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Bofanglutide: a next-generation, once-every-2-weeks GLP-1 e…

Bofanglutide: a next-generation, once-every-2-weeks GLP-1 entering the global Phase 3 journey

Menarini Group has partnered with Gan & Lee Pharmaceuticals to advance bofanglutide (GZR18) in Europe, with a potential deal value of up to €726 million, excluding royalties.

The deal

Gan & Lee has granted Menarini an exclusive license to register and commercialize bofanglutide across 39 territories: the 27 EU member states, plus the UK, Switzerland, Norway, Iceland, Liechtenstein, and Balkan countries. Gan & Lee stands to receive a €62 million upfront payment, up to €664 million in milestones, and double-digit royalties on net sales.

Why this Phase 3 matters

The current GLP-1 obesity market is essentially a two-horse race between semaglutide and tirzepatide, both dosed once weekly. Bofanglutide's pivotal Phase 3 in China and Phase 2 in the US already met their primary endpoints, showing weight-loss efficacy and a tolerability profile consistent with the class. A global Phase 3 program is now needed to support registration in Europe and other highly regulated markets, and that's the real test. It has to show it can go head to head with semaglutide and tirzepatide on efficacy and safety at scale, not just clear a bar against placebo.

How it could reshape the market

If the global Phase 3 data holds up, bofanglutide's main lever isn't necessarily superior weight loss but dosing convenience. Cutting injections from once weekly to once every two weeks is a meaningful adherence advantage in a category where persistence on therapy is already a known challenge. It also signals that Chinese biopharma is moving from being fast followers to genuine global contenders in metabolic disease, arriving right as supply constraints and pricing pressure on incumbent GLP-1s are pushing payers and patients to look for alternatives. A less frequent, potentially lower cost entrant with comparable efficacy could pressure both pricing and market share once it clears the regulatory bar.

The bigger picture

For Gan & Lee, long known as a Chinese insulin manufacturer, this is another step in becoming a global metabolic disease innovator. For Menarini, it's a deliberate expansion into obesity and metabolic disease, an area where a differentiated dosing profile could open real room in a market currently defined by weekly injectables.

Check out : https://www.menarini.com/en-us/news/news-detail/gan-lee-and-menarini-group-partner-to-advance-bofanglutide-in-europe.html

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

www.menarini.com

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

<p>Gan &amp; Lee Pharmaceuticals (&quot;Gan &amp; Lee&quot;; stock code: 603087.SH) announced that it has entered into an exclusive license agreement with the multinational biopharmaceutical company The Menarini Group (&quot;Menarini&quot;). Under the agreement, the parties will collaborate on the registration and commercialization of Gan &amp; 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.&nbsp;</p>

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