Recently, the third-generation insulin analog Insulin Aspart Injection from Gan & Lee Pharmaceuticals (hereinafter referred to as Gan & Lee) has been approved by the National Medical Products Administration for listing.
A notice announcing the approval of the Gan & Lee Insulin Aspart Injection
Gan & Lee Pharmaceuticals, the first domestic company in China to obtain approval of Insulin Aspart by the National Medical Products Administration. This is another great milestone for Gan & Lee Pharmaceuticals indicating that China has the first Insulin Aspart researched and developed independently that is as effective as imported products with regard to clinical efficacy and safety. According to the IDF Diabetes Atlas (2019), there were 463 million diabetics throughout the entire world in 2019 1, and more than 110 million in China2. It is predicted that the number of diabetics worldwide will reach 578 million in 2030 1. Gan & Lee's approval for listing of Insulin Aspart will be a beneficent news for hundreds of millions of people suffering from diabetes.
Aspart appeared on European market in 1999, the sales in China reached RMB 712 million in 2018 2, making it the focus of the domestic insulin market. Compared with soluble human insulin, Gan & Lee Insulin Aspart Injection has a faster onset of action and a shorter duration of action after subcutaneous injection.
Insulin Aspart can be given immediately after a meal and can significantly improve postprandial blood glucose and has become a preferred choice for fast acting insulin for the treatment of diabetes. Based upon the data obtained from the 24-week study open label, randomized multicenter, Phase 3 study demonstrated that Gan & Lee Insulin Aspart Injection is safe, effective, and well tolerated. Therefore, Aspart has become a crucial prandial insulin in the treatment of diabetes and the preferred choice for fast-acting insulin in intensive treatment.
1. International Diabetes Federation. IDF Diabetes Atlas, 9th edn. Brussels, Belgium: 2019. Available at: http://www.diabetesatlas.org
2. The Goldman Sachs Group, Inc. (2019). China Biotech Primer Guidebook for a new chapter of healthcare investment.
About Gan & Lee
As the first high-tech biopharmaceutical company in China possessing the technology of industrialized production of recombinant insulin analog, Gan & Lee Pharmaceuticals has a complete R & D pipeline for insulins. At present, the company has four recombinant insulin analogs including long-acting glargine (Basalin®), fast-acting lispro (Prandilin®), mixed protamine zinc recombinant lispro injection (25R) (Prandilin®25) and Aspart, as well as prefilled pen and insulin pen. The products cover all insulin function segments of long-acting, fast-acting and medium-acting.
In the future, Gan & Lee Pharmaceuticals will achieve a comprehensive coverage of the product line in the field of diabetes diagnosis and treatment, and further enhance the company's market competitiveness in diabetes treatment. The company will also take an active part in tumor disease, chemical drugs, eukaryotic and prokaryotic protein engineering, cardiovascular, metabolic disease and other research fields, moving forward to become a world-class pharmaceutical company.
Zijia (Dolly) Chen
Tel. +86 010 56965167