Tonghua Dongbao Pharmaceutical Co., Ltd (hereinafter referred to as "Tonghua Dongbao") has recently obtained the clinical trial approval notification of Degu Insulin Liraglutide Injection issued by the Center for Drug Evaluation (CDE) of the State Drug Administration.

The clinical approval of Degu Insulin Liraglutide Injection is another significant progress in the research and development of insulin analog GLP-1RA compound preparation, which will further enhance the company's competitiveness in the field of endocrine therapy. In the future, the Company is expected to accelerate the process of clinical trials and speed up the approval and listing of its products by virtue of its R&D advantages accumulated in the field of diabetes treatment over the years, so as to provide richer and better choices for clinical medication.

Degu Insulin Liraglutide Injection has a broad market prospect in the future, and the market scale shows a rapid growth trend. Its original Degu Insulin Liraglutide Injection (trade name: Xultophy/Noheyi), which was approved by the European Medicines Agency (EMA) for the treatment of type 2 diabetes mellitus in adults in September 2014, was approved for marketing by the U.S. Food and Drug Administration (FDA) in November 2016, and was approved by the China National Drug Administration (NMPA) in October 2021 for Marketing. According to Novo Nordisk's periodic reports, Novozymes China (including China, Hong Kong, and Taiwan) sales revenue grows rapidly from $45 million to $431 million from 2022 to 2023.

About Degu Insulin Liraglutide Injection

Degu Insulin Liraglutide Injection is the world's first marketed combination of a basal insulin analog and a GLP-1 analog, which breaks new ground by combining the dual-component strengths of the two drugs in a complementary mechanism that multi-targets multiple pathophysiological mechanisms of type 2 diabetes and regulates glucose homeostasis.

Degu Insulin Liraglutide Injection can be administered at any time of the day to increase adherence to medication. After subcutaneous injection, the two components maintain their respective pharmacokinetic profiles, which are complementary and do not interfere with each other. At the same or lower doses of insulin, it has a better glucose-lowering effect than basal insulin, has a higher rate of glycated hemoglobin compliance, and reduces the risk of hypoglycemia and improves weight gain. With good clinical efficacy and safety, Degu Insulin Liraglutide Injection has been included in the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes Mellitus (2020 Edition), which has a promising future market prospect.

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