Gan & Lee Partners with Menarini for Bofanglutide Commercialization

BEIJING and FLORENCE, Italy, Gan & Lee Pharmaceuticals, a leading biopharmaceutical company in China, has entered into an exclusive license agreement with Menarini Group, a multinational biopharmaceutical firm, to advance the registration and commercialization of bofanglutide, an independently developed glucagon-like peptide-1 receptor agonist (GLP-1 RA) for the treatment of obesity and overweight adults. Under the terms of the agreement, Menarini will handle regulatory submissions and commercialization in a total of 39 countries, including the European Union, the United Kingdom, and other Balkan nations.

Gan & Lee is eligible for an upfront payment of €62 million and potential milestone payments totaling up to €664 million, with double-digit royalties on net sales. The total potential value of the deal is €726 million, excluding royalties.

Bofanglutide, developed by Gan & Lee, is a Class 1 investigational drug that features a once-every-two-weeks subcutaneous dosing regimen, reducing administration frequency by 50% compared to once-weekly GLP-1 RAs. Clinical studies in China and the United States have demonstrated weight-loss efficacy and a consistent tolerability profile with other GLP-1RA class therapies.

Dr. Wei Chen, Chairman and CEO of Gan & Lee, stated, "This partnership marks a significant milestone for bofanglutide's entry into the European market and underscores Gan & Lee's transition from a leader in insulin to a global innovator in metabolic disease. By leveraging Menarini's regulatory strategy and commercial expertise, we aim to bring alternative therapies to millions of people living with obesity or overweight."

Elcin Barker Ergun, Group CEO of Menarini, commented, "The clinical study results for bofanglutide have shown promising weight reduction and secondary metabolic benefits, with a safety profile consistent with expectations. Its dosing regimen offers a differentiation opportunity. We look forward to collaborating closely with Gan & Lee to complete further pivotal studies and bring this potential new option to patients across our territories."

This agreement represents a transformative milestone for both companies. For Gan & Lee, it signifies an expanded geographical presence in highly regulated markets, reinforcing its position as a global innovator in metabolic disease. For Menarini, the partnership is a crucial step in its mission to expand its footprint in the metabolic space and accelerate innovation in primary and specialty care.

Gan & Lee is actively advancing its global development plan for bofanglutide and intends to initiate a global Phase 3 clinical development program to support registration in Europe and other highly regulated markets. The company remains committed to expanding its global footprint through innovative research and development.

Bofanglutide (GZR18) is an investigational, long-acting GLP-1 RA in clinical development for weight management in adults with obesity or overweight, type 2 diabetes mellitus, and other metabolic conditions. It is not authorized for commercial distribution by the European Medicines Agency (EMA) or other health authorities.

Gan & Lee, with a focus on insulin analogs and a comprehensive biologic research and development pipeline, is dedicated to achieving comprehensive coverage across diabetes and obesity treatment landscapes. The company is also pursuing innovative chemical drugs and biologics, with a strategic focus on metabolic diseases, cardiovascular diseases, immunology diseases, and other therapeutic areas.

The Menarini Group, headquartered in Florence, Italy, is a global pharmaceutical company with a presence in 140 countries and a €4.88 billion turnover. Through its commitment to R&D and high-quality manufacturing, Menarini contributes to worldwide patient health, maintaining the highest quality standards.