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仙琚制药(002332) - 关于雌二醇片、雌二醇地屈孕酮片复合包装药品注册申请获得受理的公告
2025-12-18 08:15
证券代码:002332 证券简称:仙琚制药 公告编号:2025-057 1 产品名称 剂型 规格 申请事项 受理号 雌二醇片/雌二醇 地屈孕酮片复合 包装 片剂 雌二醇片含雌二醇 1mg; 雌二醇地屈孕酮片含雌 二醇 1mg 和地屈孕酮 10mg 境内生产药品注 册上市许可 CYHS2504314 雌二醇片/雌二醇 地屈孕酮片复合 包装 片剂 雌二醇片含雌二醇 2mg; 雌二醇地屈孕酮片含雌 二醇 2mg 和地屈孕酮 10mg 境内生产药品注 册上市许可 CYHS2504315 一、受理通知书主要内容 多个国家上市销售。 本次公司申报的雌二醇片/雌二醇地屈孕酮片复合包装规格与原研已批准上 市的规格一致,按化学药品 4 类进行申报。 浙江仙琚制药股份有限公司 关于雌二醇片/雌二醇地屈孕酮片复合包装药品注册申请获得受 理的公告 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。 浙江仙琚制药股份有限公司(以下简称"公司")于近日收到国家药品监督 管理局下发的雌二醇片/雌二醇地屈孕酮片复合包装境内生产药品注册受理通知 书,现将相关情况公告如下: 二、药品的相关情况 雌二 ...
仙琚制药:公司与奥默医药共同研发的新药奥美克松纳近期已递交相关制剂及原料药补充资料
Zheng Quan Ri Bao Wang· 2025-12-18 08:10
证券日报网讯12月17日,仙琚制药(002332)在互动平台回答投资者提问时表示,据了解,公司与奥默 医药共同研发的新药奥美克松纳近期已递交相关制剂及原料药补充资料,敬请投资者注意投资风险。 ...
仙琚制药:董事会换届选举人选综合考量合规性、专业性与治理效能等
Zheng Quan Ri Bao· 2025-12-18 07:49
证券日报网讯 12月17日,仙琚制药在互动平台回答投资者提问时表示,董事会换届选举人选综合考量 合规性、专业性与治理效能,兼顾性别、年龄、专业背景多元化,同时对履职能力要求能投入足够时间 精力,具备决策、统筹、公司治理等能力,兼顾管理团队稳定性。 (文章来源:证券日报) ...
仙琚制药(002332.SZ):克拉司酮原料药尚在国内申报准备阶段
Ge Long Hui· 2025-12-17 08:39
格隆汇12月17日丨仙琚制药(002332.SZ)在投资者互动平台表示,克拉司酮原料药尚在国内申报准备阶 段。 (原标题:仙琚制药(002332.SZ):克拉司酮原料药尚在国内申报准备阶段) ...
浙江仙琚制药股份有限公司关于盐酸尼卡地平注射液通过一致性评价的公告
登录新浪财经APP 搜索【信披】查看更多考评等级 证券代码:002332 证券简称:仙琚制药 公告编号:2025-056 浙江仙琚制药股份有限公司 关于盐酸尼卡地平注射液通过一致性评价的公告 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。 浙江仙琚制药股份有限公司(以下简称"公司")于近日收到国家药品监督管理局核准签发的关于盐酸尼 卡地平注射液的《药品补充申请批准通知书》(通知书编号:2025B05803和2025B05804),公司盐酸 尼卡地平注射液通过仿制药质量和疗效一致性评价。现将相关情况公告如下: 一、药品基本信息 ■ 申请内容:申报仿制药质量和疗效一致性评价。 2025年12月10日 二、药品的其他相关情况 盐酸尼卡地平注射液是一种钙离子拮抗剂药物,主要用于快速降低血压和处理急性高血压情况,如手术 中或急诊环境。它通过扩张血管来促进血流,保护心、脑、肾等重要器官,效果迅速但需在医生监控下 使用。 本公司盐酸尼卡地平注射液已批准上市的规格为10ml:10mg(药品批准文号为国药准字H20258264)和 5ml:5mg(药品批准文号为国药准字H202 ...
12月9日晚间重要公告一览
Xi Niu Cai Jing· 2025-12-09 10:29
Group 1 - Wanma Technology has been pre-awarded a total of 59.9434 million yuan for multiple State Grid projects, which accounts for 14.49% of its latest audited main business revenue [1] - Tianen Kang's subsidiary received a drug registration certificate for Methimazole tablets, a medication used for hyperthyroidism [2] - Taijing Technology invested 10 million yuan to establish a special fund focused on high-speed network communication chips [3] Group 2 - Youyou Foods plans to use 10 million yuan of its own funds to purchase principal-protected financial products with an expected annual yield of 0.5%-5.0% [4] - Yangfan New Materials announced the release of detention measures against its controlling shareholder, allowing him to resume his duties [5] - Xianju Pharmaceutical received approval for a supplementary application for Nicardipine injection, a calcium channel blocker used for acute hypertension [6] Group 3 - Jingu Co. plans to repurchase shares worth 30-60 million yuan for employee stock ownership plans or equity incentives [7] - Double Tower Foods' Thai subsidiary has completed the construction of its production line and is in the initial production phase [8] - Tongyi Zhong intends to invest approximately 198 million yuan in a project for the industrialization of ultra-high molecular weight polyethylene fibers [9][10] Group 4 - Zhangyue Technology received a dividend of 4.99 million yuan from its stake in Dianzhong Technology, which represents 10.12% of its audited net profit for 2024 [11] - Sihua Electronics announced the resignation of its general manager due to job transfer, with the current manager continuing until a new one is appointed [12] - Jiutian Pharmaceutical's new drug JMHT06 has received approval for clinical trials for acute gouty arthritis [13] Group 5 - Anlian Ruishi has established a joint venture for embodied intelligent robots with a registered capital of 20 million yuan [14] - Kelin Electric's application for a private placement has been accepted by the Shanghai Stock Exchange [15] - Guoyao Modern's subsidiary has received approval for the listing of Agomelatine raw materials, used in antidepressant synthesis [16] Group 6 - Xintiandi's application for the listing of Ferrous Fumarate raw materials has been approved, which is used for treating iron deficiency anemia [17] - ST Weihai, as the leading party, won a bid for a smart agriculture project worth 652 million yuan, accounting for 26.27% of its 2024 audited revenue [18] - Tian Youwei plans to purchase 100% of Krämer Automotive Systems for 1 million euros [19] Group 7 - Guangdong Yuedian A's subsidiary has successfully put into operation the third unit of its Dapu Power Plant project [20] - China Life's total premium exceeded 700 billion yuan as of November 30, 2025 [21] - Shoukai Co. achieved a total signed amount of 15.988 billion yuan in the first 11 months of 2025 [22] Group 8 - Kehua Bio's subsidiary has obtained a medical device registration certificate for an automatic chemiluminescence immunoassay analyzer [23] - Chengyi Pharmaceutical received a drug registration certificate for Torasemide tablets, which have passed the consistency evaluation [24] - Chongqing Construction won a bid for a municipal engineering project worth approximately 1.714 billion yuan [25] Group 9 - Hanjian Heshan signed a procurement contract for pipes worth 388 million yuan [26] - Jiuzhou Pharmaceutical plans to use up to 1 billion yuan of idle raised funds for cash management [27] - Xinwufeng reported an 80.97% year-on-year increase in pig sales in November 2025 [28] Group 10 - Luoniushan reported a 13.57% year-on-year increase in pig sales revenue in November 2025 [29] - Fushilai received a drug registration certificate for Alpha-Lipoic Acid tablets, used for diabetic neuropathy [30] - Dizhe Pharmaceutical presented research data on two innovative drugs at the 67th American Society of Hematology conference [31] - David Medical's subsidiary received two medical device registration certificates for single-use gastric tubes and electronic ureteral endoscope catheters [32]
仙琚制药(002332.SZ):盐酸尼卡地平注射液通过一致性评价
Ge Long Hui A P P· 2025-12-09 09:21
盐酸尼卡地平注射液是一种钙离子拮抗剂药物,主要用于快速降低血压和处理急性高血压情况,如手术 中或急诊环境。它通过扩张血管来促进血流,保护心、脑、肾等重要器官,效果迅速但需在医生监控下 使用。 格隆汇12月9日丨仙琚制药(002332.SZ)公布,公司于近日收到国家药品监督管理局核准签发的关于盐酸 尼卡地平注射液的《药品补充申请批准通知书》(通知书编号:2025B05803 和 2025B05804),公司盐 酸尼卡地平注射液通过仿制药质量和疗效一致性评价。 ...
仙琚制药:盐酸尼卡地平注射液通过一致性评价
Xin Lang Cai Jing· 2025-12-09 09:21
仙琚制药公告,公司于近日收到国家药品监督管理局核准签发的关于盐酸尼卡地平注射液的《药品补充 申请批准通知书》,公司盐酸尼卡地平注射液通过仿制药质量和疗效一致性评价。 ...
仙琚制药:公司盐酸尼卡地平注射液通过仿制药一致性评价
Xin Lang Cai Jing· 2025-12-09 09:21
仙琚制药12月9日公告,公司近日收到国家药品监督管理局核准签发的关于盐酸尼卡地平注射液的《药 品补充申请批准通知书》,公司盐酸尼卡地平注射液通过仿制药质量和疗效一致性评价。盐酸尼卡地平 注射液是一种钙离子拮抗剂药物,主要用于快速降低血压和处理急性高血压情况,如手术中或急诊环 境。它通过扩张血管来促进血流,保护心、脑、肾等重要器官,效果迅速但需在医生监控下使用。 ...
仙琚制药(002332) - 关于盐酸尼卡地平注射液通过一致性评价的公告
2025-12-09 09:15
证券代码:002332 证券简称:仙琚制药 公告编号:2025-056 盐酸尼卡地平注射液是一种钙离子拮抗剂药物,主要用于快速降低血压 和处理急性高血压情况,如手术中或急诊环境。它通过扩张血管来促进血流, 保护心、脑、肾等重要器官,效果迅速但需在医生监控下使用。 浙江仙琚制药股份有限公司 关于盐酸尼卡地平注射液通过一致性评价的公告 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。 浙江仙琚制药股份有限公司(以下简称"公司")于近日收到国家药品 监督管理局核准签发的关于盐酸尼卡地平注射液的《药品补充申请批准通知 书》(通知书编号:2025B05803 和 2025B05804),公司盐酸尼卡地平注射 液通过仿制药质量和疗效一致性评价。现将相关情况公告如下: 申请内容:申报仿制药质量和疗效一致性评价。 审批结论:根据《中华人民共和国药品管理法》、《国务院关于改革药 品医疗器械审评审批制度的意见》(国发〔2015〕44 号)、《关于仿制药质 量和疗效一致性评价工作有关事项的公告》(2017 年第 100 号)和《国家药 监局关于开展化学药品注射剂仿制药质量和疗效一致性 ...