Gan & Lee from China reveals mid-stage data for domestic obesity drug

As Novo Nordisk and Eli Lilly secure approvals for their obesity drugs in China, Beijing-based Gan & Lee Pharmaceuticals has released promising Phase IIb results for its GZR18, a bi-weekly GLP-1 receptor agonist. This randomized study, conducted at clinical trial centers across China, enrolled 340 adults who were either obese (BMI≥28) or overweight (BMI≥24) with at least one weight-related comorbidity.

Participants were administered GZR18 in various dosages: 12 mg, 18 mg, 24 mg, and 48 mg every two weeks, or a once-weekly 24 mg dose, or a placebo over a 30-week period. Gan & Lee reported significant weight loss among participants in the GZR18 groups compared to those on placebo. The most notable result came from the once-weekly injection group, which saw an average body weight reduction of 17.78% from baseline. Close behind was the 48-mg bi-weekly dose group with a 17.29% reduction in body weight. The company noted that there was no significant difference between these two groups.

Other dosage groups also showed promising results: the bi-weekly 12-mg, 18-mg, and 24-mg groups experienced weight changes of 11.15%, 13.22%, and 14.25%, respectively. In contrast, the placebo group showed a modest change of -0.99% over the same period. The study also indicated that GZR18 injections were generally safe and well-tolerated, with the most commonly reported adverse events being mild-to-moderate gastrointestinal reactions, aligning with the known safety profile of the drug class. Detailed results from this Phase IIb study are expected to be published later this year in a peer-reviewed journal.

The landscape for obesity treatments in China is heating up following the recent approvals of Eli Lilly’s dual GIP/GLP-1 receptor agonist tirzepatide, marketed as Zepbound, and Novo Nordisk's GLP-1 agonist Wegovy (semaglutide). With the potential success of GZR18, Gan & Lee could provide Chinese patients a homegrown alternative to these foreign offerings. The bi-weekly dosing of GZR18 might serve as a competitive edge, given that both Zepbound and Wegovy require weekly injections.

However, Gan & Lee's path forward with GZR18 is likely to be challenging. Both Novo Nordisk and Eli Lilly are making substantial investments to scale up their production capacities to meet the increasing global demand for their obesity treatments. Recently, Eli Lilly committed $5.3 billion to expand its Indiana production site, and Novo Nordisk announced plans to build a $4.1-billion fill-finish facility in the United States, along with plans to expand its manufacturing site in Tianjin, China.

As Gan & Lee contemplates moving GZR18 into Phase III trials, the company faces the challenge of competing against these global pharmaceutical giants. Nevertheless, the promising results from the Phase IIb study suggest that GZR18 has the potential to be a viable obesity treatment option in China, offering a unique dosing schedule and a domestically developed alternative in an increasingly competitive market.