1. Introduction to the Project

1.1 Introduction to technical achievements

The project team has been focusing on the development of Class 1.1 chemical drugs using natural products and modifications of ginseng and American ginseng for many years. Through chemical and enzymatic modifications, it has obtained various natural product modifications and discovered their unique pharmacological effects. Especially, the unique saponin modifications of American ginseng have anti-inflammatory effects similar to glucocorticoids, but without many side effects of glucocorticoids. By specifically inhibiting macrophage polarization and improving the renal inflammatory microenvironment, they have good therapeutic effects on acute and chronic kidney disease models in rats and mice.

1.2 Technical analysis and advantages

1.2.1 Core technical analysis

This project uses ginsenoside Rg2 as the raw material to obtain a semi synthetic modified ginsenoside unique to American ginseng, and uses PEG as the main excipient to obtain a drop pill preparation. After oral gavage for 10 weeks, the levels of urinary microalbumin/urinary creatinine, serum creatinine and urea nitrogen in the diabetes nephropathy model mice are significantly reduced, the serum and renal homogenate pro-inflammatory factors IL-6 and NO are decreased, and the anti-inflammatory factor IL-10 is significantly increased from 2 weeks after administration. In addition, it has preventive and therapeutic effects on renal fibrosis in the late stage of diabetes nephropathy, which is better than valsartan and metformin, the clinical drugs.

1.2.2 Technological innovation and advantages

By now, the clinical treatment strategies for diabetes nephropathy mainly focus on improving lifestyle, controlling blood sugar and blood pressure steadily, regulating blood lipids, and applying angiotensin converting enzyme inhibitors/angiotensin receptor antagonists (captopril/valsartan), but most of them are in the perspective of improving the symptoms of primary diabetes, and then alleviating kidney damage. They lack new drugs that have non hypoglycemic effects and improve the mechanism of renal inflammatory microenvironment damage.

At present, most of the new anti-diabetes nephropathy drugs are derived from the new indications of hypoglycemic drugs, such as sodium glucose cotransporter 2 inhibitor (dagelin) and glucagon like peptide-1 receptor agonist (smeglutide), which are all in clinical trials. This product mainly uses non hypoglycemic new mechanisms to target the regulation of macrophage function, improve the inflammatory microenvironment of the kidneys, and protect the inherent cells of the kidneys to form a unique track. In addition, the safety of natural products is also another advantage of this product. The products developed in this project can be used alone or in combination with other clinical medications, creating synergy from different mechanisms and forming a unique competitive advantage.

1.3 Main products and applications of technical achievements

This project uses ginseng and American ginseng natural products and modifications to develop Class 1.1 chemicals, which can be used to treat diabetes, nephropathy and other diseases.

1.4 Technical achievement commercialization stage

The project has already completed the pharmaceutical preparation and pilot test process of the modified saponin peculiar to American ginseng, pharmacodynamics, pharmacokinetics and preliminary toxicology research, which is expected to be developed as a class 1.1 chemical drug targeting macrophages and non-hypoglycemic new mechanism for anti-diabetes-and-nephropathy.

1.5 Technical team

The technical team has been engaged in the development of ginseng and American ginseng natural products for a long time, and has professional expertise in pharmacy, pharmacology and toxicology, molecular biology, nano material synthesis, etc.

The project leader is the Director of the Pharmacology Teaching and Research Office of the School of Basic Medicine, one of the main technical leaders of Jilin Province New Drug Pharmacology Evaluation Technology Innovation Center, Jilin Province Nanoengineering Laboratory, and Jilin Province Key Laboratory of New Drug Research and Development. He has been deeply involved in the field of new drug pharmacodynamics and toxicology for many years, accumulated a lot of experience, completed more than 30 new drug development projects, and published more than 60 SCI papers. The project team has won one first prize, two second prizes, and one first prize for scientific and technological progress in Jilin Province, and has been granted more than 10 national invention patents.

2. Market Potential Analysis

Diabetes or kidney disease is one of the most serious complications of diabetes patients, and also an important cause of end-stage kidney disease. The awareness rate of diabetes nephropathy is low, the treatment is difficult, and the treatment effect is not ideal, which seriously reduces the quality of life of patients, threatens the life and health of patients, and brings serious mental and economic burden to many diabetes patients and their families. In the Global Health Assessment Report 2019 released by the World Health Organization in 2020, kidney disease has been listed as one of the top ten causes of death worldwide.

In 2023, there will be about 700 million chronic kidney disease (CKD) patients worldwide, including 130 million CKD patients caused by type 2 diabetes (T2D). The prevalence of diabetes with CKD is 27.1%~83.6%. In China, there are about 132.3 million patients with CKD, and about 31.08 million patients with CKD caused by T2D, and diabetes combined with CKD has become the first hospitalized cause of CKD in China. CKD combined with T2D carries a risk of CKD progression and cardiovascular events, which can eventually develop into end-stage renal disease over time. According to authoritative institutions, the global chronic kidney disease market is expected to grow at a potential growth rate of 5%. It is expected to have reached a scale of 20.96 billion US dollars by 2028.

The main factors driving the global chronic kidney disease market are a large number of elderly population, and the rapid rise in the prevalence of hypertension, diabetes and cardiovascular diseases related to risk factors. The Asia Pacific is expected to become the fastest-growing market.

According to the Epidemiological Survey of Chronic Kidney Disease in China, the prevalence of chronic kidney disease among adults in China is approximately 10.8%. Based on this calculation, there are over 100 million adult patients with chronic kidney disease in China. In China, the chronic kidney disease is the eighth leading cause of disability caused by diseases, resulting in a loss of healthy lifespan.

This product can be used alone to protect acute and chronic kidney damage caused by various incentives, and can also be used together with existing first-line and second-line hypoglycemic, antihypertensive, and lipid-lowering drugs to treat diabetes nephropathy, reduce urinary protein excretion, improve renal function, and improve patients’ quality of life, which will bring good social benefits and economic benefits.

3. Financing Needs and Financing Purposes

The project is planned to raise 50 million yuan, with the funds mainly used for IND application and to assist in the subsequent clinical trial development of the product.

4. Cooperative Needs

(1) Seeking team members with relevant professional backgrounds and industry experience in management, operation, research and development production;

(2) Seeking cooperation and development with the enterprises with relevant professional backgrounds and research and development capabilities.

5. Analysis of Technical Achievements and Benefits

5.1 Economic benefits

After the industrialization of the project, the annual output value of technical achievements is about 100 million yuan.

5.2 Social benefits

The construction of the project conforms to industrial policies, helps to build a healthy China, increases people’s well-being, and becomes a driving force for economic growth. After project operation, it can increase the local fiscal revenue and play a positive role in promoting the regional economic growth.

6. Contact Method

Contact person: Xu Wan

Tel: 13756652164