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]

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：2025-011 四川汇宇制药股份有限公司 关于使用部分闲置自有资金进行投资理财的公告 四川汇宇制药股份有限公司（以下简称"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《关于使用 部分闲置自有资金进行投资理财的议案》，同意公司在风险可控且不影响正常经 营和主营业务发展的前提下，拟使用不超过人民币 3000 万元(含本数) （即任一 时点交易金额不超过 3,000 万元）的自有闲置资金进行投资理财，使用期限在审 议批准之日起 12 个月内。在上述额度和期限内，资金可以循环进行投资，滚动 使用，且期限内任一时点的交易金额（含前述投资的收益进行再投资的相关金额） 不应超过前述审议额度。现将有关情况公告如下： 一、投资理财概述 （一）投资目的 在风险可控且不影响公司正常经营和主营业务发展的前提下，使用部分自有 闲置资金进行适度的投资理财，有利于提高资金使用效率，增加投资收益，为公 投资种类：新股配售或申购、证券回购、股票及存托凭证投资、债券投 资、交易型开放式指数基金（ETF）投资、国债逆回购以及上海 ...