Beijing, China/Bridgewater, New Jersey U.S, July 21, 2022 — Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan & Lee, stock code: 603087. SH) is pleased to announce the initiation of its phase II development program with the dosing of the first patient in phase II clinical trials in China with the company's Class 1 innovative glucagon-like peptide-1 receptor agonist (GLP-1RA)-GZR18.

For GZR18, the company started two multicenter, randomized, double-blind, placebo-controlled Phase Ib/IIa clinical studies to evaluate the safety, tolerability, pharmacokinetics, and efficacy of GZR18 injection in Chinese adult subjects with type 2 diabetes mellitus (T2DM), and in obese/overweight Chines subjects. The Phase II trials are multiple-dose studies.

The percentage of people with type 2 diabetes is increasing in most countries, accounting for approximately 90% of all diabetes cases.¹ In addition, the proportions of overweight, obese, and abdominal obesity among adults with diabetes in China were 41%, 24.3%, and 45.4%.² Studies have shown that appropriate weight loss can effectively reduce blood glucose and reduce the use of hypoglycemic drugs in patients with T2DM.³ Therefore, there is market demand for GLP-1RA anti-diabetic drugs as a classic given their potential weight-loss effect.

However, the weekly formulations of GLP-1 RA drugs for overweight or obesity management are still in the early phases of development. Currently, only one GLP-1 RA weekly formulation has been approved for chronic weight management in adult patients with a specific body mass index (BMI) in the United States, while no similar product has been approved in China.

The Phase II trials of GZR18 in China provide the opportunity to advance the progress of treating diabetes and managing obesity/overweight in China, which may bring a new therapeutic option to the patient.

References:

1. IDF Diabetes Atlas 2021; 10th:[Available from: https://diabetesatlas.org/atlas/tenth-edition/.

2. Hou, X., et al., Impact of waist circumference and body mass index on risk of cardiometabolic disorder and cardiovascular disease in Chinese adults: a national diabetes and metabolic disorders survey. PLoS One, 2013. 8(3): p. e57319.

3. Wing, R.R., et al., Benefits of modest weight loss in improving cardiovascular risk factors in overweight and obese individuals with type 2 diabetes. Diabetes Care, 2011. 34(7): p. 1481-6.

About Gan & Lee

Gan & Lee Pharmaceuticals has developed the first Chinese domestic biosynthetic human insulin. Currently, we have five recombinant insulin analogs commercialized in China including 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.