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山东步长制药股份有限公司关于公司获得药品补充申请批准通知书的公告
Shang Hai Zheng Quan Bao· 2025-11-14 19:27
Group 1 - Company has received the approval notice for the supplementary application of the drug "Xiaolin Baidu San" from the National Medical Products Administration [1] - "Xiaolin Baidu San" is a unique product of the company, primarily used for clearing heat and detoxifying, and treating symptoms related to urinary tract infections [1] - The company has invested approximately 28.15 million RMB in research and development for "Xiaolin Baidu San" and its pill form [1] Group 2 - The company has obtained a change in its drug production license from the Shandong Provincial Drug Administration, allowing for the addition of workshops, production lines, and production scope [4] - The production license now includes the addition of a comprehensive preparation workshop for pill production, enhancing the company's production capabilities [5] - The extension of the entrusted production validity period for various medications will help maintain stable production capacity and meet market demand [6]
步长制药:关于公司获得药品补充申请批准通知书的公告
Zheng Quan Ri Bao· 2025-11-14 13:39
Core Viewpoint - The company has received approval from the National Medical Products Administration for the supplementary application of a drug called Xiaolinbaituxian [2] Group 1 - The announcement was made on the evening of November 14 [2] - The approval pertains to the drug Xiaolinbaituxian, indicating a potential expansion in the company's product offerings [2]
步长制药(603858.SH):获得药品补充申请批准通知书
Ge Long Hui A P P· 2025-11-14 09:45
Core Viewpoint - Company has received approval from the National Medical Products Administration for the drug "Xiaolinbaituxian," which will enhance product quality and meet market demand, positively impacting future operations [1][2]. Group 1: Drug Approval and Details - The drug "Xiaolinbaituxian" has been approved for marketing, with the original approval number remaining unchanged [1]. - The marketing authorization holder has been changed from "Shandong Kongfu Pharmaceutical Co., Ltd." to "Shandong Buchang Pharmaceutical Co., Ltd." [1]. - The drug is used for clearing heat and detoxifying, treating symptoms related to lower jiao damp-heat syndrome and non-specific lower urinary tract infections [1]. Group 2: Research and Development Investment - The company has invested approximately 28.15 million RMB in research and development for "Xiaolinbaituxian" and its pill form [1]. - The company emphasizes the importance of drug research and development, maintaining strict quality and safety controls throughout the drug development, manufacturing, and sales processes [2].
步长制药:获得药品补充申请批准通知书
Ge Long Hui· 2025-11-14 09:40
Core Viewpoint - Company has received approval from the National Medical Products Administration for the drug "Xiaolinbaituxian," which will enhance product quality and meet market demand, positively impacting future operations [1][2]. Group 1: Drug Approval and Details - The drug "Xiaolinbaituxian" has been approved for marketing, with the original approval number remaining unchanged [1]. - The marketing authorization holder has been changed from "Shandong Kongfu Pharmaceutical Co., Ltd." to "Shandong Buchang Pharmaceutical Co., Ltd." [1]. - The drug is used for clearing heat and detoxifying, particularly for symptoms related to lower urinary tract infections [1]. Group 2: Research and Development Investment - The company has invested approximately 28.15 million RMB in research and development for "Xiaolinbaituxian" and its pill form [1]. - The company emphasizes the importance of quality and safety in drug research, manufacturing, and sales [2].