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].

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]

Core Viewpoint - Kangyuan Pharmaceutical has received the Clinical Trial Approval Notice for Cheqianzi Tablets from the National Medical Products Administration, indicating progress in its drug development pipeline for treating diabetic kidney disease [1] Group 1: Company Developments - The approval pertains to Cheqianzi Tablets, which are indicated for promoting diuresis, clearing heat, and transforming dampness, specifically for the treatment of diabetic kidney disease with damp-heat syndrome [1]