According to the Zhitong Finance APP, Huadong Medicine (000963.SZ) announced that on December 31, 2024, its wholly-owned subsidiary Hangzhou Sino-American Huadong Pharmaceutical Co., Ltd. (referred to as "Sino-American Huadong") received the "Drug Clinical Trial Approval Notification" (Notification No.: 2024LP03036 and 2024LP03037) approved and issued by the National Medical Products Administration (NMPA), which grants approval for the clinical trial application of HDM1005 injection submitted by Sino-American Huadong.

HDM1005 injection is a Class 1 chemical new drug developed by Hangzhou Sino-American Huadong Pharmaceutical Co., Ltd. and holds Global intellectual property rights. It is a long-acting agonist with dual targets for peptide human GLP-1 (glucagon-like peptide 1) receptors and GIP (glucose-dependent insulinotropic polypeptide) receptors. Preclinical studies have shown that HDM1005 can promote the production of cyclic adenosine monophosphate (cAMP) by activating GLP-1 and GIP receptors, increase insulin secretion, suppress appetite, delay gastric emptying, improve metabolic function, thus improving plasma volume, reducing oxidative stress and systemic inflammation, and enhancing cardiovascular adaptability; it has effects in lowering blood sugar, reducing weight, improving MASH, and ameliorating heart failure with preserved ejection fraction (HFpEF). Meanwhile, existing data indicates that HDM1005 has good drug-like properties and safety.

The HDM1005 injection is a dual-target long-acting agonist of peptide-based human GLP-1 receptors and GIP receptors. GLP-1 products have effects such as weight loss, glucose lowering, and cardiovascular benefits, making them relatively mature and safe targets. The approval of this HDM1005 injection clinical trial represents another important advancement in the product's research and development process and will further enhance the company's core competitiveness in the field of endocrine therapy.