Beijing, China — Recently, Gan & Lee Pharmaceuticals (Stock Code: 603087.SH) announced that their independently developed long-acting GLP-1 receptor agonist (GLP-1 RA) drug, GZR18, has completed the first subject dosing for two Phase IIb clinical trials in China. These trials are aimed at evaluating the efficacy and safety of GZR18 in adult patients with Type 2 Diabetes Mellitus (T2DM) and in patients with  obese/overweight.

The multi-center, randomized, controlled Phase IIb clinical studies initiated by Gan & Lee aim to assess the efficacy and safety of GZR18 injections in Chinese adult patients with T2DM and in patients with obese/overweight, respectively. The trials will involve multiple dosing and plan to enroll 225 adult T2DM patients and 260 obese/overweight participants.

In recent years, chronic non-communicable diseases such as cardiovascular diseases, diabetes, and certain cancers have accounted for nearly 90% of total deaths in China, posing a significant public health challenge both nationally and globally. Overweight and obesity are among the primary risk factors for these diseases¹. T2DM, one of the most prevalent chronic diseases, affects approximately 11.9% of adults in China, with obesity and overweight significantly increasing the risk².

T2DM is caused by a combination of declining β-cell function, insulin action defects, and abnormal secretion of glucagon-like peptide. GLP-1 RA, a new class of antidiabetic drugs in the T2DM treatment landscape, can significantly address some of the key pathophysiological defects of T2DM. They offer benefits beyond glucose control, such as reducing cardiovascular disease risk, improving atherosclerosis, weight reduction, lowering systolic blood pressure, and improving lipid profiles³. With the increasing clinical application of GLP-1RA, its hypoglycemic effects, weight loss benefits, and safety have been widely recognized by domestic and international guidelines⁴.

The initiation of the Phase II clinical trial of GZR18 in China will accelerate the research and development process of GZR18, potentially providing patients with more safe and effective drug treatment options domestically.

About GZR18

GZR18, developed by Gan & Lee, is a GLP-1 receptor agonist intended for the treatment of T2DM in adults and for weight management in obese/overweight individuals. Preclinical data suggests that GZR18 has potential benefits in reducing blood glucose levels and weight. Some clinical studies have confirmed its efficacy in these areas, and it has a good safety profile. Currently, the global development of GZR18 has entered the Phase II clinical research stage.

References

1. Wang YF, Sun MX, Yang YX, et al. China blue paper on obesity prevention and control[M]. Beijing: Peking University Medical Press, 2019.

2. Chinese Diabetes Society. Guidelines for the prevention and treatment of type 2 diabetes in China (2020 edition)[J]. Chinese Journal of Diabetes Mellitus,2021,13(4):317-411.

3. Pedrosa, Maurício Reis et al. “GLP-1 Agonist to Treat Obesity and Prevent Cardiovascular Disease: What Have We Achieved so Far?.” Current atherosclerosis reports vol. 24,11 (2022): 867-884. doi:10.1007/s11883-022-01062-2

4. Guangdong Pharmaceutical Association. Pharmaceutical expert consensus on the clinical application of glucagon-like peptide-1 receptor agonists (GLP-1RA)[J/OL]. Pharmacy Today:1-38 [2023-04-21]. http://kns.cnki.net/kcms/detail/44.1650.R.20230421.0935.004.html.

About Gan & Lee

Gan & Lee Pharmaceuticals has developed the first Chinese domestic biosynthetic human insulin. Currently, we have six core insulin products, including five insulin analog varieties: long-acting glargine injection (Basalin^®), fast-acting lispro injection (Prandilin^™), fast-acting aspart injection (Rapilin^®), mixed protamine zinc lispro injection (25R) (Prandilin^™25), aspart 30 injection (Rapilin^®30), and one human insulin injection - mixed protamine human insulin injection (30R) (Similin^®30). We have two approved medical devices in China, namely reusable insulin injection pen (GanleePen), and disposable pen needle (GanleeFine^®).

In the future, Gan & Lee strives to achieve a comprehensive coverage in the field of diabetes diagnosis and treatment. Moving forward to advance our goal of becoming a world-class pharmaceutical company, we will also take an active part in developing new chemical entities, and work on the treatment of cardiovascular diseases, metabolic diseases, cancer, and other therapeutics.