Gan & Lee Pharmaceuticals Co., Ltd. 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.
| BEIJING and BRIDGEWATER, N.J., Oct. 14, 2021 /PRNewswire/ -- Gan & Lee Pharmaceuticals, 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®). 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 working on the treatment of cardiovascular diseases, metabolic diseases, cancer, and other therapeutics. For more information, please contact us at investorrelations@ganlee.us. Contact:
SOURCE Gan & Lee Pharmaceuticals Co., Ltd. | ||
Company Codes: Shanghai:603087 |
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