BEIJING and BRIDGE WATER, NJ., July 2, 2021 / PRNewswire / – Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan & Lee, stock code: 603087.SH), Announced Positive Phase 1 Clinical Trial Results at the American Diabetes Association (ADA) 81st Scientific Meeting), 25th June– 29. The new data related to three proposed biosimilars from Gan & Lee insulin analogues, insulin aspart (GL-ASP), insulin lispro (GL-LIS) and insulin glargine (GL-GLA) and were approved by the main reviewers of Profil (Germany).
All three Phase 1 studies met their primary PK and primary PD analyzes. These data demonstrate the pharmacokinetic and pharmacodynamic bioequivalence between each of the proposed biosimilars Gan & Lee Insulins and their respective reference compounds. In addition, the safety profiles between each of the three proposed biosimilars Gan & Lee Insulins and their respective reference substances were comparable1,2,3.
The data presented from the abstracts are an important milestone in Gan & Lee’s clinical biosimilar development programs. Although 2021 mark On the centenary of the discovery of insulin, access to insulin remains a global health concern. “We are excited to be taking a step closer to bringing biosimilar insulins into clinical practice to help reduce the global burden of diabetes,” said Jia Lu, Executive Director for Clinical Sciences. The three abstracts were recently published on the website of the journal Diabetes® and the poster presentation numbers for the GL-ASP, GL-LIS and GL-GLA abstracts are 738-P, 736-P and 740-P, respectively.
About Gan & Lee
Gan & Lee successfully developed the first domestic human biosynthetic insulin China. The company currently has five recombinant insulin analogs and other products that are 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) and aspart 30 -Injection (Rapilin®) ™ 30), reusable insulin injection pen (GanleePen ™) and disposable pen needle (Ganlee Fine ™).
Gan & Lee is committed to advancing its goal of becoming a world-class pharmaceutical company by providing extensive coverage in the field of diabetes diagnosis and treatment, and also by being actively involved in the development of new chemical agents for the treatment of cardiovascular disease , Metabolic diseases, cancer and other diseases. For more information, please contact us at investorrelations@ganlee.us.
References:
1. Leona plum– Mörschel et. al. The proposed biosimilar insulin aspart (GL-ASP) shows pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence to US-licensed and EU-approved insulin aspart. June 22, 2021.
2. Eric Zijlstra, et al. The proposed biosimilar insulin lispro (GL-LIS) shows pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence to US-licensed and EU-approved insulin lispro. June 22, 2021.
3. Tim Heise, et al. The proposed biosimilar insulin glargine (GL-GLA) shows pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence to US-licensed and EU-approved insulin glargine. June 22, 2021.
Gina Antonucci,
888-288-5395
investorrelations@ganlee.us
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