Chinese drugmaker Gan & Lee Pharmaceuticals has struck an exclusive licensing deal with Italy’s Menarini Group to advance its experimental obesity drug bofanglutide across Europe, in a partnership that could generate up to €726 million, excluding royalties.

 

The agreement gives Gan & Lee an immediate €62 million upfront payment, with as much as €664 million in milestone payments and double-digit royalties on net sales in the licensed markets.

 

Menarini will handle regulatory submissions and commercialization across 39 countries, covering all 27 European Union member states as well as the United Kingdom, Switzerland, Norway, Iceland, Liechtenstein and countries in the Balkans.

 

The deal gives Gan & Lee a major European partner as the Chinese pharmaceutical company seeks to turn bofanglutide into a global metabolic-health product and expand beyond its traditional insulin business.

 

Bofanglutide, also known as GZR18, is a long-acting glucagon-like peptide-1 receptor agonist being developed for weight management in adults with obesity or overweight. Its headline potential advantage is its once-every-two-weeks injection schedule, which the companies say cuts dosing frequency by 50% compared with once-weekly GLP-1 receptor agonists.

 

Gan & Lee said its pivotal Phase 3 trial in China and Phase 2 trial in the United States both met their primary endpoints in weight management, showing weight-loss efficacy and a tolerability profile consistent with the broader GLP-1 class.

 

“This partnership establishes a pivotal pathway for bofanglutide's entry into the European market and marks another milestone in Gan & Lee's transformation—from a leader in insulin to a global innovator in metabolic disease. By integrating Gan & Lee's expertise in clinical development, manufacturing, and supply with Menarini's strength in Regulatory strategy and commercial execution, we aim to bring an alternative therapy to millions of people living with obesity or overweight across the Territories," said Wei Chen, Chairman and CEO of Gan & Lee.

 

For Menarini, the deal strengthens its push into the rapidly expanding metabolic-disease market. Group CEO Elcin Barker Ergun pointed to bofanglutide’s clinical results and less frequent dosing as potential differentiators.

 

“Clinical study results for bofanglutide so far have demonstrated weight reduction, secondary metabolic benefits, and a safety profile consistent with expectations for this class, while its once-every-two-weeks dosing regimen offers an opportunity for differentiation. We look forward to closely working with Gan & Lee for successful completion of further pivotal studies to bring this potential new option to patients across all our Territories, leveraging on Menarini's established capabilities and know-how.”

 

The companies are now preparing for the next stage of development. Gan & Lee plans to launch a global Phase 3 clinical program to support potential registration in Europe and other highly regulated markets.

 

The partnership comes as competition intensifies in the obesity-drug market, where GLP-1 therapies have emerged as a major growth area in the pharmaceutical industry. A successful development and regulatory path could give bofanglutide a foothold in Europe with a dosing schedule designed to distinguish it from once-weekly competitors.