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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
尖峰北卡已具备相应的生产线,本次获得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》,表明该原料药已符合国家相关原料药审评技术标准,可在国内市场进行销售,有助于拓展子公司 的业务领域。 尖峰集团(600668.SH)发布公告,近日,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》。 ...
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]