Shanghai Pharma(601607)

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上海医药(601607) - 上海医药集团股份有限公司关于糠酸莫米松鼻喷雾剂获得美国FDA批准文号的公告


2025-05-20 08:46
证券代码:601607 证券简称:上海医药 公告编号:临2025-057 上海医药集团股份有限公司 关于糠酸莫米松鼻喷雾剂获得美国 FDA 批准文号 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"上海医药"或"公司")下 属浙江信谊瑞爵制药有限公司(以下简称"信谊瑞爵") 收到美国食品药品监 督管理局(以下简称"美国 FDA")的通知,其关于糠酸莫米松鼻喷雾剂(基 本情况详阅正文,以下简称"该药品")的简略新药申请("ANDA",即美国 仿制药申请)已获得批准("Approval"),现将相关情况公告如下: 一、该药品基本情况 药物名称:糠酸莫米松鼻喷雾剂 剂型:鼻喷雾剂 规格:50 微克/揿(0.05%)(按 C27H30Cl2O6计) 申请事项:ANDA 申请人:浙江信谊瑞爵制药有限公司 ANDA 号:ANDA 211706 二、该药品相关信息 糠酸莫米松鼻喷雾剂主要用于预防/治疗青少年和成人的季节性鼻炎,以及 治疗成人伴有鼻息肉的慢性鼻窦炎。糠酸莫米松鼻喷雾剂最早 ...
上海医药:常州制药厂利伐沙班片获美国FDA批准
news flash· 2025-05-20 08:25
Core Viewpoint - Shanghai Pharmaceuticals (601607) announced that its subsidiary, Changzhou Pharmaceutical Factory, has received notification from the U.S. Food and Drug Administration (FDA) that its abbreviated new drug application (ANDA) for rivaroxaban tablets has been approved, which is significant for expanding the company's overseas market presence [1] Summary by Relevant Sections - **Drug Approval** - The FDA has approved the ANDA for rivaroxaban tablets, which are primarily used to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation [1] - **Application Timeline** - The ANDA application was submitted in December 2021, and the approval was recently granted [1] - **Research and Development Investment** - As of the announcement date, the company has invested approximately 8.2 million yuan in research and development for this drug [1] - **Market Potential** - In 2023, the sales revenue of rivaroxaban tablets in the U.S. was approximately 8.13 billion dollars, with projected sales of about 6.33 billion dollars for the first three quarters of 2024 [1] - **Strategic Importance** - The approval is expected to have a positive impact on the company's efforts to further penetrate the overseas market [1]
上海医药(601607) - 上海医药集团股份有限公司关于温经汤颗粒获得批准生产的公告


2025-05-14 08:01
近日,上海医药集团股份有限公司(以下简称"上海医药"或"公司")下 属上海医药集团青岛国风药业股份有限公司(以下简称"上药国风")的温经汤 颗粒(规格:每袋相当于饮片 20g;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《药品注册证书》(证书编号:2025S01230), 该药品获得批准生产。 证券代码:601607 证券简称:上海医药 公告编号:临2025-055 上海医药集团股份有限公司 关于温经汤颗粒获得批准生产的公告 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。 温经汤颗粒处方来源于宋•陈自明《妇人大全良方》,并已列入《古代经典 名方目录(第一批)》。该药品温经补虚,化瘀止痛。用于血海虚寒,气血凝滞 证。症见妇人月经不调,脐腹作痛,脉沉紧。2024 年 7 月上药国风就该药品向 国家药监局提出注册上市申请,并获受理。截至本公告日,公司针对该药品已投 入研发费用约人民币 469 万元。 一、该药品基本情况 经查询国家药监局网站,截至本公告日,中国境内该药品已获批厂家为华润 1 三九 ...
上海医药(601607) - 上海医药集团股份有限公司关于维立西呱原料药上市申请获得批准的公告


2025-05-12 08:30
证券代码:601607 证券简称:上海医药 公告编号:临2025-054 上海医药集团股份有限公司 关于维立西呱原料药上市申请获得批准的公告 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"上海医药"或"公司")下 属控股子公司南通常佑药业科技有限公司(以下简称"南通常佑")的维立西呱 原料药(以下简称"该药物")收到国家药品监督管理局(以下简称"国家药监 局")颁发的《化学原料药上市申请批准通知书》(通知书编号:2025YS00363), 该药物获得批准生产。 一、该药物基本情况 名称:维立西呱 注册标准编号:YBY64282025 包装规格:5kg/桶 申请事项:境内生产化学原料药上市申请 审批结论:根据《中华人民共和国药品管理法》及有关规定,经审查,本品 符合药品注册的有关要求,批准注册。 截至本公告日,中国境内暂无维立西呱原料药的其他生产厂家。IQVIA 数据 库显示,2024 年全年中国大陆医院采购维立西呱制剂的金额约为人民币 8,421 万元。 三、对上市公司影响及风 ...
开展估值提升行动,加速构建创新生态,上海国资国企多举措加强市值管理
Di Yi Cai Jing· 2025-05-10 02:48
Group 1: Core Insights - The Shanghai Municipal State-owned Assets Supervision and Administration Commission and the Shanghai Stock Exchange held a performance briefing to enhance the quality of state-owned listed companies and strengthen investor relations [1][2] - The total market value of 94 state-owned listed companies in Shanghai reached 2.78 trillion yuan, an increase of 617.77 billion yuan or 28.52% from the beginning of the year [1] Group 2: Company Highlights - Shanghai Port Group achieved a container throughput of 51.51 million TEUs, a year-on-year increase of 4.8%, maintaining its position as the world's largest port for 15 consecutive years [3] - Shanghai Port Group's net profit attributable to shareholders reached 14.95 billion yuan, a 13.3% increase year-on-year [3] - Huayi Group reported a revenue of 44.6 billion yuan, a 9.3% increase, and a net profit of 910 million yuan, up 5.8% [5][6] - Shanghai Pharmaceutical achieved a revenue of 275.25 billion yuan, a 5.75% increase, and a net profit of 4.55 billion yuan, a 20.82% increase [8][9] - Pudong Development Bank's net profit reached 45.3 billion yuan, a 23.31% increase, marking the highest growth in nearly 12 years [10][11] - China Pacific Insurance Group reported a revenue of 404.09 billion yuan, a 24.7% increase, and a net profit of 44.96 billion yuan, a 64.9% increase [13][14] - DataPort achieved a revenue of approximately 1.72 billion yuan, an 11.57% increase, and a net profit of approximately 132 million yuan, a 7.49% increase [15][16] Group 3: Strategic Initiatives - Shanghai Port Group is focusing on digital, intelligent, and green transformation to enhance its core business and sustainable development capabilities [3][4] - Huayi Group is advancing major technological projects and has filed 151 patents, with 134 granted [6][7] - Shanghai Pharmaceutical is optimizing its R&D system and has established a new innovation center to accelerate the development of a collaborative ecosystem [8][9] - Pudong Development Bank is implementing a digital finance strategy and enhancing its service efficiency through various digital platforms [10][11] - China Pacific Insurance is expanding its green insurance offerings and enhancing its technology-driven services [13][14] - DataPort is deepening its IDC service capabilities and has been recognized as a top service provider in the industry [15][16]
上海医药: 上海医药集团股份有限公司关于控股股东及其一致行动人权益变动触及1%刻度的提示性公告


Zheng Quan Zhi Xing· 2025-05-09 09:13
Core Viewpoint - The announcement details a change in equity ownership by Shanghai Pharmaceuticals Holding Co., Ltd.'s controlling shareholder, Shanghai Industrial (Group) Co., Ltd., and its concerted party, Shanghai Industrial International Investment Co., Ltd., which has resulted in an increase in their shareholding without triggering a mandatory tender offer or affecting the company's control structure [1][2][3]. Group 1: Equity Change Details - The equity change is a result of the implementation of a previously disclosed share acquisition plan by Shanghai Industrial (Group) Co., Ltd. and its concerted party, which does not trigger a mandatory tender offer [1][3]. - Prior to the equity change, Shanghai Industrial (Group) held 1,371,116,337 shares, representing 36.974% of the total share capital of 3,708,361,809 shares. After the change, their holdings increased to 1,372,116,337 shares, accounting for 37.001% of the total share capital [2][3]. - The share acquisition plan is still ongoing, and the acquiring parties will continue to increase their shareholdings in accordance with the plan during the implementation period [1][2]. Group 2: Compliance and Legal Framework - The equity change complies with relevant laws and regulations, including the Company Law of the People's Republic of China, the Securities Law of the People's Republic of China, and the Management Measures for the Acquisition of Listed Companies [2][3]. - The company will continue to monitor the progress of the share acquisition plan and fulfill its information disclosure obligations as required by the relevant regulatory authorities [3].
上海医药(601607) - 上海医药集团股份有限公司关于控股股东及其一致行动人权益变动触及1%刻度的提示性公告


2025-05-09 08:32
证券代码:601607 证券简称:上海医药 公告编号:临 2025-053 上海医药集团股份有限公司 关于控股股东及其一致行动人权益变动触及1%刻度的提示性公告 上海实业(集团)有限公司及其一致行动人上实国际投资有限公司保证向本公 司提供的信息真实、准确、完整,没有虚假记载、误导性陈述或重大遗漏。 本公司董事会及全体董事保证公告内容与信息披露义务人提供的信息一致。 重要内容提示: 名称:上实国际投资有限公司 本次权益变动系上海医药集团股份有限公司(以下简称"上海医药"或"公 司")控股股东上海实业(集团)有限公司(以下简称"上实集团")及其一致行 动人上实国际投资有限公司(以下简称"上实国际")履行此前披露的增持股份计 划所致,不触及要约收购,不会导致公司股份分布不具备上市条件,亦不会导致 公司控股股东及实际控制人发生变化。 本次权益变动前,上实集团合计持有上海医药 1,371,116,337 股,占公司 总股本的 36.974%。本次权益变动后,上实集团合计持有上海医药 1,372,116,337 股,占公司总股本的 37.001%。本次增持计划尚未实施完毕,增持主体将继续按照 相关增持计划,在增持计划实施 ...
上海医药(601607):2025年一季报点评:商业增长稳健,创新业务表现亮眼
Huafu Securities· 2025-05-06 06:09
Investment Rating - The investment rating for the company is "Buy" [7][22]. Core Views - The company reported a revenue of 707.6 billion yuan in Q1 2025, reflecting a growth of 0.87%, while the net profit attributable to shareholders was 13.3 billion yuan, down by 13.6% [2][4]. - The commercial segment showed steady growth with a revenue of 649 billion yuan, up by 2.6%, and a net profit of 8.3 billion yuan, up by 0.2%. Notably, the innovative drug business achieved a revenue of 125 billion yuan, marking a significant increase of 23.2% [3][4]. - The industrial segment faced pressure with a revenue of 58.9 billion yuan, down by 15.3%, and a net profit of 5.32 billion yuan, down by 21.1%. However, multiple innovative drug research pipelines are progressing steadily [5]. - The company's gross margin was 10.25%, a decrease of 1.19 percentage points, and the net margin was 2.32%, down by 0.34 percentage points [6]. Financial Analysis - The company slightly adjusted its profit forecast for 2025-2027, estimating revenues of 2891 billion yuan, 3057 billion yuan, and 3250 billion yuan respectively, with net profits of 47.8 billion yuan, 53.7 billion yuan, and 60.8 billion yuan [7]. - The current price-to-earnings (P/E) ratios are projected to be 14, 12, and 11 for the years 2025, 2026, and 2027 respectively [7]. Summary of Financial Data - The company’s revenue for 2023 is projected at 260,295 million yuan, with a growth rate of 12%. The net profit is expected to be 3,768 million yuan, reflecting a decline of 33% [8]. - The earnings per share (EPS) for 2025 is estimated at 1.29 yuan, with a P/E ratio of 13.9 [8].
资源整合与专业赋能,益普生与上药控股达成战略合作
Zhong Guo Chan Ye Jing Ji Xin Xi Wang· 2025-05-06 05:43
2025年4月28日,全球特药领域生物制药公司益普生携手上药控股有限公司共同宣布达成战略合作协 议。益普生与上药控股的战略合作,本质上是一场优势互补的深度融合,双方通过整合资源、发挥专 长,实现互利共赢,为医药行业的合作模式提供了新的范例。 益普生中国总经理戴纪尧、益普生中国商业卓越运营部负责人薛樱花,上海医药(601607)执行董事兼 执行总裁李永忠、上药控股副总经理唐鹏程、张燕、宋潞潞等双方管理层代表出席仪式。 上海医药执行董事兼执行总裁李永忠表示:"此次上药控股与益普生的战略携手,标志着双方将资源与 优势深度融合,开启协同发展的新篇章。益普生核心治疗领域的卓越品牌影响力与上药控股成熟的全国 终端覆盖网络以及专业化的学术推广矩阵形成优势互补。上药控股将始终秉持'服务为荣'的理念,依托 对产品核心领域的深入理解和创新能力,在当前外部环境不确定的情况下,加大对创新业务CSO的推进 力度,携手益普生共同推动达菲林在中国市场的广泛覆盖,为患者带来更精准的健康服务,助力医疗行 业高质量发展。" 作为全球领先的生物制药公司,益普生已深耕中国市场30余年。秉持对中国市场的长期承诺,益普生始 终致力于将优质产品引入中国。 ...
医药生物整体业绩稳健,这些细分领域被市场看好
Zheng Quan Shi Bao· 2025-05-02 09:48
Core Viewpoint - The A-share pharmaceutical and biotechnology sector demonstrated resilience in 2024 despite a complex external environment, with innovative drugs entering a phase of realization and development progress catalyzing growth, unaffected by trade wars, positioning it as a key investment theme for 2025 [1][8]. Overall Performance - A-share pharmaceutical and biotechnology companies reported stable performance, with total revenue in 2024 reaching 2.47 trillion yuan, slightly down from 2.50 trillion yuan in 2023, and a net profit attributable to shareholders of 140.26 billion yuan [2][3]. Revenue Breakdown - The overall sector had 499 companies, with a total revenue of 24,651.04 billion yuan in 2024, reflecting a year-on-year decrease of 1.50%. The first quarter of 2025 saw total revenue of 6,037.04 billion yuan, down 6.14% year-on-year [3]. - Sub-sectors such as chemical pharmaceuticals, pharmaceutical commerce, and medical devices achieved positive revenue growth in 2024, while only the medical services sector showed positive growth in Q1 2025 [4]. Individual Company Performance - Among the companies, 234 reported revenue growth in 2024, with 59 companies exceeding a 20% increase. In terms of net profit, 231 companies saw growth, with 140 exceeding 20% [5]. - Shanghai Pharmaceuticals achieved revenue of 275.25 billion yuan in 2024, up 5.75%, with a net profit of 4.55 billion yuan, a 20.82% increase. The company also reported a significant increase in R&D investment [5]. - Jiuzhoutong reported revenue of 151.81 billion yuan in 2024, a 1.11% increase, driven by stable growth in its pharmaceutical distribution business and rapid growth in emerging sectors [6]. Market Attention - The pharmaceutical and biotechnology sector has garnered significant market attention since April, with many companies receiving institutional research interest, particularly those involved in innovative drugs [7]. - Huadong Medicine's recent annual report and Q1 performance attracted considerable institutional investor interest, focusing on product development and future industry trends [7]. Investment Outlook - Analysts remain optimistic about innovative drugs, overseas expansion, and the clearing of procurement policies, suggesting that the sector is entering a growth phase with potential in insulin, orthopedics, and certain generic drug companies [8]. - The market is expected to see increased activity in mergers and acquisitions as the pharmaceutical market undergoes a phase of concentration [8].