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

BEIJING andBRIDGEWATER,N.J.,Dec. 7,2021 -- 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,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 Pharmaceuticalshasdeveloped the first Chinese domestic biosynthetic human insulin. Currently,we havefive 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).Wehave two approved medical devices in China,namelyreusable 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 ourgoal 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

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/

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

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

Gina Antonucci,#: 888-288-5395,investorrelations@ganlee.us