Gan & Lee Pharmaceuticals Announces U.S. FDA Clearance of the IND application for the innovative Bi-weekly GLP-1RA GZR18 Injection, Bofanglutide, with chronic weight management Indication (A Phase 2 head-to-head with Tirzepatide clinical trial)
Rhea-AI Summary
Gan & Lee Pharmaceuticals announced FDA clearance of their IND application for GZR18 Injection, a bi-weekly GLP-1 receptor agonist, to conduct a Phase 2 clinical trial. The trial will be a head-to-head comparison with Eli Lilly's Tirzepatide for chronic weight management in obese or overweight patients, with or without T2DM.
According to the World Obesity Federation's 2024 report, approximately 2.2 billion adults worldwide were overweight in 2020, with projections reaching 3.3 billion by 2035. GZR18, as the first bi-weekly GLP-1 mono-agonist formulation, works by delaying gastric emptying and suppressing appetite. Current clinical data suggests weight loss effects comparable to or better than multi-target once-weekly GLP-1 formulations.
Positive
- FDA clearance received for Phase 2 clinical trial
- First bi-weekly GLP-1 mono-agonist formulation in development
- Preliminary data shows comparable or better weight loss effects than existing weekly formulations
Negative
- Early-stage development (Phase 2) indicates long path to potential commercialization
- Will face strong competition from established products like Tirzepatide (LLY)
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According to the latest data released by the World Obesity Federation (WOF) Global Obesity Report (2024), approximately 2.2 billion adults worldwide were overweight (referring to BMI ≥ 25kg/m2) in 2020, accounting for about
GZR18, as a GLP-1 receptor agonist, can delay gastric emptying by activating GLP-1 receptors expressed on the gastrointestinal tract; and enhance satiety and suppress appetite by activating GLP-1 receptors in the hypothalamus and other parts, thereby reducing the patient's weight. GZR18 injection is the first bi-weekly GLP-1 mono-agonist formulation. Current clinical data has demonstrated weight loss effects comparable to or even better than multi-target once-weekly GLP-1 formulations, providing new insights for the future development of GLP-1 drugs. The development of the bi-weekly GZR18 injection is expected to offer more flexible treatment options for obese patients , leading to improved long-term weight management efficacy and adherence.
About GZR18
GZR18 is a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist (RA) being developed by Gan & Lee Pharmaceuticals. The indications currently under development are type 2 diabetes and chronic weight management for obese or overweight patients. Clinical data shows that administering GZR18 injection once a week and every two weeks can achieve good hypoglycemic or weight loss effects2.
References:
1. World Obesity Alliance 2024 World Obesity Report [EB/OL].
2. LINONG JI, WEI CHEN, RUIHUA DONG, MINGXIA YUAN, DONG ZHAO, SHUGUANG PANG, LIYUAN ZHAO, JING ZHAO, ZHONG-RU GAN; 1858-LB: A Novel GLP-1 Analog, GZR18, Induced an
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.
Further Information:
BPRD@ganlee.com (Media)
BD@ganlee.com (Business Development)
info.medical@ganlee.com (Medical Information)
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SOURCE Gan & Lee Pharmaceuticals