According to the report of the National Association for the Promotion of Biotechnology and Medical Industry, there were 383 million people with diabetes in the world in 2017, and it is expected to be 592 million people in 2035. About 15% to 20% of people with diabetes will develop diabetic foot ulcers.

Diabetic Foot Ulcer (DFU) is one of the main causes of disability and death in diabetic patients. Due to the lack of adequate medical resources and effective drugs, the prognosis of the disease is poor, and the clinical mortality and disability rates are higher than those of cancer. More than 85% of the amputations of diabetic patients are due to DFU, which brings serious treatment and economic burdens to both patients and society. As one of the most urgent unmet needs in the field of diabetes, this disease deserves a high level of attention.

There are nearly 1,000 native diabetic foot ulcer (DFU) patients in China, with high morbidity and mortality rates, serious social and economic burdens, and the situation is very serious. However, limited by hardware resources such as medical personnel and beds, and the ineffectiveness of current treatment methods, most patients cannot be adequately and effectively treated. There is an urgent clinical hope for the emergence of new products with high healing rate, fast healing speed, low recurrence rate, cost-effectiveness and convenient application.

The scale of DFU patients in China is huge, and the mortality and disability rates are high. In the past 30 years, the prevalence of diabetes in China has soared from an average of 0.67% to 11.6%, of which the prevalence of diabetic foot ulcers is 5.5%. There are nearly 10 million people with diabetic foot ulcers in mainland China. The annual mortality rate of DFU patients is as high as 11%, and the annual mortality rate of amputation patients is as high as 22%. China has become the largest market for diabetic foot ulcers in the world. Diabetes medical care costs $110 billion, and diabetic foot ulcers account for 40%, or $44 billion. DFU medical expenses remain high and grow rapidly year by year. The average hospitalization cost for DFU patients is 26,610 yuan (CNY), and the hospitalization cost for amputee patients is 49,456 yuan (CNY). The only drug, Regranex (J&J), costs $600 for a single dose, and the average course of treatment is $3,600.

Currently, for diabetic foot ulcers, wound debridement is used to remove slough and necrotic tissue and control the infection, and then comprehensive medical and surgical treatment is performed to accelerate wound healing and repair the wound surface. There is an urgent need for new drugs that are more effective, can significantly shorten the treatment period, and are convenient to use. Although there are many methods for the treatment of diabetic foot, due to the complex mechanism of diabetic foot, the existing treatment methods cannot make the patients get adequate treatment, let alone solve this clinical problem completely. In the future, new drugs and treatments need to be continuously explored. In particular, new products with high healing rate, fast healing speed, low recurrence rate, cost-effectiveness, and convenient application can be developed. Thereby further improving the survival rate and quality of life of diabetic patients and benefiting the society.

The world's only approved diabetes drug Regranex (except for the FDA's warning) has not made progress for decades, and its research and development is very difficult. Both time and capital are major investments, and there should be no competitors entering the market in a short time.

Our company has obtained Chinese patent acceptance, application number: 201911241631.1, and according to the New Drug Law of China, the protection period of new drugs is 10 years after they are approved for marketing. 10 years)