Menarini licenses Gan & Lee's every-two-weeks GLP-1 bofanglutide for Europe
Menarini is paying $72 million up front for European rights to bofanglutide, an every-two-weeks GLP-1 still in late-stage testing, so nothing changes yet for US patients.
Italian drugmaker Menarini Group has agreed to pay Gan & Lee Pharmaceuticals €62 million ($72 million) up front for European rights to bofanglutide, an experimental GLP-1 medicine for obesity and excess weight that is injected once every two weeks [1][2]. The deal announced Sept. 3, 2026 also includes up to €664 million ($771 million) in milestone payments and double-digit royalties on sales, for a potential total of about €726 million [1][2].
Menarini will take over regulatory submissions and commercialization in 39 markets: the 27 European Union countries, the United Kingdom, Switzerland, Norway, Iceland, Liechtenstein and the Balkan countries [1][2].
Bofanglutide is not approved in Europe, and no European registration package came with the license [1]. Gan & Lee has completed a Phase 3 trial in China and a Phase 2 trial in the United States in people who were overweight, obese or had type 2 diabetes; both met their primary endpoints, with weight loss and tolerability described as consistent with other GLP-1 medicines [1][2]. In the Chinese Phase 3 trial, called GRADUAL-1, 640 adults taking bofanglutide every two weeks lost an average of 15.12% of body weight at the 24 milligram dose and 18.54% at the 48 milligram dose after 52 weeks, compared with 1.11% for placebo [1]. In the US Phase 2 trial, the 48 milligram dose produced 15.18% mean weight loss at 36 weeks, compared with 16.93% in an open-label tirzepatide arm [1]. Tirzepatide is the molecule in Mounjaro and Zepbound. Gan & Lee said weight loss with bofanglutide had not reached a plateau, so longer follow-up could show a larger gap, but that remains unproven [1].
The license covers the bofanglutide injection for obesity and excess weight. Gan & Lee keeps rights to other uses of the drug in Europe and retains the United States and other territories [1]. The company is already studying injectable bofanglutide in Phase 3 programs for type 2 diabetes and for obesity with moderate-to-severe obstructive sleep apnea [1]. It is also testing a once-monthly bofanglutide injection in a Phase 3 trial in China and an oral tablet in early clinical trials; neither company has said whether the European license extends to the pill [1].
"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," Wei Chen, chairman and CEO of Gan & Lee, said in a Sept. 3 statement [2]. Menarini group CEO Elcin Barker Ergun said clinical results so far showed weight reduction, secondary metabolic benefits and a safety profile consistent with expectations for the class, while the once-every-two-weeks regimen "offers an opportunity for differentiation" [2]. The companies said Gan & Lee intends to start a global Phase 3 program to support registration in Europe and other highly regulated markets [1].
Europe is the fourth territory Gan & Lee has licensed out, after Latin America to Carnot Laboratorios in November 2025, India to Lupin on Dec. 29 and South Korea to JW Pharmaceutical in April [1]. JW paid $5 million (€4.3 million) up front against up to $76.1 million (€65.8 million) in milestones for one country and four indications, while Menarini's €62 million up front buys 39 countries and one indication [1]. Gan & Lee's Shanghai filing calls the European deal bofanglutide's largest by potential value [1].
Competitors have already moved beyond injections in Europe. The European Commission approved the Wegovy pill, semaglutide, on July 15; it has been on sale in the UK since July, and Novo Nordisk launched it in Germany on Sept. 1 [1]. Eli Lilly's Foundayo pill, orforglipron, launched in the UK in late August [1]. Menarini is also waiting on a European Commission decision on NewAmsterdam's cholesterol pill obicetrapib, which the CHMP recommended for approval in July with Menarini as applicant and European seller [1].
Why it matters for patients
For people taking semaglutide or tirzepatide now, this deal changes nothing. Bofanglutide is a late-stage development program, not a launch-ready product, and the license covers Europe, not the United States [1]. The clearest potential difference is convenience: one injection every two weeks instead of weekly [1][2]. The reported data so far show no efficacy advantage. In the only head-to-head comparison cited, the 48 milligram dose trailed an open-label tirzepatide arm on mean weight loss at 36 weeks, 15.18% versus 16.93% [1]. The Phase 3 results come from a trial in China, and whether they carry over to European or American populations has not been established. Because the license covers only the injection, an oral version would not automatically be part of this European arrangement [1].
What happens next
Gan & Lee says it intends to begin a global Phase 3 trial to support registration in Europe and other highly regulated markets, but neither company disclosed a start date [1][2]. No European marketing application for bofanglutide has been filed, and no timeline for one has been reported [1]. Separately, a European Commission decision on obicetrapib is pending after the July CHMP recommendation [1].
Sources
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