On November 15, according to the official website of CDE, the Class 1 new drug DR10624 injection of Huadong Medicine's subsidiary Daoer Biotechnology has obtained implicit approval for clinical trials, and its indications are metabolic-related fatty liver disease/metabolic-related fatty hepatitis. According to public information, the drug is a GLP-1R/GCGR/FGF21R triple agonist.
DR10624 is a chimeric peptide segment targeting GLP1R/GCGR at the N-terminus, fused to an engineered IgG1 Fc, and a recombinant FGF21 mutant is fused to the C-terminus of the Fc. Preclinical study results show that DR10624 has strong metabolic regulation and improved efficacy. Huadong Medicine mentioned in the announcement that DR10624 is a symmetrical dimer in structure. While having the biological activity of GLP-1R, GCGR, and FGF21R triple agonists, it can also be fused with a deglycosylated IgG1 Fc to extend the half-life.

In April 2022, Doer Biopharma was approved to conduct a Phase I clinical trial of DR10624 in New Zealand, and is currently conducting a Phase Ib/IIa clinical trial for obesity and hypertriglyceridemia. In July 2023, the clinical trial application for DR10624 submitted by Doer Biopharma was approved by NMPA, which agreed to conduct clinical trials in China for weight management indications. In addition, IND applications for DR10624 for type 2 diabetes and severe hypertriglyceridemia (SHTG) were also approved in China. Currently, the product is conducting a domestic Phase II clinical trial for severe hypertriglyceridemia in China, and is in the subject enrollment stage. The approval of the
clinical trial application for DR10624 for metabolic-related fatty liver disease/metabolic-related fatty hepatitis has further expanded the clinical application prospects of the drug, while strengthening Huadong Medicine's pipeline layout in the endocrine field.

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