China-based Gan & Lee Pharmaceuticals (603087.SH) reported simultaneous positive Phase III readouts for two metabolic disease candidates on June 12, positioning the company with a credible dual-pipeline story in diabetes and obesity at a time when both markets are being reshaped by GLP-1 receptor agonists. The results matter because they extend the evidence base for once-weekly basal insulin — a format still seeking broad regulatory validation — while also offering early indication that bofanglutide, Gan & Lee's biweekly GLP-1 agonist, can produce weight loss magnitudes competitive with approved therapies.
Trial data
The pivotal readout for long-actal basal insulin ludefen (GZR4) came from SUPER-3, a 26-week, treat-to-target trial enrolling 596 adults with type 2 diabetes previously treated with basal-bolus, premixed, or dual insulin analogs — a more complex population than the insulin-naïve or basal-only patients studied in earlier SUPER trials. Once-weekly ludefen combined with prandial insulin aspart demonstrated superior HbA1c reduction versus once-daily Sanofi's Lantus (insulin glargine U100), with a between-group difference of −0.17% (p=0.0021). No severe hypoglycemia occurred in the ludefen arm, compared with three events in the glargine group. SUPER-1 and SUPER-2 had previously shown superiority over glargine and Novo Nordisk's Tresiba (insulin degludec), respectively, in simpler patient populations; SUPER-3 now extends that signal into patients with heavier injection burdens and longer disease duration.
For bofanglutide, the GRADUAL-1 Phase III trial in 640 adults with overweight or obesity in China met its primary endpoint after 52 weeks. Participants receiving biweekly bofanglutide at 24 mg and 48 mg lost a mean 15.12% and 18.54% of body weight, respectively, versus 1.11% for placebo. A concurrent Phase II study (NCT06737042) enrolling 326 participants across 20 US sites also met its primary endpoint; the 48 mg bofanglutide group achieved 15.18% weight loss at 36 weeks, while an open-label tirzepatide comparator arm reached 16.93%. Gastrointestinal adverse events were the most common finding in both studies, described as mild and transient, consistent with the GLP-1 receptor agonist class profile.