糖尿病肾脏疾病治疗
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江苏康缘药业股份有限公司关于收到车前子片临床试验批准通知书的公告
Shang Hai Zheng Quan Bao· 2026-01-20 19:31
Core Viewpoint - Jiangsu Kangyuan Pharmaceutical Co., Ltd. has received the clinical trial approval notice for Cheqianzi Tablets, which will be used for the treatment of diabetic kidney disease (DKD) [1][2]. Group 1: Drug Development and Related Information - Cheqianzi Tablets are indicated for diuresis and dampness elimination, specifically targeting the treatment of DKD with damp-heat syndrome. Preclinical studies have shown significant therapeutic effects on DKD, including reductions in blood glucose, insulin resistance index, and glycosylated hemoglobin levels [2]. - In spontaneous diabetic mouse models, Cheqianzi Tablets significantly reduced 24-hour urinary microalbumin, total protein, and the microalbumin/creatinine ratio, while effectively improving kidney pathology [2]. - Toxicological studies indicate that Cheqianzi Tablets have good safety profiles and a wide safety dosage range [2]. Group 2: Market Situation and Product Approval Process - DKD is a common and severe microvascular complication of diabetes, with approximately 20% to 40% of diabetic patients eventually developing DKD, and the incidence is trending younger [2]. - Current clinical treatments primarily focus on controlling blood pressure, blood glucose, and diet to slow the progression of DKD [2]. - The development of Cheqianzi Tablets is expected to have significant clinical value and a promising market outlook, as there are limited traditional Chinese medicine options specifically targeting DKD with damp-heat syndrome [3]. - Following the receipt of the clinical trial notice, the company must complete clinical trials and obtain approval from the National Medical Products Administration before the product can be manufactured and marketed [3].