一、 药品基本情况 二、药品的其他相关情况 塞替派是一种多功能的细胞毒类药物，其化学结构和药理作用与氮芥相关。 塞替派的类辐射样作用被认为是通过释放亚乙基亚胺基，像辐照一样破坏 DNA 键而产生。其中一个主要的 DNA 键破坏是由 N-7 位点鸟嘌呤烷基化而产生，其 切断了嘌呤碱基与糖之间的连接，释放出烷基化的鸟嘌呤。 注射用塞替派适用于重型 β-地中海贫血儿童（＜18 周岁）异基因造血干细 胞移植（allo-HSCT）前预处理。 证券代码：688553 证券简称：汇宇制药 公告编号：2025-018 四川汇宇制药股份有限公司 自愿披露注射用塞替派获得药品注册证书的公告 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。 四川汇宇制药股份有限公司（以下简称"公司"）全资子公司四川汇宇海玥 医药科技有限公司于近日收到国家药品监督管理局核准签发的公司产品注射用 塞替派获得的《药品注册证书》，现将相关情况公告如下： | 药品名称 | 注射用塞替派 | | --- | --- | | 剂型 | 注射剂 | | 规格 | 15mg；10 ...

Financial Performance - Total revenue for 2024 reached RMB 1,093.20 million, an increase of 17.92% compared to the previous year[3] - Operating profit surged to RMB 354.91 million, reflecting a growth of 185.37% year-over-year[3] - Net profit attributable to shareholders was RMB 330.89 million, up 136.71% from the prior year[3] - The net profit excluding non-recurring gains was RMB 100.63 million, representing a 52.44% increase year-over-year[3] - Basic earnings per share increased to RMB 0.78, a rise of 137.6% compared to the previous year[3] Assets and Equity - Total assets at the end of the reporting period were RMB 5,208.53 million, an 11.16% increase from the beginning of the period[3] - Shareholders' equity attributable to the parent company was RMB 3,978.76 million, up 5.41% from the start of the period[3] Market Growth - The company experienced significant growth in international markets, with revenue from international operations increasing by RMB 77.50 million[6] Investment Gains - The fair value change gain from the investment in Zhejiang Tongyuan Kang Pharmaceutical Co., Ltd. was RMB 211 million during the reporting period[6] Financial Reporting Assurance - The company does not foresee any major uncertainties affecting the accuracy of the financial report[9]

Investment Rating - The report assigns a "Buy" rating for the company, Huayu Pharmaceutical (688553.SH), for the first time [1]. Core Insights - Huayu Pharmaceutical focuses on the oncology field, with a strategy driven by overseas expansion and innovation, aiming for new growth [5]. - The company has over 100 projects in development, including 13 first-class innovative drugs and 5 improved new drug projects, primarily targeting oncology and related fields [5]. - The projected net profits for the company from 2024 to 2026 are estimated to be CNY 357 million, CNY 384 million, and CNY 423 million, respectively, with corresponding EPS of CNY 0.84, CNY 0.91, and CNY 1.00, leading to PE ratios of 16.9, 15.7, and 14.2 times [5]. Summary by Sections Company Overview - Huayu Pharmaceutical is a research-driven pharmaceutical company established in 2010, primarily engaged in the R&D, production, and sales of anti-tumor and injection drugs [16]. - The company has a stable and concentrated shareholding structure, with the actual controller holding 26.93% of the shares [18]. Financial Performance - The company’s revenue for the first three quarters of 2024 reached CNY 852 million, a year-on-year increase of 29.2%, while the net profit attributable to shareholders was CNY 230 million, up 155.6% year-on-year [21][22]. - The gross profit margin for 2023 was 85.93%, with a net profit margin of 11.77% for the first three quarters of 2024 [25]. Product Sales and Market Position - The company’s domestic sales have rebounded, with a total of CNY 722 million in domestic sales for the first three quarters of 2024, showing an increase of over 20% [27]. - The drug Oxaliplatin has become the largest single product, accounting for 37.02% of sales [27]. International Expansion - The company’s overseas sales have rapidly increased, with CNY 102 million in overseas sales for the first three quarters of 2024, representing a year-on-year growth of 76.74% [6]. - The overseas market is expected to become a new growth point for the company as it expands its product offerings and geographical coverage [6]. R&D Investment - The company invested CNY 225 million in R&D in the first three quarters of 2024, accounting for 26.42% of its revenue [7]. - Multiple innovative drugs are in clinical trials, focusing on targeted therapy and immunotherapy [7].

Investment Rating - The report assigns a "Buy" rating for the company, Huayu Pharmaceutical (688553.SH) [1]. Core Insights - Huayu Pharmaceutical focuses on the oncology field, with a strategy driven by overseas expansion and innovation, aiming for new growth opportunities [5]. - The company has over 100 projects in development, including 13 first-class innovative drugs and 5 improved new drug projects, primarily targeting oncology and related fields [5]. - The projected net profits for the company from 2024 to 2026 are estimated to be 357 million, 384 million, and 423 million yuan respectively, with corresponding EPS of 0.84, 0.91, and 1.00 yuan, leading to PE ratios of 16.9, 15.7, and 14.2 times [5]. Summary by Sections Company Overview - Huayu Pharmaceutical is a research-driven pharmaceutical company established in 2010, primarily engaged in the R&D, production, and sales of anti-tumor and injection drugs [16]. - The company has a stable and concentrated shareholding structure, with significant ownership held by the actual controller, Ding Zhao [18]. Financial Performance - The company experienced a significant revenue drop in 2022 due to national procurement policies, but has shown recovery in 2024 with a revenue of 852 million yuan in the first three quarters, a year-on-year increase of 29.2% [21]. - The net profit for the same period reached 230 million yuan, reflecting a year-on-year growth of 155.6% [21]. Product Sales and Market Position - Domestic sales have rebounded, with the drug Oxaliplatin becoming the largest single product, accounting for 37.02% of sales [27]. - The company has successfully entered multiple national procurement programs, with the impact of these policies gradually diminishing [29]. International Expansion - The company has seen rapid growth in overseas sales, with a total of 102 million yuan in international sales from Q1 to Q3 of 2024, representing a year-on-year increase of 76.74% [6]. - The overseas market is expected to become a new growth point for the company's performance as it expands its product offerings and geographical coverage [6]. R&D Investment - R&D investment reached 225 million yuan in the first three quarters of 2024, accounting for 26.42% of revenue, indicating a strong commitment to innovation [7]. - The company is focusing on targeted therapies and immunotherapies, with several innovative drugs entering clinical trials [7].

证券代码：688553 证券简称：汇宇制药 公告编号：2025-016 四川汇宇制药股份有限公司 自愿披露公司产品获得境外上市许可的公告 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。 四川汇宇制药股份有限公司（以下简称"公司"）子公司 Seacross Pharma (Europe) Ltd. 及 Seacross Pharmaceuticals Ltd.分别于近期收到土库曼斯坦药品管 理局、西班牙药品和医疗器械管理局、意大利卫生部和英国药品和健康产品管理 局分别核准签发的公司产品注射用培美曲塞二钠、注射用赛替派、注射用环磷酰 胺、注射用帕瑞昔布钠的上市许可。现将相关情况公告如下： 二、药品的其他相关情况 （一）注射用培美曲塞二钠 注射用培美曲塞二钠联合顺铂可用于化疗不可切除的恶性胸膜间皮瘤以及 局部晚期或转移性肺癌（非鳞状细胞为主）的一线治疗。该产品也可适用于局部 晚期或转移性非小细胞肺癌的单药维持治疗。 公司注射用培美曲塞二钠研发成功后已进行了多国注册申报，分别已在中国、 英国、德国、芬兰、巴勒斯坦等 14 个国家获 ...

Core Viewpoint - Seacross Pharma and Seacross Pharmaceuticals, subsidiaries of Huayu Pharmaceutical, have received marketing approvals for several injectable products from regulatory authorities in Turkmenistan, Spain, Italy, and the UK [1] Group 1 - The approved products include injectable pemetrexed disodium, injectable satraplatin, injectable cyclophosphamide, and injectable parecoxib sodium [1] - The approvals were granted by the respective drug regulatory agencies in Turkmenistan, Spain, Italy, and the UK [1]

证券代码：688553 证券简称：汇宇制药 公告编号：2025-015 四川汇宇制药股份有限公司 自愿披露公司产品获得境外上市许可的公告 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。 四川汇宇制药股份有限公司（以下简称"公司"）子公司 Seacross Pharma (Europe) Ltd. 及 Seacross Pharmaceuticals Ltd.分别于近期收到荷兰健康产品监管 局、哥斯达黎加卫生部、秘鲁药品和药物管理局、巴基斯坦药品监管局和卫生部 分别核准签发的公司产品注射用环磷酰胺、盐酸伊立替康注射液、普乐沙福注射 液、氟维司群注射液的上市许可。现将相关情况公告如下： 二、药品的其他相关情况 （一）注射用环磷酰胺 注射用环磷酰胺是一种肿瘤药，主要用于治疗慢性淋巴细胞白血病（CLL）； 急性淋巴细胞白血病（ALL）；作为骨髓移植的条件，联合全身照射或白消安治 疗急性淋巴细胞白血病、慢性淋巴细胞白血病和急性髓系白血病；霍奇金淋巴瘤、 非霍奇金淋巴瘤和多发性骨髓瘤；转移性卵巢癌和乳腺癌；乳腺癌的辅助治疗； 尤文氏肉 ...

证券代码：688553 证券简称：汇宇制药 公告编号：2025-012 四川汇宇制药股份有限公司 关于开展外汇套期保值业务的公告 （一）投资目的 随着国际化战略的不断推进，公司国际贸易业务和境外子公司的规模不断扩大， 日常经营涉及的外汇结算业务日益频繁。基于外汇保值、防范市场风险及增强公司 财务稳健性的目的，公司及子公司将与有关政府部门批准、具有相关业务经营资质 的银行等金融机构开展外汇套期保值业务，运用外汇衍生品锁定汇率、财务费用及 1 为有效规避外汇市场风险，防范汇率大幅波动对公司造成不利影响，同时 为提高外汇资金使用效率，合理降低财务费用，公司及子公司预计进行外 汇套期保值业务资金额度不超过900万美元或等值外币，资金来源为自有资 金，不涉及募集资金，额度有效期为自公司董事会审议通过之日起12个月， 上述额度在审批期限内可循环滚动使用，开展期限内任一时点的交易金额 （含前述外汇套期保值业务的收益进行再交易的相关金额）不超过前述总 额度。 已履行的审议程序：公司于2025年1月23日召开第二届董事会第十三次会议、 第二届监事会第十三次会议，审议通过了《关于开展外汇套期保值业务的 议案》。本事项不构成关联交 ...

中信建投证券股份有限公司 关于四川汇宇制药股份有限公司 2025 年度预计日常性关联交易的核查意见 中信建投证券股份有限公司（以下简称"中信建投证券"或"保荐机构"） 作为四川汇宇制药股份有限公司（以下简称"汇宇制药"或"公司"）首次公开 发行股票并在科创板上市的保荐机构，根据《中华人民共和国公司法》《中华人 民共和国证券法》《证券发行上市保荐业务管理办法》《上海证券交易所科创板股 票上市规则》等相关法律法规及规范性文件的规定，对汇宇制药 2025 年度预计 日常性关联交易事项进行了核查，具体情况如下： | | | | 年 月 2024 1 | 日 1 | | | --- | --- | --- | --- | --- | --- | | | | 2024 年预计金 | -2024 年 12 月 | 31 | 预计金额与实际发生金额 | | 关联交易类别 | 关联人 | 额（不含税） | 日实际发生金额 | | 差异较大的原因 | | | | | （不含税） | | | | 向关联人购买原 | 福建南方制药股 | 1,500.00 | 1,374.81 | | - | | 材料 | 份有限公司 | | | | ...

证券代码：688553 证券简称：汇宇制药 公告编号：2025-013 1 （简历详见附件），任期自本次董事会审议通过之日起至第二届董事会任期届满之 日止。 张春平先生具备履行董事会秘书职责所必需的专业知识和工作经验，其任职资 格符合《公司法》《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1号—规范运作》等相关法律法规、规范性文件的有关 规定。张春平先生已取得深圳证券交易所董事会秘书资格证书，尚未取得上海证券 交易所颁发的科创板上市公司《董事会秘书任职培训证明》。现暂由公司董事、财 务总监高岚代行董事会秘书职责，待张春平先生取得上海证券交易所颁发的科创板 上市公司《董事会秘书任职培训证明》并经上海证券交易所任职资格审核无异议后， 将正式履行董事会秘书职责，任期至公司第二届董事会任期届满之日止。 公司董事会秘书的联系方式如下： 四川汇宇制药股份有限公司 关于公司董事、副总经理、董事会秘书辞职及聘任 副总经理、董事会秘书的公告 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。 四川汇宇制药股份 ...