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赛升药业(300485) - 非经营性资金占用及其他关联资金往来的专项说明
2025-03-28 08:35
关于北京赛升药业股份有限公司 非经营性资金占用及其他关联 资金往来的专项说明 致同会计师事务所(特殊普通合伙) 目 录 致同会计师事务所(特殊普通合伙) 中国北京 朝阳区建国门外大街 22 号 赛特广场 5 层 邮编 100004 电话 +86 10 8566 5588 传真 +86 10 8566 5120 www.grantthornton.cn 关于北京赛升药业股份有限公司 非经营性资金占用及其他关联资金往来的专项说明 关于北京赛升药业股份有限公司非经营性资金占用及其他关联资 金往来的专项说明 北京赛升药业股份有限公司 2024 年度非经营性资金占用及其他关 联资金往来情况汇总表 1 致同专字(2025)第 110A003686 号 北京赛升药业股份有限公司全体股东: 我们接受北京赛升药业股份有限公司(以下简称"赛升药业公司")委托, 根据中国注册会计师执业准则审计了赛升药业公司 2024 年 12 月 31 日的合并及 公司资产负债表,2024 年度合并及公司利润表、合并及公司现金流量表、合并 及公司股东权益变动表和财务报表附注,并出具了致同审字( 2025)第 110A005227 号无保留意见审计 ...
赛升药业(300485) - 内部控制审计报告
2025-03-28 08:35
北京赛升药业股份有限公司 二〇二四年度 内部控制审计报告 致同审字(2025)第 110A005228 号 北京赛升药业股份有限公司全体股东: 按照《企业内部控制审计指引》及中国注册会计师执业准则的相关要求, 我们审计了北京赛升药业股份有限公司(以下简称赛升药业公司)2024 年 12 月 31 日的财务报告内部控制的有效性。 一、企业对内部控制的责任 按照《企业内部控制基本规范》、《企业内部控制应用指引》、《企业 内部控制评价指引》的规定,建立健全和有效实施内部控制,并评价其有效 性是赛升药业公司董事会的责任。 二、注册会计师的责任 致同会计师事务所(特殊普通合伙) 致同会计师事务所(特殊普通合伙) 中国北京 朝阳区建国门外大街 22 号 赛特广场 5 层 邮编 100004 电话 +86 10 8566 5588 传真 +86 10 8566 5120 www.grantthornton.cn 内部控制审计报告 致同会计师事务所 (特殊普通合伙) 中国注册会计师 刘均山 中国注册会计师 刘霞 中国·北京 二〇二五年三月二十七日 我们的责任是在实施审计工作的基础上,对财务报告内部控制的有效性 发表审计意见, ...
赛升药业(300485) - 公司营业收入扣除情况说明专项核查报告
2025-03-28 08:35
北京赛升药业股份有限公司 营业收入扣除情况说明 专项核查报告 致同会计师事务所(特殊普通合伙) 中国北京 朝阳区建国门外大街 22 号 赛特广场 5 层 邮编 100004 电话 +86 10 8566 5588 传真 +86 10 8566 5120 www.grantthornton.cn 北京赛升药业股份有限公司 营业收入扣除情况说明专项核查报告 致同会计师事务所(特殊普通合伙) 目 录 专项核查报告 公司关于 2024 年度营业收入扣除情况及扣除后的营业收入金额 的说明 1-2 致同专字(2025)第 110A003687 号 北京赛升药业股份有限公司全体股东: 我们接受委托,在审计了北京赛升药业股份有限公司(以下简称"赛升药业 公司")2024 年 12 月 31 日的合并及公司资产负债表,2024 年度的合并及公司 利润表、合并及公司现金流量表、合并及公司股东权益变动表以及财务报表附注 的基础上,对后附的赛升药业公司《2024 年度营业收入扣除情况表及说明》(以 下简称"营业收入扣除情况表")进行了专项核查。 按照深圳证券交易所《深圳证券交易所创业板股票上市规则》(以下简称 "上市规则")和《深圳 ...
赛升药业(300485) - 2024 Q4 - 年度财报
2025-03-28 08:35
Financial Performance - The company's net profit decreased significantly due to a 170% decline in fair value changes of financial assets and investment income compared to the previous year[3]. - The company's operating revenue for 2024 was ¥416,481,789.63, a decrease of 12.61% compared to ¥476,569,581.71 in 2023[25]. - The net profit attributable to shareholders for 2024 was -¥68,853,096.03, representing a decline of 166.90% from ¥102,917,838.16 in the previous year[25]. - The net profit attributable to shareholders after deducting non-recurring gains and losses was ¥11,760,028.82, an increase of 127.94% compared to -¥42,093,070.95 in 2023[25]. - The net cash flow from operating activities for 2024 was ¥135,973,946.20, a significant increase of 541.05% from ¥21,210,975.01 in 2023[25]. - The total assets at the end of 2024 were ¥3,551,848,565.47, a decrease of 1.94% from ¥3,622,201,677.70 at the end of 2023[25]. - The net assets attributable to shareholders at the end of 2024 were ¥3,357,111,952.59, down 2.30% from ¥3,436,014,685.50 in 2023[25]. - The basic earnings per share for 2024 were -¥0.14, a decrease of 166.67% from ¥0.21 in 2023[25]. - The weighted average return on equity for 2024 was -2.03%, down 5.05% from 3.02% in 2023[25]. - The company reported a total non-operating loss of ¥80,613,124.85 in 2024, a significant decrease from a profit of ¥145,010,909.11 in 2023[31]. Market and Industry Trends - The pharmaceutical industry faces risks from government policies, including centralized procurement and changes in medical insurance regulations, impacting market access and pricing[5][7]. - The pharmaceutical manufacturing industry in China achieved a revenue of ¥25,298.5 billion in 2024, remaining stable compared to the previous year[35]. - The total profit for the pharmaceutical manufacturing sector decreased by 1.1% to ¥3,420.7 billion in 2024[35]. - The population aged 60 and above reached 31,031 million in 2024, accounting for 22.0% of the total population, indicating a growing market for healthcare products[36]. - The overall industrial revenue in China grew by 2.1% in 2024, reflecting a stable economic environment despite challenges[35]. Product Development and R&D - The company is committed to improving product quality and increasing investment in R&D to meet national drug standards and enhance product competitiveness[8][10]. - New drug development involves a lengthy process with multiple stages, posing risks of technical failure or market rejection[9]. - The company is focused on expanding its product line in cardiovascular, immunological, and neurological disease treatments, aligning with market demands[39]. - The company has established a proprietary biopolymer purification technology platform, enhancing its core process technology advantages[49]. - The company is actively pursuing research and development projects, including the registration application for Dapagliflozin tablets and clinical studies for K11 project[110]. - The company is currently conducting preclinical research on multiple new antibody drugs targeting various diseases, including Alzheimer's and ischemic stroke[62]. - The company has completed the initial research on the production process for several new drugs, including Dapagliflozin and its formulations for type 2 diabetes[62]. - The company is enhancing the quality standards for its products, including the fibrinolytic enzyme injection for treating cerebral infarction and myocardial infarction[61]. Strategic Initiatives - The company plans to enhance market expansion efforts by increasing sales team size and seeking opportunities in provincial bidding and procurement[4]. - The company is committed to expanding its presence in the life sciences and health industry through innovation, R&D, and strategic partnerships[55]. - The company is exploring potential acquisitions to strengthen its portfolio, with a focus on companies in the biotechnology sector[140]. - The company has established five strategic platforms for group development, including R&D innovation and capital industry platforms, to leverage favorable policies for sustainable growth[106]. - The company plans to strengthen its marketing strategy by enhancing brand influence and market share, with a focus on academic promotion and channel development[109]. Human Resources and Management - The company is aware of the risk of core personnel turnover and plans to monitor industry trends and consider mergers or collaborations to mitigate this risk[11]. - The company will continue to implement a "people-oriented, talent-driven" strategy, focusing on "innovation-driven, high-quality development" to enhance talent quality and build a competitive high-quality talent team[111]. - A comprehensive training system will be established to cover all employees and career stages, including professional skills and management capability training, with quarterly closed training sessions for management teams[112]. - The company has a dedicated human resources management system, ensuring all key personnel are employed directly by the company[126]. Environmental Compliance - The company maintains compliance with environmental protection regulations and holds valid discharge permits for its subsidiaries[172]. - The company has implemented pollution control measures, resulting in zero exceedances in emissions for various pollutants[173]. - The company is focused on enhancing its environmental compliance and reducing overall emissions in line with national standards[174]. - The wastewater treatment plant of Sai Sheng Pharmaceutical has a processing capacity of 200 m³/day, utilizing an "anaerobic + aerobic biological contact oxidation" process, meeting the discharge standards of DB11/307-2013[176]. - The company has established a self-monitoring plan for environmental pollutants in accordance with relevant regulations[187]. Governance and Compliance - The company has established a complete and independent organizational structure, adhering to legal governance requirements[126]. - The company is focused on maintaining compliance with regulations and ensuring effective governance and operational management[153]. - The board has proposed a profit distribution plan for the 2023 fiscal year[149]. - The company has engaged in discussions regarding external investments and related transactions[149]. - The Audit Committee conducted a review of the 2023 annual report and the 2024 financial budget report, passing all proposals unanimously[155].
赛升药业(300485) - 关于子公司收到药品注册上市许可申请受理通知书的公告
2025-03-17 08:15
证券代码:300485 证券简称:赛升药业 公告编号:2025-003 北京赛升药业股份有限公司 关于子公司收到药品注册上市许可申请受理通知书的公告 本公司及董事会全体成员保证信息披露的内容真实、准确和完整,没 有虚假记载、误导性陈述或重大遗漏。 北京赛升药业股份有限公司(以下简称"公司")子公司北京赛而生物药业有 限公司(以下简称"赛而生物")近日收到了国家药品监督管理局下发的达格列净 片境内生产药品注册上市许可申请的《受理通知书》。现将相关信息公告如下: 一、《受理通知书》主要内容 | (一)申请单位:北京赛而生物药业有限公司 | | --- | | 申请事项:境内生产药品注册上市许可 | | 产品名称:达格列净片 | | 注册分类:化学药品 4 类 | | 规 格:5mg(以 C21H25C106 计) | | 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:CYHS2501*** | | (二)申请单位:北京赛而生物药业有限公司 | 申请事项:境内生产药品注册上市许可 产品名称:达格列净片 注册分类:化学药品 4 类 根据《中华人民共和国行政许可法》 ...
赛升药业(300485) - 关于子公司获得药物临床试验批准通知书的公告
2025-03-17 08:15
证券代码:300485 证券简称:赛升药业 公告编号:2025-004 北京赛升药业股份有限公司 关于子公司获得药物临床试验批准通知书的公告 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。 北京赛升药业股份有限公司子公司沈阳君元药业有限公司收到国家药品监 督管理局的《药物临床试验批准通知书》,同意开展用于乳腺增生症的临床试验。 具体情况如下: 一、药物基本情况 1、药物名称:丹香颗粒 2、申报企业:沈阳君元药业有限公司 3、规格:每袋装 6g(每 1g 相当于饮片 2.42g) 4、注册分类:1.1 类中药 二、药物其他相关情况 丹香颗粒适应症为疏肝行气、祛痰化瘀、散结止痛。用于肝郁气滞、痰 凝血瘀所致的乳癖(乳腺增生症)(中医辨证为肝郁气滞、痰凝血瘀证)。症见 乳房肿块,质韧不坚;乳房胀痛或刺痛,症状随月经周期或情绪变化消长, 胸闷胁胀,善郁易怒,或咽喉异物感,心烦口苦,舌底脉络迂曲,苔白腻, 脉弦。 三、风险提示 获得药物临床试验通知书后,沈阳君元药业有限公司将按相关法规规定 组织开展临床试验。该药物从临床试验到获准上市销售尚存在诸多环节及不 确定性,敬请 ...
赛升药业(300485) - 2024 Q4 - 年度业绩预告
2025-01-24 08:00
Financial Performance Forecast - The company expects a net loss for 2024 between 105.09 million and 85.99 million RMB, compared to a profit of 122.16 million RMB in the same period last year, representing a decline of approximately 186.03% to 170.39%[4] - The total profit is projected to decrease significantly, primarily due to a reduction in fair value changes of financial assets and investment income from joint ventures, estimated at around -110 million RMB, a decline of about 170%[7] - The net profit attributable to shareholders is expected to be a loss between 88.76 million and 59.17 million RMB, compared to a profit of 102.92 million RMB last year[4] - Non-recurring losses are estimated to impact net profit by approximately -90 million RMB, mainly from fair value changes and investment income from trading financial assets[7] Revenue and Cost Management - The company's operating revenue is projected to be between 395.85 million and 437.52 million RMB, down from 476.57 million RMB in the previous year[4] - The company anticipates a growth in net profit after deducting non-recurring gains and losses, attributed to improved internal management and cost control, with reductions in selling and administrative expenses compared to the previous year[7] Audit and Reporting - The financial data presented is preliminary and has not been audited, with detailed figures to be disclosed in the 2024 annual report[8] - The company has communicated with its auditing firm regarding the performance forecast, and there are no discrepancies reported[6] - The performance forecast period is from January 1, 2024, to December 31, 2024[3] Investor Advisory - Investors are advised to make cautious decisions and be aware of investment risks due to the preliminary nature of the financial data[8]
赛升药业(300485) - 关于子公司药品生产许可证变更的公告
2025-01-23 16:00
北京赛升药业股份有限公司(以下简称"公司")子公司沈阳君元药业有限 公司(以下简称"君元药业")近日获得了辽宁省药品监督管理局颁发的《药品 生产许可证》。本次涉及变更的事项为:同意该企业将已上市药品追风透骨片(糖 衣片)(国药准字 Z21020728)的生产场地由沈阳市东陵区凌云街 103 巷 6 号变 更为沈阳市浑南区麦子屯 603 号 9 号楼,22 号楼,其他内容不变。 现将相关信息公告如下: 一、《药品生产许可证》的基本信息 企业名称:沈阳君元药业有限公司 证券代码:300485 证券简称:赛升药业 公告编号:2025-001 北京赛升药业股份有限公司 关于子公司药品生产许可证变更的公告 本公司及董事会全体成员保证信息披露的内容真实、准确和完整,没 有虚假记载、误导性陈述或重大遗漏。 生产地址和生产范围:沈阳市浑南区麦子屯 603 号 9 号楼,22 号楼:片剂、 颗粒剂、硬胶囊剂、丸剂(水丸)、溶液剂(外用、含激素类)、酊剂(外用、 含激素类)、搽剂、栓剂、小容量注射剂 二、对公司的影响 本次《药品生产许可证》变更涉及追风透骨片(糖衣片)的生产场地变更, 有利于进一步丰富公司产品品种,完善产品结构, ...
赛升药业:关于子公司收到原料药上市申请受理通知书的公告
2024-12-23 08:51
北京赛升药业股份有限公司(以下简称"公司")子公司北京赛而生物药业 有限公司(以下简称"赛而生物")近日收到了国家药品监督管理局下发的达格 列净原料药上市申请《受理通知书》。现将相关信息公告如下: 一、《受理通知书》主要内容 申请单位:北京赛而生物药业有限公司 申请事项:上市 产品名称:达格列净 证券代码:300485 证券简称:赛升药业 公告编号:2024-058 北京赛升药业股份有限公司 关于子公司收到原料药上市申请受理通知书的公告 本公司及董事会全体成员保证信息披露的内容真实、准确和完整,没 有虚假记载、误导性陈述或重大遗漏。 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:CYHS2461*** 三、对公司的影响及风险提示 登记号:Y20240001369 二、达格列净的相关情况 达格列净原料药上市申请获得受理,表示该品种进入注册审评阶段,对公司 近期业绩不会产生重大影响,如顺利通过注册审评,将进一步丰富赛而生物原料 药产品管线,为赛而生物相关制剂生产研究开发提供原料保障。因相关产品的注 册批准文件取得时间和结果均具有不确定性,敬请投资者注意投资风险。 达格列净是新 ...
赛升药业:关于子公司药品生产许可证变更的公告
2024-11-20 08:09
关于子公司药品生产许可证变更的公告 本公司及董事会全体成员保证信息披露的内容真实、准确和完整,没 有虚假记载、误导性陈述或重大遗漏。 北京赛升药业股份有限公司(以下简称"公司")子公司北京赛而生物药业 有限公司(以下简称"赛而生物")近日获得了北京市药品监督管理局颁发的《药 品生产许可证》。本次涉及变更的事项为:经资料审查和分局现场检查,同意你 单位《药品生产许可证》天津市蓟州区京津州河科技产业园腾飞街 2 号地址项下 "原料药综合车间:合成生产线"新增生产范围:"原料药(达格列净)(仅限 注册申报使用)"。本次新增生产范围待取得药品批准证明文件并通过药品 GMP 符合性检查后方可正式生产使用。 现将相关信息公告如下: 一、《药品生产许可证》的基本信息 企业名称:北京赛而生物药业有限公司 许可证编号:京 20150048 社会信用代码:91110115742602836G 分类码:AhzChDhz 注册地址:北京市大兴区工业开发区科苑路 35 号 法定代表人:马骉 企业负责人:马骉 质量负责人:郑计 有效期至:2025 年 12 月 07 日 生产地址和生产范围: 蓟州区京津州河科技产业园腾飞街 2 号:原料 ...