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Recently, Gan & Lee Pharmaceutical Co., Ltd. (hereinafter referred to as Gan & Lee, stock code: 603087. SH), is pleased to announce that the insulin injection pen and pen needle registered by Gan & Lee Brazil, an overseas subsidiary of Gan & Lee, have been officially listed. This is the first time that the products have been approved with the Gan & Lee's brand in Brazil, enhancing Gan & Lee's globalization goal.
According to the International Diabetes Federation (IDF) Atlas 10th edition, as of 2021, about 33 million adults (aged 20 to 79) in Latin America have diabetes, with Brazil ranking first in the number of people with diabetes, with approximately 15.7 million (20 to 79 years old), accounting for 47.5% of the total number of people with diabetes in Latin America1.
"With Brazil being a key country in the strategy of globalization, this approval has laid the foundation for our products to enter the Latin American market in the future. This is an important milestone for the Gan & Lee brand. We expect to see more business results achieved from overseas subsidiaries to inject new vitality into globalization.” said Jason Wu, Senior Director of the International Business Affairs Department in Gan & Lee Pharmaceuticals.
About Gan & Lee’s Insulin Pen
With ISO 13485:2016 and CE certification, Gan & Lee’s insulin pen can be used with the Gan & Lee 3mL insulin penfill. By adjusting the dose knob, patients are allowed to set 1-60 units (U) of insulin for administration. The minimum scale of the pen is accurate to 1 unit (U), which can meet the needs of diabetic patients for daily injection.
About Gan & Lee’s Insulin Pen Needle
Pen needles can be used for subcutaneous injection of insulin, GLP-1 RA and growth hormone. There are six needle specifications applicable for most insulin pens in the market, which is able to meet the injection needs of patients of different sizes. In addition, the needle has obtained ISO: 13485: 2016 and CE certification and 510 (k) premarket notification from the U.S. FDA (No. K192464).
Reference:
1. International Diabetes Federation. IDF Diabetes Atlas, 10th edn. Brussels, Belgium: 2021. Available at:https://www.diabetesatlas.org
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.
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