Menarini licenses Gan & Lee's every-two-weeks GLP-1 for Europe

Italy's Menarini Group has agreed to pay China's Gan & Lee Pharmaceuticals €62 million upfront, up to €664 million in milestone payments, and double-digit royalties for European rights to bofanglutide, a long-acting GLP-1 drug given by injection once every two weeks ^[1][2]. The deal covers 39 markets, including the 27 European Union countries, the UK, Switzerland, Norway, Iceland, Liechtenstein, and Balkan countries ^[2]. Menarini will handle regulatory submissions and sales in that territory, while Gan & Lee keeps rights elsewhere, including the United States ^[1][2].

Bofanglutide's main selling point so far is dosing frequency rather than proven superior weight loss. In a 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 mg dose and 18.54% at the 48 mg dose after 52 weeks, compared with 1.11% for those on placebo ^[1]. In a separate US Phase 2 trial, the 48 mg dose produced 15.18% mean weight loss at 36 weeks, versus 16.93% for an open-label comparison group taking tirzepatide, the active ingredient in Mounjaro and Zepbound ^[1]. Gan & Lee has said weight loss with bofanglutide had not leveled off in that trial, meaning a longer study could show a different gap, but that has not been demonstrated ^[1]. Both the Chinese Phase 3 and the US Phase 2 trial met their primary goals, and the companies describe the drug's tolerability as consistent with other drugs in its class ^[2].

No European approval package comes with this license. Gan & Lee plans to start a global Phase 3 trial to support registration in Europe and other regulated markets, meaning further large studies still need to run before any regulatory filing ^[1][2]. Menarini's chief executive, Elcin Barker Ergun, said the drug's twice-monthly dosing schedule offers a chance for differentiation compared to weekly injections, while acknowledging that weight loss, other metabolic effects, and safety look consistent with expectations for this class of drugs ^[2].

This is the fourth region Gan & Lee has licensed out for bofanglutide, following deals for Latin America, India, and South Korea ^[1]. The South Korea deal, signed with JW Pharmaceutical, involved a $5 million upfront payment and up to $76.1 million in milestones for one country and four medical uses ^[1]. By comparison, Menarini's €62 million upfront payment covers 39 countries but only one use, weight management ^[1]. Gan & Lee's own regulatory filing describes the European deal as bofanglutide's largest by potential value ^[1].

Why it matters for patients

For now, this deal has no direct effect on people in the United States who take or are considering GLP-1 medications like Ozempic, Wegovy, Mounjaro, or Zepbound. Bofanglutide is not approved anywhere in the West, and Gan & Lee, not Menarini, holds rights to it in the US ^[2]. The license announced this week only covers European markets, and even there, no regulatory application has been filed yet ^[1][2].

The development matters mainly as a signal about competition. Novo Nordisk and Eli Lilly already sell weekly injectable and, in some markets, oral GLP-1 drugs for weight loss, and both companies have moved into pill formulations that patients may find more convenient than injections ^[1]. Whether a drug injected only twice a month offers a real advantage will depend on how bofanglutide's efficacy and side effects compare once larger trials are complete, something that is not yet known ^[1].

What happens next

Gan & Lee has said it plans to start a global Phase 3 trial to support registration in Europe and other highly regulated markets, though no start date has been given ^[1][2]. The company is also testing a once-monthly injectable version of bofanglutide in Phase 3 trials in China and has an early-stage oral tablet in clinical testing, though it is not clear whether Menarini's license extends to either of those forms ^[1].