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汇宇制药:取得药品注册证书
Mei Ri Jing Ji Xin Wen· 2025-11-14 09:24
2024年1至12月份,汇宇制药的营业收入构成为:医药占比99.18%,其他业务占比0.82%。 每经AI快讯,汇宇制药(SH 688553,收盘价:21.46元)11月14日晚间发布公告称,四川汇宇制药股份 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依托泊苷注射液的《药品注册证书》。 每经头条(nbdtoutiao)——展望"十五五"|专访财科院院长杨志勇:遏制地方政府新增隐性债务,债务 信息要透明,尽可能降低利息成本 (记者 王晓波) 截至发稿,汇宇制药市值为91亿元。 ...
汇宇制药(688553.SH):依托泊苷注射液获得药品注册证书
智通财经网· 2025-11-14 09:22
智通财经APP讯,汇宇制药(688553.SH)发布公告,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》。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。 ...
汇宇制药(688553) - 自愿披露依托泊苷注射液获得药品注册证书的公告
2025-11-14 09:15
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 | ...
汇宇制药:依托泊苷注射液获得药品注册证书
Ge Long Hui· 2025-11-14 09:04
格隆汇11月14日丨汇宇制药(688553.SH)公布,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》,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。 公司获批的依托泊苷注射液注册分类为化学药品 3 类,按照与参比制剂质量和疗效一致的技术要求审评 并获批,批准后视同通过仿制药质量和疗效一致性评价。根据国家相关政策,通过一致性评价的药品品 种在医保支付及医疗机构采购等领域将获得更大的支持力度。公司研发的依托泊苷注射液通过仿制药一 致性评价,提升了自身的竞争能力,对公司的发展起到积极作用。 ...
汇宇制药(688553) - 关于召开2025年第三季度业绩说明会的公告
2025-11-06 08:00
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 ...
汇宇制药股价跌5.03%,泓德基金旗下1只基金重仓,持有5万股浮亏损失5.6万元
Xin Lang Cai Jing· 2025-11-04 06:53
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]
汇宇制药的前世今生:营收7.42亿行业排名60,净利润-5506.99万行业排87,创新研发提速
Xin Lang Zheng Quan· 2025-10-31 23:53
Core Viewpoint - Huiyu Pharmaceutical is a leading player in the domestic oncology and complex injectable drug sector, with a full industry chain advantage [1] Financial Performance - In Q3 2025, Huiyu Pharmaceutical achieved revenue of 742 million yuan, ranking 60th out of 110 in the industry, significantly lower than the top players, East China Pharmaceutical at 32.664 billion yuan and Fosun Pharma at 29.393 billion yuan, and below the industry average of 2.8 billion yuan, but close to the median of 838 million yuan [2] - The net profit for the same period was -55.07 million yuan, ranking 87th out of 110, with a substantial gap compared to the leading companies, Hengrui Medicine at 5.76 billion yuan and Fosun Pharma at 3.056 billion yuan, and below the industry average of 299 million yuan and median of 78.29 million yuan [2] Financial Ratios - As of Q3 2025, Huiyu Pharmaceutical's debt-to-asset ratio was 23.69%, slightly up from 23.21% year-on-year, but lower than the industry average of 35.26%, indicating strong solvency [3] - The gross profit margin for Q3 2025 was 80.49%, down from 83.15% year-on-year, yet still above the industry average of 57.17%, reflecting strong profitability [3] Shareholder Information - As of September 30, 2025, the number of A-share shareholders decreased by 14.45% to 13,900, while the average number of circulating A-shares held per shareholder increased by 16.89% to 24,700 [5] - The top ten circulating shareholders include Ping An Medical Health Mixed A (003032), which is the seventh largest shareholder with 6.8378 million shares, indicating new shareholder interest [5] Strategic Developments - Southwest Securities noted that the impact of centralized procurement is gradually diminishing, and new products are expected to be launched; the company is accelerating innovation with 14 ongoing Class I innovative drug projects, with 2-3 expected to enter clinical research each year over the next three years [5] - The company has launched a total of 43 products, with overseas revenue share increasing from 9.1% in 2023 to 20% in the first half of 2025, projecting revenues of 1.04 billion, 1.09 billion, and 1.2 billion yuan for 2025-2027 [5] Market Position and Growth - Huaxin Securities highlighted that in the first half of 2025, the company experienced steady growth, with five new domestic drug approvals and 50 new foreign drug approvals; the innovative drug pipeline is expanding with 14 ongoing projects [6] - The company reported rapid growth in overseas sales, achieving 93 million yuan in overseas revenue in the first half of 2025, a year-on-year increase of 27.18% [6] - Progress has been made in the medical device sector, with three Class I medical device registrations completed and three Class II medical device product approvals obtained [6]
汇宇制药:公司产品注射用紫杉醇(白蛋白结合型)获得葡萄牙和英国上市许可
Jing Ji Guan Cha Wang· 2025-10-31 18:09
Core Viewpoint - The company has received marketing approvals for its injectable paclitaxel (albumin-bound) from regulatory authorities in Portugal and the UK, indicating a significant step in expanding its product offerings in the oncology market [1] Group 1: Product Approval - The company's subsidiaries, Seacross (Europe) Pharma Ltd. and Seacross Pharmaceuticals Ltd., have obtained marketing licenses for injectable paclitaxel from the Portuguese Medicines and Health Products Regulatory Authority and the UK Medicines and Healthcare products Regulatory Agency [1] - The injectable paclitaxel is primarily indicated for the treatment of adult patients with metastatic breast cancer, pancreatic adenocarcinoma, and non-small cell lung cancer [1] Group 2: Market Expansion - The product has already received marketing authorization in the UK, Portugal, Denmark, Netherlands, Ireland, Finland, and Sweden [1] - Additionally, registration applications have been submitted in Italy, France, Spain, and seven other countries, indicating a proactive approach to market expansion [1]
汇宇制药:关于自愿披露公司产品获得境外上市许可的公告
Zheng Quan Ri Bao· 2025-10-31 11:13
Core Viewpoint - The company Seacross (Europe) Pharma Ltd. and Seacross Pharmaceuticals Ltd., subsidiaries of Huiyu Pharmaceutical, have received marketing authorization for their injectable paclitaxel (albumin-bound) from regulatory authorities in Portugal and the UK [2]. Group 1 - The marketing authorization was granted by the Portuguese Medicines and Health Products Authority and the UK Medicines and Healthcare products Regulatory Agency [2].
汇宇制药(688553) - 关于自愿披露公司产品获得境外上市许可的公告
2025-10-31 08:03
证券代码:688553 证券简称:汇宇制药 公告编号:2025-087 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 二、公司产品的其他相关情况 注射用紫杉醇(白蛋白结合型)主要单药疗法适用于治疗成人转移性乳腺癌 患者(这些患者在一线治疗转移性疾病后病情未见好转,且标准的含蒽环类药物 治疗方案不适用);与吉西他滨联合使用适用于成人转移性胰腺腺癌患者的首次 治疗;与卡铂联合使用,适用于不适合接受可能具有治愈效果的手术和/或放疗 的成年非小细胞肺癌患者的初始治疗。 公司注射用紫杉醇(白蛋白结合型)研发成功后已进行了多国注册申报,目前 已在英国、葡萄牙、丹麦、荷兰、爱尔兰、芬兰、瑞典获得上市许可。截至目前, 公司已在包含意大利、法国、西班牙等 7 个国家提交注册申请。 三、对公司的影响及风险提示 公司研发的注射用紫杉醇(白蛋白结合型)分别获得葡萄牙、英国的上市许可, 有利于公司在国际市场产品管线的丰富,提升市场的品牌形象,持续拓展国际业 务的广度和深度,为国际市场的可持续发展进一步夯实了基础。 公司已开展产品上市销售的前期准备工作,同时受产品的非唯一性、同类产 品竞争以及未来公司业务的推广效 ...