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Home / Company News / Gan & Lee Pharmaceuticals Announces U.S. FDA Clearance of Investigational New Drug (IND) Application for the innovative once-weekly ultra-long-acting insulin, GZR4
Gan & Lee Pharmaceuticals Announces U.S. FDA Clearance of Investigational New Drug (IND) Application for the innovative once-weekly ultra-long-acting insulin, GZR4
Date:2022-08-08

Beijing, China/Bridgewater, New Jersey U.S, August 8, 2022 — Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan & Lee, stock code: 603087. SH), is pleased to announce that the Food and Drug Administration (" FDA ") has cleared the Investigational New Drug (IND) application for GZR4 to conduct a Phase I clinical trial in the US (IND No. 159549). GZR4 is anticipated to be administered as a once-weekly subcutaneous injection to improve the treatment of diabetes. It has been approved by National Medical Products Administration to conduct clinical trials in China in July 2022.

 

According to the latest data released by the International Diabetes Federation (IDF) Diabetes Atlas 10th Edition (2021), an estimated 537 million adults (20-79 years old) are currently living with diabetes worldwide (10.5% of the global population). 1 Based on the Evaluate forecast, the global diabetes market will reach US$78.3 billion by 2026.2


Ultra-long-acting once-weekly insulin preparations have the characteristics of longer half-life, lower dosing frequency, more stable blood drug concentration, and drug effect, less day-to-day variation in blood glucose, and lower risk of hypoglycemia. Therefore, it is one of the key directions of new drug research and development for diabetes enterprises. So far, no once-weekly insulin preparation product has been approved for marketing globally. The clearance of the IND for GZR4 in the United States facilitates bringing innovative treatment options to diabetic patients worldwide.

 

 

References :

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

2. The data comes from the Evaluate database



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) (Prandilin25), 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. 


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