Beijing/Florence – September 08, 2026 -- Gan & Lee Pharmaceuticals (603087.SH) has signed an exclusive licensing agreement with Italy's The Menarini Group for its GLP-1 receptor agonist bofanglutide, a deal worth up to €726 million excluding royalties.
Gan & Lee secures €62 million upfront payment plus milestone potential of €664 million
Under the terms, Gan & Lee will receive a €62 million upfront payment, up to €664 million in milestone payments, and double-digit royalties on net sales across the licensed territory. Menarini will handle regulatory filings and commercialization in 39 countries, covering all 27 European Union member states, the United Kingdom, Switzerland, Norway, Iceland, Liechtenstein and Balkan nations.
Bofanglutide's once-every-two-weeks dosing cuts injection frequency by 50% versus weekly rivals
Bofanglutide, internally coded GZR18, is a Class 1 investigational GLP-1 receptor agonist developed independently by Gan & Lee for adults with obesity or excess body weight. Its subcutaneous dosing schedule of once every two weeks halves the injection frequency compared with weekly GLP-1 RA therapies currently on the market. A pivotal Phase 3 trial in China and a Phase 2 trial in the United States both met primary endpoints, showing weight-loss efficacy and a tolerability profile consistent with other drugs in the GLP-1 RA class.
Menarini gains new metabolic-disease asset to expand beyond its cardiometabolic and oncology base
The agreement expands Menarini's footprint in metabolic disease, an area the Florence-based group has flagged as a strategic priority alongside its existing cardiometabolic, oncology, gastroenterology, diabetology, pneumology and anti-inflammatory portfolios. Menarini currently operates in 140 countries with consolidated revenue of €4.88 billion and more than 17,000 employees.
Gan & Lee plans global Phase 3 program to support European and other strictly regulated market filings
Gan & Lee intends to launch a global Phase 3 clinical program for bofanglutide to support regulatory submissions in Europe and other tightly regulated markets. Wei Chen, Chairman and CEO of Gan & Lee, said the partnership marks the company's transformation from an insulin leader into a global innovator in metabolic disease, combining its clinical development, manufacturing and supply capabilities with Menarini's regulatory strategy and commercial execution strength.
Elcin Barker Ergun, CEO of Menarini Group, said the biweekly dosing regimen offers a differentiation opportunity as the company works with Gan & Lee to complete further pivotal studies and bring the drug to patients across its territories.
Drug remains unapproved as safety and efficacy await review by EMA and other health authorities
Bofanglutide has not been evaluated or authorized by the European Medicines Agency or any other health authority, and it is not approved for commercial distribution in any market.