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*ST双成:注射用紫杉醇(白蛋白结合型)ANDA已获得美国FDA上市许可批准并已在美国实现出口销售
Mei Ri Jing Ji Xin Wen· 2025-08-05 06:06
Core Viewpoint - The company has received FDA approval for its injectable paclitaxel (albumin-bound) and has commenced export sales to the United States [2] Group 1 - The company’s injectable paclitaxel (albumin-bound) is available in a specification of 100 mg per bottle [2] - The company confirmed that the product information will be disclosed in accordance with legal regulations [2] - The company will provide updates through designated disclosure media and the Giant Tide Information Network [2]
*ST双成(002693.SZ):公司注射用紫杉醇(白蛋白结合型)ANDA已在美国实现出口销售
Xin Lang Cai Jing· 2025-08-05 03:29
Core Viewpoint - *ST Shuangcheng (002693.SZ) has received FDA approval for its injectable paclitaxel (albumin-bound) product, which is now available for export sales in the United States [1] Company Summary - The company announced that its ANDA for injectable paclitaxel (100 mg/vial) has been approved by the U.S. FDA [1] - The product information will be disclosed in accordance with legal regulations, and investors are advised to refer to the company's announcements on designated media and the Giant Tide Information Network [1]
*ST双成(002693) - 海南双成药业股份有限公司股票交易异常波动及风险提示性公告
2025-08-04 09:16
海南双成药业股份有限公司 股票交易异常波动及风险提示性公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整,没有虚 假记载、误导性陈述或重大遗漏。 重要风险提示: 证券代码:002693 证券简称:*ST双成 公告编号:2025-052 东及实际控制人,有关情况说明如下: 1、公司于 2025 年 4 月 29 日披露了《关于公司股票被实施退市风险警示暨 停牌的公告》(公告编号:2025-028),因公司 2024 年度经审计的利润总额、净 利润、扣除非经常性损益后的净利润三者孰低者为负值,且扣除后的营业收入低 于 3 亿元,公司股票交易被深圳证券交易所实施退市风险警示。敬请广大投资者 注意投资风险。 2、公司 2025 年 7 月 31 日披露了《2025 年半年度报告》及《2025 年半年度 报告摘要》(公告编号:2025-049),公司 2025 年半年度实现营业收入 8,412.21 万元,归属于上市公司股东的净利润-1,846.66 万元,归属于上市公司股东的扣 除非经常性损益的净利润-2,101.58 万元。如公司 2025 年度存在《深圳证券交 易所股票上市规则》第 9.3.12 条规 ...
*ST双成:已通过美国FDA和欧盟EMA的GMP检查
Sou Hu Cai Jing· 2025-08-04 08:04
Core Viewpoint - The company is exploring opportunities to leverage the benefits of the Hainan Free Trade Zone (Port) policies to enhance its business in the pharmaceutical and healthcare sectors, including drug research and development, clinical trials, and cross-border medical services [1] Group 1: Company Strategy - The company is a national high-tech enterprise and has maintained an internationalization strategy over the years [1] - It has successfully passed GMP inspections from the US FDA, EU EMA, Philippines FDA, and Saudi Arabia SFDA, covering peptide raw materials and sterile injectables [1] - The company possesses comprehensive capabilities in generic drug research, registration, and patent management [1] Group 2: Business Development - The company has a rich pipeline of research and development projects [1] - To mitigate the risk of delisting, the company's board is actively implementing measures in marketing, peptide business exports, production, and cost control [1]
海南双成药业股份有限公司关于 精氨加压素注射液获得澳大利亚药物管理局(TGA)上市许可的公告
Group 1 - The core point of the announcement is that Hainan Shuangcheng Pharmaceutical Co., Ltd. has received marketing authorization from the Australian Therapeutic Goods Administration (TGA) for its vasopressin injection [1][3]. - The vasopressin injection is indicated for the prevention and treatment of postoperative abdominal distension, clearing interference gas shadows in abdominal X-ray examinations, and treating diabetes insipidus [1][2]. - The product is developed by Par Pharmaceutical and was previously approved by the FDA in the United States on April 17, 2014 [2]. Group 2 - The global sales for the vasopressin injection are projected to be approximately $72 million in 2024, with the U.S. market accounting for about $46 million of that total [2]. - The approval for the Australian market is expected to positively impact the company's overseas market expansion and overall performance [3]. - There are uncertainties regarding the product's sales timeline, market size, and future expansion in Australia due to factors such as market demand fluctuations, policy changes, exchange rate volatility, and market competition [3].
*ST双成(002693.SZ):精氨加压素注射液获得澳大利亚药物管理局(TGA)上市许可
Ge Long Hui· 2025-08-01 12:29
Core Viewpoint - *ST Shuangcheng (002693.SZ) has recently received marketing authorization for its arginine vasopressin injection from the Australian Therapeutic Goods Administration (TGA) [1] Group 1: Company Developments - The company has obtained a significant regulatory approval for its arginine vasopressin injection, which is a critical step for market entry [1] - The product is available in a specification of 20 pressor units per 1 mL [1] Group 2: Market Insights - According to the Insight database, the global sales for arginine vasopressin injection are projected to reach approximately $72 million in 2024 [1] - The U.S. market is expected to contribute around $46 million to the total sales [1]
*ST双成(002693) - 海南双成药业股份有限公司关于精氨加压素注射液获得澳大利亚药物管理局(TGA)上市许可的公告
2025-08-01 10:45
一、药品基本情况 1、药品商品名:精氨加压素注射液 2、剂型:注射剂 3、规格:20 pressor units/1 mL 4、获批适应症:适用于预防和治疗术后腹胀;清除腹部 X 射线检查中的干 扰性气体阴影;以及用于治疗尿崩症。 上市许可的公告 证券代码:002693 证券简称:*ST双成 公告编号:2025-051 海南双成药业股份有限公司 本公司及董事会全体成员保证信息披露内容的真实、准确和完整,没有虚 假记载、误导性陈述或重大遗漏。 关于精氨加压素注射液获得澳大利亚药物管理局(TGA) 海南双成药业股份有限公司(以下简称"公司") 于近日收到澳大利亚药 物管理局(TGA)签发的精氨加压素注射液的上市许可,现将相关情况公告如下: 根据 Insight 数据库查询到的销售信息显示,精氨加压素注射液(20 pressor units/1 mL 规格)2024 年全球销售总额约 7,200 万美元,其中美国市场销售额 约为 4,600 万美元。 三、对公司的影响及风险提示 本次精氨加压素注射液获得澳大利亚药物管理局签发的上市许可,表明公司 精氨加压素注射液具备了在澳大利亚进行销售的资质。对公司拓展海外市场、提 ...
海南双成药业股份有限公司2025年第一次临时股东会决议公告
登录新浪财经APP 搜索【信披】查看更多考评等级 本公司及董事会全体成员保证信息披露的内容真实、准确、完整,没有虚假记载、误导性陈述或重大遗 漏。 重要提示: 1、本次股东会没有出现否决议案的情形。 2、本次股东会没有涉及变更前次股东会决议。 一、会议召开和出席情况 1、现场会议召开时间:2025年7月31日(星期四)下午14:30 网络投票时间:2025年7月31日 (1)通过深圳证券交易所交易系统进行网络投票的具体时间为:2025年7月31日9:15-9:25,9:30-11:30 和13:00-15:00; (2)通过深圳证券交易所互联网投票系统投票的时间为2025年7月31日9:15-15:00期间的任意时间。 2、会议召开地点:海南省海口市秀英区兴国路16号公司会议室 3、会议召开方式:现场投票结合网络投票方式 4、会议召集人:公司董事会 现场出席会议的股东海南双成投资有限公司、HSP Investment Holdings Limited及王成栋先生为关联股 东,合计持有公司股份203,226,831股。关联股东在审议本议案时回避表决。 5、会议主持人:董事长王成栋 6、本次股东会会议的召集、召开 ...
*ST双成2025年中报简析:净利润减8.97%
Zheng Quan Zhi Xing· 2025-07-31 22:11
Core Viewpoint - *ST Shuangcheng (002693) reported a decline in net profit by 8.97% for the first half of 2025, with total operating revenue decreasing by 11.35% year-on-year, indicating ongoing financial struggles and operational challenges [1]. Financial Performance Summary - Total operating revenue for 2025 was 84.12 million yuan, down from 94.89 million yuan in 2024, reflecting an 11.35% decrease [1]. - The net profit attributable to shareholders was -18.47 million yuan, compared to -16.95 million yuan in 2024, marking an 8.97% decline [1]. - The gross profit margin fell to 46.72%, a decrease of 24.34% year-on-year, while the net profit margin was -27.38%, down 7.28% [1]. - Total expenses (selling, administrative, and financial) amounted to 59.18 million yuan, accounting for 70.35% of revenue, a reduction of 10.3% [1]. - Earnings per share remained at -0.04 yuan, with a year-on-year decrease of 8.8% [1]. Cash Flow and Asset Changes - Cash and cash equivalents decreased by 89.41%, primarily due to expenditures on investments and loan repayments [3]. - Accounts receivable increased by 44.1%, attributed to new drug export payments [3]. - The company experienced a significant increase in intangible assets by 85.37%, due to drug registration approvals [3]. - The net cash flow from operating activities improved by 93.23%, driven by increased sales collections and reduced expenses [4]. Debt and Financial Health - The company’s interest-bearing debt rose by 4.05%, reaching 266.6 million yuan [1]. - The asset-liability ratio for interest-bearing liabilities stood at 26.35%, indicating a concerning level of debt relative to assets [5]. - The company has faced challenges with cash flow, as indicated by a negative average operating cash flow over the past three years [5]. Strategic Outlook - The company plans to enhance performance through increased R&D investment, expanding sales channels, optimizing marketing strategies, and improving operational efficiency [5].
*ST双成(002693) - 北京市中伦律师事务所关于海南双成药业股份有限公司2025年第一次临时股东会的法律意见书
2025-07-31 10:30
北京市中伦律师事务所 关于海南双成药业股份有限公司 2025 年第一次临时股东会的 法律意见书 二〇二五年七月 北京市中伦律师事务所 关于海南双成药业股份有限公司 2025 年第一次临时股东会的 法律意见书 致:海南双成药业股份有限公司 北京市中伦律师事务所(以下简称"本所")接受海南双成药业股份有限公 司(以下简称"公司")的委托,根据《中华人民共和国公司法》(以下简称《公 司法》)、《中华人民共和国证券法》《上市公司股东会规则》(以下简称《股东会 规则》)等法律、法规、规范性文件及《海南双成药业股份有限公司章程》(以下 简称《公司章程》)的有关规定,就公司 2025 年第一次临时股东会(以下简称"本 次股东会")有关事宜出具本法律意见书。 本法律意见书仅就本次股东会的召集人资格、召集和召开程序、出席本次股 东会人员的资格(但不包含网络投票股东的资格)、会议表决程序是否符合法律、 法规、规范性文件及《公司章程》的规定以及表决结果是否合法有效发表意见, 而不对本次股东会所审议的议案内容以及该等议案所表述的相关事实或数据的 真实性、准确性或合法性发表意见。 本法律意见书仅供本次股东会之目的而使用,未经本所书面同 ...