Beijing, China/Bridgewater, New Jersey U.S, March 10, 2022 — 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 Phase I, double-blinded, randomized, placebo-controlled, sequential, single, ascending dose clinical study in the U.S. for the company’s investigational drug, GZR18.

GZR18 is a glucagon-like peptide-1 receptor agonist (GLP-1RA) with the potential to treat patients with type 2 diabetes. Currently, type 2 diabetes mellitus accounts for approximately 90% of all diabetes cases while a 46% increase in the number of people with diabetes is expected by 2045, globally¹ 。Glucagon-like peptide-1 (GLP-1) is an incretin hormone responsible for many glucoregulatory effects such as the stimulation of insulin secretion and the inhibition of glucagon when blood glucose is high². Many of these glucoregulatory effects are often impaired in patients with type 2 diabetes³.

The primary objective of this Phase 1 study is to investigate the safety and tolerability of GZR18 in healthy volunteers. In addition, the secondary objective is to determine the pharmacokinetic (PK) parameters of GZR18. “The start of this Phase 1 clinical trial of GZR18 at a U.S. site, is a significant milestone for our global clinical development program. This trial demonstrates Gan & Lee’s long-term commitment to strengthening our pipeline in diabetes and other therapeutic areas to benefit the patient and medical community” said Dr. Mike Hu, the Chief Executive Officer (CEO) & President of Gan & Lee Pharmaceuticals USA Corporation.

References

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

2. Nauck MA, Quast DR, Wefers J, Meier JJ. GLP-1 receptor agonists in the treatment of type 2 diabetes - state-of-the-art. Mol Metab. 2021 Apr; 46:101102. doi: 10.1016/j.molmet.2020.101102. Epub 2020 Oct 14. PMID: 33068776; PMCID: PMC8085572. Available at: https://www.ncbi.nlm.nih.gov/books/NBK551568/

3. 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.