Recently, Zhejiang Doer Biologics Co., Ltd. (hereinafter referred to as "Doer Biologics") received notification from the National Medical Products Administration of China (hereinafter referred to as "China NMPA") that the clinical trial application for DR10624 injection, submitted by Doer Biologics, has been approved by China NMPA for conducting clinical trials in China. The approved indication is for the treatment of heart failure with preserved ejection fraction / heart failure with mildly reduced ejection fraction (HFpEF/HFrEF) in adults.
DR10624 is a global first-in-class long-acting tri-specific agonist independently developed by Doer Biologics, targeting the fibroblast growth factor 21 receptor (FGF21R), glucagon receptor (GCGR), and glucagon-like peptide-1 receptor (GLP-1R). DR10624 consists of an N-terminal chimeric peptide targeting GLP-1R/GCGR fused to an engineered IgG1 Fc, with a recombinant FGF21 mutant fused to the C-terminus of the Fc.
DR10624 injection completed the first clinical registration of its Phase 3 pivotal studies (DR10624-301, DR10624-302) for the severe hypertriglyceridemia (SHTG) indication in June 2026. Another Phase 2 clinical study of DR10624 injection for metabolic dysfunction-associated steatotic liver disease/metabolic dysfunction-associated steatohepatitis completed enrollment of all subjects in January 2026. In addition, China clinical trial applications for DR10624 in type 2 diabetes, weight management in overweight or obese populations, and hypertriglyceridemia, as well as U.S. clinical trial applications for SHTG and MASLD indications, have also been approved successively. In January 2026, it was granted Breakthrough Therapy designation by China NMPA for the SHTG indication.
In May 2026, Doer Biologics submitted a clinical trial application to China NMPA for DR10624 injection in the treatment of heart failure with preserved ejection fraction / heart failure with mildly reduced ejection fraction (HFpEF/HFrEF) in adults, which received NMPA approval recently.
This approval of the clinical trial application in China marks another significant milestone in the product's development, further enhancing Doer Biologics' core competitiveness in the cardiovascular and endocrine therapeutic areas. Looking ahead, Doer Biologics will continue to advance the clinical development and registration of this product, striving to provide more treatment options for patients in need.