Beijing, China, February 18, 2025 – Gan & Lee Pharmaceuticals (hereafter referred to as "Gan & Lee," stock code: 603087.SH) announced that the first participant has been dosed in a Phase 3 clinical trial (SUPER-3) of once-weekly basal insulin GZR4 injection, in Chinese participants with type 2 diabetes mellitus (T2DM) who previously received either basal+ prandial insulin therapy or premixed/dual insulin analog therapy. This milestone marks the initiation of the third large-scale Phase 3 clinical trial for GZR4 injection.

This Phase 3 clinical trial (clinicaltrials.gov registration number: NCT06767761) was designed to evaluate the efficacy and safety of once-weekly GZR4 injection compared to once-daily insulin glargine U100 (Lantus^?) in combination with insulin aspart (with or without non-insulin antidiabetic agents) in participants with T2DM who previously received either basal+ prandial insulin therapy or premixed/dual insulin analog therapy. The study plans to enroll 580 participants who will be randomly assigned to receive treatment in either the GZR4 group or the insulin glargine U100 group. The primary endpoint is the percentage change from baseline in glycosylated hemoglobin (HbA1c) at week 26.

Previously, a Phase 2 study (NCT06202079) of once-weekly GZR4 injection in Chinese participants with T2DM demonstrated a superior or comparable HbA1c reduction compared to once-daily insulin degludec after 16 weeks of treatment. Additionally, improvements in time-in-range (TIR) were comparable between GZR4 injection and insulin degludec. In this study, GZR4 injection exhibited good safety and tolerability, with no severe hypoglycemic events observed.

Professor Zhiguang Zhou from The Second Xiangya Hospital of Central South University, the leading principal investigator of the SUPER-3 study, stated, “In diabetes treatment, an intensive regimen combining basal insulin with prandial insulin is a key strategy for achieving precise and intensive glycemic control. However, the traditional multiple daily injection regimen often leads to reduces patient adherence, which affects long-term treatment efficacy. As a once-weekly basal insulin, GZR4 injection has the potential to reduce injection frequency, streamline treatment regimens, and enhance patient adherence when used in combination with prandial insulin. This Phase 3 clinical study aims to provide robust evidence for further optimizing intensive insulin therapy, offering new possibilities for glycemic management and improving life quality for patients with diabetes.”

Reference:

1. Chinese Diabetes Society. Guideline for the prevention and treatment of diabetes mellitus in China (2024 edition) [J]. Chinese Journal of Diabetes Mellitus. 2025,17(01): 16-139. DOI:10.3760/cma.j.cn115791-20241203-00705

About GZR4

Gan & Lee Pharmaceuticals' independently developed GZR4  injection is an ultra-long-acting weekly insulin preparation that is expected to provide more stable glucose-lowering effects and reduced intra- or inter-day blood glucose variability. GZR4 is anticipated to help patients with diabetes overcome injection barriers, enable earlier initiation of insulin therapy, optimize long-term diabetes management, and enhance patients' quality of life via once-weekly subcutaneous injection. Early clinical findings indicate that GZR4 demonstrates comparable reduction in HbA1c to insulin degludec in patients with inadequate glycemic control through oral antidiabetic medications. Currently, the global development of GZR4 has entered the Phase 3 clinical trial stage.

Forward-looking statements

Forward-looking statements are based on our expectations and assumptions as of the date of the statements. Actual results may differ materially from those expressed in these forward-looking statements due to a variety of factors, and we can give no assurance that such results will be achieved in the future. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

About Gan & Lee

Gan & Lee Pharmaceuticals developed the first Chinese domestic insulin analog. Currently, Gan & Lee has 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). The company has two approved medical devices in China, namely reusable insulin injection pen (GanleePen), and disposable pen needle (GanleeFine^?).

In China's 2024 National Insulin-Specific Centralized Procurement, Gan & Lee Pharmaceuticals ranked  first among all selected companies in terms of procurement demand for insulin analogs. The company is also making strides in international markets, with the disposable pen needle (GanleeFine^?) approved by the US Food and Drug Administration (FDA) in 2020 and received GMP inspection approval from the European Medicines Agency (EMA) in 2024. These achievements significantly boost Gan & Lee’s competitiveness in both international and domestic markets.

In the future, Gan & Lee will strive for comprehensive coverage in diabetes treatment. Moving forward with its mission to become a world-class pharmaceutical company, Gan & Lee will also actively develop new chemical entities and biological drugs, focusing on treatments for metabolic diseases, cardiovascular diseases, and other therapeutic areas.