Daor Biologics' First-in-Class Long-Acting Triple Agonist DR10624 Granted Breakthrough Therapy Designation for Severe Hypertriglyceridemia (SHTG)

CDE has decided through an expedited review meeting that DR10624 Injection meets the scope requirements of the "Measures for Drug Registration" and the "Announcement of the National Medical Products Administration on Issuing the Procedures for the Review of Breakthrough Therapy Drugs (Trial) and Two Other Documents" (No. 82 [2020]). Therefore, it is recommended to include it as a breakthrough therapy product.

The core logic of this designation lies in the fact that SHTG has serious unmet clinical needs.DR10624 demonstrated excellent efficacy in preclinical studies and Phase II clinical trials.Provides a potential innovative solution for the treatment of this disease.

DR10624 is a globally pioneering long-acting triple-target agonist independently developed by Doer Biologics, featuring highly innovative molecular design:A chimeric peptide targeting the N-terminal GLP-1R/GCGR is fused with an engineered IgG1 Fc, and a recombinant FGF21 mutant is fused to the C-terminus of the Fc, enabling simultaneous activation of the three targets: GLP-1R, GCGR, and FGF21R.

This unique mechanism of action sets it apart from traditional single-target or dual-target drugs, enabling multidimensional regulation of metabolic processes—addressing not only lipid metabolism abnormalities but also simultaneously influencing multiple physiological pathways such as blood glucose control, liver fat metabolism, and uric acid regulation. This establishes a molecular foundation for achieving comprehensive metabolic benefits. Preclinical animal studies have already confirmed,DR10624 has demonstrated clear pharmacological activities in lipid-lowering, weight-reducing, and blood sugar control, providing a solid theoretical foundation for subsequent clinical research.

In November 2025, Doer Biologics announced the Phase II clinical trial results of DR10624 for the treatment of SHTG at the AHA2025 conference.The study adopted three dosage regimens of 12.5mg, 25mg, and 50mg, administered once weekly via subcutaneous injection, demonstrating impressive data across the following three key dimensions:

The study results showed that DR10624 rapidly and continuously reduced fasting triglyceride (TG) levels in patients with SHTG.As of Week 12, the median percentage reduction in TG in all DR10624 dose groups was significantly superior to that in the placebo group (which only saw an 8.0% reduction), with the highest reduction reaching 74.5%. Meanwhile, 89.5% of patients in the DR10624 group achieved TG levels below 500 mg/dL, meeting the key clinical treatment goal. Additionally, the drug demonstrated a significant improvement in atherogenic lipid profiles, specifically reducing total cholesterol, non-HDL-C, and ApoC3 levels while increasing HDL-C, offering additional benefits for reducing cardiovascular disease risk.

SHTG patients often have liver fat accumulation, and DR10624 has shown remarkable efficacy in this area:Clinical data shows that it can rapidly and effectively reduce liver fat content (LFC) in patients, with a median percentage decrease of up to 67%, providing a new approach to improving liver metabolic function and reducing the risk of fatty liver-related complications.

In addition to its core lipid-lowering effects, DR10624 also demonstrates multi-dimensional metabolic regulatory advantages:In the 50mg dose group, patients showed a significant increase in adiponectin levels, a marked decrease in uric acid levels, along with weight loss; for patients with baseline glycated hemoglobin (HbA1c) ≥6.5%, their HbA1c levels decreased by an average of 0.68%, achieving comprehensive benefits of "lipid-lowering + glucose-lowering + weight reduction + uric acid regulation", making it particularly suitable for SHTG patients with multiple metabolic abnormalities.

Severe Hypertriglyceridemia (SHTG) is a serious disorder of lipid metabolism that significantly increases the risk of acute pancreatitis in patients. This complication can be life-threatening, posing a significant threat to the health and lives of patients. In terms of market size, there are over 1 million high-risk SHTG patients in the United States alone, and globally, the treatment needs for this condition have long been unmet, indicating vast clinical and market potential.

Recently, the SHTG treatment field has witnessed several clinical breakthroughs. Among them, Ionis Pharmaceuticals announced the top-line data of Phase III clinical trials CORE and CORE2 for the new APOC3 ASO drug Olezarsen at the AHA 2025 conference.Its fasting triglyceride levels were reduced by up to 72% (placebo-adjusted), and acute pancreatitis events were decreased by 85%, making it the first and only SHTG drug to achieve this therapeutic goal.

Different from the mechanism of action of Olezarsen, which focuses on lipid metabolism,DR10624, as a tri-target agonist, has a more comprehensive mechanism of action.In addition to lipid-lowering, it also has beneficial effects on blood glucose control, liver fat metabolism, fibrosis improvement, and uric acid regulation, forming a differentiated competitive advantage. It is expected to provide SHTG patients with a more comprehensive treatment option.

DR10624 Injection Proposed for Inclusion in Breakthrough Therapy, Marking a Significant Advance in China’s Biopharmaceutical Innovation for Metabolic Diseases. Its Globally First-of-a-Kind Triple-Target Design, Robust Clinical Data, and Comprehensive Metabolic Benefits Not Only Fill the Gap in "Comprehensive Metabolic Regulation" for SHTG Treatment but Also Have the Potential to Disrupt the Current Treatment Landscape, Offering Patients an Innovative Solution that Combines Safety and Efficacy.

With the advancement of the breakthrough treatment program, the subsequent clinical development and market launch process of DR10624 will be accelerated. It is expected to become one of the core drugs for SHTG treatment in the future. At the same time, it will further consolidate Huadong Medicine's innovative position in the field of metabolic diseases, contributing Chinese wisdom and solutions to the global treatment of dyslipidemia.