By Fineline Cube Gan & Lee Pharmaceuticals (SHA: 603087) announced that its insulin glargine injection and pre‑filled insulin glargine injection pen have received approval from the Ethiopian Food and Drug Authority, marking the company’s entry into the African market and challenging Sanofi’s dominant position.
Regulatory Milestone
| Item | Detail |
|---|---|
| Company | Gan & Lee Pharmaceuticals (603087.SH) |
| Products | Insulin glargine injection; Pre‑filled insulin glargine injection pen |
| Approval | Ethiopian Food and Drug Authority |
| Indication | Diabetes mellitus |
| Approval Date | 14 Jan 2026 |
| Market Status | First Chinese insulin glargine in Ethiopia |
Drug Profile & Mechanism
Insulin glargine is a long‑acting basal insulin administered via once‑daily subcutaneous injection, providing 24‑hour blood glucose‑lowering effects with:
- Prolonged duration of action
- Stable blood concentration without peaks
- Consistent blood sugar control
This profile offers improved patient compliance and reduced hypoglycemia risk compared to intermediate‑acting insulins.
Market Opportunity & Competitive Landscape
| Parameter | Ethiopia | Sanofi’s Global Sales |
|---|---|---|
| Diabetes Prevalence | 5.2 million | – |
| Insulin‑Dependent Patients | 420,000 | – |
| Insulin Glargine Market Share | 100 % (Sanofi) | – |
| Sanofi’s Lantus 2024 Sales | – | EUR 2.855 billion |
| Gan & Lee Pricing Strategy | 30 % discount to Lantus | – |
| Addressable Market Value | USD 45 million (2030E) | – |
- Current Standard: Sanofi’s Lantus is the sole supplier in Ethiopia’s insulin glargine market
- Unmet Need: Limited access to affordable basal insulin in sub‑Saharan Africa
- Differentiation: Gan & Lee’s pre‑filled pen offers convenience at a lower cost
Strategic Positioning
- Geographic Expansion: Marks Gan & Lee’s first regulatory approval in Africa, establishing a foothold in the fast‑growing diabetes market
- Manufacturing: Company’s Beijing biologics facility (capacity 10,000 L) will supply Ethiopia, with cold‑chain logistics partnerships already established
- Pricing Advantage: 30 % discount to Sanofi’s Lantus positions Gan & Lee as a cost‑effective alternative in price‑sensitive markets
- Revenue Forecast: Ethiopia launch expected Q2 2026, projecting USD 8 million in first‑year sales and USD 45 million by 2030
Forward‑Looking Statements
This brief contains forward‑looking statements regarding market penetration, revenue forecasts, and competitive dynamics for Gan & Lee’s insulin glargine in Ethiopia. Actual results may differ due to pricing pressures, regulatory changes, and market access challenges.-Fineline Info & Tech