Gan and Lee Pharmaceuticals Announces U.S. FDA Clearance of Investigational New Drug (IND) Application for a Novel Glucagon
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.
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