Sito Bio(300583)

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赛托生物:关于子公司收到化学原料药上市申请批准通知书的公告
2024-05-30 09:05
证券代码:300583 证券简称:赛托生物 编号:2024-023 山东赛托生物科技股份有限公司 关于子公司收到化学原料药上市申请批准通知书的公告 申请事项:境内生产化学原料药上市申请 生产企业:山东斯瑞药业有限公司 生产地址:山东省菏泽市定陶区东外环路南段 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,批准生产本品。质量标准、标签及生产工艺照所附执 行。 与制剂关联审评审批结果:A 本公司及董事会全体成员保证信息披露的内容真实、准确、完整,没有虚假记载、误 导性陈述或重大遗漏。 山东赛托生物科技股份有限公司(以下简称"公司")控股子公司山东斯瑞 药业有限公司近日收到国家药品监督管理局签发的丙酸氟替卡松《化学原料药上 市申请批准通知书》,现将相关情况公告如下: 一、原料药登记信息 化学原料药名称:丙酸氟替卡松/Fluticasone Propionate 登记号:Y20200000871 包装规格:0.5kg/桶,1.0kg/桶,2.0kg/桶 四、报备文件 《化学原料药上市申请批准通知书》 特此公告。 二、原料药的相关情况 丙酸氟替卡松原料药可以用于生产丙酸氟替 ...
赛托生物:关于子公司收到化学原料药欧洲CEP证书的公告
2024-05-07 08:54
证券代码:300583 证券简称:赛托生物 编号:2024-022 山东赛托生物科技股份有限公司 关于子公司收到化学原料药欧洲CEP证书的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整,没有虚假记载、误 导性陈述或重大遗漏。 山东赛托生物科技股份有限公司(以下简称"公司")控股子公司山东斯瑞 药业有限公司(以下简称"斯瑞药业")近日收到欧洲药品质量管理局(以下简 称"EDQM")签发的原料药欧洲药典适用性证书(以下简称"CEP 证书"),现将 相关情况公告如下: 一、原料药注册批件信息 化学原料药名称:FLUTICASONE PROPIONATE 丙酸氟替卡松 生产地址:山东省菏泽市定陶区东外环路南段 证书编号:CEP2022-282-Rev00 发证机关:欧洲药品质量管理局(EDQM) 有效期:自 2024 年 5 月 3 日起五年内有效 二、原料药的相关情况 丙酸氟替卡松原料药可以用于生产丙酸氟替卡松相关剂型药品,丙酸氟替卡 松乳膏剂可用于缓解用于缓解对糖皮质激素有应答的皮肤病的炎症和瘙痒症状, 吸入剂可用于缓解哮喘相关症状,鼻喷剂可用于预防和治疗季节性过敏性鼻炎和 常年性过敏性鼻炎。 公 ...
中间体有望企稳回升,产业链延伸稳步推进
China Post Securities· 2024-05-07 05:30
Investment Rating - The report maintains a "Buy" rating for the company, with an expected relative outperformance of over 20% compared to the benchmark index within the next 6 months [16][22] Core Views - The company's intermediate product prices are stabilizing and recovering, and the API (active pharmaceutical ingredient) sector is entering a harvest period, contributing to revenue and profit growth [4][19] - The construction of the formulation plant is progressing steadily, and the acquisition of Yingu Pharmaceutical is on track, which will help the company expand into the formulation sector and achieve synergies with existing businesses [5][26] - The company's high-margin, high-value-added intermediate products are expected to strengthen its leading position in the steroid intermediate segment [19] - The company's API business is gaining momentum, with several products already approved or under review, including Fluticasone Propionate and Budesonide [19] Financial Performance and Projections - In 2023, the company reported revenue of RMB 1.28 billion (-2.46% YoY) and net profit attributable to the parent company of RMB 45.6 million (+8.67% YoY) [18] - For 2024-2026, the company is projected to achieve revenue of RMB 1.38 billion, RMB 1.51 billion, and RMB 1.67 billion, with YoY growth rates of 7.83%, 9.53%, and 10.72%, respectively [6] - Net profit attributable to the parent company is expected to grow to RMB 59.13 million, RMB 76.35 million, and RMB 89.84 million in 2024-2026, with growth rates of 29.65%, 29.13%, and 17.67%, respectively [6] - EPS is projected to increase from RMB 0.24 in 2023 to RMB 0.31, RMB 0.40, and RMB 0.47 in 2024-2026 [6] - The company's P/E ratio is expected to decline from 61.19 in 2023 to 47.20, 36.55, and 31.06 in 2024-2026, reflecting improved valuation metrics [6] Business Highlights - The company's steroid intermediate business generated revenue of RMB 1.125 billion in 2023, with a gross margin of 23.98%, up 0.49 percentage points YoY [19] - The company has a diversified product portfolio in the intermediate sector, including five core mother nuclei series and over ten high-end intermediates [19] - In the API sector, the company has obtained production licenses for nine products, including Fluticasone Propionate and Budesonide, with several under review [19] - The company's finished drug business achieved revenue of RMB 100 million in 2023, up 27.16% YoY, with two imported drugs, Triamcinolone Acetonide and Calcitonin Salmon, already on the market [26] - The acquisition of Yingu Pharmaceutical, which has three formulation products including a Class 1.1 innovative drug, is expected to enhance the company's formulation capabilities and extend its industrial chain [26] Valuation and Recommendations - The report recommends a "Buy" rating, with a target PE of 47.20x, 36.55x, and 31.06x for 2024-2026, based on the company's growth prospects and improving financial performance [26]
2023年年报&2024年一季报点评:打造全产业链布局,收购银谷制药加速进行
Minsheng Securities· 2024-04-29 13:00
Investment Rating - The report maintains a "Recommended" rating for the company [4]. Core Insights - In 2023, the company achieved a revenue of 1.28 billion yuan, a year-on-year decrease of 2.46%, while the net profit attributable to shareholders was 45.6 million yuan, an increase of 8.67% [2]. - For Q1 2024, the company reported a revenue of 244 million yuan, a year-on-year decline of 27.00%, and a net profit of 3.07 million yuan, down 80.00% year-on-year [2]. - The company is a leader in the steroid raw material drug segment and is focused on building a complete industrial chain, covering five major series of steroid raw materials [2]. - The company has obtained production licenses for nine raw materials in the high-end respiratory drug sector and is currently undergoing separate reviews for four additional raw materials [2]. - The company plans to acquire 60% of Yingu Pharmaceutical, which will enhance its clinical development capabilities and production capacity in the respiratory drug sector [2]. - The company forecasts revenues of 1.404 billion, 1.538 billion, and 1.669 billion yuan for 2024, 2025, and 2026, respectively, with corresponding net profits of 57 million, 73 million, and 84 million yuan [2][3]. Financial Summary - The company’s revenue is projected to grow at rates of 9.70%, 9.50%, and 8.50% for the years 2024, 2025, and 2026, respectively [3]. - The net profit is expected to grow by 25.59%, 27.70%, and 15.08% for the same years [3]. - The earnings per share (EPS) is forecasted to be 0.30 yuan in 2024, 0.39 yuan in 2025, and 0.44 yuan in 2026 [3]. - The price-to-earnings (PE) ratio is projected to decrease from 57 in 2023 to 31 in 2026 [3].
赛托生物:关于公司向控股股东借款暨关联交易的公告
2024-04-28 07:42
证券代码:300583 证券简称:赛托生物 编号:2024-017 一、本次关联交易概述 山东赛托生物科技股份有限公司(以下简称"公司")为满足公司经营和发 展需要,拟向控股股东山东润鑫投资有限公司(以下简称"山东润鑫")借款不 超过人民币 20,000.00 万元,用于补充流动资金,借款利率为山东润鑫实际融资 利率,且年化利率不超过 5.50%。计息方式按照借款实际使用金额和天数计息, 在股东大会审议通过后的 24 个月内循环滚动使用。 上述事项已经公司于 2024 年 4 月 25 日召开的第四届董事会第三次会议及 第四届监事会第三次会议审议通过,关联董事米奇先生回避表决。该议案已经公 司独立董事专门会议审议通过,保荐机构国金证券股份有限公司对该事项发表了 无异议的核查意见。 本项关联交易尚需提交股东大会审议,关联股东山东润鑫投资有限公司、米 超杰先生、米奇先生、米嘉女士需回避表决。 本次关联交易不构成《上市公司重大资产重组管理办法》规定的重大资产重 组,无需经过有关部门批准。 | 公司名称 | 山东润鑫投资有限公司 | | --- | --- | | 登记机关 | 菏泽市定陶区市场监督管理局 | | 统 ...
赛托生物:关于提请股东大会授权董事会以简易程序向特定对象发行股票的公告
2024-04-28 07:41
证券代码:300583 证券简称:赛托生物 公告编号:2024-019 山东赛托生物科技股份有限公司 关于提请股东大会授权董事会以简易程序 向特定对象发行股票的公告 一、本次授权具体内容: 1、确认公司是否符合以简易程序向特定对象发行股票的条件 授权董事会根据相关法律、法规、规范性文件以及《公司章程》的规定,对 公司实际情况及相关事项进行自查论证,并确认公司是否符合以简易程序向特定 对象发行股票的条件。 2、发行证券的种类和数量 发行股票的种类为人民币普通股(A 股),每股面值人民币 1.00 元。发行股 票募集资金总额不超过人民币 3 亿元且不超过最近一年末净资产的 20%。发行数 量按照募集资金总额除以发行价格确定,不超过发行前公司股本总数的 30%。 3、发行方式、发行对象及原股东配售的安排 发行股票采用以简易程序向特定对象发行的方式,发行对象为符合监管部门 规定的法人、自然人或其他合法投资组织等不超过 35 名的特定对象。证券投资 基金管理公司、证券公司、合格境外机构投资者、人民币合格境外机构投资者以 其管理的二只以上产品认购的,视为一个发行对象。信托公司作为发行对象的, 只能以自有资金认购。最终发行 ...
赛托生物:关于2023年度利润分配预案的公告
2024-04-28 07:41
山东赛托生物科技股份有限公司(以下简称"公司")于 2024 年 4 月 25 日 召开的第四届董事会第三次会议、第四届监事会第三次会议审议通过了《关于 2023 年度利润分配预案的议案》,现将相关事项公告如下: 证券代码:300583 证券简称:赛托生物 公告编号:2024-013 山东赛托生物科技股份有限公司 关于 2023 年度利润分配预案的公告 一、2023 年度利润分配预案 本公司及董事会全体成员保证信息披露的内容真实、准确、完整,没有虚假记载、误 导 性陈述或重大遗漏。 经天健会计师事务所(特殊普通合伙)审计确认,2023 年度公司实现归属于 上市公司普通股股东的净利润为 45,603,990.98 元,母公司实现净利润 60,390,945.73 元;按照《公司法》和《公司章程》的规定提取法定盈余公积 6,039,094.57 元,截止 2023 年 12 月 31 日公司合并报表累计可供投资者分配的 净利润为 452,829,022.56 元,母公司累计可供投资者分配的净利润为 803,593,720.88 元。根据利润分配应以母公司的可供分配利润及合并财务报表 的 可 供 分 配 利 润 孰 ...
赛托生物(300583) - 2024 Q1 - 季度财报
2024-04-28 07:41
Revenue and Profit - The company's revenue for Q1 2024 was ¥244,395,524.04, a decrease of 27.00% compared to ¥334,785,915.82 in the same period last year[4] - Net profit attributable to shareholders was ¥3,070,728.65, down 80.00% from ¥15,355,110.28 year-on-year[4] - The company reported a basic earnings per share of ¥0.02, down 77.78% from ¥0.09 in the same quarter last year[4] - Net profit for Q1 2024 was ¥3,711,472.71, a decline of 79% from ¥17,525,308.93 in Q1 2023[20] Cash Flow - The net cash flow from operating activities increased by 98.51% to ¥21,248,864.71, compared to ¥10,704,060.35 in Q1 2023[11] - The net cash flow from financing activities surged by 1,424.34% to ¥101,263,266.17, compared to ¥6,643,103.13 in Q1 2023[11] - The company received cash related to operating activities totaling ¥202,674,544.42, a decrease from ¥248,042,987.04 in the previous year[22] - In Q1 2024, the net cash flow from investing activities was -12,909,484.64, compared to -27,232,006.03 in Q1 2023, indicating an improvement[23] - The total cash inflow from financing activities was 536,827,460.79, up from 381,974,721.80 in the same quarter last year, reflecting a 40.6% increase[23] - The company experienced a net increase in cash and cash equivalents of 109,895,640.36 in Q1 2024, contrasting with a decrease of -11,191,652.48 in Q1 2023[23] Assets and Liabilities - Total assets at the end of Q1 2024 were ¥3,370,087,418.79, reflecting a 4.01% increase from ¥3,240,242,403.84 at the end of the previous year[4] - Total liabilities amounted to ¥1,299,942,942.85, compared to ¥1,174,795,832.63 previously[17] - The company reported cash and cash equivalents of ¥351,284,155.10 at the end of Q1 2024, an increase from ¥238,490,756.82 at the beginning of the period[16] - Accounts receivable stood at ¥271,654,095.00, slightly down from ¥272,117,151.74[16] - Inventory increased to ¥730,067,778.48 from ¥722,624,129.92, indicating a growth in stock levels[16] Shareholder Information - Total number of common shareholders at the end of the reporting period is 12,521[13] - The largest shareholder, Shandong Runxin Investment Co., Ltd., holds 22.82% of shares, totaling 43,297,382 shares, with 15,280,000 shares pledged[13] Operating Costs and Expenses - The company’s operating costs decreased by 28.88% to ¥174,821,291.66, down from ¥245,803,460.08 in the previous year[9] - Total operating costs for Q1 2024 were ¥238,473,780.69, down 24% from ¥313,685,870.45 year-over-year[19] - Research and development expenses for Q1 2024 were ¥14,321,901.84, slightly up from ¥13,999,442.81 in Q1 2023[19] Equity and Investments - The company reported a total equity attributable to shareholders of the parent company of ¥2,016,119,568.37, up from ¥2,012,156,809.24 year-over-year[20] - Long-term investments increased to ¥67,022,673.30 from ¥65,119,540.60[16] - The company's equity remains stable with a share capital of ¥189,702,126.00[17] Other Financial Metrics - The weighted average return on equity decreased to 0.15% from 0.89% year-on-year, a decline of 0.74%[4] - Other comprehensive income after tax for Q1 2024 was ¥986,432.02, compared to a loss of ¥1,525,944.83 in Q1 2023[20] - The company has not reported any changes in the status of preferred shareholders or significant changes in shareholding structure[15] Audit Status - The first quarter report for 2024 was not audited, which may affect the reliability of the financial data presented[24]
赛托生物:2023年度非经营性资金占用及其他关联资金往来情况的专项审计说明
2024-04-28 07:41
目 录 一、非经营性资金占用及其他关联资金往来情况的专项 审计说明…………………………………………………………第 1—2 页 二、非经营性资金占用及其他关联资金往来情况汇总表……………第 3 页 非经营性资金占用及其他关联资金往来情况的 专项审计说明 天健审〔2024〕3785 号 山东赛托生物科技股份有限公司全体股东: 我们接受委托,审计了山东赛托生物科技股份有限公司(以下简称赛托生物 公司)2023 年度财务报表,包括 2023 年 12 月 31 日的合并及母公司资产负债表, 2023 年度的合并及母公司利润表、合并及母公司现金流量表、合并及母公司所 有者权益变动表,以及财务报表附注,并出具了审计报告。在此基础上,我们审 计了后附的赛托生物公司管理层编制的 2023 年度《非经营性资金占用及其他关 联资金往来情况汇总表》(以下简称汇总表)。 一、对报告使用者和使用目的的限定 本报告仅供赛托生物公司年度报告披露时使用,不得用作任何其他目的。我 们同意将本报告作为赛托生物公司年度报告的必备文件,随同其他文件一起报送 并对外披露。 为了更好地理解赛托生物公司 2023 年度非经营性资金占用及其他关联资金 往来 ...
赛托生物:2023年度募集资金年度存放与使用情况鉴证报告
2024-04-28 07:41
目 录 一、募集资金年度存放与使用情况鉴证报告………………………第 1—2 页 二、关于募集资金年度存放与使用情况的专项报告…………… 第 3—17 页 募集资金年度存放与使用情况鉴证报告 天健审〔2024〕3784 号 山东赛托生物科技股份有限公司全体股东: 我们鉴证了后附的山东赛托生物科技股份有限公司(以下简称赛托生物公司) 管理层编制的 2023 年度《关于募集资金年度存放与使用情况的专项报告》。 一、对报告使用者和使用目的的限定 本鉴证报告仅供赛托生物公司年度报告披露时使用,不得用作任何其他目的。 我们同意将本鉴证报告作为赛托生物公司年度报告的必备文件,随同其他文件一 起报送并对外披露。 二、管理层的责任 赛托生物公司管理层的责任是提供真实、合法、完整的相关资料,按照《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)和《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(2023 年 12 月修订)》(深证上〔2023〕 1146 号)的规定编制《关于募集资金年度存放与使用情况的专项报告》,并保 证其内 ...