By Fineline Cube 
China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) announced that the Drug Regulatory Authority of Pakistan (DRAP) has approved its two denosumab biosimilars, 9MW0311 (Rexeva) and 9MW0321 (Denosu). This milestone represents the first time a denosumab biosimilar has been cleared by DRAP and constitutes Mabwell’s inaugural approval outside China.
Product Overview
| Biosimilar | Reference Product | Therapeutic Indication | Approved in China |
|---|---|---|---|
| 9MW0311 – Rexeva | Prolia (60 mg) | Osteoporosis in post‑menopausal women at high fracture risk | March 2023 |
| 9MW0321 – Denosu | XGEVA (120 mg) | Unresectable giant cell tumor of bone (GCTB) or surgery‑unfeasible cases | March 2024 |
Denosumab, originally engineered by Amgen, is a fully human monoclonal antibody that blocks RANKL, thereby inhibiting osteoclast‑mediated bone resorption.
Significance for Mabwell
- Global Expansion – The DRAP approval opens a new market in South Asia, diversifying Mabwell’s international footprint.
- Market Differentiation – By offering two distinct dosing options, Mabwell can cater to a broader patient population, from osteoporosis to aggressive bone tumors.
- Regulatory Milestone – This clearance demonstrates Mabwell’s ability to meet stringent international standards, potentially paving the way for approvals in other emerging markets.
Outlook
Mabwell plans to launch Rexeva and Denosu in Pakistan later this year, with targeted distribution through major hospital networks and specialty pharmacies. The company is also evaluating opportunities in neighboring markets such as India, Bangladesh, and the Middle East, leveraging its proven biosimilar platform and clinical data portfolio.-Fineline Info & Tech