Gan & Lee Pharmaceuticals Concludes Phase 3 Studies of Gan & Lee Insulin Glargine (GL-GLA)
- Category: Proteins and Peptides
- Published on Thursday, 14 October 2021 17:19
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BEIJING, China and BRIDGEWATER, NJ, USA I October 14, 2021 I Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan & Lee) (Shanghai: 603087.SH), is pleased to announce the completion of two randomized, multicenter, phase 3 studies that compare proposed biosimilar Gan & Lee insulin glargine (GL-GLA) to a reference biologic. The two studies were conducted separately in subjects with type 1 (n=576) and type 2 diabetes mellitus (n=567).
The primary purpose of these 26-week studies was to assess the equivalence in treatment-induced (TI) immunogenicity between GL-GLA and the reference biologic using pre-specified similarity margins. The secondary objectives were to assess the equivalence in efficacy and evaluate safety. Both studies concluded there was equivalent TI immunogenicity. Efficacy estimates between groups were within pre-specified similarity margins and concluded to be equivalent. Safety endpoints were comparable between GL-GLA and the reference biologic.
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 approved in China - 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®).
SOURCE: Gan & Lee Pharmaceuticals Co.