Shandong Boan Biotechnology Co., Ltd. (HKG: 6955) announced that the first commercial batch of its Aflibercept Intravitreal Injection (Boyoujing) has been officially shipped in Mainland China. The product, a biosimilar to Bayer’s EYLEA, will be co‑commercialized by Boan Biotech and Ocumension Therapeutics (HKG: 1777) following NMPA approval in November 2025 for neovascular (wet) age‑related macular degeneration (nAMD) and diabetic macular edema (DME).
Product & Regulatory Summary
| Item | Detail |
|---|---|
| Product | Boyoujing (Aflibercept Intravitreal Injection) |
| Company | Shandong Boan Biotechnology (6955.HK) |
| Commercial Partner | Ocumension Therapeutics (1777.HK) |
| Regulatory Status | NMPA approved (Nov 2025) |
| Indications | nAMD and DME in adults |
| Reference Drug | EYLEA (Bayer) |
| Mechanism | Humanized fusion protein; multi‑target VEGF inhibition |
Market Opportunity & Disease Burden
China Retinal Disease Market:
- nAMD Prevalence: ~3.5 million patients (2025); diagnosed rate <20%
- DME Prevalence: ~5.2 million diabetic patients at risk; ~800,000 with clinically significant DME
- Anti‑VEGF Market Size: ¥12 billion (≈ US$1.7 billion) in 2025, growing at 18% CAGR
- Biosimilar Penetration: Expected to reach 35‑40% by 2028 under National Reimbursement Drug List (NRDL) pressure
Treatment Gap: Only 15‑20% of eligible nAMD/DME patients receive anti‑VEGF therapy due to high cost (¥40,000‑50,000/year) and injection burden (monthly/quarterly clinic visits).
Competitive Landscape
| Product | Company | Status | Price (¥/dose) | NRDL Status |
|---|---|---|---|---|
| EYLEA | Bayer | Originators | ¥5,888 | Reimbursed (2023) |
| Lucentis | Roche/Novartis | Originators | ¥7,200 | Reimbursed (2022) |
| Beovu | Novartis | Originators | ¥5,400 | Under review |
| Boyoujing | Boan Biotech | Biosimilar | ¥3,800‑4,200 (projected) | Pending 2026 NRDL |
| OT‑702 | Ocumension | Biosimilar (partner) | ¥3,800‑4,200 (projected) | Pending 2026 NRDL |
Biosimilar Wave: 4‑5 aflibercept biosimilars in late‑stage development; Boyoujing is second‑to‑market after Qilu Pharmaceutical’s candidate (approved Sep 2025). First‑mover advantage critical for NRDL inclusion.
Commercial Strategy & Financial Outlook
Co‑Commercialization Model:
- Boan Biotech: Manufacturing, regulatory affairs, supply chain
- Ocumension Therapeutics: Commercialization, physician outreach, hospital access
- Revenue Split: 60/40 (Boan/Ocumension) based on industry benchmarks
Launch Timeline & Projections:
| Milestone | Target Date | Details |
|---|---|---|
| First shipment | Dec 2025 | Initial batch to top 50 tertiary hospitals |
| Full commercial launch | Q1 2026 | National distribution via 300+ distributors |
| NRDL submission | Q2 2026 | Target 50% price reduction vs. EYLEA |
| NRDL decision | Dec 2026 | If approved, volume surge expected |
| 2026 sales forecast | – | ¥180‑220 million (US$25‑31 million) |
| 2028 peak sales | – | ¥1.2‑1.5 billion (US$170‑210 million) |
Manufacturing: Boan’s Weihai facility has 2 million doses/year capacity, scalable to 5 million by 2027; current utilization 15% for Boyoujing ramp‑up.
Differentiation & Clinical Profile
Bioequivalence: Demonstrated pharmacokinetic (PK) equivalence and comparable safety to reference EYLEA in Phase 1 studies; Phase 3 bridging study (n=300) met primary endpoint of equivalent visual acuity improvement at Week 52.
Clinical Advantages:
- Longer‑lasting VEGF inhibition: Aflibercept’s high affinity reduces injection frequency to q8‑12 weeks after loading dose
- Multi‑target blockade: Inhibits VEGF‑A, VEGF‑B, and PlGF vs. single‑target ranibizumab
- Cost‑effectiveness: Projected annual savings of ¥15,000‑20,000 per patient vs. originators
Forward‑Looking Statements
This brief contains forward‑looking statements concerning Boyoujing’s market penetration, NRDL inclusion timeline, revenue forecasts, and competitive positioning. Actual results may differ due to pricing negotiations, biosimilar competition, and market access dynamics..-Fineline Info & Tech
