Gan & Lee and Menarini Group Partner to Advance Bofanglutide in Europe

BEIJING and FLORENCE, Italy, Sept. 3, 2026 /PRNewswire/ -- Gan & Lee Pharmaceuticals ("Gan & Lee"; stock code: 603087.SH) announced that it has entered into an exclusive license agreement with the multinational biopharmaceutical company The Menarini Group ("Menarini"). Under the agreement, the parties will collaborate on the registration and commercialization of Gan & Lee's independently developed glucagon-like peptide-1 receptor agonist (GLP-1 RA), bofanglutide (development code: GZR18), under development for the treatment of adults with obesity or overweight, administered once every two weeks.

Under the agreement, Gan & Lee is eligible to receive an upfront payment of EUR 62million, milestone payments totaling up to EUR 664million, and double-digit royalties on net sales in the licensed territory. The aggregate potential deal value is up to EUR 726million, excluding royalties.

Menarini will be responsible for regulatory submissions and commercialization in the licensed territory in a total of 39 countries: the 27 Member States of the European Union; the United Kingdom, Switzerland, Norway, Iceland, Liechtenstein and Balkans countries.

This agreement marks a strategic milestone in Menarini's mission to expand its footprint in the metabolic space, a critical area that affects an increasingly broad patients' population in need.

Bofanglutide is a China Class 1 investigational drug independently developed by Gan & Lee. Its key feature is a once-every-two-weeks subcutaneous dosing regimen, which reduces administration frequency 50% compared with once-weekly GLP-1 RAs. The pivotal Phase 3 study in China and the Phase 2 study in the United States for weight management in adults with obesity or overweight both met their primary endpoints, demonstrating weight-loss efficacy and consistent tolerability profile with other GLP-1RA class therapies.    

Gan & Lee regards bofanglutide as a flagship product of its innovative pipeline and is advancing its registration and commercialization through global partnerships. Menarini will represent a strategic partner to expand Bofanglutide's presence in highly regulated markets, accelerating the development potential of such strategic asset on a global footprint.      

Looking ahead, Gan & Lee is actively advancing the 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 will continue to expand its global footprint through innovative R&D and high-quality products.

Commenting on the agreement, Dr. Wei Chen, Chairman and CEO of Gan & Lee said, "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."

Elcin Barker Ergun, Group CEO of Menarini, said, "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."      

From a global strategy perspective, this agreement represents a transformative milestone for both companies. For Gan & Lee, it marks an extended geographical expansion for its innovative pipeline, further strengthening its presence in highly regulated markets. For Menarini, the partnership is a critical step in its mission to expand its footprint in the metabolic space and accelerate its journey towards innovation in Primary and Specialty Care.      

This license agreement represents another important milestone in the continued advancement of Gan & Lee's global strategy. As a leading European pharmaceutical company with deep market expertise and an established commercial network, Menarini is an ideal partner for bofanglutide in Europe. Through close collaboration, Gan & Lee and Menarini aim to advance this differentiated investigational medicine efficiently and broaden access for patients.       

About Bofanglutide

Bofanglutide (GZR18) is an investigational, long-acting glucagon-like peptide-1 receptor agonist (GLP-1 RA) independently developed by Gan & Lee Pharmaceuticals. It is currently in clinical development under a once-every-two-weeks administration schedule for weight management in adults living with obesity or overweight, type 2 diabetes mellitus (T2DM), and other metabolic conditions. Bofanglutide is an investigational compound; its safety and efficacy have not been established or authorized by the European Medicines Agency (EMA) or other health authorities, and it is not approved for commercial distribution.                 

About Gan & Lee

Gan & Lee Pharmaceuticals is a high-tech biopharmaceutical company and the first in China to master industrial-scale manufacturing technologies for recombinant insulin analogs. The Company has established a comprehensive biologic research and development pipeline. Looking forward, Gan & Lee is committed to achieving comprehensive coverage across the diabetes and obesity treatment landscape and further enhancing its competitive position in this therapeutic area. The Company will also actively pursue the development of innovative chemical drugs and biologics, with a strategic focus on metabolic diseases, cardiovascular diseases, immunology diseases, and other therapeutic areas. www.ganlee.com

About The Menarini Group

The Menarini Group, with headquarters in Florence, is present in 140 countries worldwide to date, with €4.88 billion in consolidated turnover and more than 17,000 employees. Menarini's products are present in the most important treatment areas, including those of cardiometabolic, oncology, gastroenterology, diabetology, pneumology, and anti-inflammatory/analgesic products. Through its commitment in R&D and high quality manufacturing activities, Menarini continuously contributes to patients' health worldwide, maintaining the highest quality standards. www.menarini.com

(Translations: in the event of any discrepancy, the English language version prevails)

SOURCE Menarini Industrie Farmaceutiche Riunite