Huadong Medicine (000963.SZ): Clinical trial application for Class 1 chemical new drug HDM1005 injection approved.

Huadong Medicine (000963.SZ) announced that on February 24, 2025, its wholly-owned subsidiary Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. ("Zhongmei Huadong") received the "Drug Clinical Trial Approval Notification" (Notification No.: 2025LP00440 and 2025LP00441) issued by the National Medical Products Administration (NMPA) for the clinical trial application of HDM1005 injection. HDM1005 injection is a Class 1 new chemical drug developed and globally patented by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. It is a dual-target long-acting stimulant for the GLP-1 (glucagon-like peptide-1) receptor and GIP (glucose-dependent insulinotropic polypeptide) receptor. Preclinical studies have shown that HDM1005 can activate GLP-1 and GIP receptors, promote cyclic adenosine monophosphate (cAMP) production, increase insulin secretion, suppress appetite, delay gastric emptying, improve metabolic function, enhance plasma volume, reduce oxidative stress and systemic inflammation, improve cardiovascular adaptability, and have effects on blood sugar reduction, weight loss, and MASH. Additionally, existing data indicates that HDM1005 has good drug properties and safety. The announcement stated that HDM1005 injection is a dual-target long-acting stimulant for the GLP-1 and GIP receptors, and GLP-1 products have effects on weight loss, blood sugar reduction, and cardiovascular benefits, making them relatively mature and safe targets. The approval of the clinical trial for HDM1005 injection is another significant advancement in the development process of this product, which will further enhance the company's core competitiveness in the field of endocrine therapy.