China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study for its Category 1 biologic preparation, DR10624, aimed at weight management for overweight or obese populations.
DR10624: A Novel Agonist for Weight Management
DR10624 is a first-in-class agonist that targets the GLP-1 receptor, GCG receptor, and FGFR1c/Klothoβ. The product is expressed by Chinese hamster ovary (CHO) cells and is obtained after purification. Structurally, DR10624 is a symmetrical dimer and possesses the biological activity of triple agonists for GLP-1R, GCGR, and FGF21R. Additionally, it is fused with deglycosylated IgG1 FC, which serves to prolong its half-life. Preclinical animal studies have demonstrated significant effects on reducing blood glucose, lipids, and weight, indicating its potential as an effective treatment for obesity.
Initiation of Phase I Clinical Study in Obesity
Earlier this week, the drug initiated a multiple ascending dosage Phase I study in obesity in New Zealand. This marks a significant step towards understanding the safety, tolerability, and initial efficacy of DR10624 in human subjects, further advancing Huadong Medicine’s pipeline and contributing to the global effort to address weight management challenges.-Fineline Info & Tech
