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Home / Company News / Gan & Lee Pharmaceuticals Announces IND Clearance by NMPA for Premixed Insulin GZR101
Gan & Lee Pharmaceuticals Announces IND Clearance by NMPA for Premixed Insulin GZR101
Date:2022-05-12

Beijing, China/Bridgewater, New Jersey U.S, May 12, 2022 — Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan & Lee, stock code: 603087. SH), is pleased to announce that China’s National Medical Products Administration (NMPA) has cleared its investigational new drug (IND) application for GZR101, an investigational compound which is independently developed by Gan & Lee Pharmaceuticals, for the treatment of patients with diabetes. GZR101 is a premixed insulin formulation composed of 50% rapid-acting Gan & Lee Insulin Aspart and 50% long-acting insulin (investigational compound, GZR33).

 

Following the data released by the IDF Diabetes Atlas, 10th edition (2021), it is estimated that 537 million adults (aged 20–79 years) are currently living with diabetes worldwide1, while China has the highest number of diabetes patients with estimates of over 140 million people in 2021 and is expected to reach over 174 million by 20452.

 

Premixed insulins have been developed as an additional treatment option for patients with diabetes. Premixed insulins can closely mimic physiological endogenous insulin secretion, so they can meet the needs of patients who require both basal and prandial insulin but wish to limit the number of daily injections3. The IND clearance for GZR101 in China allows Gan & Lee to potentially expand the company’s product pipeline further while continuing our goal of bringing new therapies to patients with diabetes worldwide.



References

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

2. Sun H, Saeedi P, Karuranga S, Pinkepank M, Ogurtsova K, Duncan BB, Stein C, Basit A, Chan JCN, Mbanya JC, Pavkov ME, Ramachandaran A, Wild SH, James S, Herman WH, Zhang P, Bommer C, Kuo S, Boyko EJ, Magliano DJ. IDF diabetes Atlas: Global, regional and country-level diabetes prevalence estimates for 2021 and projections for 2045. Diabetes Res Clin Pract. 2021 Nov 24:109119. doi: 10.1016/j.diabres.2021.109119. Epub ahead of print. PMID: 34879977.

3. Garber AJ. Premixed insulin analogues for the treatment of diabetes mellitus. Drugs. 2006;66(1):31-49. doi: 10.2165/00003495-200666010-00003. PMID: 16398567.



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 the reusable insulin injection pen (GanleePen™), and the 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. 



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