PR94936

BEIJING and BRIDGEWATER, N.J., Mar 10, 2022, /PRNewswire=KYODO JBN/--

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 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, globally[1]. 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 high[2].

Many of these glucoregulatory effects are often impaired in patients with type

2 diabetes[3].

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.  

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].        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.

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

Source: Gan & Lee Pharmaceuticals Co., Ltd.