Gan & Lee Pharmaceuticals Announces U.S. FDA Clearance of Investigational New Drug (IND) Application for a Novel Glucagon-Like Peptide-1 Analogue, GZR18

Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan & Lee, stock code: 603087.SH), is pleased to announce that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for the company's compound, GZR18, to improve the management of type 2 diabetes mellitus. The investigational compound, GZR18, is a novel analogue of glucagon-like peptide-1 (GLP-1), an incretin hormone responsible for many glucoregulatory effects such as the stimulation of insulin secretion and the inhibition of glucagon, when blood glucose is high.1

Currently, there are 537 million adults (20-79 years) living with diabetes worldwide2, while type 2 diabetes mellitus accounts for approximately 90% of all diabetes cases.3 Gan & Lee understands the global burden of type 2 diabetes mellitus. "The FDA's clearance of the IND application for GZR18, is a significant milestone for our company as we strive to globally provide additional treatment options to patients with type 2 diabetes," said Kaushik Dave RPh., PhD, MBA, Vice President, Global Regulatory Affairs. This IND acceptance by the FDA will allow Gan & Lee to proceed with GZR18 Phase 1 clinical trial.

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. For more information, please contact us at investorrelations@ganlee.us.

References

1. Collins L, Costello RA. Glucagon-like Peptide-1 Receptor Agonists. [Updated 2021 Jun 25]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2021 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK551568/

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

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

Source: Gan & Lee Pharmaceuticals Co., Ltd.