格隆汇1月20日丨康缘药业(600557.SH)公布，江苏康缘药业股份有限公司近日收到国家药品监督管理局 签发的车前子片《药物临床试验批准通知书》。 糖尿病肾脏病是糖尿病最常见且严重的微血管并发症之一，也是导致终末期肾脏病的主要原因。糖尿病 肾脏病早期起病多隐匿，且无明显临床症状。大约20%~40%的糖尿病患者最终会发展成为 DKD，且发 病率呈年轻化趋势。临床治疗主要通过控制血压、血糖及饮食等，以延缓糖尿病肾脏病的进展。 中医临床在长期诊疗中归纳总结出"湿热不除，蛋白难消"的核心病机认识。当前临床针对 DKD 适应症 治疗的中成药选择相对有限，且中医临床治疗DKD多从"补肾固本、益气活血、祛风除湿"等治法治则 着手，而专门针对糖尿病肾脏病湿热证的中成药尚属空白。车前子片的研发预期具有明显的临床价值和 良好的市场前景。 车前子片功能主治为利水渗湿、泄热化浊，用于糖尿病肾脏病(diabetickidneydisease, DKD)湿热证的治 疗。临床前主要药效学研究显示，车前子片对糖尿病肾脏病具有良好的治疗效果。在自发性糖尿病小鼠 肾脏病模型中，车前子片能显著降低模型小鼠血糖、胰岛素抵抗指数和糖化血红蛋白水平， ...

Core Insights - Kangyuan Pharmaceutical has received approval from the National Medical Products Administration for the clinical trial of Cheqianzi Tablets, which are intended for the treatment of diabetic kidney disease (DKD) with a focus on damp-heat syndrome [1][2] - Preclinical studies indicate that Cheqianzi Tablets show significant therapeutic effects on DKD, including reductions in blood glucose, insulin resistance, and various proteinuria markers in diabetic mouse models [1] - The development of Cheqianzi Tablets is expected to fill a gap in the market for traditional Chinese medicine targeting DKD, which currently has limited options [2] Company Summary - Kangyuan Pharmaceutical has announced the approval for clinical trials of Cheqianzi Tablets, which are aimed at treating DKD [1] - The company’s research highlights the safety and efficacy of Cheqianzi Tablets, showing a wide safety margin in toxicological studies [1] Industry Summary - Diabetic kidney disease is a common and severe microvascular complication of diabetes, affecting approximately 20% to 40% of diabetic patients, with an increasing incidence among younger populations [2] - Current clinical treatments for DKD primarily focus on controlling blood pressure, blood sugar, and diet, indicating a need for more targeted therapies [2] - The lack of traditional Chinese medicine options specifically addressing damp-heat syndrome in DKD presents a significant opportunity for Cheqianzi Tablets in the market [2]