Beijing, China/Bridgewater, New Jersey U.S, September 9, 2021 — Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan & Lee, stock code: 603087.SH), is excited to present positive data from five abstracts which will be featured as short oral discussions at the 57th Annual European Association for the Study of Diabetes (EASD) Meeting. The meeting will be held virtually from September 27th – October 1st, 2021.

The following new data will be presented on September 30th, 2021, 11:45 – 13:15 CEST:

•  Novel GLP-1 analogue, GZR18: a preclinical evaluation in type 2 diabetes models

•  Phase 3 confirmatory study comparing efficacy and safety of proposed biosimilar and reference insulin aspart, combined with   metformin, in patients with diabetes

In addition, recent results from our encore Phase 1 clinical trials will also be presented on September 30^th, 2021, 11:45 – 13:15 CEST:

• Proposed biosimilar insulin aspart (GL-ASP) shows pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence to US-licenced and EU-authorised insulin aspart

• Proposed biosimilar insulin lispro (GL-LIS) shows pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence to US-licenced and EU-authorised insulin lispro 

• Proposed biosimilar insulin glargine (GL-GLA) shows pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence to US-licenced and EU-authorised insulin glargine

The data that will be presented at the EASD Annual Meeting, are important milestones for the clinical development programs at Gan & Lee. Furthermore, the abstracts mentioned above demonstrate Gan & Lee’s dedication to providing solutions for patients with diabetes. “We are pleased to have all five abstracts published by the EASD as we continue to seek scientific solutions for diabetes care”, said Michelle Mazuranic, Head of Global Medical Affairs. The presentation numbers for GZR18, GL-ASP (Phase 3 in China), GL-ASP (Phase 1), GL-LIS, and GL-GLA are 463, 513, 510, 514, and 511, respectively.

References

• Leona Plum- M?rschel, et. al. Proposed biosimilar insulin aspart (GL-ASP) shows pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence to US-licenced and EU-authorised insulin aspart. Diabetes. June 22, 2021.

• 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. Diabetes. June 22, 2021.

• 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. Diabetes. June 22, 2021.

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?), 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 injection approved in China - mixed protamine human insulin injection (30R) (Similin?30). We have two approved medical devices in China, namely reusable 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 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.