By Fineline Cube Mabwell (Shanghai) Bioscience Co., Ltd. (SHA: 688062, HKG: 2493) announced that it has entered into licensing agreements with local partners in the Philippines, Vietnam, and Malaysia for 9MW0813 (aflibercept). Under the agreements, Mabwell will work with its partners to advance the product’s registration and commercialization in these countries.
Deal Overview
| Item | Detail |
|---|---|
| Company | Mabwell (Shanghai) Bioscience Co., Ltd. (HKG: 2493) |
| Agreement Type | Licensing agreements with local partners |
| Product | 9MW0813, a biosimilar candidate referencing aflibercept (EYLEA) |
| Territories | Philippines, Vietnam, Malaysia |
| Announcement Date | 12 Aug 2026 |
| Next Steps | Registration and commercialization in the three markets |
Product Profile
- Candidate: 9MW0813, Mabwell’s biosimilar candidate referencing EYLEA (aflibercept), originally developed by Bayer.
- Molecule: Aflibercept is a humanized fusion protein that binds to vascular endothelial growth factors (VEGF‑A and VEGF‑B) and placental growth factor (PlGF), offering a broader range of targets compared to anti‑VEGF monoclonal antibody therapies.
- Indications: Aflibercept is a first‑line therapy for various retinal diseases, including neovascular (wet) age‑related macular degeneration (nAMD) and diabetic macular edema (DME).
Market Impact & Outlook
- Large Ophthalmology Market: Wet AMD and DME are among the leading causes of vision loss in aging and diabetic populations — aflibercept has been one of the world’s best‑selling ophthalmic drugs, making biosimilar entry a significant commercial opportunity.
- Southeast Asia Expansion: The Philippines, Vietnam, and Malaysia represent growing markets for intravitreal therapies, where affordability remains a key barrier — a setting where a lower‑priced biosimilar can expand patient access.
- Local Partner Model: Partnering with established local distributors and registrants reduces execution risk and accelerates market entry versus a direct commercialization approach.
- Biosimilar Pipeline Momentum: The deals reinforce Mabwell’s strategy of leveraging its biosimilar portfolio for international commercialization ahead of reference‑product exclusivity expiries in emerging markets.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding regulatory approvals and commercialization plans for 9MW0813. Actual results may differ due to risks including registration timelines, market adoption, and competitive dynamics.-Fineline Info & Tech