Shandong Boan Biotechnology Co., Ltd. (HKG: 6955) has granted Nanjing King-friend Biochemical Pharmaceutical Co., Ltd. (SHA: 603707) exclusive rights to commercialize two Denosumab biosimilar injections, BA6101 and BA1102, in the United States. Genor BioTech, Kingfriend’s biologics arm, will lead stateside sales and promotion.
Transaction Structure
| Component | Details |
|---|---|
| Products Licensed | BA6101 (Prolia® biosimilar) & BA1102 (Xgeva® biosimilar) |
| Territory | United States only |
| Upfront Payment | $15 million (payable on contract execution) |
| Milestone Payments | Up to $60 million ($20 M on first commercial sale, $40 M on achieving $100 M cumulative net sales) |
| Royalties | Tiered 15–20% of annual net U.S. sales |
| Responsibilities | Kingfriend/Genor: Sales, marketing, distribution; Boan: MAH, commercial manufacturing, supply |
| Effective Date | 1 Jan 2026 (pending FTC antitrust review) |
Product Portfolio
| Attribute | BA6101 (Prolia Biosimilar) | BA1102 (Xgeva Biosimilar) |
|---|---|---|
| Reference Product | Prolia® (Amgen) | Xgeva® (Amgen) |
| Indication | Postmenopausal osteoporosis | Bone metastases, giant cell tumor |
| China Approval | 2022 (commercial launch Q2 2023) | 2024 (launch pending) |
| US Filing Status | BLA submission planned H2 2026 | BLA submission planned H1 2027 |
| Peak US Sales Forecast | $120 million (2029) | $85 million (2030) |
US Market Opportunity
The U.S. Denosumab market exceeds $4.5 billion annually (Prolia $3.2 B, Xgeva $1.3 B, 2024). With Prolia’s core patent expiring in 2025 and Xgeva’s in 2027, biosimilar entry is poised to capture 30–40% share within three years, driven by payer pressure and clinic‑level switching protocols. Boan’s cost‑advantaged manufacturing in China positions BA6101/BA1102 at a 30–50% discount to Amgen’s WAC pricing.
Strategic Implications
- For Boan: Monetizes its biosimilar pipeline while retaining high‑margin manufacturing; validates its CMC platform for regulated markets.
- For Kingfriend: Transforms from domestic generics player to U.S. biologics commercial entity; Genor BioTech will expand its field force by 150 reps by Q3 2026.
- Competitive Landscape: Pfizer/Celltrion’s proposed Denosumab biosimilars are 12–18 months behind; first‑mover advantage could secure preferential formulary placement.
Forward‑Looking Statements
This brief includes projections on FDA filing timelines, market penetration, and financial milestones that are subject to regulatory clearance, biosimilar interchangeability designations, and Amgen patent litigation. Actual results may differ materially.-Fineline Info & Tech
