Beijing, China, December 1^st, 2023 — Gan & Lee Pharmaceuticals (hereinafter referred to as "Gan & Lee", stock code: 603087.SH) announced that its subsidiary, Gan & Lee Pharmaceuticals Shandong, has received approval from the National Medical Products Administration (NMPA) for the clinical trial of its Class 1 innovative biological product, GZR18 Tablet (acceptance numbers CXSL2300633, CXSL2300634, and CXSL2300635 and approval notice numbers 2023LP02424, 2023LP02425, and 2023LP02426). The proposed indication of GZR18 Tablet is the treatment of Type 2 Diabetes Mellitus (T2DM).

T2DM is the most prevalent form of diabetes, accounting for over 90% of all cases worldwide. Its causes include a combination of genetic predisposition, obesity, and lifestyle factors such as lack of exercise¹. According to the latest data from the 10th edition (2021) of the International Diabetes Federation (IDF) Diabetes Atlas, approximately 537 million adults aged 20-79 were living with diabetes in 2021, with this number expected to rise to 643 million by 2030 and 783 million by 2045². Moreover, China leads the world with 140 million people with diabetes as of 2021, expected to increase to 174 million by 2045³.

Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are a new class of antidiabetic drugs in the field of T2DM treatment, significantly improving key pathophysiological defects of T2DM. GLP-1 RAs stimulate insulin secretion in a glucose-dependent manner, making them less likely to cause hypoglycemia. Besides their effective glycemic control, GLP-1 RAs also offer other benefits including weight control, cardiovascular benefits, and liver and kidney protection⁴. To enhance patient treatment efficacy and compliance, the development of oral formulations of GLP-1 RAs is underway, aiming for less invasive and more convenient clinical applications.

Gan & Lee's GZR18 injection, currently in Phase II clinical trials, is indicated for the treatment of T2DM in adults and weight management in obese/overweight patients. Compared to traditional injectable formulations requiring subcutaneous injection, the GZR18 tablet is expected to effectively address the issues of low bioavailability and suboptimal efficacy of oral peptide-based GLP-1 RAs, while improving patient compliance and providing a broader range of treatment options.

Reference：

1. Temneanu, O.R., Trandafir, L.M., and Purcarea, M.R.（2016）. Type 2 diabetes mellitus in children and adolescents: a relatively new clinical problem within pediatric practice. Journal of medicine and life 9, 235-239.

2. International Diabetes Federation. IDF Diabetes Atlas, 10th edn. Brussels, Belgium: 2021. Available at: https://www.diabetesatlas.org

3. Sun H, Saeedi P, Karuranga S, Pinkepank M, Ogurtsova K, Duncan BB, Stein C, Basit A, Chan JCN, Mbanya JC, Pavkov ME, Ramachandaran A, Wild SH, James S, Herman WH, Zhang P, Bommer C, Kuo S, Boyko EJ, Magliano DJ. IDF diabetes Atlas: Global, regional and country-level diabetes prevalence estimates for 2021 and projections for 2045. Diabetes Res Clin Pract. 2021 Nov 24:109119. doi: 10.1016/j.diabres.2021.109119. Epub ahead of print. PMID: 34879977.

4. Drucker, D.J.（2018）. Mechanisms of Action and Therapeutic Application of Glucagon-like Peptide-1. Cell metabolism 27, 740-756.

5. Challenges in Diabetes Management: Glycemic Control, Medication Adherence, and Healthcare Costs. Supplements and Featured Publications, 2017.

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.