DAO Bio's First-in-Class Trispecific Agonist DR10624 Receives Approval for Phase I Clinical Trial in New Zealand

On April 7, Huadong Medicine Co., Ltd. announced that its controlling subsidiary, Doer Biologics, had received final approval from New Zealand's Medicines and Medical Devices Safety Authority (Medsafe) and the Health and Disability Ethics Committee (HDEC) to conduct a Phase I clinical trial of injectable DR10624 locally for the treatment of type 2 diabetes, obesity, metabolic syndrome, etc.

On April 26, 2021, Huadong Medicine's wholly-owned subsidiary Sinopharm-Zhongmei Huadong acquired 75% of Doer Biologics' equity. Injectable DR10624 is one of Doer Biologics' key innovative drugs under development.

In December 2021, Doer Biologics submitted a Phase I clinical trial application for injectable DR10624 to the New Zealand Health and Disability Ethics Committee (HDEC) and Medsafe, the New Zealand Medicines and Medical Devices Safety Authority. Recently, Medsafe and HDEC approved Doer Biologics to conduct a Phase I clinical trial for injectable DR10624 in New Zealand.

DR10624 is a globally first-in-class long-acting triple agonist targeting GLP-1 receptor (GLP-1R), GCG receptor (GCGR), and FGFR1c/Klothoβ (FGF21R). It consists 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. DR10624 is expressed in Chinese hamster ovary (CHO) cells and purified thereafter. Structurally, DR10624 is a symmetric dimer with biological activity as a triple agonist for GLP-1R, GCGR, and FGF21R, and incorporates deglycosylated IgG1 Fc to extend its half-life. Preclinical animal studies have shown that DR10624 exhibits significant efficacy in lowering blood glucose, reducing lipids, and promoting weight loss.

Currently, there is no long-acting triple agonist drug targeting GLP-1R, GCGR, and FGF21R available on the global market. The approval of DR10624 injection for Phase I clinical trials in New Zealand marks the first clinical trial application approved overseas by Doer Biologics and represents the world's first long-acting triple agonist targeting GLP-1R, GCGR, and FGF21R to enter clinical research.