儿童小柴胡颗粒主要用于小儿胃肠型感冒(邪犯少阳证)。光华药业于2023年5月获得国家药品监督管理 局签发的《药物临床试验批准通知书》，详情请见公司于2023年5月12日发布的《广州白云山医药集团 股份有限公司关于子公司获得药物临床试验批准通知书的公告》(公告编号：2023-024)。儿童小柴胡颗 粒获得临床试验批准通知书后，光华药业完成了伦理审查，并获得伦理批件，将开展儿童小柴胡颗粒的 Ⅱ期临床试验。目前国内外尚无儿童小柴胡颗粒的同类产品上市，无其国内外销售数据。 截至本公告日，该项目已投入研发费用约人民币1,858.79万元(未经审计)。 格隆汇9月22日丨白云山(00874.HK)公告，广州白云山医药集团股份有限公司("公司")子公司广州白云山 光华制药股份有限公司("光华药业")研发的儿童小柴胡颗粒于近日在国家药品监督管理局药物临床试验 登记与信息公示平台公示了II期临床试验登记信息。 ...

Core Viewpoint - The company announced that its subsidiary, Guangzhou Baiyunshan Guanghua Pharmaceutical Co., Ltd., has registered the Phase II clinical trial for its pediatric Xiaochaihu granules, focusing on the treatment of pediatric gastrointestinal colds [1] Group 1: Clinical Trial Information - The Phase II clinical trial is designed as a randomized, double-blind, parallel-controlled, multi-center study to evaluate the efficacy and safety of pediatric Xiaochaihu granules for treating pediatric gastrointestinal colds [1] - The pediatric Xiaochaihu granules are primarily used for treating pediatric gastrointestinal colds, specifically targeting the "邪犯少阳证" syndrome [1] Group 2: Regulatory Approvals - Guanghua Pharmaceutical received the clinical trial approval notice from the National Medical Products Administration in May 2023 [1] - Following the approval, the company completed the ethical review and obtained the ethical approval to proceed with the Phase II clinical trial of pediatric Xiaochaihu granules [1]

智通财经APP讯，白云山(00874)发布公告，公司子公司广州白云山光华制药股份有限公司("光华药业") 研发的儿童小柴胡颗粒于近日在国家药品监督管理局药物临床试验登记与信息公示平台公示了II期临床 试验登记信息。试验专业题目：儿童小柴胡颗粒治疗小儿胃肠型感冒邪犯少阳证有效性及安全性的随 机、双盲、平行对照设计、多中心Ⅱ期临床研究。 儿童小柴胡颗粒主要用于小儿胃肠型感冒(邪犯少阳证)。 光华药业于2023年5月获得国家药品监督管理局签发的《药物临床试验批准通知书》。儿童小柴胡颗粒 获得临床试验批准通知书后，光华药业完成了伦理审查，并获得伦理批件，将开展儿童小柴胡颗粒的Ⅱ 期临床试验。 ...

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性或完 整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部份內容而產生或因倚賴該等內 容而引致的任何損失承擔任何責任。 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第13.10B條而作出的。 茲刊載廣州白雲山醫藥集團股份有限公司（「本公司」）在上海證券交易所網站(www.sse.com.cn)刊登的 本公司關於子公司藥物進入II期臨床試驗的公告之中文全文，僅供參考。 廣州白雲山醫藥集團股份有限公司 董事會 中國廣州，2025年9月22日 於本公告日，本公司董事會成員包括執行董事李小軍先生、程寧女士、程洪進先生、唐和平先生與 黎洪先生，及獨立非執行董事陳亞進先生、黃民先生、黃龍德先生與孫寶清女士。 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。 广州白云山医药集团股份有限公司（"公司"）子公司广州白云山光 华制药股份有限公司（"光华药业"）研发的儿童小柴胡颗粒于近日在国 家药品监督管理局药物临床试验登记与信息公示平台公示了I ...

Core Viewpoint - Guangzhou Baiyunshan Pharmaceutical Holdings Company Limited (600332.SH) announced that its subsidiary, Guangzhou Baiyunshan Guanghua Pharmaceutical Co., Ltd., has registered the Phase II clinical trial for its pediatric Xiao Chai Hu granules on the National Medical Products Administration's clinical trial registration platform, focusing on the efficacy and safety of the treatment for pediatric gastrointestinal colds [1] Group 1 - The clinical trial is designed as a randomized, double-blind, parallel-controlled, multi-center Phase II study [1] - The study aims to evaluate the effectiveness and safety of pediatric Xiao Chai Hu granules in treating pediatric gastrointestinal colds with Shao Yang syndrome [1]

Core Viewpoint - Baiyunshan (600332.SH) announced that its subsidiary, Guangzhou Baiyunshan Guanghua Pharmaceutical Co., Ltd., has registered the Phase II clinical trial information for its pediatric Xiaochaihu granules on the National Medical Products Administration's clinical trial registration and information disclosure platform [1] Group 1 - The clinical trial is designed to evaluate the efficacy and safety of pediatric Xiaochaihu granules in treating pediatric gastrointestinal colds with Shaoyang syndrome through a randomized, double-blind, parallel-controlled, multi-center Phase II clinical study [1] - The common title of the trial is "Phase II Clinical Trial of Pediatric Xiaochaihu Granules for Treating Pediatric Gastrointestinal Colds with Shaoyang Syndrome" [1]

Core Viewpoint - The company announced that its subsidiary, Guangzhou Baiyunshan Guanghua Pharmaceutical Co., Ltd., has registered the Phase II clinical trial information for its pediatric Xiao Chai Hu granules on the National Medical Products Administration's clinical trial registration and information disclosure platform [1] Group 1 - The clinical trial is designed to evaluate the efficacy and safety of pediatric Xiao Chai Hu granules in treating pediatric gastrointestinal colds with Shaoyang syndrome through a randomized, double-blind, parallel-controlled, multi-center Phase II clinical study [1] - The common title of the trial is "Phase II Clinical Trial of Pediatric Xiao Chai Hu Granules for Treating Pediatric Gastrointestinal Colds with Shaoyang Syndrome" [1]

试验专业题目：儿童小柴胡颗粒治疗小儿胃肠型感冒邪犯少阳证有效 性及安全性的随机、双盲、平行对照设计、多中心Ⅱ期临床研究 证券代码：600332 证券简称：白云山 公告编号：2025－072 广州白云山医药集团股份有限公司 关于子公司药物进入 II 期临床试验的公告 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。 广州白云山医药集团股份有限公司（"公司"）子公司广州白云山光 华制药股份有限公司（"光华药业"）研发的儿童小柴胡颗粒于近日在国 家药品监督管理局药物临床试验登记与信息公示平台公示了II期临床试 验登记信息，现将相关情况公告如下： 一、临床试验相关情况 药物名称：儿童小柴胡颗粒 申请人名称：广州白云山光华制药股份有限公司 试验登记号：CTR20253842 试验方案编号：GZBYS-ETXCHKL-Ⅱ 试验通俗题目：儿童小柴胡颗粒治疗小儿胃肠型感冒邪犯少阳证Ⅱ期 临床试验 二、药物其他相关情况 儿童小柴胡颗粒主要用于小儿胃肠型感冒（邪犯少阳证）。 光华药业于2023年5月获得国家药品监督管理局签发的《药物临床试 1 验批 ...

Core Viewpoint - Baiyunshan (600332) announced that its subsidiary Guanghua Pharmaceutical has recently registered the Phase II clinical trial information for its children's Xiao Chai Hu granules on the National Medical Products Administration's clinical trial registration and information disclosure platform [1] Group 1 - The announcement was made on September 22 [1] - The product in focus is children's Xiao Chai Hu granules, which is a traditional Chinese medicine [1] - The registration of the clinical trial indicates progress in the development of this pediatric medication [1]

白云山公告，子公司广州白云山光华制药股份有限公司研发的儿童小柴胡颗粒于近日在国家药品监督管 理局药物临床试验登记与信息公示平台公示了II期临床试验登记信息。该药物主要用于小儿胃肠型感冒 （邪犯少阳证），目前国内外尚无同类产品上市。截至公告日，该项目已投入研发费用约1858.79万元 （未经审计）。 ...