Gan & Lee and Menarini Advance Bofanglutide in Europe

Beijing, China & Florence, Italy, September 3, 2026

Gan & Lee Advances Bofanglutide Toward Europe

Bofanglutide is a long-acting GLP-1 receptor agonist independently developed by Gan & Lee and currently undergoing clinical development for weight management in adults with obesity or overweight, as well as type 2 diabetes and other metabolic conditions. A key feature of the investigational therapy is its once-every-two-weeks subcutaneous dosing schedule, potentially reducing administration frequency by 50% compared with commonly used once-weekly GLP-1 receptor agonists. Gan & Lee has positioned the dosing regimen as a potential differentiating characteristic as it advances bofanglutide through global development. Importantly, bofanglutide remains an investigational compound, and its safety and efficacy have not been established or authorized by the European Medicines Agency or other health authorities for commercial distribution. The companies reported that bofanglutide has already generated positive results in two important clinical development programs. The pivotal Phase 3 study in China evaluating weight management and the Phase 2 study in the United States both met their primary endpoints, according to the companies. The reported findings demonstrated weight-loss efficacy and a tolerability profile consistent with expectations for the GLP-1 RA class. Gan & Lee now plans to advance a global Phase 3 development program intended to support regulatory registration in Europe and other highly regulated markets. Menarini will provide regulatory and commercial expertise within its licensed territories as the program progresses.

Menarini Takes European Regulatory and Commercial Role

Under the agreement, Menarini will assume responsibility for regulatory submissions and commercialization of bofanglutide throughout the licensed European territory. The scope covers the EU’s 27 member states together with the United Kingdom, Switzerland, Norway, Iceland, Liechtenstein and Balkan markets. Gan & Lee will retain rights in the territories outside the licensed region while continuing to lead the broader global development strategy. The partnership combines Gan & Lee’s capabilities in clinical development, manufacturing and supply with Menarini’s established expertise in regulatory strategy and commercial execution. For Menarini, the agreement represents an expansion of its activities in the metabolic health sector, an area characterized by increasing demand for effective therapies addressing obesity, overweight and related metabolic conditions. The company said the potential differentiation offered by biweekly dosing is one of the factors supporting its interest in bofanglutide. Menarini will work with Gan & Lee as additional pivotal studies are conducted, with the objective of potentially bringing the therapy to European patients if regulatory requirements are successfully met.

Bofanglutide Strengthens Global Metabolic Pipeline

The licensing agreement is part of Gan & Lee’s broader strategy to transform from an established insulin manufacturer into a global biopharmaceutical innovator with an expanding focus on metabolic diseases. The company is developing a pipeline spanning diabetes, obesity, cardiovascular disease and immunology, while using international partnerships to extend the reach of its innovative candidates. Bofanglutide has become a flagship asset within this strategy, with Gan & Lee pursuing additional regional partnerships alongside its global clinical development plans. The European agreement also illustrates the increasingly competitive landscape surrounding GLP-1-based therapies for obesity and metabolic disease. While weekly injectable GLP-1 medicines have become an established treatment approach, less frequent administration could potentially offer an additional option for patients if supported by clinical evidence and regulatory approval. The planned global Phase 3 program will therefore be an important next step in determining the longer-term efficacy, safety and benefit-risk profile of bofanglutide in broader patient populations. Until those studies and regulatory reviews are completed, the candidate should be considered investigational rather than an approved obesity treatment. For the biopharmaceutical sector, the €726 million potential licensing agreement highlights the strategic value placed on differentiated metabolic therapies and international development partnerships. Gan & Lee’s development expertise and Menarini’s European regulatory and commercialization capabilities create a framework for advancing bofanglutide toward potential registration in highly regulated markets. The next major milestones will include initiation and progress of the global Phase 3 program, regulatory interactions and eventual submission activities supporting the candidate’s potential European development pathway.

Source: Gan & Lee Pharmaceuticals, Menarini Group press release