Beijing, China, August 8, 2025 — Gan & Lee Pharmaceuticals (hereafter referred to as “Gan & Lee”, stock code: 603087.SH) announced that the first patient has been dosed in a phase 2 clinical study of GZR102 injection, a once-weekly fixed-ratio combination of basal insulin and glucagon-like peptide-1 receptor agonist (GLP-1 RA), in Chinese adults with type 2 diabetes mellitus (T2DM).

This phase 2 study (clinicaltrials.gov registration number: NCT07055386) aims to compare the efficacy, safety, and tolerability of once-weekly GZR102 injection versus bi-weekly GLP-1 RA bofanglutide (GZR18) injection in Chinese adult participants with T2DM whose were inadequate glycemic control on GLP-1 RAs, with or without oral antidiabetic drugs (OADs). The study plans to enroll 90 participants who will be randomly assigned to receive treatment in either the GZR102 injection or bofanglutide injection. The primary endpoint is the change from baseline in glycated hemoglobin (HbA1c) at Week 24.

Fixed-ratio combinations of basal insulin and GLP-1 RA are expected to simplify treatment regimens for T2DM by providing potent glucose-lowering effects while mitigating adverse effects associated with basal insulin therapy, including weight gain and hypoglycemia¹. This approach aims to achieve greater efficacy with fewer side effects and improve patient adherence². Compared with traditional once-daily regimens, a long-acting once-weekly formulation can reduce injection frequency by more than 80% annually, which may enhance treatment experience and long-term adherence³. To date, no once-weekly fixed-ratio basal insulin/GLP-1RA combination has been approved globally. With GZR102 rapidly advancing into phase 2 clinical development, it has the potential to become a preferred option for combination therapy in China and to further broaden Gan & Lee's diabetes portfolio.

Reference：

1. 胰高糖素样肽-1受体激动剂联合胰岛素治疗2型糖尿病专家共识（2025版）[J].中华糖尿病杂志, 2025, 17(4):421-430.DOI: 10.3760/cma.j.cn115791-20241213-00729.

2. 中国糖尿病防治指南（2024版）. 中华糖尿病杂志,2025,17(01)：16-139. DOI:10.3760/cma.j.cn115791-20241203-00705

3. Polonsky, W. H., Arora, R., Faurby, M., Fernandes, J., & Liebl, A. (2022). Higher Rates of Persistence and Adherence in Patients with Type 2 Diabetes Initiating Once-Weekly vs Daily Injectable Glucagon-Like Peptide-1 Receptor Agonists in US Clinical Practice (STAY Study). Diabetes therapy : research, treatment and education of diabetes and related disorders, 13(1), 175–187. https://doi.org/10.1007/s13300-021-01189-6

About GZR102 Injection

Gan & Lee Pharmaceuticals' proprietary GZR102 injection is a once-weekly fixed-ratio combination of basal insulin and GLP-1 RA, composed of the weekly basal insulin GZR4 injection and the GLP-1 RA bofanglutide (GZR18) injection in a fixed ratio. As a once-weekly subcutaneous formulation, GZR102 is designed to maximize the synergistic effects of both components. The insulin/GLP-1RA combination addresses multiple pathophysiological defects in T2DM, demonstrating enhanced glycemic control with reduced daily insulin requirements while mitigating adverse effects such as hypoglycemia and weight gain, positioning it as a potentially optimal therapeutic option that is effective, safe, and convenient for diabetes patients. GZR102 has now entered phase 2 clinical development globally.

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 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.