By Fineline Cube Shandong Boan Biotechnology Co., Ltd. (HKG: 6955) announced the submission of a Biologics License Application (BLA) to Brazil’s Health Regulatory Agency (ANVISA) for its Aflibercept Intravitreous Injection (BA9101), a biosimilar to Bayer’s EYLEA. The product is indicated for the treatment of neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME) in adults, representing a significant step in the company’s global expansion strategy following its November 2025 approval in China under the trade name Boyoujing.
Regulatory Milestone | BA9101
| Parameter | Detail |
|---|---|
| Product | BA9101 (Aflibercept Intravitreous Injection) |
| Reference Product | Bayer’s EYLEA (aflibercept) |
| Chinese Approval | November 2025 (trade name: Boyoujing) |
| Current Submission | BLA to Brazil’s ANVISA (05 Aug 2026) |
| Indications | nAMD and DME in adults |
| Commercial Rights | Licensed to Shenzhen Kexing Risedo Pharm (excluding China, EU, UK, US, Japan) |
| Next Steps | Regulatory review timeline and potential approval in Brazil |
Product Profile & Mechanism of Action
- Molecular Structure: Humanized fusion protein that binds vascular endothelial growth factors (VEGF-A and VEGF-B) and placental growth factor (PlGF)
- Therapeutic Advantage: Reaches more targets than anti-VEGF monoclonal antibodies, providing broader inhibition of angiogenic pathways
- Clinical Position: First-line treatment for nAMD, DME, and other retinal diseases
- Efficacy Profile: Sustainably inhibits intraocular VEGFs to effectively improve visual acuity with durable efficacy
- Safety: Demonstrates a favorable overall safety and tolerability profile in clinical studies
Commercial Strategy & Partnership
Exclusive Licensing Agreement (June 2025)
- Partner: Shenzhen Kexing Risedo Pharm Co., Ltd., wholly-owned subsidiary of Kexing Biopharm
- Territory: Exclusive rights to commercialize BA9101 in all countries and regions excluding Chinese mainland, European Union, United Kingdom, United States, and Japan
- Implementation Status: Regulatory submissions and commercial launches progressing according to established plan
- Strategic Rationale: Leverages Kexing’s international commercial infrastructure while retaining key developed markets for potential future partnerships
Market Opportunity & Strategic Implications
Brazil-Specific Considerations
- Patient Population: Large and growing prevalence of diabetic retinopathy and AMD in Latin America’s largest economy
- Pricing Advantage: Biosimilar positioning offers significant cost savings compared to originator EYLEA
- Market Access: Potential inclusion in Brazil’s public healthcare system (SUS) could drive substantial volume adoption
Global Biosimilar Landscape
- Competitive Positioning: BA9101 enters an increasingly competitive aflibercept biosimilar market with multiple candidates in development globally
- Differentiation Strategy: Broader target profile (VEGF-A/B + PlGF) may provide clinical differentiation versus other biosimilars
- Emerging Markets Focus: Strategic emphasis on high-growth emerging markets where biosimilar adoption rates are accelerating
The ANVISA submission represents Boan Biotech’s first major regulatory filing outside China and validates the company’s transition from domestic manufacturer to global ophthalmic player, supported by strategic partnerships that accelerate international commercialization.
Forward‑Looking Statements
This brief contains forward-looking statements regarding regulatory submissions, commercial partnerships, and market opportunities. Actual results may differ materially due to regulatory decisions, competitive dynamics, market acceptance, and partnership execution risks.-Fineline Info & Tech