Gan & Lee Pharmaceuticals Concludes Phase 3 Studies of Gan & Lee Insulin Glargine (GL-GLA)

BEIJING and BRIDGEWATER,N.J.,Oct. 14,2021 -- 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 Pharmaceuticalshasdeveloped the first Chinese domestic biosynthetic human insulin. Currently,we havefive 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 injectionapproved in China - mixed protamine human insulin injection (30R) (Similin®30).Wehave two approved medical devices in China,namelyreusable 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 ourgoal 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

+1 888-288-5395

investorrelations@ganlee.us