Huadong Medicine's HDM1005 Receives NMPA Approval for MAFLD/MASH Clinical Trial

Huadong Medicine’s HDM1005 Receives NMPA Approval for MAFLD/MASH Clinical Trial

Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its investigational drug HDM1005. This long-acting agonist targets both the GLP-1 receptor and GIP receptor and will be tested in metabolic associated fatty liver disease (MAFLD) and metabolic dysfunction-associated steatohepatitis (MASH). The indication for this trial was previously cleared in the US in November of the previous year.

HDM1005: A Promising Treatment for Metabolic Disorders
Pre-clinical studies of the Category 1 chemical drug HDM1005 have demonstrated its ability to activate GLP-1 receptors and GIP receptors, which are crucial in the regulation of glucose homeostasis and energy balance. The drug has shown promising effects in promoting insulin release, inhibiting appetite, and significantly improving glucose tolerance, lowering blood sugar levels, and facilitating weight loss.

Safety and Medicinal Properties of HDM1005
Existing data on HDM1005 indicates that it possesses good medicinal properties and safety, making it a potentially valuable asset in the treatment of metabolic disorders. The approval to proceed with clinical trials in China further validates the drug’s potential and marks a significant step towards bringing this therapy to patients suffering from MAFLD and MASH.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry