Tong Hua Dong Bao Pharmaceutical Co., Ltd (hereinafter referred to as the "Company") has initiated the Phase I clinical trial in China after receiving the notification of approval for the clinical trial of Degu Insulin Liraglutide Injection from the State Drug Administration and has recently successfully completed the first case of patient dosing.

The completion of Phase I clinical trial of Degu Insulin Liraglutide Injection is another significant progress in the development of GLP-1RA compound formulation of insulin analog, which will further enhance the competitiveness of the Company 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 Mainland China, Hong Kong and Taiwan) sales revenue has rapidly grown from $45 million to $431 million from 2022 to 2023, and China sales revenue has reached approximately $332 million in the first quarter of 2024, representing a year-over-year increase of approximately 602%.

About Degu Insulin Liraglutide Injection Phase I Clinical Study

After obtaining the approval of clinical trials from the State Drug Administration, the Company has initiated "a randomized, open, two-cycle, crossover-designed pharmacokinetic study to evaluate Degu Insulin Liraglutide Injection versus Novozymes® single-dose administration in healthy subjects in China - a Phase I study", with the primary objective of evaluating Degu Insulin Liraglutide Injection and Novozymes® single-dose administration in China. study", the primary objective of which is to assess the pharmacokinetic similarity between single subcutaneous injection of Degu Insulin Liraglutide Injection and Novozymes® in healthy Chinese subjects; the secondary objectives include assessing the pharmacokinetic profiles of single subcutaneous injection of Degu Insulin Liraglutide Injection and Novozymes® in healthy Chinese subjects; and assessing the pharmacokinetic characteristics of single subcutaneous injection of Degu Insulin Liraglutide Injection and Novozymes® in healthy Chinese subjects. The safety and tolerability of Degu Insulin Liraglutide Injection with Novozymes® were evaluated in healthy Chinese subjects.

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 to regulate 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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