PR92325

BEIJING and BRIDGEWATER, N.J., Oct. 14 2021 /PRNewswire=KYODO JBN/ --

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