increase compared to ¥167,510,229.44 in the same period last year[21]. - The net profit attributable to shareholders for the same period was ¥20,148,134.88, an increase of 8.09% from ¥18,640,527.67 year-on-year[21]. - The company reported a total revenue of 18,210.00 million RMB, with a net profit of 1,559.61 million RMB, reflecting a significant increase compared to the previous period[68]. - The net profit attributable to the parent company was 20.15 million yuan, up 8.09% year-on-year[88]. User Growth - User data indicates a growth in active users by 15%, reaching 1.2 million users by the end of June 2023[1]. - User data indicates a growth in active users by 15%, reaching a total of 3 million users by June 30, 2023[12]. Research and Development - Research and development expenses increased by 30% to 100 million CNY, reflecting the company's commitment to innovation[1]. - The company has established partnerships with two leading research institutions to enhance its R&D capabilities[1]. - The company has a strong emphasis on R&D investment, continuously innovating to meet the market demand for peptide pharmaceuticals[30]. - The company has developed 16 self-researched peptide raw materials, with 11 varieties obtaining production licenses or activation records in the domestic market[34]. - The company has achieved significant progress in R&D, with multiple products passing consistency evaluations and several raw materials submitted for market registration[58]. - The R&D personnel count increased to 215, representing 21.84% of the total workforce, up from 19.68% the previous year[70]. - The company has 11 R&D products submitted for registration with the National Medical Products Administration, and 19 projects in mid-to-long-term research[72]. Market Expansion - The company is expanding its market presence in Southeast Asia, targeting a 10% market share by the end of 2024[1]. - The company is actively pursuing new product development and market expansion strategies to enhance its competitive position in the pharmaceutical industry[36]. - The company has established partnerships with well-known pharmaceutical enterprises such as Fresenius, Masung, and Yangtze River Pharmaceutical Group, expanding its market presence in Europe, the United States, and South Korea[36]. Product Development - New product launches in the pipeline include three innovative biopharmaceuticals expected to enter the market by Q4 2023[1]. - The company is currently in the clinical phase III for its new diabetes drug, with expected market approval by Q4 2023[12]. - A new peptide-based drug is under development, with a projected launch date in early 2024[12]. - The company is focusing on expanding its product pipeline in areas such as oncology, chronic hepatitis B, diabetes, obstetrics, digestive system, and immune system diseases[78]. Financial Management - The company has approved a share buyback program of up to 50 million CNY to enhance shareholder value[1]. - The company has invested RMB 200 million in new technology for drug manufacturing, aiming to improve production efficiency by 30%[12]. - The company has received domestic approval for multiple raw materials, including Enfuvirtide for HIV treatment and Bivalirudin for anticoagulation during PCI procedures[35]. Environmental Responsibility - The company has established an environmental protection mechanism and is classified as a key pollutant discharge unit[114]. - The company emphasizes sustainable development and environmental protection, implementing a waste management system and utilizing advanced treatment processes for wastewater and waste gas[125]. - The company has received environmental impact assessment approvals for multiple projects, including the peptide drug production line and waste solvent comprehensive utilization technology renovation project[119]. Shareholder Commitments - The controlling shareholder, Sino Investment, commits to not transferring or entrusting the management of shares for 36 months post-listing, with a lock-up extension of 6 months if share price falls below the issue price for 20 consecutive trading days[137]. - The company will not reduce shares if under investigation by the China Securities Regulatory Commission or if publicly reprimanded by the stock exchange within the last 3 months[139]. - The employee stock ownership platform, Saint No Management, also adheres to a 36-month lock-up period and similar reduction commitments post-lock-up[143]. Related Party Transactions - The company has disclosed related party transactions, including the purchase of liquid phase chromatographs for approximately CNY 3,497,176.20[179]. - The total amount of related party transactions for 2022 was confirmed to be RMB 84.6415 million, exceeding the previously estimated total by RMB 0.6915 million[180]. Strategic Investments - The company invested a total of RMB 15 million in Chengdu Yuansheng Kechuang Angel Venture Capital Partnership, accounting for 12.24% of the registered capital of RMB 122.5 million, with the first phase investment of RMB 6 million made in June 2023[96]. - The company plans to apply for a bank credit facility of up to RMB 30 million for its wholly-owned subsidiary, with a guarantee amount of up to RMB 3 million[186].
圣诺生物:第四届监事会第九次会议决议公告
2023-08-17 09:44
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、准确性和完整性依法承担法律责任。 一、监事会会议召开情况 成都圣诺生物科技股份有限公司(以下简称"公司")第四届监事会第九次 会议通知于 2023 年 8 月 8 日以电话及邮件方式向各位监事发出,并于 2023 年 8 月 17 日在公司会议室以现场方式召开。会议由监事会主席曾德志先生召集和主 持。本次会议应出席监事 3 人,实际出席监事 3 人。本次会议的召集和召开程序 符合有关法律、法规、规范性文件和《成都圣诺生物科技股份有限公司章程》(以 下简称"《公司章程》")的有关规定。 证券代码:688117 证券简称:圣诺生物 公告编号:2023-050 成都圣诺生物科技股份有限公司 第四届监事会第九次会议决议公告 二、监事会会议审议情况 经与会监事审议,做出如下决议: (一)审议通过《关于<公司 2023 年半年度报告及其摘要>的议案》 表决结果:同意 3 票,反对 0 票,弃权 0 票。 特此公告。 成都圣诺生物科技股份有限公司 监事会 2023 年 8 月 18 日 (二)审议通过《关于<公司 2023 ...
圣诺生物:关于2023年半年度募集资金存放与实际使用情况的专项报告
2023-08-17 09:44
证券代码:688117 证券简称:圣诺生物 公告编号:2023-051 成都圣诺生物科技股份有限公司 具体情况如下: 单位:人民币万元 关于2023年半年度募集资金存放与实际使用情况 的专项报告 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。 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(2022 年修订)》(证监会公告〔2022〕15 号)、《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》及相关格式指引的要求,成都圣诺 生物科技股份有限公司(以下简称"公司"或"圣诺生物")董事会就 2023 年 半年度募集资金存放与实际使用情况作如下专项报告: 一、募集资金基本情况 (一)实际募集资金的金额及到账情况 经中国证券监督管理委员会《关于同意成都圣诺生物科技股份有限公司首次 公开发行股票注册的批复》(证监许可〔2021〕1497 号)同意注册,公司获准 向社会公众公开发行人民币普通股(A 股)20,000,000 股,每股面值人民币 1 元,每股发行价为人民币 17.90 元, ...