DAO Bio's First-in-Class Trispecific Agonist DR10624 Receives FDA IND Approval for Severe Hypertriglyceridemia in the U.S.

Oct 21, 2025 20:41 CST Updated 20:41

Huadong Medicine

Large Comprehensive Pharmaceutical Product Developer

Doer Biologics

Biological Drug Developer

Recently, Huadong Medicine Co., Ltd. (hereinafter referred to as "the Company") received a notification from the U.S. Food and Drug Administration (hereinafter referred to as "U.S. FDA") that the Investigational New Drug (IND) application for DR10624 Injection submitted by its holding subsidiary, Zhejiang Doer Biologics Co., Ltd. (hereinafter referred to as "Doer Biologics"), has been approved by the U.S. FDA. Clinical trials can now be conducted in the United States for the indication of Severe Hypertriglyceridemia (SHTG).

DR10624 is a globally first-in-class long-acting trispecific agonist independently developed by Doer Biologics, targeting 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 segment targeting GLP-1R/GCGR fused with an engineered IgG1 Fc, along with a recombinant FGF21 mutant fused to the C-terminus of the Fc region.

DR10624 Injection has successfully completed the Phase II clinical study for severe hypertriglyceridemia (SHTG) and obtained positive topline results after unblinding. Previously, at the EASL Congress 2025, Doer Biologics presented the results of a Phase Ib/IIa clinical trial in New Zealand showing that DR10624 reduced liver fat by up to 89% and decreased triglycerides by over 70% from baseline in patients with obesity and hypertriglyceridemia. In September 2025, the results of the Phase II clinical study of DR10624 for the treatment of severe hypertriglyceridemia ("DR10624-201 Study") were selected as part of the Late-Breaking Science session at the AHA Scientific Sessions 2025 and highlighted as a Groundbreaking Trial in Cardiometabolic Therapeutics. The first patient was enrolled in April 2025 in another Phase II clinical study of DR10624 injection for metabolic dysfunction-associated steatohepatitis (MASH) with high-risk liver fibrosis and metabolic-alcoholic related steatohepatitis. Additionally, the clinical trial applications for DR10624 for weight management in type 2 diabetes, overweight, or obese populations have been successively approved in China.

In September 2025, Doer Biologics completed the submission of the clinical trial application for DR10624 injection to the U.S. FDA and recently received FDA approval. The approval of the U.S. clinical trial application for DR10624 injection marks another significant progress in the development of this product, which will further enhance the company's core competitiveness in the field of endocrine therapy. In the future, the company will continue to fully advance the clinical development and registration work of this product, striving to provide more treatment options for the majority of patients!

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Reduces Liver Fat by Up to 89%! DR10624 New Zealand Phase 1b/2a Clinical Results Released, Selected as EASL 2025 Latest Breakthrough

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Statement

1. This news aims to share the frontier progress of the company's (or partners') R&D work, not for advertising purposes. The relevant information is not targeted at patients and is only for reference by healthcare professionals.

2. The content in this press release does not involve any recommendation for any drug and/or indication;

3. The information involved in this press release is for reference only, and the specific information shall be subject to the documents released by the company on the Shenzhen Stock Exchange. The company's press releases and announcements cannot replace professional medical guidance in any way and should not be regarded as medical treatment advice. If you wish to learn specific disease diagnosis and treatment information, please follow the advice or guidance of doctors or other healthcare professionals.

4. As of the publication of this article, DR10624 Injection has not been approved for marketing by the National Medical Products Administration;

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