四川汇宇制药股份有限公司 证券代码：688553 证券简称：汇宇制药 公告编号：2025-021 持股 5%以上股东减持股份计划公告 本公司董事会、全体董事及相关股东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： 大股东持股的基本情况 截至本公告披露之日，四川汇宇制药股份有限公司(以下简称"公司") 股东黄乾益持有公司股份数量为 27,219,439 股，占公司总股本的 6.426%；上述股份来源于公司首次公开发行前取得的股份，且已于 2022 年 10 月 26 日起解除限售并上市流通。 减持计划的主要内容 因自身资金需求，股东黄乾益拟通过集中竞价或大宗交易的方式减持 公司股份不超过 12,708,000 股，合计减持股份比例不超过公司股份总 数的 3%。 减持期间为自本公告披露之日起 15 个交易日后的 3 个月内。 若减持计划实施期间公司有派息、送股、资本公积金转增股本、配股 等除权除息事项，减持股份数将进行相应调整。 | 股东名称 | 黄乾益 | | | | --- | --- | --- | --- | | 股东身份 ...

证券代码：688553 证券简称：汇宇制药 公告编号：2025-020 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.分别于近期收到意大利卫生部、葡 萄牙国家药品和健康产品管理局、沙特阿拉伯食品药品管理局分别核准签发的公 司产品丙戊酸钠注射用浓溶液、唑来膦酸注射液、注射用替考拉宁、普乐沙福注 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）丙戊酸钠注射用浓溶液 丙戊酸钠注射用浓溶液是一种抗癫痫药，在成人和儿童中，当暂时不能服用 口服剂型时，用于替代口服剂型，主要用于治疗全身性发作，表现为失神性发作、 肌肉抽搐性发作、强直-阵挛性发作，以及局灶性和继发性全身性发作。 公司丙戊酸钠注射用浓溶液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、荷兰、葡萄牙、爱 ...

Core Viewpoint - Sichuan Huiyu Pharmaceutical Co., Ltd. has received the drug registration certificate for injectable methotrexate hydrochloride, which is expected to enhance its competitive position in the market [1][4]. Drug Information - Injectable methotrexate hydrochloride is a cytotoxic alkylating agent effective against both resting and rapidly dividing tumor cells, particularly used for high-dose pre-treatment before hematopoietic stem cell transplantation in multiple myeloma patients [1][2]. - The drug is classified as a Category 4 chemical drug and has passed the consistency evaluation for generic drug quality and efficacy [4]. Market Context - The original manufacturer, Acrotech Biopharma Inc., has already launched injectable methotrexate hydrochloride in China, with Xian Libang holding the approval for the drug [2]. - According to data from Minet, the sales revenue of injectable methotrexate hydrochloride in urban public hospitals in China was approximately 86 million yuan in the first half of 2024 [3]. Company Impact - The approval of injectable methotrexate hydrochloride is expected to provide greater support in areas such as medical insurance payments and procurement by medical institutions due to its passing of the consistency evaluation [4]. - The company has initiated preparations for the product's market launch, although future revenue generation remains uncertain due to competition and market dynamics [4].

自愿披露注射用盐酸美法仑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。 证券代码：688553 证券简称：汇宇制药 公告编号：2025-019 四川汇宇制药股份有限公司 原研 Acrotech Biopharma Inc.的注射用盐酸美法仑已在国内上市，目前国内 有西安力邦持有注射用盐酸美法仑的批件并通过或视同通过仿制药质量和疗效 一致性评价，公司为第二家视同通过仿制药质量和疗效一致性评价的企业。 根据米内网数据显示，2024 年上半年中国城市公立医院终端注射用盐酸美 法仑销售额约为 0.86 亿元。 四川汇宇制药股份有限公司（以下简称"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盐酸美法仑的《药品注册证书》，现将相关情 况公告如下： | 药品名称 | 注射用盐酸美法仑 | | --- | --- | | 剂型 | 注射剂 | | 规格 | 50mg（按 C₁₃H₁₈Cl₂N₂O₂计） | | 注册分类 | 化学药品4类 | | 药品有效期 | 18个月 | | 上市许可持有人 | ...

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]