Huadong Medicine Co., Ltd (SHE: 000963), a China-based pharmaceutical company, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study for its Category 1 chemical drug, HDM1005, in metabolic associated steatohepatitis (MASH). This development marks a significant step forward for the company in the global metabolic disease treatment landscape.
HDM1005’s Mechanism and Clinical Progress
HDM1005 is a long-acting dual agonist of the human glucagon-like peptide-1 (GLP-1) receptor and glucose-dependent insulinotropic polypeptide (GIP) receptor. It has previously obtained clinical clearance in the US for the treatment of overweight/obesity in April of this year. Preclinical studies have demonstrated that HDM1005 can promote insulin release, suppress appetite, and significantly improve glucose tolerance, lower blood sugar, and facilitate weight loss by activating GLP-1 and GIP receptors. These actions suggest a potential therapeutic benefit in conditions like MASH, where insulin resistance and metabolic dysregulation play a central role.
Safety and Pharmacological Profile
Existing data indicates that HDM1005 possesses good pharmacological and safety properties, which is crucial for advancing to clinical trials and eventual patient use. The drug’s dual agonist mechanism offers a novel approach to treating metabolic disorders by targeting two key receptors involved in glucose homeostasis and energy balance.-Fineline Info & Tech
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