Workflow
CSBIO(300255)
icon
Search documents
常山药业(300255.SZ):依诺肝素钠注射液获美国药品注册批准
智通财经网· 2026-01-09 11:56
Core Viewpoint - Changshan Pharmaceutical (300255.SZ) has received approval from the U.S. Food and Drug Administration (FDA) for its new abbreviated new drug application (ANDA) for Enoxaparin Sodium Injection, indicating a significant milestone for the company in the U.S. market [1] Group 1: Product Approval - The Enoxaparin Sodium Injection is indicated for the prevention of venous thromboembolic diseases, particularly related to orthopedic or general surgery [1] - It is also used for the treatment of established deep vein thrombosis, with or without pulmonary embolism, in clinically stable patients, excluding those requiring surgical intervention or thrombolytic therapy for pulmonary embolism [1] - The product can be used in combination with aspirin for the treatment of unstable angina and non-Q-wave myocardial infarction [1] - Additionally, it is utilized in hemodialysis to prevent thrombosis during extracorporeal circulation [1]
常山药业:依诺肝素钠注射液获美国药品注册批准
Zhi Tong Cai Jing· 2026-01-09 11:54
Core Viewpoint - Changshan Pharmaceutical (300255.SZ) has received approval from the U.S. Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for Enoxaparin Sodium Injection, indicating a significant milestone for the company in the U.S. market [1] Group 1: Product Approval - The Enoxaparin Sodium Injection is indicated for the prevention of venous thromboembolism, particularly related to orthopedic or general surgery [1] - It is also used for the treatment of established deep vein thrombosis, with or without pulmonary embolism, in clinically stable patients [1] - The drug can be used in combination with aspirin for the treatment of unstable angina and non-Q-wave myocardial infarction [1] - Additionally, it is utilized in hemodialysis to prevent thrombosis during extracorporeal circulation [1]
常山药业:依诺肝素钠注射液获得美国药品注册批准
Xin Lang Cai Jing· 2026-01-09 11:49
Core Viewpoint - The company Changshan Pharmaceutical has received approval from the U.S. Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for Enoxaparin Sodium Injection, which is used for various medical conditions related to thrombosis [1] Group 1 - The approved drug, Enoxaparin Sodium Injection, is indicated for the prevention of venous thromboembolic diseases, particularly those associated with orthopedic or general surgery [1] - It is also used for the treatment of established deep vein thrombosis, with or without pulmonary embolism [1] - The drug can be used in combination with aspirin for the treatment of unstable angina and non-ST elevation myocardial infarction [1] - Additionally, it is utilized in hemodialysis to prevent thrombosis during extracorporeal circulation [1]
常山药业(300255) - 关于依诺肝素钠注射液获得美国药品注册批准的公告
2026-01-09 11:46
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。 河北常山生化药业股份有限公司(以下简称公司)于近日收到通知,公司药 品依诺肝素钠注射液在美国的新药简略申请(以下简称 ANDA,即美国仿制药申 请)获得美国食品药品监督管理局(以下简称美国 FDA)的批准。现将相关情况 公告如下: 证券代码:300255 证券简称:常山药业 公告编号:2026-2 河北常山生化药业股份有限公司 关于依诺肝素钠注射液获得美国药品注册批准的公告 三、对公司的影响及风险提示 一、注册药品的基本情况 药品名称:依诺肝素钠注射液 剂型:注射剂 ANDA 号:218775 规格:30mg/0.3mL、40mg/0.4mL、60mg/0.6mL、80mg/0.8mL、100mg/1mL、 120mg/0.8mL、150mg/1mL 二、药品的其他相关情况 依诺肝素钠注射液用于预防静脉血栓栓塞性疾病(预防静脉内血栓形成),特 别是与骨科或普外手术有关的血栓形成;治疗已形成的深静脉栓塞,伴或不伴有 肺栓塞,临床症状不严重,不包括需要外科手术或溶栓剂治疗的肺栓塞;与阿司 匹林合用,治疗不稳定性心绞痛 ...
1月6日医疗健康(980016)指数涨0.88%,成份股华大智造(688114)领涨
Sou Hu Cai Jing· 2026-01-06 10:56
Core Viewpoint - The Medical Health Index (980016) closed at 6354.84 points, up 0.88%, with a trading volume of 29.705 billion yuan and a turnover rate of 1.0% on January 6 [1] Group 1: Index Performance - On the same day, 38 of the index's constituent stocks rose, with BGI Genomics leading with a 6.95% increase, while 11 stocks fell, with Zai Lab leading the decline at 3.72% [1] - The top ten constituent stocks of the Medical Health Index are detailed, with WuXi AppTec holding the highest weight at 10.23% and a latest price of 96.25 yuan, showing a 1.78% increase [1] Group 2: Market Capitalization - The total market capitalization of WuXi AppTec is approximately 287.187 billion yuan, while the highest market cap among the top ten is held by Hengrui Medicine at 418.542 billion yuan [1] - The market capitalization of the top ten stocks ranges from 489 million yuan for Kelun Pharmaceutical to 418.542 billion yuan for Hengrui Medicine [1] Group 3: Capital Flow - The net outflow of main funds from the constituent stocks totaled 471 million yuan, while retail investors saw a net inflow of 200 million yuan [1] - Detailed capital flow shows that WuXi AppTec had a net inflow of 180 million yuan from main funds, while Yeye Eye Care experienced a net outflow of 157 million yuan from retail investors [2]
常山药业(300255) - 关于为全资子公司提供担保的进展公告
2026-01-05 08:00
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。 证券代码:300255 证券简称:常山药业 公告编号:2026-1 河北常山生化药业股份有限公司 关于为全资子公司提供担保的进展公告 一、担保情况概述 河北常山生化药业股份有限公司(以下简称公司)于 2025 年 5 月 19 日召开 的 2024 年度股东大会审议并通过《关于提供担保额度预计的议案》,同意公司为 全资子公司河北常山凯库得生物技术有限公司(以下简称凯库得)借款融资提供 不超过 3.6 亿元的担保额度,上述额度期限自股东大会审议通过之日起至 2025 年度股东大会之日。具体内容详见公司刊登于巨潮资讯网的《关于提供担保额度 预计的公告》(公告编号:2025-14)。 二、担保进展 2026 年 1 月 1 日,公司与中国农业银行股份有限公司正定县支行(以下简 称农业银行)签订了《保证合同》,公司为凯库得与农业银行签订的固定资产借 款合同下 545.53 万元的本金及利息提供连带责任保证。 本次担保事项在已经审议的年度担保额度范围内,无需再提交公司董事会或 股东大会审议。 三、被担保人基本情况 1.企业 ...
常山药业:第六届董事会第六次会议决议公告
Zheng Quan Ri Bao· 2025-12-30 13:43
证券日报网讯 12月30日,常山药业发布公告称,公司第六届董事会第六次会议审议通过《关于吸收合 并全资子公司的议案》,拟整体吸收合并河北梅山多糖多肽科技有限公司,合并后后者将注销,授权董 事长及管理层办理相关税务、工商等全部事宜。 (文章来源:证券日报) ...
常山药业:12月30日召开董事会会议
Mei Ri Jing Ji Xin Wen· 2025-12-30 08:24
Group 1 - The company Changshan Pharmaceutical held its sixth board meeting on December 30, 2025, to discuss the proposal for the absorption and merger of its wholly-owned subsidiary [1] - The meeting was conducted in a hybrid format, combining in-person attendance and remote voting [1] Group 2 - A new type of chip has been developed in China, which aims to bypass the restrictions imposed by lithography machines [1] - This new chip supports AI training and embodied intelligence and can be mass-produced using mature processes of 28 nanometers and above [1]
常山药业(300255.SZ):拟吸收合并全资子公司梅山科技
Ge Long Hui A P P· 2025-12-30 08:22
Core Viewpoint - Changshan Pharmaceutical (300255.SZ) plans to optimize its asset allocation and reduce management costs by absorbing its wholly-owned subsidiary, Hebei Meishan Polysaccharide Peptide Technology Co., Ltd. (Meishan Technology) [1] Group 1 - The absorption merger will result in the legal cancellation of Meishan Technology [1] - All business operations, assets, debts, and other rights and obligations of Meishan Technology will be inherited by the company [1]
常山药业(300255) - 关于吸收合并全资子公司的公告
2025-12-30 08:18
证券代码:300255 证券简称:常山药业 公告编号:2025-53 河北常山生化药业股份有限公司 关于吸收合并全资子公司的公告 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。 一、吸收合并情况概述 河北常山生化药业股份有限公司(以下简称公司)于 2025 年 12 月 30 日召 开的第六届董事会第六次会议审议通过了《关于吸收合并全资子公司的议案》。 为进一步优化公司资产配置,降低管理成本,拟以公司为主体吸收合并全资子公 司河北梅山多糖多肽科技有限公司(以下简称梅山科技)。吸收合并完成后,梅 山科技将依法注销,梅山科技全部业务、资产、债权、债务及其他一切权利和义 务由公司依法承继。 本次吸收合并事项不构成关联交易,不构成《上市公司重大资产重组管理办 法》规定的重大资产重组。根据《深圳证券交易所创业板股票上市规则》《公司 章程》的相关规定,该事项属于公司董事会审批权限,无需提交股东会审议。 二、合并双方基本情况 (一)合并方基本情况 1.公司名称:河北常山生化药业股份有限公司 2.企业类型:其他股份有限公司(上市) 3.注册地址:中国(河北)自由贸易试验区正定 ...