The biologics license application (BLA) of Insulin Aspart Injection, Insulin Aspart 30 Injection and Insulin Aspart 50 Injection developed by Jilin Huisheng Biopharmaceutical Co., Ltd. ("Huisheng Biopharmaceutical””), a non-wholly owned subsidiary of the Group, has been accepted by the National Medical Products Administration (“NMPA”). Huisheng Biopharmaceutical is currently the only company in China that has simultaneously applied for the biologics license of all types of insulin aspart and with all applications having been accepted, fully demonstrating the comprehensiveness and integrity of the Company’s R&D strategy to meet the clinical needs of different insulin treatment options for diabetic patients.
Insulin Aspart Injection is a fast-acting insulin analog, which is more effective than human insulin, better controls post-prandial blood glucose, reduces the risk of hypoglycemia and allows more flexible injection time; Insulin Aspart 30/50 Injection is a biphasic insulin consisting of 30%/50% soluble insulin aspart and 70%/50% protamine insulin aspart. Compared with human insulin, it can better control the fasting and post-prandial blood glucose at the same time, reduce the risk of hypoglycemia and reduce the number of injections, thereby improving patients’ treatment compliance. Insulin Aspart Injection, Insulin Aspart 30 Injection and Insulin Aspart 50 Injection are all included in Category B of the National Reimbursement Drug List (2021 version).
Diabetes is prevalent in China, with 129.8 million diabetic patients in China in 2020 and a prevalence rate of 12.8%, according to epidemiological data. Diabetes is a chronic disease that requires the life-long use of hypoglycemic drugs. Insulin and its analog products play an important role in the treatment of diabetes. The general market has a huge demand for insulin and its analog products and such products have a market share of more than 50%.
Insulin aspart series products are currently the most widely used fast-acting and pre-mixed insulin analog products for the treatment of diabetes in China. According to the annual report of Novo Nordisk, the revenues of Insulin Aspart Injection and pre-mixed Insulin Aspart Injection in the PRC market in 2020 were RMB2.2 billion and RMB5 billion, respectively, representing a year-on-year increase of 21.7% and 15%, respectively. According to IQVIA data, the domestic sales of Insulin Aspart Injection, Insulin Aspart 30 Injection and Insulin Aspart 50 Injection in 2020 were RMB1.697 billion, RMB3.365 billion and RMB217 million, respectively, representing a year-on-year increase of 11.13%, 8.27% and 13.61%, respectively.
Dr. Che Fengsheng, Chairman and Executive Director of Sihuan Pharmaceutical Holdings Group said, “With insulin analogs further replacing the human insulin market and the continuous penetration of analog market, and leveraging on the outstanding marketing capabilities of the Group, upon the launch of Huisheng Biopharmaceutical’s Insulin Aspart Injection, Insulin Aspart 30 Injection and Insulin Aspart 50 Injection, it is expected that the sales volume will grow rapidly and the market share will be rapidly seized with great potential. This will also help the Group to accelerate the development of its diabetes product pipelines, enhance the Group’s comprehensive strength and significantly strengthen the Group’s core competitiveness.”