注射用紫杉醇(白蛋白结合型)

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汇宇制药:注射用紫杉醇(白蛋白结合型)获得境外上市许可
Zhi Tong Cai Jing· 2025-10-09 08:25
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。 汇宇制药(688553.SH)发布公告,公司子公司Seacross Pharma (Europe) Ltd.于近期分别收到荷兰药品评价 委员会、爱尔兰健康产品监管局、芬兰药品监管局、瑞典药品监督管理局核准签发的公司产品注射用紫 杉醇(白蛋白结合型)的上市许可。 ...
汇宇制药(688553.SH):注射用紫杉醇(白蛋白结合型)获得境外上市许可
智通财经网· 2025-10-09 08:22
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。 智通财经APP讯,汇宇制药(688553.SH)发布公告,公司子公司Seacross Pharma (Europe) Ltd.于近期分别 收到荷兰药品评价委员会、爱尔兰健康产品监管局、芬兰药品监管局、瑞典药品监督管理局核准签发的 公司产品注射用紫杉醇(白蛋白结合型)的上市许可。 ...
汇宇制药:公司产品注射用紫杉醇(白蛋白结合型)获得多国境外上市许可
Zheng Quan Shi Bao Wang· 2025-10-09 08:05
人民财讯10月9日电,汇宇制药(688553)10月9日公告,子公司Seacross Pharma(Europe)Ltd.于近期分别收 到荷兰药品评价委员会、爱尔兰健康产品监管局、芬兰药品监管局、瑞典药品监督管理局核准签发的公 司产品注射用紫杉醇(白蛋白结合型)的上市许可。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)等。 ...
四川汇宇制药股份有限公司2025年第一次临时股东大会决议公告
Shang Hai Zheng Quan Bao· 2025-09-15 21:15
证券代码:688553 证券简称:汇宇制药 公告编号:2025-073 四川汇宇制药股份有限公司 2025年第一次临时股东大会决议公告 本公司董事会及全体董事保证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: ● 本次会议是否有被否决议案:无 一、会议召开和出席情况 (三)出席会议的普通股股东、特别表决权股东、恢复表决权的优先股股东及其持有表决权数量的情 况: ■ (四)表决方式是否符合《公司法》及公司章程的规定,大会主持情况等。 本次会议由公司董事会召集,由公司董事长丁兆先生主持,采用现场投票和网络投票相结合的方式召 开。本次会议的召集、召开程序符合《公司法》、《证券法》、《公司章程》的规定。 (五)公司董事、监事和董事会秘书的出席情况 1、公司在任董事8人,出席8人,现场结合通讯方式出席8人; 二、议案审议情况 (一)非累积投票议案 1、议案名称:《关于取消监事会、修订〈公司章程〉及其附件并办理工商变更登记的议案》 审议结果:通过 表决情况: ■ 2、议案名称:《关于制定和修订部分公司治理制度的议案》 2.01、议案名称:《关于修 ...
汇宇制药及下属公司多项产品取得境外上市许可
Zhi Tong Cai Jing· 2025-09-15 10:05
汇宇制药(688553.SH)公告,公司及其子公司Seacross Pharma(Europe)Ltd.和Seacross Pharmaceuticals Ltd. 于近期分别收到丹麦药品管理局、德国联邦药品和医疗器械管理局、乌兹别克斯坦共和国药品监督管理 局、孟加拉国药品监督管理局分别核准签发的公司产品注射用紫杉醇(白蛋白结合型)、注射用环磷酰 胺、紫杉醇注射液、注射用唑来膦酸浓溶液、注射用阿扎胞苷的上市许可。 ...
汇宇制药(688553.SH)及下属公司多项产品取得境外上市许可
智通财经网· 2025-09-15 10:04
Core Viewpoint - The company, Huyou Pharmaceutical (688553.SH), and its subsidiaries have received marketing approvals for several products from various regulatory authorities in Europe and Asia [1] Group 1: Regulatory Approvals - Huyou Pharmaceutical and its subsidiaries, Seacross Pharma (Europe) Ltd. and Seacross Pharmaceuticals Ltd., have recently obtained marketing licenses for the following products: - Injectable Paclitaxel (Albumin-Bound) - Injectable Cyclophosphamide - Paclitaxel Injection - Injectable Zoledronic Acid Concentrate - Injectable Azacitidine [1]
汇宇制药:多个产品获境外上市许可
Zheng Quan Shi Bao Wang· 2025-09-15 09:58
Core Viewpoint - The company, Huyou Pharmaceutical, has received marketing approvals for several of its products from various regulatory authorities in Europe and Asia, indicating a significant expansion of its market presence and product portfolio [1]. Group 1: Regulatory Approvals - Huyou Pharmaceutical and its subsidiaries, Seacross Pharma (Europe) Ltd. and Seacross Pharmaceuticals Ltd., have recently obtained marketing approvals from the Danish Medicines Agency, the German Federal Institute for Drugs and Medical Devices, the Uzbekistan Drug Regulatory Authority, and the Bangladesh Drug Regulatory Authority [1]. - The approved products include injectable paclitaxel (albumin-bound), injectable cyclophosphamide, paclitaxel injection, injectable zoledronic acid solution, and injectable azacitidine [1].
汇宇制药:多个产品获得境外上市许可
Ge Long Hui· 2025-09-15 09:52
Core Viewpoint - The company, Huyou Pharmaceutical, has received marketing approvals for several of its products from regulatory authorities in Denmark, Germany, Uzbekistan, and Bangladesh, enhancing its international market presence and product pipeline [1] Group 1: Product Approvals - Huyou Pharmaceutical and its subsidiaries Seacross Pharma (Europe) Ltd. and Seacross Pharmaceuticals Ltd. have obtained marketing licenses for the following products: injectable paclitaxel (albumin-bound), injectable cyclophosphamide, paclitaxel injection, injectable zoledronic acid concentrated solution, and injectable azacitidine [1] - The approvals were granted by the Danish Medicines Agency, the German Federal Institute for Drugs and Medical Devices, the Uzbekistan Drug Regulatory Authority, and the Bangladesh Drug Regulatory Authority [1] Group 2: Market Impact - The recent approvals are expected to enrich the company's product pipeline in international markets, enhance its brand image, and facilitate the continuous expansion of its international business [1] - These developments lay a solid foundation for the sustainable growth of the company in the international market [1]
恒瑞医药创新药销售引领业绩增长 上半年归母净利为44.5亿元 同比增长29.7%
Zhi Tong Cai Jing· 2025-08-20 12:35
Core Insights - The company reported a revenue of approximately RMB 15.761 billion for the first half of 2025, representing a year-on-year growth of 15.9% [1] - Net profit attributable to shareholders was RMB 4.45 billion, reflecting a year-on-year increase of 29.7% [1] - Basic earnings per share were RMB 0.70 [1] Revenue Breakdown - The growth in revenue and profit was primarily driven by increased sales and licensing income from innovative drugs, which amounted to RMB 9.561 billion, a year-on-year increase of 26.8%, accounting for 60.7% of total revenue [1] - Sales revenue from innovative drugs reached RMB 7.57 billion [1] Innovative Drug Performance - Key innovative drugs such as Rivoceranib, Darsylin, and Henggrelizumab have effectively addressed unmet clinical needs, with strong clinical data gaining recognition from doctors and patients, leading to continued rapid revenue growth [1] - Earlier launched innovative drugs like Arixtra, Remimazolam, Pyrotinib, and Fluorouracil have expanded their application scope due to accumulating post-market research evidence and new indications, contributing to sales revenue [1] - Other innovative products like Apatinib, Sulfapyridine, and Hecuqipob have also seen growth during the reporting period [1] Licensing Income - The company recognized licensing income as a regular business activity, with significant payments received from Merck Sharp & Dohme (USD 200 million) and IDEAYA Biosciences (USD 75 million), further boosting operational performance [2] Generic Drug Performance - Although sales revenue from generic drugs included in centralized procurement experienced a slight decline, high-quality generic products such as Liposomal Bupivacaine and the first approved generic product of Albumin-bound Paclitaxel in the U.S. saw rapid revenue growth, leading to a slight overall increase in generic drug business revenue [2]
恒瑞医药(01276)创新药销售引领业绩增长 上半年归母净利为44.5亿元 同比增长29.7%
智通财经网· 2025-08-20 12:24
Core Insights - The company reported a revenue of approximately RMB 15.761 billion for the first half of 2025, representing a year-on-year growth of 15.9% [1] - Net profit attributable to shareholders reached RMB 4.45 billion, marking a 29.7% increase compared to the same period last year [1] - Basic earnings per share were RMB 0.70 [1] Revenue and Profit Growth - The growth in revenue and profit was primarily driven by increased sales and licensing income from innovative drugs [1] - Sales and licensing income from innovative drugs amounted to RMB 9.561 billion, a 26.8% increase year-on-year, accounting for 60.7% of total revenue [1] - Innovative drug sales revenue was RMB 7.57 billion [1] Innovative Drug Performance - Key innovative drugs such as Rivoceranib, Darsylin, and Henggrelin have effectively addressed unmet clinical needs, gaining recognition from doctors and patients, leading to sustained revenue growth [1] - Earlier launched innovative drugs like Arixtra, Remimazolam, Pyrotinib, and Fluorouracil have expanded their application scope due to accumulating clinical evidence and new indications, contributing to sales growth [1] - Other innovative products like Apatinib, Sulfapyridine, and Hecolin also experienced growth during the reporting period [1] Future Growth Potential - Some innovative products have not yet fully realized their sales potential due to their recent market entry and lack of inclusion in medical insurance [1] - The company aims to promote the widespread use of new products and accelerate the commercialization of high-quality innovative products to drive stronger future growth [1] Licensing Income - Licensing income from external partnerships has become a significant component of the company's revenue, with the company receiving USD 200 million from Merck Sharp & Dohme and USD 75 million from IDEAYA Biosciences during the reporting period [2] - This licensing income has further contributed to the growth of operational performance metrics [2] Generic Drug Performance - Although sales revenue from generic drugs included in centralized procurement saw a slight decline, high-quality generic products like Liposomal Bupivacaine and the first approved generic product of Albumin-bound Paclitaxel in the U.S. achieved rapid sales growth [2] - Overall, the generic drug business revenue experienced a slight increase due to these factors [2]