PR90424

New Data on Phase 1 Proposed Biosimilar Gan & Lee Insulins Aspart (GL-ASP), Lispro (GL-LIS), and Glargine (GL-GLA) Presented at the American Diabetes Association's 81st Scientific Sessions

BEIJING and BRIDGEWATER, NJ. July 2, 2021 /PRNewswire=KYODO JBN/ --

Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan & Lee,

stock code: 603087.SH), announced positive Phase 1 clinical trial results at

the 81st Scientific Sessions of the American Diabetes Association (ADA), June

25th - 29th. The new data pertained to three proposed biosimilar Gan & Lee

insulin analogs, insulin aspart (GL-ASP), insulin lispro (GL-LIS), and insulin

glargine (GL-GLA), and were presented by the primary investigators from Profil,

(Germany).

All three phase 1 studies met their primary PK and primary PD analyses. These

data demonstrate pharmacokinetic and pharmacodynamic bioequivalence between

each of the proposed biosimilar Gan & Lee insulins and their respective

reference compounds. In addition, the safety profiles were comparable between

each of the three proposed biosimilar Gan & Lee insulins and their respective

reference compounds(1),(2),(3).  

The data presented from the abstracts, are a major milestone in the biosimilar

clinical development programs at Gan & Lee. Although 2021 marks the centenary

of insulin's discovery, insulin access remains a global health issue. "We are

excited as we move one step closer to bringing biosimilar insulins into

clinical practice with a goal of helping reduce the global burden of diabetes,"

said Jia Lu, Executive Director of Clinical Sciences. The three abstracts have

recently been published on the journal Diabetes(R) website and the poster

presentation numbers for the GL-ASP, GL-LIS, and GL-GLA abstracts are 738-P,

736-P, and 740-P, respectively.

About Gan & Lee

Gan & Lee has successfully developed the first domestic biosynthetic human

insulin in China. Currently, the company has five recombinant insulin analogs

and other products commercialized in China including long-acting glargine

injection (Basalin(R)), fast-acting lispro injection (Prandilin(R)),

fast-acting aspart injection (Rapilin(TM)), mixed protamine zinc lispro

injection (25R) (Prandilin(R)25) and aspart 30 injection (Rapilin(TM)30),

reusable insulin injection pen (GanleePen(TM)), and disposable pen needle

(Ganlee Fine(TM)).

Moving forward, Gan & Lee strives to advance its goal of becoming a world-class

pharmaceutical company by providing a comprehensive coverage in the field of

diabetes diagnosis and treatment, and also taking an active part in developing

new chemical entities for the treatment of cardiovascular diseases, metabolic

diseases, cancer, and other diseases. For more information, please contact us

at investorrelations@ganlee.us.

References:

1.  Leona Plum- Morschel, et. al. Proposed biosimilar insulin aspart (GL-ASP)

shows pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence to

US-licenced and EU-authorised insulin aspart. June 22, 2021.

2.  Eric Zijlstra, et. al. Proposed biosimilar insulin lispro (GL-LIS) shows

pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence to US-licenced and

EU-authorised insulin lispro. June 22, 2021.

3.  Tim Heise, et. al. Proposed biosimilar insulin glargine (GL-GLA) shows

pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence to US-licenced and

EU-authorised insulin glargine. June 22, 2021.

Gina Antonucci

888-288-5395

investorrelations@ganlee.us

SOURCE: Gan & Lee Pharmaceuticals Co., Ltd.