Beijing, China/Bridgewater, New Jersey U.S, December 10, 2021 — Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan & Lee, stock code: 603087.SH), is pleased to announce the first subject has been dosed in our double-blinded, randomized, placebo-controlled, dose-escalating phase 1 study in China for the company’s investigational compound, GZR18. GZR18 is an investigational compound which may have potential to treat patients with type 2 diabetes and those who are overweight or obese, as a once-weekly, long-acting glucagon-like peptide 1 receptor agonist (GLP-1 RA). The percentage of people with type 2 diabetes is increasing in most countries as it accounts for approximately 90% of all diabetes cases¹. Glucagon-like peptide-1 (GLP-1) is a hormone responsible for a variety of glucoregulatory effects, such as glucose-dependent promotion of insulin secretion, and the inhibition of glucagon release, which are impaired in people with type 2 diabetes².

The primary objective of this phase 1 study of GZR18, is to investigate the safety and tolerability of GZR18 in healthy subjects, while the secondary objectives are to determine the pharmacokinetic (PK) and pharmacodynamic (PD) parameters. “The start of this phase 1 clinical trial of GZR18 is a new milestone for Gan & Lee’s drug development in the field of diabetes as we are committed and will continue to seek additional treatment options for global patients with diabetes”, said Dr. Wei Chen, the Vice President of Research and Development at Gan & Lee. 

References

1. International Diabetes Federation. IDF Diabetes Atlas, 9th edn. Brussels, Belgium: 2019. Available at: https://www.diabetesatlas.org

2. Brunton SA, Wysham CH. GLP-1 receptor agonists in the treatment of type 2 diabetes: role and clinical experience to date. Postgrad Med. 2020 Nov;132(sup2):3-14. doi: 10.1080/00325481.2020.1798099. Epub 2020 Sep 8. PMID: 32815454.

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.