PR93504

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

BEIJING and BRIDGEWATER, N.J., Dec. 6, 2021 /PRNewswire=KYODO JBN/ --

Gan and Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan and 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

worldwide(2), while type 2 diabetes mellitus accounts for approximately 90% of

all diabetes cases.(3) Gan and 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 and Lee to proceed with GZR18 Phase 1

clinical trial.

About Gan and Lee

Gan and 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(R)),

fast-acting lispro injection (Prandilin(TM)), fast-acting aspart injection

(Rapilin(R)), mixed protamine zinc lispro injection (25R) (Prandilin(TM)25),

aspart 30 injection (Rapilin(R)30), and one human insulin injection - mixed

protamine human insulin injection (30R) (Similin(R)30). We have two approved

medical devices in China, namely reusable insulin injection pen (GanleePen),

and disposable pen needle (GanleeFine(R)).

In the future, Gan and 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

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

Source:  Gan and Lee Pharmaceuticals Co., Ltd.