Beijing, China, October 28, 2025 — Gan & Lee Pharmaceuticals (hereinafter referred to as "Gan & Lee" stock code: 603087.SH) announced that the first participants has been dosed in a phase 3 clinical study (GRADUAL-2) of bi-weekly Bofanglutide (research code: GZR18), a glucagon-like peptide-1 receptor agonist (GLP-1RA), in Chinese participants with overweight or obesity. GRADUAL-2 is the second large-scale phase 3 trial of bofanglutide in weight management of overweight or obese patients, continuing to explore its potential to improve weight-related outcomes, glucose metabolism, and other metabolic parameters, as well as cardiovascular risk factors.

This multicenter, randomized, open-label, parallel-group phase 3 study (ClinicalTrials.gov registration number: NCT07150975) was designed to compare the efficacy and safety of bofanglutide injection with semaglutide (Wegovy^®) in adults with obesity or overweight who have inadequate weight control with diet and exercise. Professor Linong Ji from Peking University People's Hospital is the leading principal investigator of the GRADUAL-2 study. The study plans to enroll 471 participants, including up to 20% with type 2 diabetes mellitus. Eligible participants will be randomized to receive either bi-weekly 24 mg of bofanglutide, bi-weekly 48 mg of bofanglutide or once-weekly semaglutide (Wegovy^®) 2.4 mg. The primary endpoint is the percent change in body weight from baseline at week 52.

Previously, Bofanglutide has conducted in a phase 3 study (GRADUAL-1) in Chinese adults with obesity or overweight to assess its efficacy and safety profile. This head-to-head phase 3 GRADUAL-2 study compared with semaglutide (Wegovy^®) will further evaluate the efficacy and safety of bofanglutide in this population and assess its comprehensive impact on metabolic parameters and cardiovascular risk factors.

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.