BGM0504 Achieves 19.3% Robust Weight Reduction, 16.5 cm Waist Circumference Decrease, Significant SBP/DBP Improvements of 22.9/12.9 mmHg, and 70.7 μmol/L Uric Acid Reduction; Phase III Trial Meets Primary Endpoint and All Key Secondary Endpoints

SUZHOU, China, May 5, 2026 /PRNewswire/ -- BrightGene Bio-Medical Technology Co., Ltd. (hereinafter referred to as " BrightGene Bio-Medical" or "the Company") announced that its proprietary GLP-1 (glucagon-like peptide-1)/GIP (glucose-dependent insulinotropic polypeptide) dual receptor agonist, BGM0504 injection, has achieved positive topline results from a Phase III clinical trial (Study No.: BGM0504-III-WL) evaluating its efficacy and safety in participants with overweight or obesity. The study successfully met its primary endpoint and all key secondary endpoints. Data demonstrated that BGM0504 achieved a mean body weight reduction of 19.3% and waist circumference reduction of 16.5 cm. In participants with hypertension, systolic and diastolic blood pressure decreased by a mean of 22.9 mmHg and 12.9 mmHg, respectively, from baseline after 36 weeks of treatment. Additionally, mean uric acid levels decreased by 70.7 μmol/L, while total body/lumbar spine/hip bone mineral density increased by 0.3%, 1.4%, and 3.9%, respectively. Blood lipid, blood glucose, and other cardiometabolic markers also showed substantial comprehensive improvements. Furthermore, while achieving robust efficacy, BGM0504 injection demonstrated favorable overall safety and tolerability, with treatment discontinuation rates due to adverse events of 1.7%, 1.2%, and 0.7% in the 5 mg, 10 mg, and 15 mg dose groups, respectively, over the 52-week treatment period.

BGM0504-III-WL is a randomized, double-blind, placebo-controlled Phase III clinical trial. The study enrolled 652 participants with overweight or obesity, including a subset of participants with baseline comorbid hypertension whose blood pressure was not adequately controlled and who remained largely free of antihypertensive medications during the study. Enrolled participants had a mean baseline body weight of 96.2 kg and mean baseline BMI of 33.9 kg/m². Baseline characteristics were well-balanced across treatment groups. Participants were randomized to receive BGM0504 injection at doses of 5 mg, 10 mg, or 15 mg, or placebo, administered over a 52-week treatment period.

Robust Mean Weight Reduction of 19.3% with Nearly Half of Participants Achieving ≥20% Weight Loss

The results from the total randomized population demonstrated that BGM0504 injection at doses of 5 mg, 10 mg, and 15 mg resulted in mean body weight reductions from baseline of 14.3%, 17.3%, and 19.2%, respectively, compared to 3.1% with placebo. The proportion of participants achieving ≥5% weight loss from baseline was 84.7%, 89.8%, and 94.6%, respectively. In the 15 mg dose group, 67.3% of participants achieved ≥15% weight loss from baseline, and 48.9% achieved ≥20% weight loss from baseline. Additionally, the 15 mg dose group demonstrated a mean waist circumference reduction of 16.5 cm from baseline, compared to 3.3 cm in the placebo group.

The results from the per-protocol population showed that BGM0504 injection at doses of 5 mg, 10 mg, and 15 mg resulted in mean body weight reductions from baseline of 14.6%, 16.9%, and 19.3%, respectively, compared to 3.3% with placebo, consistent with the results from the total randomized population and demonstrating the robustness of the study findings.

Mean Systolic Blood Pressure Reduction of 22.9 mmHg, Mean Uric Acid Reduction of 70.7 μmol/L, and Mean Triglyceride Reduction of 33.6%

With regard to blood pressure parameters, improvements were observed as early as 4 weeks after initiation of BGM0504 injection treatment, with the improvement trend becoming more pronounced at 12 weeks, reaching optimal levels at 36 weeks and remaining stable thereafter. In participants with baseline comorbid hypertension and uncontrolled blood pressure, systolic and diastolic blood pressure decreased by a mean of 22.9 mmHg and 12.9 mmHg, respectively, from baseline after 36 weeks of treatment, with 92.9% of participants achieving blood pressure target. In the overall enrolled population, systolic and diastolic blood pressure decreased by a mean of 12.8 mmHg and 6.8 mmHg, respectively, from baseline. No hypotensive events were observed during the study.

With regard to other cardiometabolic risk factors, pooled analysis across all dose groups after 52 weeks of treatment demonstrated a mean increase of 7.3% in high-density lipoprotein cholesterol, mean reductions of 12.7% in low-density lipoprotein cholesterol, 33.6% in triglycerides, and 7.4% in total cholesterol, and a mean reduction of 70.7 μmol/L in uric acid.

With regard to glycemic parameters, after 52 weeks of treatment, hemoglobin A1c, fasting blood glucose, fasting insulin, and insulin resistance index all showed downward trends, indicating improvement in insulin resistance status.

With regard to bone metabolism, after 52 weeks of treatment, participants in the pooled treatment groups (5 mg/10 mg/15 mg combined) demonstrated increases of 0.3%, 1.4%, and 3.9% in total body bone mineral density, lumbar spine bone mineral density, and hip bone mineral density, respectively, relative to baseline, with bone mineral density not declining despite weight loss.

High-Dose Group Discontinuation Rate of Only 0.7%; High Retention Rate Enhances Long-Term Patient Adherence

With regard to safety, BGM0504 injection was generally well tolerated, with an adverse event profile consistent with the known safety characteristics of marketed GLP-1 receptor agonist class medications. Common gastrointestinal adverse events were predominantly mild to moderate in severity and transient in nature, resolving spontaneously within a short period. No hypoglycemic events occurred during the study, and no new safety signals were observed. During the 52-week treatment period, the proportion of participants who discontinued treatment due to adverse events was 1.7%, 1.2%, and 0.7% in the 5 mg, 10 mg, and 15 mg dose groups, respectively, further validating the clinical safety of BGM0504 as a long-term weight management therapy.

Professor Ji Linong, Director of the Department of Endocrinology at Peking University People's Hospital and Principal Investigator of the Phase III clinical trial of BGM0504 injection in participants with overweight or obesity, stated: "I am extremely pleased with the weight reduction results achieved in the Phase III clinical trial of BGM0504 injection. Treatment with BGM0504 injection resulted in a mean weight reduction of up to 19.3% and a mean waist circumference improvement of 16.5 cm among trial participants, with 48.9% of patients achieving a mean weight reduction of ≥20%! Beyond the significant weight improvements, trial participants also experienced substantial improvements in metabolic parameters and blood pressure, with mean reductions in systolic and diastolic blood pressure of 12.8 mmHg and 6.8 mmHg, respectively. Subgroup analysis in participants with comorbid hypertension showed mean reductions in systolic and diastolic blood pressure of up to 22.9 mmHg and 12.9 mmHg, respectively, with 92.9% of hypertensive patients achieving target blood pressure control. Additionally, BGM0504 injection achieved a mean reduction in serum uric acid levels of 70.7 μmol/L among trial participants, demonstrating potential for improving hyperuricemia. More importantly, BGM0504 injection also demonstrated favorable overall safety. In the 15 mg high-dose group, the rate of treatment discontinuation due to adverse events was as low as 0.7%. Currently, obesity and its associated cardiometabolic abnormalities impose a substantial burden on the Chinese population, particularly among individuals with moderate to severe obesity, who face significant challenges in long-term weight management and management of related metabolic abnormalities. I look forward to the early approval and launch of BGM0504 injection to provide a new therapeutic option for addressing the growing disease burden associated with obesity."

Dr. Yuan Jiandong, Chairman of BrightGene Bio-Medical, stated: "The Phase III results of BGM0504 not only validate its potent weight reduction efficacy as a globally leading GLP-1/GIP dual agonist, but also reveal our differentiated competitive advantage in delivering multidimensional cardiometabolic benefits. We have always believed that an ideal weight management therapy should focus not only on weight reduction, but also on comprehensive regulation of cardiometabolic health. BGM0504's exceptional performance in improving blood pressure and key parameters including glucose metabolism, lipid metabolism, and uric acid metabolism will continue to address the comprehensive clinical needs of patients with obesity in the cardiometabolic domain. Currently, metabolic diseases have become a central focus of global public health governance. We will accelerate the regulatory approval process for BGM0504 at full speed to benefit hundreds of millions of patients with obesity as soon as possible."

BGM0504 has received multiple recognitions from the academic and industry communities based on its outstanding research data. Previously, research findings on BGM0504's molecular structure design and mechanism of action were published in Nature - Scientific Reports. The study, titled "Molecular dynamics-guided optimization of BGM0504 enhances dual target agonism for combating diabetes and obesity," comprehensively described how structure optimization guided by molecular dynamics simulations enabled BGM0504 to achieve a precise balance of GLP-1 and GIP receptor activity. Its human pharmacokinetics and preliminary clinical safety studies were also published in Diabetes, Obesity and Metabolism (DOM), a leading academic journal. Additionally, Phase II data for BGM0504 were presented at the 85th Scientific Sessions of the American Diabetes Association (ADA), the world's premier diabetes scientific conference. On the industry's top-tier stage,  BrightGene Bio-Medical has participated multiple times in the J.P. Morgan Healthcare Conference. As a bellwether for the global healthcare industry, BrightGene Bio-Medical presented BGM0504's milestones to international investment institutions during the conference, sharing core highlights including depth of weight reduction, cardiovascular benefits, and differentiated product profile, further elevating the strategic positioning of this pipeline asset on the global innovative drug stage.

About the BGM0504-III-WL Study

This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial conducted at 41 clinical sites in China. The study results confirm that BGM0504 demonstrates favorable efficacy and safety. The Company will proceed at full speed according to its established plan to submit a New Drug Application (NDA) for BGM0504 injection for chronic weight management in China.

About BGM0504

BGM0504 is a proprietary GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic polypeptide) dual receptor agonist developed by the Company. It activates downstream pathways to produce biological effects including glycemic control, weight reduction, and treatment of metabolic dysfunction-associated steatohepatitis (MASH). Additionally, BGM0504 for the type 2 diabetes indication is currently in Phase III clinical trials in China.

About BrightGene Bio-Medical

BrightGene Bio-Medical (Stock Code: 688166.SH) is an innovation-driven global pharmaceutical company committed to delivering breakthrough outcomes in metabolic and respiratory diseases, as well as other therapeutic areas with significant unmet medical needs. Founded in 2001, the Company has leveraged its multidisciplinary expertise and industry-leading R&D capabilities to establish a diversified product portfolio comprising active pharmaceutical ingredients (APIs)/intermediates, advanced formulations, and innovative drugs. With a commercial network spanning over 40 countries and regions globally, combined with integrated operational capabilities, BrightGene Bio-Medical is well-positioned to capitalize on growing international market opportunities.

BrightGene Bio-Medical currently focuses its R&D efforts on developing globally innovative proprietary therapies for metabolic diseases and building a competitive portfolio of inhalation drug-device combination products for respiratory diseases. The Company's metabolic disease pipeline centers on two leading innovative drug candidates: BGM0504 (a GLP-1/GIP dual agonist) and BGM1812 (a long-acting amylin analogue), both of which have been developed in injectable and oral formulations to provide maximum convenience for patients. In respiratory diseases, the Company is developing high-barrier-to-entry advanced inhalation drug candidates derived from sophisticated delivery systems based on the Company's drug-device combination technology platform. Beyond its focus on metabolic and respiratory diseases, the Company is also developing drug candidates in other major therapeutic areas, including infectious diseases, immune diseases, and oncology. According to BrightGene Bio-Medical's H-share prospectus released in October, 2025, the Company has a total of seven major innovative drug candidates.

Risk Disclosure

In accordance with national drug registration laws and regulations, pharmaceutical products must complete all required clinical trials and obtain approval from the National Medical Products Administration (NMPA) before they can be manufactured. Drug development is characterized by long cycles, multiple approval stages, and substantial investment, with each stage subject to multidimensional factors. The Company will actively advance the aforementioned R&D projects and fulfill its information disclosure obligations in a timely manner in accordance with relevant laws and regulations. Investors are advised to exercise caution in their investment decisions and remain vigilant of investment risks.

SOURCE BrightGene