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)

BEIJING and BRIDGEWATER, N.J., Dec. 18, 2024 /PRNewswire/ -- Gan & Lee Pharmaceuticals (Gan & Lee, Shanghai Stock Exchange: 603087.SH), is pleased to announce that the Food and Drug Administration (" FDA ") has cleared the Investigational New Drug (IND) application for GZR18 Injection to conduct a phase 2 clinical trial, a head-to-head with Tirzepatide from Eli Lilly and Company (NYSE: LLY) in the US (NCT06737042). GZR18 is a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist (RA) being developed by Gan & Lee Pharmaceuticals. The clinical trial indication of this application is the chronic weight management for obese or overweight patients, with or without T2DM.

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 42% of the total adult population. It is expected that this number will rise to 3.3 billion by 2035¹. Obesity can lead to a series of complications, including diabetes, cardiovascular diseases and even mental diseases such as depression. The medical expenses caused by obesity and its complications have brought a heavy medical burden to patients and society.

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]. London: World Obesity Alliance,

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 18.6% Weight Reduction in Subjects with Obesity in a Phase Ib/IIa Trial. Diabetes 14 June 2024; 73 (Supplement_1): 1858–LB. https://doi.org/10.2337/db24-1858-LB  

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)

source: Gan & Lee Pharmaceuticals