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Recently, Tonghua Dongbao Pharmaceutical Co., Ltd. ("Tonghua Dongbao" or the "Company") received the Registration Approval for Insulin Aspart and Sitagliptin Metformin Tablets (II) from the National Medical Products Administration (NMPA).

About insulin aspart

Insulin aspart is a fast-acting insulin analog that binds to the insulin receptors on muscle and fat cells and lowers glucose levels by facilitating cellular uptake and utilization of glucose while inhibiting the output of glucose from the liver. Mainly used as a mealtime insulin, this medicine features high patient compliance and great efficacy in patients who show a poor response to other therapies. It is also highly cost-effective compared to human insulin and other insulin analogs. All in all, it is an effective insulin analog of great commercial value.

Among fast-acting insulins, insulin aspart has the largest and most competitive market in China. According to Novo Nordisk's annual report, the sales of insulin aspart injection and premixes were approximately DKK 6.888 billion in China in 2020, with a year-on-year growth of 20% for insulin aspart injections and 14% for its premixes.

About sitagliptin phosphate

Sitagliptin phosphate is an orally administered, highly selective, small-molecule DPP-4 inhibitor. Unlike other hypoglycemic agents, DPP-4 inhibitors do not directly stimulate insulin secretion from the pancreas, but rather increase levels of incretin hormones to achieve flexible control of insulin secretion, and hence is known as a "smart" hypoglycemic drug. Metformin is the drug of choice for diabetes recommended by the current diabetes medication guidelines. Studies have shown that the combo of sitagliptin phosphate and metformin can provide more effective blood glucose control. Sitagliptin metformin tablets contain both medications in one convenient tablet, which can be used for patients with type 2 diabetes who have a poor response to metformin monotherapy or who are on combined therapies.

China's DPP-4 inhibitor market has shown a significant upward trend in recent years. According to the financial report of Merck Sharp & Dohme (MSD), the global sales of its sitagliptin metformin tablets hit USD 1.971 billion in 2020. As China adds this medicine to the national health insurance list, its sales in the country further go up. According to data from Pharmcube, the sales of sitagliptin metformin tablets (II) in China's urban and county-level public hospitals amounted to RMB 156 million in 2020, with a compound annual growth rate of 66.13% from 2016 to 2020.

China sees a growing demand for diabetes drugs as the number of diabetic patients increases due to the aging population and poor lifestyles caused by urbanization.

The two newly approved medications further expand the Company's product portfolio and can synergize with the Company's existing diabetes drugs. They will consolidate the Company's leading position in the diabetes treatment market in China and provide more cost-effective options for diabetic patients.

Tonghua Dongbao will continue to keep a finger on the pulse of the cutting-edge and key technologies in diabetes and endocrine treatment, in a bid to build a world-class R&D and commercialization platform.