Dor Bio's First-in-Class GLP-1R/GCGR/FGF21R Triagonist DR10624 Granted Breakthrough Therapy Designation for Severe Hypertriglyceridemia

Jan 05, 2026 11:58 CST Updated 11:58

Doer Biologics

Biological Drug Developer

Huadong Medicine

Large Comprehensive Pharmaceutical Product Developer

Source: PharmaCube Info

On January 4, the CDE website showed that DR10624, developed by Doer Biologics, a holding subsidiary of Huadong Medicine, is proposed to be included in the breakthrough therapy.For the treatment of severe hypertriglyceridemia (SHTG).

DR10624 isA product developed by Doer BiologicsDR10624: A First-in-Class Long-Acting Triple Agonist Simultaneously Targeting GLP-1 Receptor (GLP-1R), GCG Receptor (GCGR), and FGFR1c/Klothoβ (FGF21R). It consists of an N-terminal chimeric peptide targeting GLP-1R/GCGR fused with an engineered IgG1 Fc, along with a recombinant FGF21 mutant fused to the C-terminus of the Fc. Preclinical animal studies have demonstrated that DR10624 exhibits significant therapeutic effects in lipid reduction, weight loss, and glucose control.

In November 2025, Doer Biologics announced DR10624 (12.5/25/50mg, once weekly, subcutaneous injection) for the treatment at AHA 2025.Results of the Phase II Study on SHTG. The results showed that DR10624 can rapidly and continuously reduce fasting triglyceride (TG) levels in SHTG patients and significantly improve atherogenic lipid profiles, including lowering total cholesterol, non-HDL-C, and ApoC3, as well as increasing HDL-C.

Specifically, at Week 12,The median percentage reduction in TG in the DR10624 group was up to 74.5%, compared to an 8.0% reduction in the placebo group.In addition, 89.5% of patients in the DR10624 group had their TG levels reduced to below 500 mg/dL. Notably, DR10624 also rapidly and effectively reduced liver fat content (LFC), with a maximum median percentage decrease of up to 67%. The 50mg dose group also demonstrated comprehensive metabolic benefits, including a significant increase in adiponectin, a marked reduction in uric acid, weight loss, and a 0.68% decrease in HbA1c in patients with baseline HbA1c ≥ 6.5%.

Disclaimer:

The content of the article is for reference only and does not constitute investment advice. Investors who take actions based on this information bear their own risks. The article maintains a neutral stance on the statements and viewpoints presented, and does not provide any explicit or implicit guarantees regarding the accuracy, reliability, or completeness of the content included. Readers are advised to use it solely as a reference and assume full responsibility for their actions.

ContactWe

Antibody 2026

Booths are booking up fast!

Scan to consult immediately

Phone: 13816031174

(Same as WeChat)

Sponsorship forms include but are not limited toSpeaking slots, exhibition booths, color pages in the conference proceedings, dinner sponsorship, promotional conference materials, etc.

Click here“"Read the original text"Consult for more exciting content!