Beijing, China, September 12, 2023 — Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan & Lee, stock code: 603087. SH) announced today that the first subject has been dosed successfully in the Phase II clinical trial of GZR4 in China.

The study (CTR20232431) is a Phase II, multicenter, randomized, open-label, parallel-controlled, treat-to-target clinical trial in Chinese adult subjects with type 2 diabetes. The primary objective of the study is to compare the efficacy, safety, and tolerability of once-weekly GZR4 with once-daily insulin Degludec after 16 weeks of treatment, with the primary endpoint being the percentage change from baseline in glycosylated hemoglobin (HbA1c) at the end of the study (week 16). This Phase II clinical trial is a multiple-dose study with a planned enrollment of 130 patients.

As a fourth-generation ultra-long-acting weekly insulin formulation, GZR4 is expected to achieve a good basal glycemic control for one week through once-weekly dosing. Compared to the daily formulation, the once-weekly insulin formulation is expected to reduce insulin injections by more than 300 injections per year, significantly reducing the frequency of injections, helping to overcome barriers to injections, and is expected to and improve overall compliance.¹ Based on results from animal studies showing a more stable efficacy and lower risk of hypoglycemia, GZR4 is expected to achieve a good overall therapeutic outcome in patients.

About Diabetes

According to the 10th edition of the Diabetes Atlas published by the International Diabetes Federation (IDF), the number of people with diabetes in China has increased to 140 million in the past decade (a 56% increase over the past). It is estimated that by 2045, the number of people with diabetes in China will exceed 175 million². Driven by the increasing prevalence and demand for diversified treatment, the domestic and global diabetes market has been expanding every year. GZR4, the company's proprietary Class 1 investigational new product, is expected to meet the treatment needs of more patients.

About GZR4

GZR4 injection is a new Class 1 biologic drug developed independently by Gan & Lee Pharmaceuticals, which is the fourth generation of ultra-long-acting- weekly insulin preparations. Compared to the marketed daily insulin formulations, GZR4 has a longer half-life and smoother blood concentration. GZR4 is expected to have a smoother glucose-lowering effect and less day-to-day variability in blood glucose levels. GZR4 is administered once weekly by subcutaneous injection, which is expected to help diabetic patients overcome injection barriers, initiate insulin therapy earlier, optimize the long-term diabetes management and improve their quality of life. Currently, the global development of GZR4 has entered Phase II clinical phase, and no once-weekly insulin product has been approved for marketing globally yet.

References:

1. Rosenstock J, Del Prato S. Basal weekly insulins: the way of the future!. Metabolism. 2022;126:154924. doi:10.1016/j.metabol.2021.154924

2. International Diabetes Federation. IDF Diabetes Atlas, 10th ed. Brussels, Belgium: 2021.  Available at: https://www.diabetesatlas.org 

About Gan & Lee

Gan & Lee Pharmaceuticals has developed the first Chinese domestic biosynthetic human insulin. Currently, we have six core insulin products, including five insulin analog varieties: 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 - 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 work on the treatment of cardiovascular diseases, metabolic diseases, cancer, and other therapeutics.