By Fineline Cube 
Innovent Biologics, Inc. (HKG: 1801) announced that mazdutide received marketing approval from Macau’s drug regulatory authority for long‑term weight management in adult patients with obesity or overweight. The drug, a dual GCG/GLP‑1 receptor agonist, is already approved in mainland China for weight management and type 2 diabetes.
Regulatory Milestone
| Item | Details |
|---|---|
| Approval Date | 15 Dec 2025 |
| Territory | Macau Special Administrative Region, China |
| Product | Mazdutide injection |
| Indication | Long‑term weight management for adults with obesity/overweight |
| Mechanism of Action | Dual GCG/GLP‑1 receptor agonist |
| Mainland Approvals | • Weight management (diet + exercise) • Type 2 diabetes (glycemic control) |
Drug Profile & Competitive Position
| Attribute | Mazdutide | Market Context |
|---|---|---|
| Mechanism | Dual GCG/GLP‑1 agonist | Similar to Lilly’s tirzepatide (GIP/GLP‑1) but adds glucagon pathway |
| Administration | Weekly subcutaneous injection | Competes with semaglutide, tirzepatide |
| Differentiation | First domestically developed dual GCG/GLP‑1 approved in China | Priced 30‑40% below imported agents |
| Mainland Launch | Weight management and diabetes indications approved 2025 | Building market presence ahead of Macau rollout |
Market Opportunity
| Metric | Value | Implication |
|---|---|---|
| Macau Obesity Prevalence | ~15% of adult population (2024) | ~60,000 eligible patients |
| Greater China GLP‑1 Market | ¥15‑20 billion (≈ US$2.1‑2.8 B) (2025) | Growing 40% annually |
| Mazdutide Peak Sales (Macau) | ¥80‑120 million (≈ US$11‑17 M) by 2029 | 30‑40% share of eligible patients |
| Pricing Strategy | Premium to mainland but competitive vs. imported agents | Supports rapid adoption in private clinics |
Strategic Implications
- For Innovent: Regional expansion into Macau strengthens Greater China franchise; demonstrates regulatory consistency across Chinese territories; builds foundation for Hong Kong filing expected 2026.
- For Patients: Local access to innovative weight management therapy; reduces need for cross‑border medical tourism; aligns with Macau’s diversification into healthcare tourism.
- For Market: Domestic innovation in metabolic disease gaining traction; dual agonist mechanism positions mazdutide as a formidable competitor to global GLP‑1 leaders; potential for global out‑licensing if US/EU trials are pursued.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding mazdutide’s commercial rollout in Macau, market penetration, and potential for further regional expansion. Actual results may differ due to pricing negotiations, competitive responses, and market access dynamics.-Fineline Info & Tech