Beijing, China/Bridgewater, New Jersey U.S, July 2, 2021 — Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan & Lee, stock code: 603087.SH), announced positive Phase 1 clinical trial results at the 81st Scientific Sessions of the American Diabetes Association (ADA), June 25^th – 29^th. The new data pertained to three proposed biosimilar Gan & Lee insulin analogs, insulin aspart (GL-ASP), insulin lispro (GL-LIS), and insulin glargine (GL-GLA), and were presented by the primary investigators from Profil, (Germany).

All three phase 1 studies met their primary PK and primary PD analyses. These data demonstrate pharmacokinetic and pharmacodynamic bioequivalence between each of the proposed biosimilar Gan & Lee insulins and their respective reference compounds. In addition, the safety profiles were comparable between each of the three proposed biosimilar Gan & Lee insulins and their respective reference compounds^1,2,3.  

The data presented from the abstracts, are a major milestone in the biosimilar clinical development programs at Gan & Lee. Although 2021 marks the centenary of insulin’s discovery, insulin access remains a global health issue. “We are excited as we move one step closer to bringing biosimilar insulins into clinical practice with a goal of helping reduce the global burden of diabetes,” said Jia Lu, Executive Director of Clinical Sciences. The three abstracts have recently been published on the journal Diabetes® website 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 has successfully developed the first domestic biosynthetic human insulin in China. Currently, the company has five recombinant insulin analogs and other products 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) and aspart 30 injection (Rapilin™30), reusable insulin injection pen (GanleePen™), and disposable pen needle (Ganlee Fine™).

Moving forward, Gan & Lee strives to advance its goal of becoming a world-class pharmaceutical company by providing a comprehensive coverage in the field of diabetes diagnosis and treatment, and also taking an active part in developing new chemical entities for the treatment of cardiovascular diseases, metabolic diseases, cancer, and other diseases.

References

1. Leona Plum- Mörschel, et. al. Proposed biosimilar insulin aspart (GL-ASP) shows pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence to US-licenced and EU-authorised insulin aspart. June 22, 2021.

2. Eric Zijlstra, et. al. Proposed biosimilar insulin lispro (GL-LIS) shows pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence to US-licenced and EU-authorised insulin lispro. June 22, 2021.

3. Tim Heise, et. al. Proposed biosimilar insulin glargine (GL-GLA) shows pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence to US-licenced and EU-authorised insulin glargine. June 22, 2021.