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尖峰集团加码抗感染领域 磷酸特地唑胺获批上市
Zheng Quan Ri Bao Wang· 2025-07-30 13:12
公告显示,磷酸特地唑胺(Tedizolid phosphate),又称磷酸泰地唑胺、特地唑胺磷酸酯、泰地唑胺磷酸 酯,是由CubistPharmaceuticals公司研发的新型抗细菌感染用药,为特地唑胺的前体,可经口服或静脉 注射后通过磷酸酯酶转化成特地唑胺。特地唑胺是第二代恶唑烷酮类抗生素,是一种蛋白质合成抑制 剂,通过与细菌核糖体50S亚基结合,抑制细菌蛋白质的合成,发挥抗菌作用,与其它类别的抗生素之 间不易产生交叉耐药。 本报讯(记者邬霁霞见习记者王楠)7月30日晚间,浙江尖峰集团(600668)股份有限公司发布公告称, 其子公司安徽尖峰北卡药业有限公司(以下简称"尖峰北卡")收到国家药品监督管理局关于化学原料药磷 酸特地唑胺的《化学原料药上市申请批准通知书》。 截至公告发布当日,磷酸特地唑胺原料药项目累计研发投入约1026.94万元,尖峰北卡已完成相关生产 线建设。此次原料药获批,标志着该产品已达到国家原料药审评技术标准,可在国内销售,有助于增强 尖峰北卡的市场竞争力。 ...
尖峰集团(600668.SH)获得磷酸特地唑胺化学原料药上市申请批准
智通财经网· 2025-07-30 08:32
Core Viewpoint - The announcement indicates that Jianfeng Group's subsidiary, Anhui Jianfeng Beika Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the marketing application of the chemical raw material drug, Phosphoric Acid Tedizolid [1] Group 1 - Jianfeng Beika has established the necessary production line for Phosphoric Acid Tedizolid, which signifies its readiness to manufacture the drug [1] - The approval confirms that the raw material drug meets the national technical standards for raw material drug review, allowing it to be sold in the domestic market [1] - This development is expected to help expand the business scope of the subsidiary [1]
尖峰集团(600668) - 尖峰集团关于子公司获得化学原料药上市申请批准通知书的公告
2025-07-30 08:30
证券代码:600668 证券简称:尖峰集团 编号:临 2025-036 浙江尖峰集团股份有限公司 关于子公司获得化学原料药上市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个别及连带责任。 风险提示:由于医药产品具有高科技、高风险、高附加值的特点,不仅 药品的前期研发及研制、报批到投产的周期长、投入大、环节多,而且药品的生 产和销售也容易受到国家政策、市场环境变化等因素影响,具有较大不确定性。 敬请广大投资者注意投资风险。 近日,浙江尖峰集团股份有限公司(以下简称"本公司")的下属子公司安徽 尖峰北卡药业有限公司(以下简称"尖峰北卡")收到国家药品监督管理局关于化 学原料药磷酸特地唑胺的《化学原料药上市申请批准通知书》(通知书编号: 2025YS00633),现将相关情况公告如下: 一、化学原料药的基本情况 化学原料药名称:磷酸特地唑胺 包装规格:5kg/桶、10kg/桶、20kg/桶 通知书编号:2025YS00633 化学原料药注册标准编号:YBY67532025 生产企业名称:安徽尖峰北卡药业有限公司 生产企 ...
尖峰集团获得磷酸特地唑胺化学原料药上市申请批准
Zhi Tong Cai Jing· 2025-07-30 08:29
Core Viewpoint - The company has received approval for the chemical raw material drug Phosphoric Acid Tezolamide, indicating compliance with national standards and enabling market sales, which will help expand the subsidiary's business scope [1] Group 1 - The subsidiary Anhui Jianfeng Beika Pharmaceutical Co., Ltd. has obtained the "Approval Notice for the Listing Application of Chemical Raw Materials" from the National Medical Products Administration [1] - The approval signifies that the raw material drug meets the relevant technical standards for chemical raw materials review in the country [1] - The establishment of the corresponding production line at the subsidiary supports the capability to produce and sell the approved drug in the domestic market [1]
尖峰集团(600668.SH):磷酸特地唑胺获得化学原料药上市申请批准通知书
Ge Long Hui A P P· 2025-07-30 08:22
格隆汇7月30日丨尖峰集团(600668.SH)公布,下属子公司安徽尖峰北卡药业有限公司收到国家药品监督 管理局关于化学原料药磷酸特地唑胺的《化学原料药上市申请批准通知书》。磷酸特地唑胺 (Tedizolidphosphate),又名磷酸泰地唑胺、特地唑胺磷酸酯、泰地唑胺磷酸酯。磷酸特地唑胺是由 CubistPharmaceuticals公司研发的新型抗细菌感染用药。 ...
尖峰集团:子公司获得化学原料药上市申请批准通知书
Mei Ri Jing Ji Xin Wen· 2025-07-30 08:17
Core Viewpoint - The announcement indicates that Jianfeng Group's subsidiary, Anhui Jianfeng Beika Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the marketing application of the chemical raw material drug, Fosfomycin Trometamol, which is a new antibacterial medication developed by Cubist Pharmaceuticals [1] Company Summary - Jianfeng Group's subsidiary has established production lines capable of manufacturing Fosfomycin Trometamol, indicating readiness to enter the market [1] - The approval signifies that the raw material drug meets the national technical standards for raw material drug review, allowing it to be sold in the domestic market [1] - This development is expected to help expand the business scope of the subsidiary [1]
尖峰集团:化学原料药磷酸特地唑胺上市申请获批
Zheng Quan Shi Bao Wang· 2025-07-30 08:17
Group 1 - The core point of the article is that Jianfeng Group (600668) announced the approval of its subsidiary Jianfeng Beika's application for the chemical raw material drug Phosphate Tedizolid by the National Medical Products Administration [1] - Phosphate Tedizolid is a new antibacterial drug developed by Cubist Pharmaceuticals [1]
浙江尖峰集团股份有限公司关于子公司获得化学原料药上市申请批准通知书的公告
Shang Hai Zheng Quan Bao· 2025-07-29 17:44
Core Viewpoint - Zhejiang Jianfeng Group's subsidiary, Jianfeng Pharmaceutical, has received approval for the listing of the chemical raw material drug, Empagliflozin, indicating compliance with national standards for raw material drug evaluation and enabling sales in the domestic market, which will help expand the subsidiary's business scope [2][5]. Group 1: Drug Approval and Details - The chemical raw material drug approved is Empagliflozin, with a packaging specification of 10kg per barrel, and the approval notification number is 2025YS00624 [2][3]. - The approval is valid until July 24, 2030, and the registration standard number is YBY66992025 [3]. Group 2: Drug Development and Investment - Empagliflozin is an SGLT2 inhibitor used as an adjunct treatment for improving blood sugar control in adult patients with type II diabetes, functioning by blocking glucose reabsorption in the kidneys [3][4]. - The total investment in the development of the Empagliflozin raw material project is approximately RMB 8.8769 million [4]. Group 3: Impact on the Company - The approval of Empagliflozin signifies that Jianfeng Pharmaceutical has the necessary production capabilities, which will facilitate the expansion of its business in the pharmaceutical sector [5].
尖峰集团: 尖峰集团关于子公司获得化学原料药上市申请批准通知书的公告
Zheng Quan Zhi Xing· 2025-07-29 16:21
Group 1 - The core announcement is that Zhejiang Jianfeng Group's subsidiary, Jianfeng Pharmaceutical, has received the approval notice for the listing application of the chemical raw material drug, Empagliflozin, from the National Medical Products Administration [1][2] - Empagliflozin is classified as a sodium-glucose co-transporter 2 (SGLT2) inhibitor, which aids in blood sugar control for adult patients with type II diabetes by blocking glucose reabsorption in the kidneys [2] - The total investment in the research and development of the Empagliflozin raw material project is approximately RMB 8.8769 million [2] Group 2 - The approval indicates that the raw material drug meets the national technical standards for raw material drug review, allowing it to be sold in the domestic market, which will help expand the subsidiary's business scope [3] - The approval notice is valid until July 24, 2030, and the production facility is located in Jinhua City, Zhejiang Province [2]
尖峰集团:全资子公司获得化学原料药上市申请批准通知书
Zheng Quan Ri Bao· 2025-07-29 13:22
证券日报网讯 7月29日晚间,尖峰集团发布公告称,近日,公司的全资子公司浙江尖峰药业有限公司收 到国家药品监督管理局关于化学原料药恩格列净的《化学原料药上市申请批准通知书》(通知书编号: 2025YS00624)。 (文章来源:证券日报) ...