Gan & Lee licenses obesity drug bofanglutide to Menarini for European markets

Gan & Lee Pharmaceuticals has signed an exclusive license agreement with the multinational biopharmaceutical company Menarini Group to jointly pursue registration and commercialization of bofanglutide, a GLP-1 receptor agonist Gan & Lee developed in-house for treating obesity and overweight in adults. The drug, known by the development code GZR18, is dosed once every two weeks.

Under the deal, Gan & Lee stands to receive an upfront payment of 62 million euros plus milestone payments that could total up to 664 million euros, along with double-digit royalties on net sales across the licensed territory. That puts the total potential deal value, excluding royalties, at up to 726 million euros. Menarini will handle regulatory filings and commercial rollout across 39 countries: all 27 European Union member states, plus the UK, Switzerland, Norway, Iceland, Liechtenstein and countries in the Balkans.

Bofanglutide is classified as a China Class 1 investigational drug. Its main differentiator is a subcutaneous dosing schedule of once every two weeks, cutting administration frequency in half compared with the once-weekly GLP-1 receptor agonists already on the market. Both a pivotal Phase 3 trial in China and a Phase 2 trial in the US, evaluating the drug for weight management in adults with obesity or overweight, hit their primary endpoints, showing weight-loss efficacy and a tolerability profile in line with other drugs in the GLP-1 class.

Gan & Lee considers bofanglutide the flagship asset in its pipeline and is pursuing global partnerships to move it through registration and commercialization. The company plans to launch a global Phase 3 program to support registration in Europe and other tightly regulated markets, and says it intends to keep expanding internationally through its own R&D and product development.

Wei Chen, Gan & Lee’s chairman and chief executive, said the partnership opens a clear path for bofanglutide to enter the European market and represents another step in the company’s shift from an insulin-focused business to a global player in metabolic disease. He said combining Gan & Lee’s strengths in clinical development, manufacturing and supply with Menarini’s regulatory and commercial expertise is meant to give millions of people living with obesity or overweight across the licensed territories another treatment option.

Elcin Barker Ergun, Menarini’s group chief executive, said bofanglutide’s clinical results to date have shown weight reduction, additional metabolic benefits, and a safety profile consistent with what’s expected from this drug class, while its twice-monthly dosing gives it room to stand out from competitors. She said Menarini is looking forward to working closely with Gan & Lee to complete further pivotal studies and bring the drug to patients across its territories, drawing on the company’s existing capabilities and market knowledge.

For Gan & Lee, the deal extends its pipeline’s geographic reach and deepens its foothold in tightly regulated markets. For Menarini, it advances the company’s push into the metabolic disease space as part of its broader strategy in primary and specialty care.

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Gan & Lee, Menarini, obesity drug bofanglutide