Gelonghui reported on December 18 that Huadong Medicine (000963.SZ) announced that on December 17, 2024, its wholly-owned subsidiary Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (referred to as "Zhongmei Huadong") received notification from the USA Food and Drug Administration (referred to as "USA FDA") that the clinical trial application for the HDM1005 injection drug filed by Zhongmei Huadong has been approved by the USA FDA, allowing for Phase I clinical trials to be conducted in the USA.
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.
