By Fineline Cube 
Gan & Lee Pharmaceuticals (SHA: 603087) announced that two pivotal Phase III clinical studies, SUPER-1 and SUPER-2, evaluating its independently developed once-weekly basal insulin candidate GZR4 injection, successfully met their pre-specified primary endpoints with superior glycated hemoglobin (HbA1c) reduction compared to established daily basal insulins.
Clinical Trial Results
| Study | Comparator | Patient Population | HbA1c Reduction (26 weeks) | Result |
|---|---|---|---|---|
| SUPER-1 | Insulin glargine U100 (Lantus) | 588 insulin-naïve Chinese T2DM adults | -1.45% vs -1.22% | Statistically superior |
| SUPER-2 | Insulin degludec (Tresiba) | 631 previously insulin-treated Chinese T2DM adults | -1.00% vs -0.58% | Statistically superior |
Drug Profile & Innovation
- Molecule: GZR4 injection – ultra-long-acting once-weekly basal insulin
- Administration: Single weekly subcutaneous injection
- Mechanism: Designed to provide effective and stable glycemic control with improved convenience
- Development Status: Independently developed by Gan & Lee Pharmaceuticals
- Safety Profile: Favorable safety and tolerability demonstrated in both Phase III studies
Study Design Details
SUPER-1 Study
- Population: 588 Chinese adult patients with type 2 diabetes (T2DM)
- Insulin Status: Insulin-naïve (no prior insulin therapy)
- Comparator: Once-daily insulin glargine U100 (Lantus)
- Background Therapy: Both arms received non-insulin glucose-lowering drugs
- Primary Endpoint: Change in HbA1c from baseline at 26 weeks
SUPER-2 Study
- Population: 631 Chinese adult patients with T2DM
- Insulin Status: Previously received basal insulin therapy
- Comparator: Once-daily insulin degludec (Tresiba)
- Background Therapy: With or without non-insulin glucose-lowering drugs
- Primary Endpoint: Change in HbA1c from baseline at 26 weeks
Market Impact & Strategic Significance
- Diabetes Treatment Landscape: Weekly basal insulin represents a significant advancement over current daily injection regimens, potentially improving patient adherence and quality of life
- Competitive Positioning: GZR4 demonstrates superior efficacy against both Lantus (Sanofi) and Tresiba (Novo Nordisk), the two leading basal insulin products globally
- Commercial Opportunity: China has over 140 million diabetes patients, representing the world’s largest diabetes market with substantial unmet needs for improved insulin therapies
- Global Potential: Successful Phase III results position GZR4 for international regulatory submissions and potential global commercialization
Development Timeline & Next Steps
- Regulatory Pathway: Gan & Lee expected to initiate New Drug Application (NDA) submissions to China NMPA in 2026
- Global Expansion: Company likely to pursue international clinical development and regulatory filings following domestic approval
- Manufacturing Scale-up: Commercial-scale manufacturing capabilities being prepared for potential market launch
Forward‑Looking Statements
This brief contains forward-looking statements regarding clinical trial results, regulatory submissions, and commercial potential for GZR4. Actual results may differ due to risks including regulatory decisions, competitive dynamics, and market acceptance.-Fineline Info & Tech