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上海医药(601607.SH):二羟丙茶碱注射液通过仿制药一致性评价
智通财经网· 2025-09-04 07:44
Core Viewpoint - Shanghai Pharmaceuticals (601607.SH) announced that its subsidiary, Shanghai Xinyi Jinzhu Pharmaceutical Co., Ltd. (referred to as "Xinyi Jinzhu"), has received a "Drug Supplement Application Approval Notice" from the National Medical Products Administration (NMPA) for its Dihydroxypropyl Theophylline Injection, which has passed the consistency evaluation of quality and efficacy for generic drugs [1] Group 1 - The Dihydroxypropyl Theophylline Injection is indicated for bronchial asthma, asthmatic bronchitis, obstructive pulmonary emphysema, and relief of wheezing symptoms [1] - The drug can also be used for wheezing caused by cardiogenic pulmonary edema [1] - Dihydroxypropyl Theophylline Injection was developed by Eisai Co., Ltd. and was launched in Japan in October 1952 [1] Group 2 - In August 2024, Xinyi Jinzhu submitted a supplementary application to the NMPA for the new specification and combined consistency evaluation of the generic drug, which was accepted [1] - As of the date of the announcement, the company has invested approximately RMB 3.05 million in research and development costs for this drug [1]
上海医药:二羟丙茶碱注射液通过仿制药一致性评价
Zhi Tong Cai Jing· 2025-09-04 07:39
Core Viewpoint - Shanghai Pharmaceuticals (601607.SH) announced that its subsidiary, Shanghai Xinyi Jinzhu Pharmaceutical Co., Ltd. (referred to as "Xinyi Jinzhu"), has received a Supplementary Application Approval Notice from the National Medical Products Administration (NMPA) for its Dihydroxypropyl Theophylline Injection, which has passed the consistency evaluation of generic drug quality and efficacy [1] Group 1 - The Dihydroxypropyl Theophylline Injection is indicated for bronchial asthma, asthmatic bronchitis, obstructive pulmonary emphysema, and relief of wheezing symptoms [1] - The drug can also be used for wheezing caused by cardiogenic pulmonary edema [1] - The drug was developed by Eisai Co., Ltd. and was launched in Japan in October 1952 [1] Group 2 - In August 2024, Xinyi Jinzhu submitted a supplementary application to the NMPA for the new specification and consistency evaluation of the generic drug, which has been accepted [1] - As of the date of the announcement, the company has invested approximately RMB 3.05 million in research and development costs for this drug [1]
上海医药(02607) - 截至二零二五年八月三十一日止月份股份发行人的证券变动月报表
2025-09-02 08:49
呈交日期: 2025年9月2日 I. 法定/註冊股本變動 FF301 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年8月31日 狀態: 新提交 致:香港交易及結算所有限公司 公司名稱: 上海醫藥集團股份有限公司 | 1. 股份分類 | 普通股 | 股份類別 | H | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02607 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 919,072,704 | RMB | | 1 RMB | | 919,072,704 | | 增加 / 減少 (-) | | | 0 | | | RMB | | 0 | | 本月底結存 | | | 919,072,704 | RMB | | 1 RMB | | 919,072,704 | | 2. 股份分類 | 普通股 | 股份類別 | A ...
国金证券:终端需求逐步复苏 医药健康行业景气度有望上行
智通财经网· 2025-09-02 03:41
Group 1: Overall Market Outlook - The report from Guojin Securities indicates an improvement in the performance of certain sectors such as ophthalmology, dentistry, and pharmacies in the first half of 2025, with a gradual decrease in performance pressure throughout 2024 [1][2] - The overall performance of traditional Chinese medicine companies is expected to improve as inventory continues to be digested and the execution time for centralized procurement of traditional Chinese medicine has been announced in multiple regions [1][2] Group 2: Traditional Chinese Medicine - In the first half of 2025, the overall performance of traditional Chinese medicine is under pressure, with both revenue and net profit being affected by lower flu incidence and inventory digestion [2] - The centralized procurement process is ongoing, but the execution progress has been slow, limiting the volume of selected products in hospitals [2] Group 3: Pharmacy Sector - The pharmacy sector experienced slight revenue pressure in the first half of 2025, although profits showed some recovery due to cost reduction and efficiency improvements [3] - The industry is undergoing consolidation, with a focus on compliance and the elimination of non-compliant stores, which may enhance market share for leading companies [3] Group 4: Medical Services and Consumer Healthcare - The medical services sector is recovering due to increased consumer demand and successful technological upgrades, with profit growth outpacing revenue growth [4] - Specific segments like ophthalmology and orthodontics are showing significant recovery, while serious medical fields face challenges due to payment reforms and cost control policies [4] - The application of AI technology is enhancing operational efficiency and accelerating business turnover, presenting opportunities for traditional medical services [4]
上海医药集团股份有限公司关于盐酸维拉帕米注射液通过仿制药一致性评价的公告
证券代码:601607 证券简称:上海医药 编号:临2025-080 上海医药集团股份有限公司 关于盐酸维拉帕米注射液通过仿制药一致性评价的公告 注册分类:化学药品 申请人:上海禾丰制药有限公司 药品批准文号:国药准字H31021343 审批结论:本品通过仿制药质量和疗效一致性评价。 二、该药品相关的信息 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、准确性和完整性承担个别及连带责任。 近日,上海医药集团股份有限公司(以下简称"公司")下属上海禾丰制药有限公司(以下简称"上药禾 丰")的盐酸维拉帕米注射液(以下简称"该药品")收到国家药品监督管理局(以下简称"国家药监 局")颁发的《药品补充申请批准通知书》(通知书编号:2025B03892),该药品通过仿制药质量和疗 效一致性评价。 一、该药品基本情况 药品名称:盐酸维拉帕米注射液 剂型:注射剂 规格:2ml:5mg 根据国家相关政策,通过一致性评价的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。 因此上药禾丰的盐酸维拉帕米注射液通过仿制药一致性评价,有利于扩大该药品的市场份额,提升市场 竞争 ...
上海医药: 上海医药集团股份有限公司关于盐酸维拉帕米注射液通过仿制药一致性评价的公告
Zheng Quan Zhi Xing· 2025-09-01 16:10
证券代码:601607 证券简称:上海医药 编号:临 2025-080 上海医药集团股份有限公司 关于盐酸维拉帕米注射液通过仿制药一致性评价的公告 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、准确性和完整性承担个别及连带责任。 近日,上海医药集团股份有限公司(以下简称"公司")下属上海禾丰制药 有限公司(以下简称"上药禾丰")的盐酸维拉帕米注射液(以下简称"该药品") 收到国家药品监督管理局(以下简称"国家药监局")颁发的《药品补充申请批 准通知书》(通知书编号:2025B03892),该药品通过仿制药质量和疗效一致 性评价。 一、该药品基本情况 药品名称:盐酸维拉帕米注射液 剂型:注射剂 规格:2ml:5mg 注册分类:化学药品 药品批准文号:国药准字 H31021343 审批结论:本品通过仿制药质量和疗效一致性评价。 二、该药品相关的信息 盐酸维拉帕米注射液主要用于:1.快速阵发性室上性心动过速的转复。应 用维拉帕米之前应首选抑制迷走神经的手法治疗(如 Valsalva 法)。2.心房扑 动或心房颤动心室率的暂时控制。心房扑动或心房颤动合并房室旁路 ...
上海医药:关于盐酸维拉帕米注射液通过仿制药一致性评价的公告
证券日报网讯 9月1日晚间,上海医药发布公告称,近日,公司下属上海禾丰制药有限公司的盐酸维拉 帕米注射液(简称"该药品")收到国家药品监督管理局颁发的《药品补充申请批准通知书》,该药品通 过仿制药质量和疗效一致性评价。 (编辑 任世碧) ...
上海医药子公司盐酸维拉帕米注射液通过仿制药一致性评价
Bei Jing Shang Bao· 2025-09-01 09:51
(文章来源:北京商报) 公告显示,盐酸维拉帕米注射液主要用于快速阵发性室上性心动过速的转复及心房扑动或心房颤动心室 率的暂时控制。 北京商报讯(记者王寅浩实习记者宋雨盈)9月1日,上海医药发布公告称,公司下属上海禾丰制药有限 公司的盐酸维拉帕米注射液收到国家药品监督管理局颁发的《药品补充申请批准通知书》,该药品通过 仿制药质量和疗效一致性评价。 ...
上海医药(02607.HK):盐酸维拉帕米注射液通过仿制药一致性评价
Ge Long Hui· 2025-09-01 08:43
盐酸维拉帕米注射液主要用于:1.快速阵发性室上性心动过速的转复。应用维拉帕米之前应首选抑制 迷走神经的手法治疗(如 Valsalva 法)。2.心房扑动或心房颤动心室率的暂时控制。心房扑动或心房颤 动合并房室旁路通道(预激综合症和 LGL 综合症)时除外。 格隆汇9月1日丨上海医药(02607.HK)发布公告,近日,公司下属上海禾丰制药有限公司(以下简称"上药 禾丰")的盐酸维拉帕米注射液收到国家药品监督管理局颁发的《药品补充申请批准通知书》(通知书编 号:2025B03892),该药品通过仿制药质量和疗效一致性评价。 ...
上海医药(02607):盐酸维拉帕米注射液通过仿制药一致性评价
智通财经网· 2025-09-01 08:42
盐酸维拉帕米注射液主要用于:1.快速阵发性室上性心动过速的转复。应用维拉帕米之前应首选抑制迷 走神经的手法治疗(如Valsalva法)。2.心房扑动或心房颤动心室率的暂时控制。心房扑动或心房颤动合并 房室旁路通道(预激综合症和LGL综合症)时除外。2024年4月,上药禾丰就该药品仿制药一致性评价向 国家药监局提出补充申请并获得受理。截至本公告日,公司针对该药品的一致性评价已投入研发费用约 为人民币329万元。 智通财经APP讯,上海医药(02607)发布公告,近日,公司下属上海禾丰制药有限公司(简称"上药禾丰") 的盐酸维拉帕米注射液收到国家药品监督管理局颁发的《药品补充申请批准通知书》(通知书编号: 2025B03892),该药品通过仿制药质量和疗效一致性评价。 ...