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(R)), 
fast-acting lispro injection (Prandilin(TM)), fast-acting aspart injection 
(Rapilin(R)), mixed protamine zinc lispro injection (25R) (Prandilin(TM)25), 
aspart 30 injection (Rapilin(R)30), and one human insulin injection approved in 
China - mixed protamine human insulin injection (30R) (Similin(R)30). We have 
two approved medical devices in China, namely reusable insulin injection pen 
(GanleePen), and disposable pen needle (GanleeFine(R)).

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: Gina Antonucci, T: +1 888-288-5395, investorrelations@ganlee.us

Source: Gan & Lee Pharmaceuticals Co., Ltd