Gan & Lee Pharmaceuticals reveals competitive Phase 2 results for bofanglutide and GZR4 at ADA 2025 sessions

What were the key clinical results presented by Gan & Lee Pharmaceuticals at ADA 2025 regarding its diabetes drug candidates?

Gan & Lee Pharmaceuticals (SSE: 603087.SH), the Chinese insulin-focused biopharma group, announced a series of promising results from multiple Phase 2 clinical trials involving its lead investigational diabetes treatments—bofanglutide and GZR4—at the 85th Scientific Sessions of the American Diabetes Association (ADA) held in June 2025. These findings highlight the company’s deepening footprint in long-acting GLP-1 receptor agonists and weekly basal insulin analogs, critical areas of competition in the expanding type 2 diabetes market.

The Beijing and Bridgewater-based pharmaceutical manufacturer showcased data from three trials assessing efficacy, safety, and metabolic impact of bofanglutide, an ultra-long-acting GLP-1 receptor agonist, and GZR4, a once-weekly basal insulin analog. The studies involved treatment-naïve and previously treated Chinese adults with type 2 diabetes mellitus (T2DM) and compared Gan & Lee’s candidates with well-established drugs including semaglutide (Ozempic®) and insulin degludec (Tresiba®).

First developed as a domestic insulin innovator in China, Gan & Lee Pharmaceuticals has since expanded its development focus to next-generation injectable therapies. Institutional investors following the company’s pipeline view these latest results as a strategic leap in addressing unmet demand in long-acting diabetic care, especially in emerging Asian markets and regulatory pathways in China.

How did the bofanglutide injection perform in the Phase 2a trial targeting Chinese patients with type 2 diabetes?

In a 23-week Phase 2a study (Clinical ID: NCT06256523), Gan & Lee Pharmaceuticals evaluated bofanglutide in 36 Chinese adults with uncontrolled T2DM despite lifestyle interventions or irregular use of oral antidiabetic agents. Patients were randomized to receive either a once-weekly bofanglutide injection (1.5 mg up to 13 mg) or placebo.

After 23 weeks of treatment, patients on bofanglutide saw a mean HbA1c reduction of 1.81%, compared to a marginal 0.12% increase in the placebo arm. The estimated treatment difference of -1.93% points was considered clinically significant. Moreover, 57.7% of patients on bofanglutide achieved HbA1c levels under 7.0%, while 46.2% reached the more aggressive target of ≤6.5%—versus none in the placebo group.

Weight loss emerged as a notable secondary benefit, with participants shedding an average of 6.92 kg (9.3% of baseline weight), compared to just 1.2% in the placebo cohort. Additional benefits included improvements in fasting plasma glucose, glycated albumin, waist circumference, blood pressure, and lipid metrics.

From a tolerability perspective, the investigational drug showed a favorable profile. Most adverse events were gastrointestinal and occurred early during dose escalation. No hypoglycemic events or treatment-related serious adverse events were recorded.

How does Gan & Lee’s bofanglutide compare to semaglutide based on head-to-head Phase 2b trial results?

Gan & Lee Pharmaceuticals reported compelling comparative efficacy for bofanglutide versus semaglutide in a randomized Phase 2b trial (NCT06256549) involving 272 Chinese patients with inadequately controlled T2DM. Participants were administered either bi-weekly or weekly doses of bofanglutide or a standard 1 mg weekly dose of semaglutide.

At week 24, HbA1c reductions in the various bofanglutide groups ranged from 1.87% to 2.32%, outperforming semaglutide, which posted a 1.60% reduction. The once-weekly 24 mg regimen and the 18 mg bi-weekly group delivered statistically superior outcomes (p < 0.001). Among drug-naïve patients, the 18 mg bi-weekly regimen achieved a 2.98% HbA1c reduction, a full percentage point better than semaglutide.

Weight loss also favored bofanglutide, with patients experiencing 4.26 to 6.54 kg in reductions across the regimens, compared to 3.25 kg for semaglutide. The therapy again delivered improvements in blood glucose, pressure, lipid panels, and other metabolic indicators.

The safety profile was consistent with GLP-1 RA class effects—mild-to-moderate gastrointestinal discomfort being most common. No treatment-related hypoglycemia was observed, suggesting a competitive therapeutic profile relative to semaglutide.

What outcomes were observed in the Phase 2 study comparing GZR4 with insulin degludec in type 2 diabetes patients?

Gan & Lee Pharmaceuticals also presented data on its once-weekly insulin analog GZR4 in a 16-week Phase 2 trial (NCT06202079) comparing it with once-daily insulin degludec (Tresiba®). The study enrolled 179 Chinese patients divided into two parts: those on oral antidiabetic drugs (Part A) and those on oral drugs plus basal insulin (Part B).

In Part A, both GZR4 and insulin degludec achieved comparable HbA1c reductions (−1.50% vs −1.48%, p=0.90). However, in Part B—patients previously on basal insulin—GZR4 achieved a significantly better reduction (−1.26%) compared to degludec (−0.87%, p<0.01). Moreover, GZR4 outperformed in achieving HbA1c targets of <7.0% and ≤6.5%, at 52.1% and 25.0% respectively, versus 29.2% and 10.4% for insulin degludec.

Importantly, GZR4 did not require a loading dose and achieved these outcomes with approximately 40–50% less insulin (molar) per week than the comparator. Time-in-range and fasting glucose improvements were similar across groups. The once-weekly formulation also showed a comparable safety profile, with no severe hypoglycemia or serious adverse events tied to the drug.

How are institutional investors and diabetes researchers interpreting Gan & Lee’s clinical momentum?

While Gan & Lee Pharmaceuticals is not yet commercializing either bofanglutide or GZR4, the Phase 2 results mark a critical inflection point for the Chinese insulin innovator. Institutional investors closely monitoring China’s expanding biotech sector interpret these data as a sign that Gan & Lee could emerge as a global contender in the long-acting injectables space, particularly with China’s strong centralized procurement systems and expanding diabetes population.

The comparative data against semaglutide and insulin degludec—two global standards of care—has strengthened perceptions of Gan & Lee’s R&D credibility. Though the trials were conducted in China, analysts suggest the pharmacodynamic characteristics, safety signals, and robust design of the studies could facilitate broader regulatory filings, including those targeting Asian, Latin American, and potentially European markets.

Given that the American market is heavily saturated and price-pressured, Gan & Lee’s strategic focus on emerging economies could carve out a niche in the competitive GLP-1 and insulin analog landscape.

What is the future outlook for Gan & Lee Pharmaceuticals’ diabetes pipeline and commercialization strategy?

Following the ADA 2025 data reveal, Gan & Lee Pharmaceuticals confirmed it has initiated large-scale Phase 3 clinical programs for both bofanglutide and GZR4 in China. These late-stage studies are expected to evaluate broader patient populations, long-term outcomes, and potential label indications.

If Phase 3 trials confirm the Phase 2 efficacy and safety trends, analysts anticipate filings with China’s National Medical Products Administration (NMPA) by late 2026. Gan & Lee could also explore international submissions through regional partnerships.

The Chinese drug developer, which ranked first in insulin analog procurement demand in 2024, continues to leverage its production scale, device portfolio—including the FDA-approved GanleeFine® needle—and clinical data to strengthen its domestic and global positioning.

Beyond diabetes, Gan & Lee is also moving into other areas of metabolic and cardiovascular disease, with a pipeline that includes both biologics and new chemical entities. The company’s goal to become a world-class pharmaceutical player appears increasingly feasible, supported by both pipeline innovation and international regulatory progress.