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国药现代(600420.SH):碳酸氢钠注射液增加规格并通过仿制药一致性评价
智通财经网· 2025-09-12 08:59
Core Viewpoint - The company, China National Pharmaceutical Group Modern (国药现代), announced that its wholly-owned subsidiary, China National Pharmaceutical Group Rongsheng Pharmaceutical Co., Ltd. (国药容生), received approval from the National Medical Products Administration for a supplementary application regarding sodium bicarbonate injection, which has now passed the consistency evaluation for generic drug quality and efficacy [1] Group 1 - The approved sodium bicarbonate injection will have an increased specification and has been granted a drug approval number [1] - Sodium bicarbonate injection is classified as an antacid and is indicated for the treatment of metabolic acidosis [1] - The injection is also used for the prevention of uric acid kidney stones, to reduce the nephrotoxicity of sulfonamide drugs, and to prevent hemoglobin deposition in renal tubules during acute hemolysis [1] Group 2 - Additionally, sodium bicarbonate injection has non-specific therapeutic effects for certain drug poisonings, such as barbiturates, salicylates, and methanol [1]
国药现代:碳酸氢钠注射液增加规格并通过仿制药一致性评价
Zhi Tong Cai Jing· 2025-09-12 08:59
Core Viewpoint - The company, China National Pharmaceutical Group Modern (600420.SH), announced that its wholly-owned subsidiary, China National Pharmaceutical Group Rongsheng Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for a supplemental application regarding sodium bicarbonate injection, which includes an increase in specifications and has passed the consistency evaluation for generic drug quality and efficacy [1]. Group 1 - The sodium bicarbonate injection is classified as an antacid [1]. - Indications for sodium bicarbonate injection include: (1) treatment of metabolic acidosis; (2) prevention of uric acid kidney stones, reduction of nephrotoxicity from sulfonamides, and prevention of hemoglobin deposition in renal tubules during acute hemolysis; (3) intravenous infusion for non-specific treatment of certain drug poisonings, such as barbiturates, salicylates, and methanol [1].
国药现代(600420.SH):子公司通过药品GMP符合性检查
Ge Long Hui A P P· 2025-09-12 08:46
Core Viewpoint - The company, China National Pharmaceutical Group Modern (国药现代), announced that its wholly-owned subsidiary, China National Pharmaceutical Group Weichida Pharmaceutical Co., Ltd. (国药威奇达), has received a notice of compliance for Good Manufacturing Practice (GMP) inspection, indicating that the production lines in Workshop 108 and the comprehensive raw material pharmaceutical workshop have passed the GMP compliance check [1] Group 1 - The subsidiary, China National Pharmaceutical Group Weichida, has successfully passed the GMP compliance inspection [1] - The inspection covers specific production lines in Workshop 108 and the comprehensive raw material pharmaceutical workshop [1]
国药现代:全资子公司获药品补充申请批准通知书
Xin Lang Cai Jing· 2025-09-12 08:46
Core Viewpoint - The approval of the sodium bicarbonate injection by the National Medical Products Administration is expected to enhance market expansion and sales for the company, although it will not have a significant impact on current performance [1]. Company Summary - The full subsidiary of China National Pharmaceutical Group, China National Pharmaceutical Group Rongsheng Pharmaceutical Co., Ltd., received the approval notice for the supplementary application of sodium bicarbonate injection [1]. - The sodium bicarbonate injection is classified as an antacid and is indicated for the treatment of metabolic acidosis and the prevention of uric acid kidney stones [1]. - The company has invested approximately 2.7442 million in research and development for this product [1]. Industry Summary - The estimated sales for public medical institutions nationwide in 2024 for sodium bicarbonate injection are approximately 580 million [1]. - Other companies that have passed the consistency evaluation include Hefei Yuanfengshun Pharmaceutical Technology Co., Ltd. [1].
国药现代(600420.SH):碳酸氢钠注射液获得药品补充申请批准通知书
Ge Long Hui A P P· 2025-09-12 08:46
格隆汇9月12日丨国药现代(600420.SH)公布,公司全资子公司国药集团容生制药有限公司(简称国药容 生)收到国家药品监督管理局核准签发的《药品补充申请批准通知书》,批准碳酸氢钠注射液增加规格 并通过仿制药质量和疗效一致性评价,核发药品批准文号。 碳酸氢钠注射液属于抗酸药,适应症如下:(1)治疗代谢性酸中毒;(2)用于尿酸性肾结石的预防, 减少磺胺类药物的肾毒性,及急性溶血防止血红蛋白沉积在肾小管;(3)静脉滴注对某些药物中毒有 非特异性的治疗作用,如巴比妥类、水杨酸类药物及甲醇等中毒。 ...
国药现代:全资子公司国药威奇达通过药品GMP符合性检查
Xin Lang Cai Jing· 2025-09-12 08:46
Core Viewpoint - The announcement indicates that the wholly-owned subsidiary of China National Pharmaceutical Group, Weichida Pharmaceutical Co., Ltd., has successfully passed the GMP compliance inspection for its production lines, which is a significant milestone for the company as it prepares for the market launch of its product, Acarbose [1] Group 1 - Weichida Pharmaceutical received a GMP compliance inspection notice for its production lines in workshop 108 and the comprehensive raw material drug workshop [1] - The inspection covered the raw material drug Acarbose, marking the first GMP compliance check prior to the product's market launch [1] - The production lines in question are renovated old factory workshops, with a total construction investment of approximately 22.76 million yuan [1] Group 2 - The current production capacity for Acarbose is designed at 12 tons per year [1]
国药现代(600420) - 关于全资子公司获得药品补充申请批准通知书的公告
2025-09-12 08:45
规格:10ml:0.84g 注册分类:化学药品 证券代码:600420 证券简称:国药现代 公告编号:2025-070 上海现代制药股份有限公司 关于全资子公司获得药品补充申请批准通知书的公告 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法律责任。 近日,上海现代制药股份有限公司(以下简称公司)全资子公司国药集团容 生制药有限公司(以下简称国药容生)收到国家药品监督管理局核准签发的《药 品补充申请批准通知书》,批准碳酸氢钠注射液增加规格并通过仿制药质量和疗 效一致性评价(以下简称一致性评价),核发药品批准文号。现将相关情况公告 如下: 一、药品基本信息 药品名称:碳酸氢钠注射液 通知书编号:2025B04233 剂型:注射剂 证券代码:600420 证券简称:国药现代 公告编号:2025-070 用于尿酸性肾结石的预防,减少磺胺类药物的肾毒性,及急性溶血防止血红蛋白 沉积在肾小管;(3)静脉滴注对某些药物中毒有非特异性的治疗作用,如巴比 妥类、水杨酸类药物及甲醇等中毒。 药品批准文号:国药准字 H20258193 上市许可持有人:国药 ...
国药现代(600420) - 关于全资子公司通过药品GMP符合性检查的公告
2025-09-12 08:45
上海现代制药股份有限公司 关于全资子公司通过药品GMP符合性检查的公告 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法律责任。 证券代码:600420 证券简称:国药现代 公告编号:2025-071 | 生产线名称 | 目前主要生产产品及设计产能 | | | | | | | --- | --- | --- | --- | --- | --- | --- | | 车间、综合原料药车间 | 线 | 阿卡波糖,设计产能 | 吨/年 | 108 | III | 12 | 近日,上海现代制药股份有限公司(以下简称公司)全资子公司国药集团威 奇达药业有限公司(以下简称国药威奇达)收到药品 GMP 符合性检查告知书, 国药威奇达的 108 车间、综合原料药车间相关生产线通过 GMP 符合性检查。现 将相关情况公告如下: 一、基本信息 企业名称:国药集团威奇达药业有限公司 生产地址:山西省大同市经济技术开发区医药工业园区 检查范围:原料药(阿卡波糖)(108车间、综合原料药车间III线) 告知书编号:SX2025029 检查时间:2025年05月08 ...
国药现代(600420) - 关于参加2025年上海辖区上市公司集体接待日暨中报业绩说明会活动的公告
2025-09-12 08:45
证券代码:600420 证券简称:国药现代 公告编号:2025-069 上海现代制药股份有限公司 关于参加 2025 年上海辖区上市公司集体接待日 暨中报业绩说明会活动的公告 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法律责任。 重要内容提示: 投资者可于 2025 年 9 月 19 日(周五)14:00 前访问 http://ir.p5w.net/zj/ 或扫描问题征集专题页面二维码进入问题征集专题页面进行会前提问。公司将在 说明会上对投资者普遍关注的问题进行回答。 上海现代制药股份有限公司(以下简称公司)已于 2025 年 8 月 30 日披露了 《2025 年半年度报告》。为进一步加强与投资者的互动交流,便于广大投资者 更全面深入地了解公司经营成果、财务状况,公司计划于 2025 年 9 月 19 日参加 2025 年上海辖区上市公司集体接待日暨中报业绩说明会,就投资者关心的问题 进行交流。 3、召开方式:本次活动将采用网络文字互动的方式举行 三、公司参会人员 董事、总裁:刘勇 会议召开时间:2025 年 9 月 19 日(星 ...
国药现代:2025年半年度权益分派实施公告
Group 1 - The core point of the article is that Guoyao Modern announced a cash dividend distribution plan for the first half of 2025, with a cash dividend of 0.10 yuan per share (tax included) [1] - The record date for the dividend is set for September 15, 2025, while the ex-dividend date and the date of cash dividend distribution are both scheduled for September 16, 2025 [1] - The total cash dividend to be distributed amounts to 134,117,269.20 yuan, based on the company's total share capital of 1,341,172,692 shares prior to the implementation of the plan [1]