Chinese Biotech Firm Ganli Pharmaceuticals Launches Phase III Clinical Trial for Novel GLP-1 Receptor Agonist

Chinese Biotech Firm Ganli Pharmaceuticals Launches Phase III Clinical Trial for Novel GLP-1 Receptor Agonist

Ganli Pharmaceuticals, a leading biotech firm in China, has announced the launch of a phase III clinical trial to evaluate the efficacy and safety of its novel GLP-1 receptor agonist, GZR18, compared to semaglutide (Novo Nordisk) in patients with type 2 diabetes.

The open-label, randomized controlled trial will enroll approximately 1100 patients across multiple sites in China. The primary endpoint is the change from baseline in HbA1c levels at 44 weeks after treatment initiation.

HbA1c is a measure of average blood sugar levels over the past 2-3 months and is directly related to the risk of diabetic complications. Baseline data refers to the patient's HbA1c level before treatment, which serves as a reference standard for assessing treatment efficacy.

The study will recruit patients who have inadequate glycemic control despite lifestyle interventions or use of oral antidiabetic drugs, and have received at least 3 months of oral antidiabetic therapy prior to enrollment.

According to previously published data from the company's phase II clinical trial, GZR18 demonstrated superior efficacy compared to semaglutide in reducing HbA1c levels and body weight. The results showed that patients treated with GZR18 achieved a greater reduction in HbA1c levels (average -2.5%) compared to those receiving semaglutide (-1.9%).

China's biotech industry is gaining momentum, with numerous companies vying for dominance in the GLP-1 receptor agonist market. Ganli Pharmaceuticals' GZR18 is one of several novel agents in development, including products from firms such as Hengrui and Sinad.

In related news, Sinad Bio announced the launch of a phase III clinical trial for its dual GLP-1/GIP receptor agonist, IBI362 (Masilin), which will directly compare the drug's efficacy to semaglutide in patients with early-stage type 2 diabetes and obesity. Hengrui Pharmaceuticals has also entered the fray, launching a phase III clinical trial to evaluate the efficacy and safety of its GLP-1R/GIPR dual agonist, HRS9531, compared to semaglutide.

The increasing competition in the GLP-1 receptor agonist market is expected to drive innovation and improve treatment options for patients with type 2 diabetes. As the global biotech industry continues to evolve, China's companies are poised to play a significant role in shaping the future of diabetes research and treatment.