Gan & Lee Pharmaceuticals announced breakthrough results from multiple Phase 2 clinical trials of its investigational diabetes therapies at the American Diabetes Association's 85th Scientific Sessions, with the ultra-long-acting GLP-1 receptor agonist bofanglutide demonstrating superior efficacy compared to semaglutide in Chinese patients with type 2 diabetes mellitus.
Bofanglutide Outperforms Semaglutide in Head-to-Head Trial
In a Phase 2b clinical trial involving 272 Chinese patients with T2DM, bofanglutide injection showed statistically significant superiority over semaglutide (Ozempic®) in glycemic control. After 24 weeks of treatment, the 18 mg bi-weekly and 24 mg once-weekly bofanglutide groups achieved mean HbA1c reductions of 2.28% and 2.32% respectively, compared to 1.60% with semaglutide (p<0.001).
The most striking results emerged in drug-naïve patients with inadequate glycemic control despite lifestyle interventions, where the 18 mg bi-weekly bofanglutide group achieved a mean HbA1c reduction of 2.98%, significantly greater than semaglutide's 2.04% reduction (p<0.001).
Weight management benefits also favored bofanglutide, with mean weight reductions ranging from 4.26 to 6.54 kg across different dosing regimens, compared to 3.25 kg with semaglutide. The proportions of patients achieving HbA1c targets of <7.0% ranged from 63.0% to 75.0% in bofanglutide groups versus 70.0% in the semaglutide group.
Phase 2a Results Demonstrate Comprehensive Metabolic Benefits
A separate Phase 2a placebo-controlled trial in 36 adults with T2DM showed bofanglutide's broad therapeutic impact. After 23 weeks of once-weekly treatment with doses escalating from 1.5 mg to 13 mg, patients experienced a mean HbA1c reduction of 1.81% compared to 0.12% with placebo, representing a treatment difference of 1.93 percentage points.
The therapy delivered substantial weight loss benefits, with participants experiencing a mean reduction of 6.92 kg (9.3% decrease) compared to minimal reduction in the placebo group. Additionally, 57.7% of patients achieved HbA1c targets of <7.0% and 46.2% reached ≤6.5%, compared to zero in the placebo group.
Bofanglutide also demonstrated comprehensive improvements in multiple metabolic parameters including fasting plasma glucose, glycated albumin, waist circumference, blood pressure, and lipid profiles.
Once-Weekly Insulin GZR4 Shows Promise with Reduced Dosing
The company's once-weekly basal insulin analog GZR4 demonstrated comparable efficacy to once-daily insulin degludec (Tresiba®) in a Phase 2 study of 179 Chinese patients with T2DM. In patients with inadequate glycemic control on oral antidiabetic drugs alone, both treatments achieved similar HbA1c reductions of approximately 1.5% after 16 weeks.
However, GZR4 showed particular advantage in patients with inadequate control on combination therapy with basal insulin, achieving significantly greater HbA1c reduction compared to insulin degludec (-1.26% vs -0.87%; p<0.01). Notably, GZR4 achieved effective glycemic control with a total weekly insulin dosage approximately 40-50% lower than insulin degludec (p<0.001).
Safety Profile Consistent with Drug Class
Both investigational therapies demonstrated favorable safety profiles consistent with their respective drug classes. For bofanglutide, the most common adverse events were gastrointestinal-related, primarily occurring during early dose-escalation periods and mostly mild to moderate in severity. No hypoglycemic events or investigational product-related serious adverse events were reported in either bofanglutide trial.
Similarly, GZR4 showed comparable safety to insulin degludec, with no severe hypoglycemic events or investigational product-related serious adverse events reported during the 16-week study period.
Advancing to Phase 3 Development
Building on these positive Phase 2 results, Gan & Lee Pharmaceuticals has initiated and is accelerating large-scale Phase 3 clinical programs in China for both bofanglutide injection and GZR4 injections for type 2 diabetes treatment. The company positions these developments as part of its strategy to provide more effective treatment options for patients with diabetes.
Gan & Lee Pharmaceuticals, which developed the first Chinese domestic insulin analog, currently markets six core insulin products and ranked first among all selected companies in China's 2024 National Insulin-Specific Centralized Procurement in terms of procurement demand for insulin analogs. The company has also gained international regulatory recognition, with FDA approval for its disposable pen needle in 2020 and GMP inspection approval from the European Medicines Agency in 2024.
