By Fineline Cube 
Tonghua Dongbao Pharmaceuticals Co., Ltd. (SHA: 600867) announced that its Insulin Aspart Injection 3 ml : 300 IU pre‑filled pen has received approval from the Ministry of Public Health and Social Assistance of the Dominican Republic, clearing the drug for commercial launch in the island nation.
Product & Regulatory Overview
| Item | Details |
|---|---|
| Product | Insulin Aspart Injection 3 ml pre‑filled pen (100 units per ml × 3 ml = 300 IU) |
| Regulator | Ministry of Public Health and Social Assistance – Dominican Republic |
| Launch Status | Market‑ready as of 13 Nov 2025 |
| Key Feature | Rapid‑acting insulin analog; on‑set 10‑20 min, duration 3–5 h |
The pre‑filled pen format allows for precise dosing and ease of use—critical attributes for post‑prandial glucose control in type 1 and insulin‑requiring type 2 diabetes patients.
Why Insulin Aspart Matters
- Fast Onset – Activity begins 10–20 min after subcutaneous injection.
- Short Duration – Effective 3–5 h, ideal for meal‑time glycaemic excursions.
- Clinical Use – Administered just before or immediately after a meal, usually combined with a long‑acting analog to meet both basal and bolus needs.
In the U.S. and Europe, insulin aspart (Humalog®, NovoRapid®) is a mainstay of basal‑bolus regimens; its global market is valued at > USD 3 billion annually.
Strategic Significance for Tonghua Dongbao
- Geographic Expansion – First entry into the Latin‑American market for a rapid‑acting insulin analog.
- Revenue Diversification – Opens a new revenue stream beyond Tonghua’s existing Chinese‑domestic portfolio.
- Supply Chain Advantage – Pre‑filled pens reduce manufacturing complexity and lower unit‑costs versus vial‑syringe systems.
Implications for the Dominican Pharmaceuticals Landscape
- Market Gap Closure – Prior to this approval, the Dominican Republic relied almost exclusively on human insulin preparations for diabetes therapy.
- Patient Adherence – The convenience of a pre‑filled pen can improve adherence and reduce diabetes‑related complications.
- Competitive Pressure – Local manufacturers of human insulin may need to re‑evaluate pricing and distribution strategies to retain market share.
Forward‑looking Statements
The perspectives expressed herein are forward‑looking and subject to risk factors that could cause actual results to differ materially.-Fineline Info & Tech