证券代码：688553 证券简称：汇宇制药 公告编号：2025-090 四川汇宇制药股份有限公司 关于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 Pharmaceuticals Ltd.于近期分别收到巴基斯坦药品监督管理局、英国药品和健康 产品管理局和北马其顿药品和医疗设备管理局核准签发的公司产品普乐沙福注 射液、注射用塞替派、注射用阿扎胞苷、注射用唑来膦酸浓溶液、唑来膦酸注射 液的上市许可。现将相关情况公告如下： 二、公司产品的其他相关情况 （一）普乐沙福注射液 普乐沙福注射液与粒细胞集落刺激因子（G-CSF）联用，适用于非霍奇金淋 巴瘤（NHL）和多发性骨髓瘤（MM）患者动员造血干细胞（HSC）进入外周血， 以便于完成 HSC 采集与自体移植。 公司产品普乐沙福注射液研发成功后已进行了多国注册申报，分别已在中国、 英国、法国、德国、荷兰、秘鲁、巴基斯坦等 30 个国家获得上市许可。截至目 前，公司已分别在包 ...

Core Viewpoint - Seacross Pharmaceuticals Ltd., a subsidiary of the company, has received marketing approvals for several products from regulatory authorities in Pakistan, the UK, and North Macedonia [1] Group 1 - The approved products include Plasmapheresis Injection, Injection of Setipiprant, Injection of Azacitidine, Concentrated Solution of Zoledronic Acid, and Zoledronic Acid Injection [1]

Core Viewpoint - Seacross Pharmaceuticals Ltd., a subsidiary of 汇宇制药 (688553.SH), has received marketing approvals for several products from regulatory authorities in Pakistan, the UK, and North Macedonia [1] Group 1: Regulatory Approvals - The company has obtained marketing licenses for the following products: - 普乐沙福注射液 (Plerixafor Injection) - 注射用塞替派 (Injectable Setipiprant) - 注射用阿扎胞苷 (Injectable Azacitidine) - 注射用唑来膦酸浓溶液 (Injectable Zoledronic Acid Concentrate) - 唑来膦酸注射液 (Zoledronic Acid Injection) from the respective drug regulatory agencies [1]

Group 1 - The core point of the news is that Huayu Pharmaceutical experienced a 5.2% drop in stock price, reaching 20.61 CNY per share, with a trading volume of 58.27 million CNY and a turnover rate of 0.80%, resulting in a total market capitalization of 8.73 billion CNY [1] - Huayu Pharmaceutical, established on October 12, 2010, and listed on October 26, 2021, focuses on the research, production, and sales of drugs in the oncology field and complex injectable drugs, with 97.27% of its revenue coming from drug sales [1] Group 2 - Among the top ten circulating shareholders of Huayu Pharmaceutical, Ping An Fund has a new entry with the Ping An Medical Health Mixed A fund (003032), holding 6.84 million shares, which is 1.99% of the circulating shares, resulting in an estimated floating loss of approximately 7.73 million CNY [2] - The Ping An Medical Health Mixed A fund, established on November 24, 2017, has a latest scale of 2.03 billion CNY, with a year-to-date return of 63.9%, ranking 315 out of 8138 in its category, and a one-year return of 62.73%, ranking 390 out of 8055 [2]

Group 1 - The core point of the article is that Huayu Pharmaceutical has received approval from the National Medical Products Administration for its product, Etoposide Injection, which is a significant regulatory milestone for the company [1] - As of the latest report, Huayu Pharmaceutical's revenue composition for the year 2024 is heavily weighted towards pharmaceuticals, with 99.18% of revenue coming from this sector, indicating a strong focus on its core business [2] - The current market capitalization of Huayu Pharmaceutical is 9.1 billion yuan, reflecting its position in the market [3]

Core Viewpoint - The company has received approval from the National Medical Products Administration for its product, Etoposide Injection, which is indicated for several types of cancer [1] Group 1: Product Approval - The company has been granted a drug registration certificate for Etoposide Injection [1] - Etoposide Injection is primarily indicated for small cell lung cancer, malignant lymphoma, malignant germ cell tumors, leukemia, neuroblastoma, rhabdomyosarcoma, ovarian cancer, non-small cell lung cancer, gastric cancer, and esophageal cancer [1]

证券代码：688553 证券简称：汇宇制药 公告编号：2025-089 四川汇宇制药股份有限公司 一、药品基本情况 二、药品的其他相关情况 依托泊苷注射液主要适应症为小细胞肺癌、恶性淋巴瘤、恶性生殖细胞瘤、 白血病，神经母细胞瘤、横纹肌肉瘤、卵巢癌、非小细胞癌，胃癌和食管癌。 原研依托泊苷注射液未在中国上市。截至目前国内已有 1 家企业持有依托泊 苷注射液批件并通过或视同通过仿制药质量和疗效一致性评价，为齐鲁制药。 根据米内网数据显示，2025 年上半年中国城市公立医院终端依托泊苷注射 液销售额约为 0.68 亿元。 自愿披露依托泊苷注射液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"）于近日收到国家药品监督 管理局核准签发的公司产品依托泊苷注射液的《药品注册证书》，现将相关情况 公告如下： | 药品名称 | 依托泊苷注射液 | | --- | --- | | 剂型 | 注射剂 | | 规格 | 5ml：100mg | | 注册分类 | 化学药品3类 | ...

Core Viewpoint - The company Huayu Pharmaceutical (688553.SH) has received approval from the National Medical Products Administration for its product, Etoposide Injection, which is indicated for various cancers, enhancing its competitive position in the market [1] Group 1: Product Approval - The Etoposide Injection is approved for treating small cell lung cancer, malignant lymphoma, malignant germ cell tumors, leukemia, neuroblastoma, rhabdomyosarcoma, ovarian cancer, non-small cell lung cancer, gastric cancer, and esophageal cancer [1] - The registration classification of Etoposide Injection is categorized as a Class 3 chemical drug, which has passed the consistency evaluation of quality and efficacy compared to reference preparations [1] Group 2: Market Impact - The approval of Etoposide Injection is expected to provide greater support in areas such as medical insurance payment and procurement by medical institutions due to national policies favoring drugs that pass consistency evaluations [1] - The successful consistency evaluation enhances the company's competitive capabilities and positively impacts its development [1]

关于召开 2025 年第三季度业绩说明会的公告 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。 重要内容提示： 投资者可于 2025 年 11 月 7 日（星期五）至 11 月 13 日(星期四)16:00 前 登录上证路演中心网站首页点击"提问预征集"栏目或通过四川汇宇制药股 份有限公司（以下简称"公司"）邮箱 ir@huiyupharma.com 进行提问。公司 将在说明会上对投资者普遍关注的问题进行回答。 公司已于 2025 年 10 月 30 日在上海证券交易所网站（www.sse.com.cn）披 露了公司 2025 年第三季度报告，为便于广大投资者更全面深入地了解公司 2025 年第三季度经营成果、财务状况等信息，公司计划于 2025 年 11 月 14 日上午 10:00-11:00 举行 2025 年第三季度业绩说明会，就投资者关心的问题进行交流。 一、 说明会类型 本次投资者说明会以线上文字互动形式召开，公司将针对 2025 年第三季度 经营成果及财务指标的具体情况与投资者进行互动交流和沟通，在信息披露允 ...

Core Viewpoint - Huyou Pharmaceutical experienced a decline of 5.03% in stock price, currently trading at 21.16 CNY per share, with a total market capitalization of 8.963 billion CNY [1] Company Overview - Sichuan Huyou Pharmaceutical Co., Ltd. was established on October 12, 2010, and went public on October 26, 2021. The company specializes in the research, production, and sales of drugs in the oncology field and complex injectable drugs [1] - The main revenue composition of the company includes 97.27% from drug sales, 1.66% from technical services, and 1.07% from other sources [1] Fund Holdings - Huyou Pharmaceutical is a significant holding in the Hongde Medical Innovation Mixed Fund A (012481), which held 50,000 shares, accounting for 6.13% of the fund's net value, ranking as the ninth largest holding [2] - The fund has reported a year-to-date return of 48.5% and a one-year return of 44.18%, with a total fund size of 14.8031 million CNY [2] - The fund manager, Cao Zhaoxu, has a tenure of 4 years and 306 days, with the fund's best and worst returns during his management being -1.98% and -35.88%, respectively [2]