Tides Express | Huadong Medicine's First-in-Class GLP-1R/GCGR/FGF21R Tri-Specific Agonist DR10624 Receives FDA IND Approval for Severe Hypertriglyceridemia

DR10624 is a globally first-in-class long-acting tri-specific agonist independently developed by Doer Biologics, targeting Fibroblast Growth Factor 21 Receptor (FGF21R), Glucagon Receptor (GCGR), and Glucagon-like Peptide-1 Receptor (GLP-1R). DR10624 is composed of an N-terminal chimeric peptide segment targeting GLP-1R/GCGR fused with an engineered IgG1 Fc, and a recombinant FGF21 mutant fused to the C-terminus of the Fc region.

DR10624 Injection has successfully completed the Phase II clinical study for severe hypertriglyceridemia (SHTG) and obtained positive topline results after unblinding. Previously, at the EASL Congress 2025, Doer Biologics presented the results of a Phase Ib/IIa clinical trial conducted in New Zealand, showing that DR10624 treatment for obesity with hypertriglyceridemia reduced liver fat by up to 89% and decreased triglycerides by over 70% relative to baseline. In September 2025, the results of the Phase II clinical study of DR10624 for the treatment of severe hypertriglyceridemia ("DR10624-201 Study") were successfully selected for the Late-Breaking Science session at the AHA Scientific Sessions 2025 and listed as a Groundbreaking Trial in Cardiometabolic Therapeutics. The first patient was enrolled in April 2025 in another Phase II clinical study of DR10624 injection for metabolic dysfunction-associated steatohepatitis (MASH) with high-risk liver fibrosis and metabolic combined alcohol-related steatohepatitis. Additionally, the clinical trial applications for DR10624 in China for weight management in patients with type 2 diabetes, overweight, or obesity have been successively approved.

In September 2025, Doer Biologics completed the submission of the clinical trial application for DR10624 injection to the U.S. FDA and recently received FDA approval. The approval of the U.S. clinical trial application for DR10624 injection marks another significant progress in the development of this product, which will further enhance the company's core competitiveness in the field of endocrine therapy.

About Huadong Medicine

Huadong Medicine Co., Ltd. was established in 1993 and listed on the Shenzhen Stock Exchange in December 1999. After more than 20 years of development, it has become a large comprehensive pharmaceutical listed company that integrates pharmaceutical research and development, production, and distribution. The company's business covers the entire pharmaceutical industry chain, with the pharmaceutical industry as the main driver, while also expanding into pharmaceutical commerce and medical aesthetics. The company always adheres to the corporate philosophy of "research-based and patient-centered" and is committed to becoming an internationally renowned pharmaceutical powerhouse driven by scientific innovation.