Hangzhou, Zhejiang, China – September 7, 2026 — Doer Biologics Co., Ltd. ("Doer Biologics"), a clinical-stage biopharmaceutical company and a majority-owned subsidiary of Huadong Medicine Co., Ltd., focused on developing innovative biologic therapeutics for metabolic diseases and cancer, today announced that the first patients have been enrolled in two Phase 3 clinical trials of DR10624, a first-in-class (FIC) long-acting trispecific agonist targeting fibroblast growth factor receptor 21 (FGF21R), glucagon receptor (GCGR), and glucagon-like peptide-1 receptor (GLP-1R), for the treatment of severe hypertriglyceridemia (sHTG).
The Phase 3 program consists of the LOTUS-1 study (DR10624-301) and the LOTUS-2 study (DR10624-302), both of which are randomized, placebo-controlled, double-blind trials designed to evaluate the efficacy and safety of two dose levels of DR10624 in adult patients with sHTG.
DR10624 received approval from China's CDE and the U.S. FDA to conduct clinical studies in sHTG in October 2023 and October 2025, respectively. In September 2025, results from the Phase 2 clinical study of DR10624 in severe hypertriglyceridemia (the "DR10624-201 study") were selected as Late-Breaking Science at the American Heart Association Scientific Sessions 2025 (AHA 2025) and were featured as a Groundbreaking Trial in Cardiometabolic Therapeutics. In November 2025, the DR10624-201 study results were presented as an opening plenary at AHA 2025. Key data are as follows: At 12 weeks, triglyceride (TG) reductions were 74.5% in the 12.5 mg dose group, 66.2% in the 25 mg dose group, and 68.9% in the 50 mg titrated dose group. Among treated subjects, 78.5% achieved a TG reduction of over 50% from baseline, and 89.5% had TG levels reduced to below 500 mg/dL. In addition, DR10624 demonstrated robust improvements in the atherogenic lipid profile. Compared with placebo, all DR10624 dose groups significantly reduced total cholesterol, non-high-density lipoprotein cholesterol (non-HDL-C), triglyceride-rich lipoprotein cholesterol, very-low-density lipoprotein cholesterol (VLDL-C), and apolipoprotein C3. At the same time, DR10624 significantly increased cardioprotective high-density lipoprotein cholesterol (HDL-C). DR10624 also showed a marked reduction in liver fat: compared with placebo, all DR10624 dose groups achieved significant reductions in liver fat content, with a median percentage decrease of up to 67%. DR10624 exhibited a favorable safety and tolerability profile across all dose groups in this study, with adverse events predominantly mild to moderate in severity.
Dr. Huang Yanshan, Founder and CEO of Doer Biologics, commented: "DR10624 is a first-in-class long-acting triple agonist targeting FGF21R, GCGR, and GLP-1R, developed using Doer Biologics' proprietary MultipleBody® platform technology, designed to achieve balanced activity for metabolic diseases. In nonclinical and clinical studies, it has demonstrated remarkable efficacy in lowering triglycerides, normalizing blood lipids, and improving liver function."
Dr. Fang Yongliang, COO of Doer Biologics, stated: "We are pleased to announce that the LOTUS-1 and LOTUS-2 studies have successfully completed first patient enrollment. The public health burden posed by sHTG is drawing increasing attention. Patients with sHTG face elevated risks of acute pancreatitis and atherosclerotic cardiovascular disease (ASCVD), which can increase the risk of hospitalization and mortality. The previously completed DR10624-201 study preliminarily suggests that DR10624 has the potential to become a novel biologic therapy that offers comprehensive benefits for sHTG patients. We look forward to completing enrollment of all subjects in these two studies in due course."
For more information on the LOTUS-1 study (DR10624-301) and the LOTUS-2 study (DR10624-302), please refer to the Drug Clinical Trial Registration and Information Disclosure Platform (Registration Nos.: CTR20262269, CTR20262355).