New Data on Phase 1 Proposed Biosimilar Gan & Lee Insulins Aspart (GL-ASP), Lispro (GL-LIS), and Glargine (GL-GLA) Presented
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.
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