• New progress: Innovative drug for diabetic nephropathy developed by WMU obtains approval for clinical trial
  • Author:    Date:January 23, 2023
  • Recently, the Category 1.1 innovative chemical drug C66 capsule for the treatment of diabetic nephropathy developed by the research group of Researcher Liang Guang of the School of Pharmaceutical Sciences and guided by Academician and President Li Xiaokun, was approved by the National Medical Products Administration for drug clinical trials. The self-developed new drug for which Wenzhou Medical University holds complete intellectual property rights has contributed to China’s progress in the research and development of innovative drugs for diabetic nephropathy.

    More than 130 million people in China live with diabetes. Although there are many antidiabetic drugs for blood sugar regulation, diabetic complications remain a problem hard to control. Diabetic complications are the main factor in the physical deterioration and death of diabetic patients. More than 35% of patients with diabetes have diabetic nephropathy, which is the leading cause of death among diabetic patients. According to statistics, the number of diabetic nephropathy patients ranks first among hospitalized patients with chronic kidney disease in China, and diabetic nephropathy contributes to over 30% of renal dialysis cases. At present, there is an urgent shortage of effective drugs for the treatment of diabetic nephropathy worldwide. In China, only Irbesartan, Finerenone, and some Chinese patent medicines are used for the clinical treatment of diabetic nephropathy, which have an unsatisfactory therapeutic effect and are unable to reverse the progression of the disease, making diabetic nephropathy one of the common and serious refractory diseases in clinical practice.

    Under the guidance of Academician Li Xiaokun, Researcher Liang Guang developed the compound C66, a "First-in-class" new drug for the treatment of diabetic nephropathy, after 12 years of research with team members Wang Yi, Wu Wenqi, Qian Jianchang, Wu Di, Luo Wu, Tang Qidong, Zhang Yali, Pan Yong, Liu Zhiguo, and Cai Yuepiao. In the past 12 years, the team independently carried out the design and synthesis of the new drug and discovered C66, a new compound with high druggability. The team systematically studied its structure, synthesis, solubilization, efficacy, pharmacological targets, and mechanism, and achieved a series of original results, elucidating C66’s pharmacological mechanisms in the treatment of diabetic nephropathy by targeting inflammatory regulatory proteins and inhibiting chronic inflammation. Based on their research, they have published 11 SCI papers in international leading journals such as Diabetes and British Journal of Pharmacology, applied for Chinese patents and international PCT patents on its chemical structure, crystal form, preparation technology, clinical indications, etc., and won fundings from the Major New Drugs Innovation and Development Scheme of the National Science and Technology Major Projects in 2019. According to preclinical studies, C66 is effective at a low dose and has better efficacy at medium and high dose range than the positive control drug Irbesartan. Besides, C66 treatment can significantly increase creatinine clearance, showing substantially better results than treatment with either Irbesartan or Canagliflozin.

    Translated by Miao Yu, reviewed by Sun You