Beijing, China, December 11, 2023——Gan & Lee Pharmaceuticals (referred to as Gan & Lee, stock code: 603087.SH) announced the initiation and completion of the first patient dosing in the Phase II clinical study of its Class 1 Innovative drug, GZR101 injection.

This study (Registration Number, CTR20232521) is a multicenter Phase II clinical trial that compares the efficacy, safety, and tolerability of GZR101 injection with Insulin Degludec (Tresiba^®) in patients with Type 2 diabetes mellitus who are poorly controlled by oral hypoglycemic drugs (Part A) or by basal/premixed insulin (Part B).

The study is comprised of two parts, Part A and B. The primary objective of Part A is to compare the efficacy of GZR101 injection and Insulin Degludec (Tresiba^®) administered once daily for 16 weeks; The primary objective of Part B is to compare the efficacy of GZR101 injection in combination with Insulin Aspart Injection and twice-daily Insulin Degludec (Tresiba^®) over 16 weeks. The study plans to enroll 150 patients across 25 clincial sites nationwide.

Insulin Therapy in Diabetes Treatment

Patients with Type 1 diabetes primarily uses insulin for treatment, and patient with Type 2 diabetes also requires insulin therapy at certain stages of disease progression¹. With a deeper understanding of diabetes, treatment is evolving towards more closely mimicking physiological insulin secretion and action patterns. The goals of blood glucose control in insulin therapy have become more comprehensive, emphasizing controlling blood glucose fluctuations, mimicking basal and mealtime physiological insulin secretion, and managing fasting and postprandial blood glucose². Hence, dual insulin analogs, which combine basal and mealtime insulin analogs and offer higher glucose control rate, greater safety, fewer injections, and better mimicry of physiological insulin secretion, are becoming the ideal choice for diabetes treatment. Compared to traditional premixed insulin, dual insulin analogs do not require mixing before use, offering more flexibility in treatment and improving patient compliance while achieving a good blood glucose control³.

About GZR101 Injection

GZR101 injection is a dual insulin analog made from a combination of ultra-long-acting basal insulin GZR33 injection and rapid-acting insulin aspart injection (Rapilin^®). GZR101 is expected to mimic the biphasic pattern of physiological insulin secretion with once-daily dosing, managing both fasting and postprandial blood sugar levels, providing stable blood glucose reduction, and improving the rate of blood glucose control. It simplifies treatment, enhances patient compliance, reduces the treatment burden, optimizes long-term diabetes management, and helps lower or delay the occurrence of complications.

References：

1. Mathieu C, Martens PJ, Vangoitsenhoven R. One hundred years of insulin therapy. Nat Rev Endocrinol. 2021;17(12):715-725. doi:10.1038/s41574-021-00542-w

2. American Diabetes Association Professional Practice Committee. 6. Glycemic Targets: Standards of Medical Care in Diabetes-2022[J]. Diabetes Care, 2022, 45（Supplement_1）: S83-S96

3. Philis‐Tsimikas A, Astamirova K, Gupta Y, et al. Similar glycaemic control with less nocturnal hypoglycaemia in a 38‐week trial comparing the IDegAsp co‐formulation with insulin glargine U100 and insulin aspart in basal insulin‐treated subjects with type 2 diabetes mellitus[J]. Diabetes Res Clin Pract, 2019, 147: 157‐165. DOI: 10.1016/j.diabres.2018.10.024.

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.