Gan & Lee Pharmaceuticals' Phase 1 Study Results of Bofanglutide Injection Published in Diabetes, Obesity and Metabolism

Gan & Lee Pharmaceuticals (hereafter referred to as "Gan & Lee," stock code: 603087.SH) recently published the results of two phase 1 clinical studies on Bofanglutide (GZR18) injection, a Class 1 innovative drug independently developed by the company, in the prestigious endocrine metabolism journal Diabetes, Obesity and Metabolism (Impact Factor 5.8, 2024, Chinese Academy of Sciences, Region II). The studies demonstrated that Bofanglutide has a favorable safety and tolerability profile in healthy subjects from both the Chinese and U.S. populations, with no significant ethnic differences observed 1 . These findings provide a solid foundation for the global clinical development of Bofanglutide. Bofanglutide is an ultra-long-acting glucagon-like peptide-1 receptor agonist (GLP-1 RA) developed by Gan & Lee. Preclinical studies have confirmed its significant glucose-lowering and weight-reducing effects 2 . The published phase 1 clinical trials were randomized, double-blind, placebo-controlled, dose-escalation studies independently conducted in the U.S. and China. The U.S. study enrolled participants across three dose cohorts (1–10 μg/kg), while the Chinese study included six dose cohorts (5–50 μg/kg). The trials evaluated the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of once-weekly subcutaneous administration of Bofanglutide in healthy participants. In addition, a population pharmacokinetic (PopPK) analysis was conducted to assess potential ethnic differences between Chinese and U.S. populations. Results showed a favorable dose-dependent profile for Bofanglutide. The geometric mean ratios of the area under the curve from time zero to the last measurable concentration (AUC 0–t ) and maximum drug concentration (C max ) between Chinese and U.S. participants were both close to 1, indicating high PK comparability. In the Chinese study, healthy subjects experienced body weight reductions of up to 1.25–1.86 kg (1.88%–3.11% from baseline) after two doses, highlighting a notable weight loss potential of bofanglutide. The safety profile was consistent with other GLP-1 RAs, with mild decreased appetite and nausea being the most common adverse events. No hypoglycemic events or serious adverse events were reported. Importantly, the PK profiles observed in Chinese and U.S. subjects were highly consistent, and PopPK analysis confirmed that ethnicity did not significantly impact Bofanglutide’s PK profile. Having successfully completed phase 1 trials in both China and the United States, Bofanglutide has demonstrated notable clinical potential and differentiation as an innovative, domestically developed GLP-1 RA. It stands out as a competitive candidate among currently available therapies. Furthermore, the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for a head-to-head phase 2 clinical trial comparing bofanglutide to tirzepatide for weight management. The first subject is expected to be dosed shortly. Gan & Lee remains committed to advancing innovation, accelerating the development of novel therapies, and delivering high-quality, effective, and accessible treatment options to patients worldwide. References: 1.Liu Y, Chen W, He X, He A, Zhao L, Xie T, Li Y, Zhao J, Hunt A, Shi A, Gan ZR. The safety, tolerability, pharmacokinetics and pharmacodynamics of GZR18 in healthy American and Chinese adult subjects. Diabetes Obes Metab. 2025 Mar 3. doi: 10.1111/dom.16285. Epub ahead of print. PMID: 40028667. 2.Zhang M, Zhang Y, Peng X, He A, Wang Y, Deng Y, Cui C, Xue F, Wei B, Xing W, Qian Y, Mazuranic M, Chen W. GZR18, a novel long-acting GLP-1 analog, demonstrated positive in vitro and in vivo pharmacokinetic and pharmacodynamic characteristics in animal models. Eur J Pharmacol. 2022 Aug 5;928:175107. doi: 10.1016/j.ejphar.2022.175107. Epub 2022 Jun 16. PMID: 35718129. 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.

The release as fetched from its publisher. ganlee.com ↗