Beijing, China, February 17, 2025 – Gan & Lee Pharmaceuticals (hereafter referred to as "Gan & Lee," stock code: 603087.SH) announced that the first participant has been dosed in a large-scale Phase 3 clinical trial (SUPER-2) of once-weekly basal insulin GZR4 injection in basal insulin-treated Chinese participants with type 2 diabetes mellitus (T2DM). This is the first Phase 3 clinical study for GZR4 injection globally.

This Phase 3 clinical trial was designed to compare the efficacy and safety of once-weekly GZR4 injection with once-daily insulin degludec (Tresiba^?), with or without non-insulin antidiabetic agents, in participants with T2DM previously treated with basal insulin (clinicaltrials.gov registration number: NCT06767748). The leading principal investigators of the study are Professor Yiming Mu from The First Medical Center of PLA General Hospital and Professor Guang Wang from Beijing Chaoyang Hospital of Capital Medical University. A total of 620 participants will be enrolled and randomly assigned to receive either GZR4 or insulin degludec. The primary endpoint is the percentage change from baseline in glycosylated hemoglobin (HbA1c) at week 26.

Previously, a Phase 2 study (NCT062020791) 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 the GZR4 injection and insulin degludec. In this study, GZR4 injection exhibited a favorable safety and tolerability profile, with no severe hypoglycemic events observed.

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.