On October 19, 2026, Huadong Medicine Co., Ltd. (hereinafter referred to as "Huadong Medicine") announced that the results of the Phase II clinical trial ("DR10624-202 Study") of DR10624, a first-in-class long-acting trispecific agonist independently developed by its holding subsidiary Zhejiang Daer Biotechnology Co., Ltd. (hereinafter referred to as "Daer Biotechnology") for the treatment of metabolic-associated fatty liver disease (MASLD)/metabolic steatohepatitis (MASH), have been successfully selected as the Late Breaking Abstract (LBA) of The Liver Meeting® (TLM) 2026 of the American Association for the Study of Liver Diseases (AASLD) and will be presented in the form of a Late Breaking Parallel Presentation.
The principal investigator of this study, Associate Vice-President (Research) and Professor Mok Hing-yiu of Medicine at the Chinese University of Hong Kong, along with Professor Wong Wai-sun, Assistant Dean (Development) of the Faculty of Medicine and Head of the Department of Gastroenterology and Hepatology, will deliver a presentation on behalf of the research team at the conference. The Latest Breakthrough Abstract (LBA) is the most prestigious abstract category at the AASLD Annual Meeting, and the selection of DR10624-202 signifies that its research findings in the MASLD/MASH field have gained international attention in the hepatology community.
A world-first three-target agonist targeting unmet needs in metabolic-related liver diseases.
According to the data, DR10624 is a first-in-class, long-acting, trispecific agonist independently developed by Daer Biotech, targeting fibroblast growth factor 21 receptor (FGF21R), glucagon receptor (GCGR), and glucagon-like peptide-1 receptor (GLP-1R). DR10624 consists of a chimeric peptide targeting GLP-1R/GCGR at the N-terminus, fused with engineered IgG1 Fc, and a recombinant FGF21 mutant fused at the C-terminus of the Fc.
The American Association for the Study of Liver Diseases (AASLD) TLM 2026 Annual Meeting will be held from November 5th to 9th, 2026 in Denver, Colorado, USA. Founded in 1950, the AASLD's annual meeting (The Liver Meeting®) is one of the world's largest and most prestigious academic conferences on liver disease. The Latest Breakthrough Abstracts (LBA) are the most prestigious category at the AASLD meeting, with high entry requirements, demanding research content and data of significant clinical importance. The LBAs presented at each AASLD annual meeting are often considered a highlight and trendsetter for global new drug development in liver disease that year.
The DR10624-202 study enrolled this time is a randomized, double-blind, placebo-controlled phase II clinical trial designed to evaluate the efficacy and safety of DR10624 injection at four different dose levels (12.5 mg, 25 mg, 50 mg, 75 mg) in subjects with metabolic-associated fatty liver disease at high risk of liver fibrosis. The primary inclusion criteria included: liver fat content (LFC) ≥10% (measured by magnetic resonance proton density fat fraction (MRI-PDFF); liver stiffness (LSM) ≥8 kPa and <15 kPa (assessed by FibroScan®). Enrollment for the DR10624-202 study was completed in January 2026, with a total of 110 MASLD/MASH subjects (103 from mainland China and 7 from Hong Kong) participating in this once-weekly, 12-week study. In addition, the clinical trial application for DR10624 injection for the treatment of MASLD in the United States was approved by the FDA in January 2026.
The advantages of DR10624's three-target mechanism are being gradually validated by data from multiple pipelines. In the core area of severe hypertriglyceridemia (sHTG), the DR10624-201 Phase II study has been completed and positive topline results have been read. The earlier New Zealand Ib/IIa study (EASL 2025) has shown that it can reduce liver fat by up to 89% and triglycerides by more than 70% in obese patients with hypertriglyceridemia, providing a basis for the subsequent development of MASLD/MASH.
Building on this, the pipeline advancement of DR10624 has significantly accelerated. In September 2026, the first patient was enrolled in the two Phase III sHTG studies, LOTUS-1 (DR10624-301) and LOTUS-2 (DR10624-302), marking the entry of this indication into the pivotal registration clinical phase. In October 2026, the first patient was also enrolled in the Phase II study (DR10624-204) for the treatment of moderate hypertriglyceridemia with diabetic nephropathy, further extending the benefits of three-target lipid-lowering to the DKD population. Simultaneously, the indications for DR10624 are expanding into the cardiovascular field. It has been selected for the National Science and Technology Major Project for Innovative Drug Development, "Research and Development of Innovative Drugs for Heart Failure," and in July 2026, it received NMPA approval to conduct a clinical trial in adults with preserved ejection fraction/mildly reduced heart failure (HFpEF/HFrEF).
A comprehensive layout in the field of endocrinology, with the metabolic leader's innovative full matrix steadily advancing.
Currently, FGF21 has become one of the most promising potential targets in the field of metabolic diseases after GLP-1. FGF21 (fibroblast growth factor 21) is a secreted protein that regulates metabolism. Since 2025, Novo Nordisk, Roche, and GSK have successively made significant investments in FGF21 single-target molecules through acquisitions, making this target a highly competitive area for pharmaceutical giants. It is noteworthy that no FGF21 therapy has yet been approved for marketing globally, indicating substantial market potential.
In the endocrinology and metabolism field, Huadong Medicine's strategic layout is becoming increasingly clear. Starting with traditional hypoglycemic drugs, it is systematically entering the weight loss market, and then extending to cutting-edge scenarios such as severe hypertriglyceridemia (sHTG), MASLD/MASH, and even heart failure, continuously expanding the technological boundaries of the company's metabolic pipeline. At the same time, the company's related pipelines have been selected for international academic conferences such as EASLD, AHA, and EASD multiple times, gradually gaining global attention in the field of metabolism.
Currently, Huadong Medicine has built a comprehensive and differentiated product pipeline around the GLP-1 target, combining long-acting and multi-target global innovative drugs and biosimilars, including oral tablets and injections. It has not only made breakthrough progress in the field of multi-target agonists, but its GLP-1-related products under development are also steadily advancing in clinical development, covering multiple important indications such as diabetes and weight management, forming a rich and diverse product matrix with multiple targets, laying a solid foundation for future sustainable development.
Key developments include the oral small-molecule GLP-1 receptor agonist HDM1002, whose Phase III study on weight loss achieved positive topline results in September 2026 and is about to submit an NDA application. Another GLP-1R/GIPR dual-target long-acting peptide agonist, HDM1005, has successfully completed its Phase III clinical trial in China for weight management, achieving the 40-week primary endpoint in its interim analysis, and is expected to submit a Pre-NDA communication application in the fourth quarter of 2026.
In addition, the marketing application for semaglutide injection for remanufacture indications was accepted by the NMPA in April 2026. The marketing application for insulin degludec injection was submitted and accepted in February 2025.
The inclusion of DR10624 in the AASLD LBA is a milestone achievement, representing the culmination of Huadong Medicine's long-term R&D investment in the endocrinology field and validating the company's platform-based capabilities in developing multi-target metabolic drugs. While steadily advancing registration and commercialization preparations, the company will continue to expand its indications, building a portfolio of innovative metabolic products covering the entire spectrum of glucose-lowering, weight-loss, and lipid-lowering therapies, contributing more clinical options and long-term value to the comprehensive management of metabolic diseases globally.

Source: https://news.yaozh.com/archive/49179.html