Workflow
GZBL(002424)
icon
Search documents
贵州百灵“糖宁通络片”新增用于2型糖尿病的临床试验许可
Core Viewpoint - Guizhou BaiLing Pharmaceutical Group's subsidiary has received approval for clinical trials of a new traditional Chinese medicine, Tang Ning Tong Luo Pian, aimed at treating Type 2 Diabetes Mellitus (T2DM) and its complications, marking a significant advancement in the company's strategy in the metabolic disease sector [1][2][4] Group 1: Product Development - Tang Ning Tong Luo Pian is the first traditional Chinese medicine to enter clinical trials for both diabetes treatment and its complications in China [1] - The drug has shown promising pharmacological effects by adjusting endocrine functions and improving biochemical indicators in T2DM patients [1][2] - The development of Tang Ning Tong Luo Pian addresses the clinical needs for diabetes prevention, treatment, and management of complications [2][4] Group 2: Market Context - The global diabetes patient population is projected to reach 589 million by 2024, with China having 148 million patients, the highest in the world [2] - The diabetes medication market in China is expected to grow significantly, reaching 116.1 billion yuan by 2025 and 167.5 billion yuan by 2030 [3] - Despite the large market size, a significant portion is dominated by imported drugs, indicating a gap in meeting clinical needs [3] Group 3: Competitive Advantage - Tang Ning Tong Luo Pian is based on Miao medicine principles and has demonstrated unique advantages in treating diabetes and its complications through modern research methods [3][4] - The drug has shown effectiveness in lowering glycosylated hemoglobin levels and delaying the progression of diabetic retinopathy and other complications [3] - If approved, capturing just 1% of the market could yield approximately 2 billion yuan in sales, highlighting its potential impact [4] Group 4: Strategic Vision - The company aims to establish a comprehensive approach to diabetes management through Tang Ning Tong Luo Pian, addressing both prevention and treatment of complications [4] - The chairman of the company emphasized the innovative model of integrating traditional medicine with modern research to enhance the global reach of ethnic medicine [4]
A股创新药概念股再度集体走强,贵州百灵、罗欣药业涨停
Ge Long Hui· 2025-10-16 02:45
Core Viewpoint - The A-share market continues to show strength in innovative drug concept stocks, with significant gains observed across multiple companies on October 16 [1] Group 1: Stock Performance - Guizhou BaiLing and Luoxin Pharmaceutical reached the daily limit up [1] - Yifang Bio increased by over 7% [1] - Laime Pharmaceutical, Guangsheng Tang, Anglikang, and Shutaishen all rose by over 6% [1] - Dize Pharmaceutical and Lianhuan Pharmaceutical saw increases of over 5% [1]
中药板块震荡拉升,贵州百灵涨停
Mei Ri Jing Ji Xin Wen· 2025-10-16 01:57
每经AI快讯,10月16日,中药板块震荡拉升,贵州百灵涨停,维康药业、达仁堂、方盛制药、盘龙药 业、沃华医药跟涨。 (文章来源:每日经济新闻) ...
中药板块震荡拉升 贵州百灵涨停
南方财经10月16日电,中药板块震荡拉升,贵州百灵涨停,维康药业、达仁堂、方盛制药、盘龙药业、 沃华医药跟涨。 ...
贵州百灵:全资子公司获得药物临床试验批准通知书
Zheng Quan Ri Bao· 2025-10-15 14:10
Core Points - Guizhou Bailing announced that its wholly-owned subsidiary, Bailing Yuxiu (Zhuhai) Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration (NMPA) for clinical trials of Tangning Tongluo tablets for the treatment of type 2 diabetes [2] Company Summary - The clinical trial approval is significant for Bailing Yuxiu as it allows the company to advance its research and development efforts in diabetes treatment [2] - The approved clinical trial is expected to enhance the company's product portfolio and potentially increase its market share in the diabetes medication sector [2]
贵州百灵:全资子公司糖宁通络片临床试验申请获批准
Core Viewpoint - Guizhou BaiLing's subsidiary BaiLing YuXiu has received approval from the National Medical Products Administration (NMPA) to conduct clinical trials for its drug, Tang Ning Tong Luo Pian, aimed at treating type 2 diabetes [1] Company Summary - Guizhou BaiLing's full subsidiary BaiLing YuXiu (Zhuhai) Pharmaceutical Co., Ltd. has been granted a Clinical Trial Approval Notice by NMPA [1] - The approved clinical trial is specifically for Tang Ning Tong Luo Pian, which is intended for use in type 2 diabetes treatment [1]
贵州百灵(002424) - 关于全资子公司获得药物临床试验批准通知书的公告
2025-10-15 09:45
证券代码:002424 证券简称:贵州百灵 公告编号:2025-043 贵州百灵企业集团制药股份有限公司 关于全资子公司获得药物临床试验批准通知书的 公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整, 没有虚假记载、误导性陈述或重大遗漏。 2025 年 10 月 15 日,贵州百灵企业集团制药股份有限公司(以 下简称"公司")全资子公司百灵毓秀(珠海)医药有限公司(以下 简称"百灵毓秀")收到国家药品监督管理局(NMPA)核准签发的《药 物临床试验批准通知书》(通知书编号:2025LP02703),由百灵毓秀 申报的糖宁通络片临床试验申请获得批准,同意本品开展用于 2 型糖 尿病的临床试验。现将相关情况公告如下: 一、药物基本信息 药品名称:糖宁通络片 剂型:片剂 受理号:CXZL2500055 申请人:百灵毓秀(珠海)医药有限公司 适应症:用于 2 型糖尿病(湿热蕴结证)的适应症 结论:根据《中华人民共和国药品管理法》及有关规定,经审查, 糖宁通络片临床试验申请符合药品注册的有关要求,在进一步完善临 床试验方案的基础上,同意本品开展用于 2 型糖尿病的临床试验。 本品曾于 2024 年获得用于 ...
贵州百灵(002424.SZ):糖宁通络片临床试验申请获批准
智通财经网· 2025-10-15 09:41
Group 1 - The core point of the article is that Guizhou Bailing (002424.SZ) announced that its wholly-owned subsidiary, Bailing Yuxiu (Zhuhai) Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration (NMPA) for the clinical trial of Tangning Tongluo tablets, which are intended for the treatment of type 2 diabetes [1] Group 2 - The approval allows Bailing Yuxiu to conduct clinical trials for Tangning Tongluo tablets, marking a significant step in the company's development of diabetes treatment options [1]
贵州百灵(002424.SZ):糖宁通络片获得药物临床试验批准通知书
Ge Long Hui A P P· 2025-10-15 09:41
Core Viewpoint - Guizhou Bailing (002424.SZ) announced that its wholly-owned subsidiary, Bailing Yuxiu (Zhuhai) Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration (NMPA) for the clinical trial of its drug, Tangning Tongluo Tablets, aimed at treating type 2 diabetes [1] Group 1 - The clinical trial application for Tangning Tongluo Tablets has been approved, allowing the drug to enter clinical trials for type 2 diabetes [1] - Tangning Tongluo Tablets is a Class 1 new traditional Chinese medicine that has been in development for over ten years and has been used in clinical settings since 2014 as a hospital preparation [1] - The drug has accumulated significant human usage experience and has shown good efficacy in improving symptoms and reversing biochemical indicators in both treated and untreated type 2 diabetes patients [1] Group 2 - The approval for the clinical trial of Tangning Tongluo Tablets is based on prior clinical research, and it is noteworthy that it is the first traditional Chinese medicine to transition from a hospital preparation to a new drug, bypassing Phase I and II trials to directly enter Phase III trials [1] - The drug is designed to adjust the body's endocrine functions, demonstrating its pharmacological effects in treating type 2 diabetes [1]
贵州百灵:全资子公司中药新药糖宁通络片获得2型糖尿病临床试验批准
Xin Lang Cai Jing· 2025-10-15 09:41
Core Viewpoint - Guizhou BaiLing's wholly-owned subsidiary has received approval for clinical trials of a new traditional Chinese medicine for type 2 diabetes, enhancing the company's product line in diabetes treatment [1] Group 1: Clinical Trial Approval - The company announced that its subsidiary BaiLing YuXiu received the "Drug Clinical Trial Approval Notice" from the National Medical Products Administration, allowing the clinical trial of Tang Ning Tong Luo Pian for type 2 diabetes [1] - This approval is based on over ten years of research and development, with the product already used in clinical settings since 2014 as a hospital preparation, accumulating significant human usage experience [1] Group 2: Product Development and Market Position - Tang Ning Tong Luo Pian is classified as a Class 1 traditional Chinese medicine and is notable for being the first to transition from a hospital preparation to a new drug under the "Special Regulations on the Registration of Traditional Chinese Medicine" [1] - The drug has demonstrated good efficacy in treating both treated and untreated type 2 diabetes patients by adjusting endocrine functions and improving disease symptoms, thus reversing biochemical indicators [1]