BEIJING — November 27, 2025. Gan & Lee Pharmaceuticals has initiated GRADUAL-3, its third Phase 3 clinical study evaluating bofanglutide (GZR18), a next-generation once-monthly GLP-1 receptor agonist developed for long-term weight management in adults with obesity or overweight. This milestone marks the first large-scale clinical evaluation of a monthly GLP-1 RA regimen developed in China, aiming to improve adherence, support sustained weight loss, and reduce the treatment burden associated with weekly injectable GLP-1 therapies. The GRADUAL program now encompasses three Phase 3 trials across more than 1,000 participants, positioning bofanglutide as one of China’s most advanced metabolic-disease drug candidates.
Science Significance
The initiation of GRADUAL-3 highlights substantial scientific progress in developing extended-interval GLP-1 receptor agonists, a class central to global innovations in metabolic-disease therapeutics. Bofanglutide has demonstrated significant weight-loss and glucose-lowering effects in previous clinical studies, offering comprehensive metabolic benefits and a safety profile consistent with marketed GLP-1 RAs. The GRADUAL-3 study evaluates 24-week efficacy and safety of a once-monthly dosing strategy, seeking to determine whether extended intervals can maintain weight-loss durability, reduce relapse and improve long-term metabolic control. The broader GRADUAL program includes the first global head-to-head comparison of a Chinese GLP-1 RA against semaglutide 2.4 mg (Wegovy®), reinforcing the scientific ambition of establishing bofanglutide as a competitive, high-performing therapy in obesity management.
Regulatory Significance
The launch of GRADUAL-3 advances bofanglutide along the pivotal regulatory pathway for obesity treatment in China. Conducted under registration identifier CTR20254659, this Phase 3 study is designed to generate critical data on weight-maintenance outcomes, the percentage change in body weight and overall tolerability—key endpoints typically required for regulatory review of weight-management medications. With three ongoing Phase 3 trials underway, Gan & Lee is assembling a comprehensive body of evidence to support future filings for obesity and type 2 diabetes indications. The inclusion of robust controlled comparisons, long-duration dosing evaluations and metabolic-parameter profiling aligns the development program with evolving regulatory expectations for chronic-disease therapeutics.
Business Significance
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Bofanglutide represents a major strategic asset in Gan & Lee’s expanding metabolic-disease portfolio. As the global GLP-1 RA market accelerates, driven by soaring demand for obesity and diabetes therapies, a once-monthly GLP-1 RA offers clear commercial differentiation by addressing adherence challenges and long-term regimen fatigue. With GRADUAL-1, GRADUAL-2 and GRADUAL-3 enrolling more than 1,000 patients, Gan & Lee strengthens its competitive position in a high-growth therapeutic category dominated by multinational players. Successful clinical outcomes could enable Gan & Lee to enter both domestic and international markets with a lower-frequency, potentially more convenient treatment, enhancing patient uptake, physician adoption and long-term revenue potential in the rapidly expanding weight-management sector.
Patients’ Significance
For patients living with obesity or overweight—conditions strongly linked to diabetes, cardiovascular disease and metabolic dysfunction—a once-monthly GLP-1 RA offers meaningful progress toward accessible, sustainable weight-management care. Many individuals struggle with adherence to weekly injectable regimens, leading to weight regain and diminishing therapeutic benefit. Bofanglutide’s monthly dosing schedule could improve consistency, reduce treatment fatigue, and support stable, long-term weight loss. With demonstrated metabolic improvements and an established safety profile, bofanglutide has the potential to help patients achieve better control over body weight, glucose levels and overall quality of life through a more manageable treatment cadence.
Policy Significance
The GRADUAL-3 study aligns with national and global public-health priorities addressing the growing burden of obesity and metabolic disease. China faces a rapidly rising prevalence of overweight and obesity, increasing pressure on healthcare systems and long-term chronic-disease management programs. A domestically developed, once-monthly GLP-1 RA could support policy aims of improving population-level metabolic health, reducing healthcare expenditures and expanding affordable access to innovative therapies. Additionally, advancing Chinese-developed metabolic therapeutics enhances national capabilities in drug innovation, chronic-disease intervention and long-term disease-prevention strategies, reinforcing public-health objectives through science-driven solutions.
The initiation of the GRADUAL-3 Phase 3 clinical trial marks a significant inflection point in the development of China’s first once-monthly GLP-1 RA, underscoring Gan & Lee’s commitment to advancing high-impact metabolic therapeutics. Building on extensive Phase 3 work from GRADUAL-1 and GRADUAL-2, the study will provide critical insights into long-term adherence, weight-maintenance durability and real-world patient suitability. As Gan & Lee continues its mission to deliver innovative, accessible treatments for obesity and type 2 diabetes, bofanglutide stands poised to contribute meaningfully to the future of weight-management therapy and chronic-disease prevention.
Source: Gan & Lee Pharmaceuticals press release
