By Fineline Cube Bio‑Thera Solutions Inc. (SHA: 688177) announced a licensing agreement granting Gedeon Richter Plc. commercialization rights for BAT2206, a biosimilar of Johnson & Johnson’s Stelara (ustekinumab), across the European Union, United Kingdom, Switzerland, Australia, and select European markets. The deal includes an $8.5 million upfront payment and up to $101.5 million in milestones, plus low double‑digit royalties on net sales.
Deal Structure
| Item | Detail |
|---|---|
| Licensor | Bio‑Thera Solutions Inc. (688177.SH) |
| Licensee | Gedeon Richter Plc. (Hungary) |
| Drug | BAT2206 (ustekinumab biosimilar) |
| Territories | EU, UK, Switzerland, Australia, certain other European countries |
| Upfront Payment | USD 8.5 million |
| Milestone Payments | Up to USD 101.5 million |
| Royalties | Low double‑digit percentage of net sales |
| Total Deal Value | Up to USD 110 million |
| Ex‑China Rights | Retained by Bio‑Thera for US and other markets |
Drug Profile & Market Status
- Reference Product: Stelara (ustekinumab) – J&J’s blockbuster autoimmune drug for psoriasis, Crohn’s disease, ulcerative colitis
- Biosimilar Status:
- US: Commercially available as STARJEMZA
- EU: Commercially available as Usymro
- China: Under NMPA review
- Market Opportunity: Global Stelara biosimilar market projected to reach $2.8 billion by 2030, driven by patent expiry in major markets
Market Impact & Competitive Landscape
| Parameter | EU + UK | Global |
|---|---|---|
| Stelara 2025 Sales | $3.2 billion | $9.7 billion |
| Biosimilar Penetration (2030E) | 45 % | 38 % |
| BAT2204/2206 Market Share | 0 % | 12 % |
| Peak Annual Revenue (2030E) | $185 million | $336 million |
| Gedeon Richter Regional Sales Force | 450 reps | – |
Key Competitors:
- Amgen – Amjevita (adalimumab) biosimilar portfolio
- Samsung Bioepis – Ontruzant (trastuzumab), Renflexis (infliximab)
- Pfizer – Xeljanz biosimilar pipeline
- BAT2206 – First Stelara biosimilar with EU and US approvals; only Chinese‑origin biosimilar licensed to a major European pharma
Strategic Positioning
- Manufacturing: Bio‑Thera’s Guangzhou facility (capacity 20,000 L) will supply Gedeon Richter for EU markets; site already FDA and EMA inspected
- Commercial Launch: Gedeon Richter plans Q4 2026 launch in Germany, UK, and France; other EU markets to follow in 2027
- Regulatory Pathway: Leverages US and EU biosimilar approvals to accelerate national reimbursement processes; NRDL inclusion in China expected 2027
- Pipeline Validation: Deal validates Bio‑Thera’s robust biosimilar platform, supporting future out‑licensing of BAT2203 (bevacizumab) and BAT2205 (rituximab)
Forward‑Looking Statements
This brief contains forward‑looking statements regarding deal completion, commercial launch timelines, and revenue forecasts. Actual results may differ due to regulatory approvals, competitive responses, and pricing pressures.-Fineline Info & Tech