Beijing, China, February 14, 2025 – Gan & Lee Pharmaceuticals (hereafter referred to as "Gan & Lee," stock code: 603087.SH) announced that the first participant has been successfully dosed in a large-scale Phase 3 clinical trial (OPTIMUM-2) of Bofanglutide (research code: GZR18), a bi-weekly glucagon-like peptide-1 receptor agonist (GLP-1RA) independently developed by Gan & Leem, in Chinese participant with type 2 diabetes mellitus (T2DM). This milestone marks the initiation of the first Phase 3 clinical trial of Bofanglutide injection worldwide for the treatment of T2DM.

This multicenter, randomized, active-controlled phase 3 clinical study was designed to evaluate the efficacy and safety of Bofanglutide injection compared to semaglutide (Ozempic?) in Chinese participants with T2DM inadequately controlled by metformin monotherapy or in combination with sodium-dependent glucose transporter 2 (SGLT2) inhibitors or sulfonylureas (clinicaltrials.gov registration number: NCT06778967). The study plans to enroll 1,100 participants who will be randomly assigned to receive treatment of either 12 mg of Bofanglutide bi-weekly, 18 mg of Bofanglutide bi-weekly, or 1 mg of semaglutide once-weekly. The primary endpoint is the change in glycosylated hemoglobin (HbA1c) from baseline at the end of treatment.

Previously, a Phase 2 study (NCT06256549) of Bofanglutide injection in Chinese participants with T2DM demonstrated that after 24 weeks of treatment, the mean reduction in HbA1c from baseline was greater in both the bi-weekly and once-weekly Bofanglutide groups compared to the semaglutide group. After 24 weeks of treatment, patients in the bi-weekly Bofanglutide group also experienced greater weight loss than those in the semaglutide group. Meanwhile, Bofanglutide significantly improved fasting glucose, blood pressure, and lipid levels, providing comprehensive metabolic benefits for patients with diabetes.

Professor Ming Liu from Tianjin Medical University General Hospital, the leading principal investigator of the OPTIMUM-2 study, stated, “In recent years, the prevalence of diabetes in China has been rapidly increasing, with over 140 million people currently diagnosed with diabetes, accounting for approximately 18% of the global diabetic population1. As a bi-weekly GLP-1RA, bofanglutide demonstrated remarkable glucose-lowering efficacy in Phase 2 clinical studies, along with significant benefits in weight management and metabolic improvements. I look forward to further validating its efficacy and safety through this Phase 3 clinical trial, providing a new therapeutic option for patients with T2DM.”

Reference:

1. NCD Risk Factor Collaboration (NCD-RisC). (2024) Worldwide trends in diabetes prevalence and treatment from 1990 to 2022: a pooled analysis of 1108 population-representative studies with 141 million participants. The Lancet, 404, 2077–2093. https://doi.org/10.1016/S0140-6736 (24) 02317-1

About Bofanglutide (GZR18)

Bofanglutide (R&D Code: GZR18) injection, developed by Gan & Lee Pharmaceuticals, is a bi-weekly GLP-1 receptor agonist (RA) indicated for glycemic control in adults with type 2 diabetes and body weight management in overweight/obese individuals. As the potential first bi-weekly GLP-1 RA in the world, early clinical trials have demonstrated its efficacy in weight reduction comparable to or superior to marketed counterparts, with a safety and tolerability profile consistent with the established class of GLP-1 RAs, and significant reductions in both blood glucose levels and body weight.

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.