By Fineline Cube 
Shandong Boan Biotechnology Co., Ltd. (HKG: 6955) announced that its self‑developed Aflibercept Intravitreal Injection (Boyoujing) received National Medical Products Administration (NMPA) marketing approval for neovascular (wet) age‑related macular degeneration (nAMD) and diabetic macular edema (DME) in adults. Boan Biotech will partner with Ocumension Therapeutics for mainland China commercialization and has authorized Shenzhen Kexing Pharmaceutical for exclusive sales in select global territories.
Regulatory Milestone
| Item | Detail |
|---|---|
| Product | Boyoujing (Aflibercept Intravitreal Injection) |
| Company | Shandong Boan Biotechnology Co., Ltd. (6955.HK) |
| Agency | NMPA (China) |
| Approval Type | Marketing authorization |
| Indications | nAMD and DME in adults |
| Biosimilar Reference | Bayer’s EYLEA (aflibercept) |
| China Partner | Ocumension Therapeutics (commercialization) |
| Global Partner | Shenzhen Kexing Pharmaceutical (exclusive sales, ex‑China/EU/UK/US/Japan) |
Drug Profile
- Mechanism: Humanized fusion protein binding VEGF‑A, VEGF‑B, and Placental Growth Factor (PlGF) – broader target range than anti‑VEGF monoclonal antibodies
- Differentiation: Biosimilar to EYLEA with comparable efficacy/safety profile; offers cost advantage vs. originator in price‑sensitive China market
- Administration: Intravitreal injection; well‑established safety profile from reference product
Market Context & Outlook
| Metric | Value |
|---|---|
| China nAMD Patients | ~3.5 million (2024) |
| China DME Patients | ~4.2 million (2024) |
| Anti‑VEGF Market Size (China) | ¥18 billion (US$2.5 billion) |
| Growth CAGR | 15% (2024‑2030) |
| Peak Sales Forecast (Boyoujing) | ¥3.5‑4.5 billion (~US$480‑610 million) by 2032 |
| Market Share Target | 20‑25% of aflibercept‑class market |
- Competitive Landscape: Dominated by Bayer’s EYLEA (~60% share) and Roche’s Lucentis (~25%); Boyoujing’s biosimilar pricing (30‑40% discount) and Ocumension’s ophthalmology specialist network (covers 8,000+ hospitals) provide strong market access
- Global Strategy: Kexing partnership covers Latin America, Southeast Asia, Middle East, Africa – markets with limited anti‑VEGF access and high diabetes burden
- Reimbursement Path: Likely automatic NRDL inclusion under China’s biosimilar policy; pricing expected at ¥8,000‑10,000 per dose vs. EYLEA’s ¥12,000
Forward‑Looking Statements
This brief contains forward‑looking statements regarding Boyoujing’s commercial launch, market penetration, and partnership execution. Actual results may differ materially due to risks including competitive responses, reimbursement negotiations, and manufacturing scale‑up.-Fineline Info & Tech