Sihuan Pharmaceutical Holdings Group Ltd is pleased to announce Jilin Huisheng Biopharmacutical Co., Ltd. (the “Jilin Huisheng Biopharmaceutical”), an indirect non-wholly owned subsidiary of the Company (held as to approximately 82.68% by the Group), has successfully obtained the approval for the conduction of clinical trials from the National Medical Products Administration of the People’s Republic of China (“China”) in relation to its anti-diabetic drug insulin degludec and insulin aspart injection (the “Product”), with its research and development progress being the first with respect to biosimilar in China. Apart from Novo Nordisk’s already marketed original drug Ryzodeg, no other products from other companies has been approved for clinical trials in China. The Product has been officially included in the National Reimbursement Drug List for patients with type II diabetes that is difficult to control with other insulin or oral medications.
“Dual-insulin”: one injection for blood glucose control on an empty stomach or postprandial
The product is a soluble double insulin preparation, consisting of 70% of ultra-long acting basal insulin (insulin degludec) and 30% of bolus insulin (insulin aspart), which is characterized as a combination of basal insulin and prandial insulin. It is the world's first and only combination of soluble long-acting and rapid-acting insulin and can quickly control fasting and postprandial blood sugar with only one injection. In addition, insulin degludec and insulin aspart is more convenient to use. As a non-co-crystalline compound, the productcan be used without mixing, which enhances the convenience of the product and avoids the injection risk of mixing preparations.
Better initial treatment solution for patients with type II diabetes; more stable blood glucose at night
As the plasma insulin release curve of insulin degludec and insulin aspart injection is very gentle, compared with the use of insulin glargine and insulin aspart, insulin degludec and insulin aspart injection has lower risk of nighttime hypoglycemia (low blood glucose), which is more conducive to the regulation of blood glucose in diabetic patients. This “dual-insulin” combination presents a more significant advantage as an initial treatment solution for patients with type II diabetes. Injection at the main meal can provide rapid-acting prandial insulin, while night blood glucose is more stable.
Reduce the number of injections and improve patient compliance
As a long-term chronic disease, diabetes requires multiple injections per day, which often produces fear and resistance from patients, leading to poor compliance. The insulin degludec and insulin apart can reduce the number of injections in a treatment regimen. To the general type II diabetic patients or type I patients with regular lifestyle patterns, reducing the injection times can improve patient compliance and efficacy, thereby ease the medical burden, and is expected to increase the life expectancy of patients.
With over 10 million diabetic patients, market scale grow rapidly
According to the International Diabetes Federation (IDF), China is the world’s largest country with diabetes, with over 100 million people suffering from the disease. As type II diabetes progresses, diabetic patients need supplemental exogenous insulin therapy. About one-third of type II diabetic patients in China use insulin preparations, and about two-thirds of them use premixed insulin preparations, and this is related to the high carbohydrate diet in China and the clinical characteristics of diabetic patients with high postprandial glucose. According to IQVIA’s forecast, the sales of the insulin degludec and insulin aspart (a novel insulin) in China are expected to grow rapidly in the country, and the market size is expected to grow to RMB3 billion by 2025.
Dr. Che Fengsheng, Chairman and Executive Director of Sihuan Pharmaceutical Holdings Group Ltd., said: “Sihuan Pharmaceutical has a multi-variety and multi-mechanism product line layout in the field of diabetes treatment. Insulin Degludec/Insulin Aspart injection has achieved breakthrough progress and is entering the clinical trial stage. The product will lay a strong cornerstone for the Group to build a diabetes treatment platform and it is expected that the annual sales of the new insulin degludec and insulin apart willalso increase in accordance with the trend after it is approved for listing in the future, with great potential. This will also help the group speed up the development of diabetes product pipeline, improve the group's overall strength, and greatly enhance the group's core competitiveness.
Leading diabetes development with the most comprehensive pipeline in China
Diabetes is one of the focus areas of Sihuan Pharmaceutical’s long-term strategic development goals (the others being cerebrovascular, tumor, and medical aesthetics). Jilin Huisheng Biopharmaceutical is a biopharmaceutical company focusing on providing comprehensive solutions for diabetes and the complications, it is one of the few leading companies in China with full product coverage in the field of diabetes and the complications, and have a product pipeline with dozens of premium diabetes and complications products. Jilin Huisheng Biopharmaceutical intends to establish an independent and efficient sales network to facilitate rapid commercialization of its products.