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*ST双成(002693) - 海南双成药业股份有限公司关于董事会换届选举的公告
2025-12-23 10:46
证券代码:002693 证券简称:*ST双成 公告编号:2025-075 上述独立董事候选人兼任境内上市公司独立董事均未超过三家,且均已取得 独立董事资格证书,其中,肖建华先生为会计专业人士。独立董事候选人的任职 资格和独立性按规定尚需提交深圳证券交易所审核无异议后方可提交股东会表 决。 上述董事候选人尚需提交公司股东会选举,并采用累积投票制方式表决。上 述董事候选人经公司股东会选举通过后,将与公司职工代表大会选举的职工董事 共同组成公司第六届董事会,任期自股东会审议通过之日起三年。董事会董事候 选人中兼任公司高级管理人员的董事以及由职工代表担任的董事人数总计未超 过公司董事总数的二分之一,独立董事人数未低于公司董事会成员总人数的三分 之一,符合相关法规的要求。 白晶女士在第五届董事会任期届满后,将不再担任公司董事职务,亦不担任 公司其他任何职务。为确保董事会的正常运作,在第六届董事会董事就任前,公 司第五届董事会董事仍将依照法律、行政法规及规范性文件的要求与《公司章程》 的规定履行相关职责。公司对第五届董事会各位董事在任职期间为公司所做出的 贡献表示衷心感谢! 特此公告。 海南双成药业股份有限公司董事会 2 ...
*ST双成(002693) - 海南双成药业股份有限公司独立董事提名人声明(肖建华)
2025-12-23 10:46
证券代码: 002693 证券简称: *ST 双成 海南双成药业股份有限公司 独立董事提名人声明与承诺 提名人海南双成药业股份有限公司董事会现就提名肖建华为海南双成药业股份有限公司第 6 届董事会独立董事 候选人发表公开声明。被提名人已书面同意作为海南双成药业股份有限公司第 6 届董事会独立董事候选人(参见该独 立董事候选人声明)。本次提名是在充分了解被提名人职业、学历、职称、详细的工作经历、全部兼职、有无重大失 信等不良记录等情况后作出的,本提名人认为被提名人符合相关法律、行政法规、部门规章、规范性文件和深圳证券 交易所业务规则对独立董事候选人任职资格及独立性的要求,具体声明并承诺如下事项: 一、被提名人已经通过海南双成药业股份有限公司第 5 届董事会提名委员会或者独立董事专门会议资格审查,提名人 与被提名人不存在利害关系或者其他可能影响独立履职情形的密切关系。 √是 □否 二、被提名人不存在《中华人民共和国公司法》第一百七十八条等规定不得担任公司董事的情形。 四、被提名人符合公司章程规定的独立董事任职条件。 √是 □否 五、被提名人已经参加培训并取得证券交易所认可的相关培训证明材料(如有)。 √是 □否 ...
*ST双成(002693) - 海南双成药业股份有限公司关于召开2026年第一次临时股东会的通知
2025-12-23 10:45
一、召开会议的基本情况 1、股东会届次:2026 年第一次临时股东会 2、股东会的召集人:董事会 3、本次会议的召集、召开符合《中华人民共和国公司法》《深圳证券交易所股票 上市规则》《深圳证券交易所上市公司自律监管指引第 1 号——主板上市公司规范运作》 等法律、行政法规、部门规章、规范性文件及《公司章程》的有关规定。 4、会议时间: (1)现场会议时间:2026 年 1 月 8 日 14:30 证券代码:002693 证券简称:*ST 双成 公告编号:2025-076 海南双成药业股份有限公司 关于召开 2026 年第一次临时股东会的通知 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。 海南双成药业股份有限公司(以下简称"公司")第五届董事会第二十五次会议于 2025 年 12 月 23 日召开,会议定于 2026 年 1 月 8 日(星期四)召开 2026 年第一次临 时股东会,现将本次股东会的有关事项通知如下: (2)网络投票时间:通过深圳证券交易所系统进行网络投票的具体时间为 2026 年 1 月 8 日 9:15-9:25,9:30-11:30,13 ...
*ST双成(002693) - 海南双成药业股份有限公司第五届董事会第二十五次会议决议公告
2025-12-23 10:45
证券代码:002693 证券简称:*ST双成 公告编号:2025-074 海南双成药业股份有限公司 第五届董事会第二十五次会议决议公告 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。 一、董事会会议召开情况 海南双成药业股份有限公司(以下简称"公司")第五届董事会第二十五次 会议通知于 2025 年 12 月 19 日以书面送达或电子邮件等方式发出,并于 2025 年 12 月 23 日 10:00 以现场结合通讯表决的方式召开。会议应出席董事 6 人,实际 参加表决的董事 6 人。本次会议由董事长王成栋先生主持,会议的召开符合有关 法律法规、公司章程的规定。 二、董事会会议审议情况 (一)审议通过《关于董事会换届选举第六届董事会非独立董事的议案》 鉴于公司第五届董事会董事任期即将届满,根据《公司法》《公司章程》等 有关规定,经公司第五届董事会提名委员会资格审查,公司董事会同意提名王成 栋先生、Wang Yingpu 先生为第六届董事会非独立董事候选人,任期自股东会审 议通过之日起三年。 1、审议通过了《选举王成栋先生为公司第六届董事会非独立董事》 表决情况: ...
海南双成药业股份有限公司 关于注射用硼替佐米ANDA获得美国FDA上市许可的公告
Core Viewpoint - The company has received approval from the U.S. FDA for its injectable bortezomib abbreviated new drug application (ANDA), indicating that the product is bioequivalent and therapeutically equivalent to the original drug, which enhances the company's international market presence and product pipeline [1][4]. Drug Basic Information - Drug Name: Injectable Bortezomib - Dosage Form: Injection - Specification: 3.5 mg - Approved Indications: - Treatment of multiple myeloma patients who have not received prior treatment and are not suitable for high-dose chemotherapy, in combination with melphalan and prednisone [1]. - Part of a combination therapy for multiple myeloma patients under 65 years old who have not received prior treatment, used for high-dose chemotherapy with autologous stem cell rescue following induction therapy [1]. - Treatment of multiple myeloma patients who have received at least one prior treatment and whose disease has progressed [2]. - Treatment of adult patients with mantle cell lymphoma who have not received prior treatment, in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone [2]. Other Drug-Related Information - In April 2024, the product received a drug registration certificate from the National Medical Products Administration of China, indicating it passed the consistency evaluation [3]. - In October 2025, the product obtained marketing authorization from the Australian Therapeutic Goods Administration (TGA) [3]. Impact on the Company - The approval of the injectable bortezomib ANDA by the U.S. FDA signifies that the company's research and production meet original drug standards, showcasing its international research and production capabilities [4]. - This approval enriches the company's international sales product pipeline and advances its internationalization strategy, positively impacting the company's product influence and future operating performance [4]. - The approval grants the drug legal sales rights in the U.S., enhancing the company's market competitiveness and providing a new profit growth point for sustainable development [4].
*ST双成(002693.SZ):公司产品注射用紫杉醇(白蛋白结合型)目前没有在国内申报
Ge Long Hui· 2025-12-19 07:04
Group 1 - The core viewpoint of the article is that *ST Shuangcheng (002693.SZ) has confirmed that several of its products are included in the medical insurance catalog [1] - The products that are included in the medical insurance catalog are: Thymosin injection, Somatostatin injection, Famotidine injection, Clindamycin hydrochloride injection, Chuanxiong phosphate injection, and Octreotide acetate injection [1] - The company has not submitted an application for its product, Paclitaxel injection (albumin-bound), in the domestic market [1]
*ST双成:公司主要收入来源为药品销售收入,主要品种为注射用胸腺法新、注射用紫杉醇等
Mei Ri Jing Ji Xin Wen· 2025-12-19 04:26
Group 1 - The company responded to an investor inquiry regarding the export volume of paclitaxel in the fourth quarter, indicating that financial data will be disclosed in periodic reports as per regulations [2] - The main source of revenue for the company is from pharmaceutical sales, with key products including injectable thymosin alpha 1, injectable paclitaxel (albumin-bound), injectable somatostatin, injectable bivalirudin, and injectable clindamycin hydrochloride [2]
*ST双成(002693)披露注射用硼替佐米ANDA获得美国FDA上市许可,12月18日股价下跌0.3%
Sou Hu Cai Jing· 2025-12-18 14:33
Core Viewpoint - Hainan Shuangcheng Pharmaceutical Co., Ltd. has received FDA approval for its injectable Bortezomib ANDA, marking a significant milestone in its international expansion and product portfolio enhancement [1] Group 1: Company Performance - As of December 18, 2025, *ST Shuangcheng (002693) closed at 6.58 yuan, down 0.3% from the previous trading day, with a total market capitalization of 2.729 billion yuan [1] - The stock opened at 6.59 yuan, reached a high of 6.79 yuan, and a low of 6.55 yuan, with a trading volume of 32.0879 million yuan and a turnover rate of 1.17% [1] Group 2: Regulatory Approvals - The injectable Bortezomib ANDA has been recognized by the FDA as being bioequivalent and therapeutically equivalent to the reference drug [1] - The product has also received approval from the National Medical Products Administration of China and has passed the consistency evaluation, along with obtaining listing permission from Australia's TGA [1] Group 3: Strategic Implications - The FDA approval signifies that the company's product meets international standards, which is expected to enhance its international influence and operational performance [1] - This development will enrich the company's international sales product line and advance its globalization strategy [1] - The announcement also notes that overseas sales may be affected by regulations, policies, market conditions, and exchange rate fluctuations [1]
*ST双成:注射用硼替佐米ANDA获得美国FDA上市许可
Mei Ri Jing Ji Xin Wen· 2025-12-18 08:32
Core Viewpoint - The approval of the abbreviated new drug application (ANDA) for injectable bortezomib by the U.S. FDA marks a significant milestone for the company, indicating that its product meets the safety and efficacy standards of the original research level, which is expected to enhance the company's international influence and future operating performance [2]. Group 1 - The company received notification from the U.S. FDA regarding the approval of its ANDA for injectable bortezomib [2]. - The approval signifies that the company's research and production of injectable bortezomib have reached the original research level in terms of safety and efficacy [2]. - This development is anticipated to have a positive impact on the company's international product influence and future business performance [2].
*ST双成(002693) - 海南双成药业股份有限公司关于注射用硼替佐米ANDA获得美国FDA上市许可的公告
2025-12-18 08:30
证券代码:002693 证券简称:*ST双成 公告编号:2025-073 海南双成药业股份有限公司 关于注射用硼替佐米 ANDA获得美国 FDA上市许可的公告 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。 海南双成药业股份有限公司(以下简称"公司")于近日收到美国食品和药 品监督管理局(以下简称"FDA")的通知,公司向美国 FDA 提交的注射用硼替 佐米简略新药申请(以下简称"ANDA")已获得美国 FDA 的批准。美国 FDA 对公 司递交的注射用硼替佐米 ANDA 申报资料进行了全面技术审评,认定公司的产品 与 原 研 药 品 生 物 等 效 和 疗 效 等 效 ( bioequivalent and therapeutically equivalent)。现将相关信息公告如下: 一、药品基本情况 1、药品商品名:注射用硼替佐米 2、剂型:注射剂 3、规格:3.5mg 二、药品相关的其他情况 2024 年 4 月,公司产品注射用硼替佐米获得中国国家药品监督管理局批准 签发的《药品注册证书》,该产品获批视同其通过一致性评价。具体内容详见 2024 年 4 ...