By Fineline Cube Bio-Thera Solutions (SHA: 688177) announced a licensing agreement with Avalon Pharma, granting the Saudi Arabia‑headquartered company exclusive rights to distribute and market BAT3306, a biosimilar version of Merck’s Keytruda (pembrolizumab), in Saudi Arabia and the entire North Africa region. Financial terms were not disclosed.
Partnership Structure & Strategic Terms
| Item | Detail |
|---|---|
| Licensor | Bio-Thera Solutions (688177.SH) |
| Licensee | Avalon Pharma (Saudi Arabia) |
| Asset | BAT3306 (biosimilar of Merck’s Keytruda/pembrolizumab) |
| Territory | Saudi Arabia and North Africa (exclusive) |
| Financial Terms | Not disclosed |
| Regulatory Filings | Under preparation for China, US, and EU |
Drug Profile & Market Context
- Biosimilar Innovation: BAT3306 is a biosimilar candidate to Keytruda, the world’s top‑selling oncology drug with $25 billion in 2025 global sales
- Filings Underway: Bio-Thera is preparing market applications for China, US, and EU, positioning BAT3306 for potential launch in major markets by 2027–2028
- Territory Opportunity: Middle East and North Africa represent a $500 million oncology market, with limited biosimilar penetration creating first‑mover advantage for Avalon
Market Impact & Strategic Outlook
- Global Biosimilar Market: Pembrolizumab biosimilars projected to capture $3–5 billion : in annual sales by 2030 as patents expire in key markets
- Strategic Validation: Deal validates Bio-Thera’s biosimilar platform and manufacturing capabilities; Avalon gains access to a blockbuster oncology asset
- Revenue Potential: Analysts estimate the Middle East/North Africa territory could generate $50–80 million : peak annual sales for BAT3306
- Next Steps: Regulatory filings in China expected Q2 2026; Avalon to initiate market access activities in Saudi Arabia Q3 2026
Forward‑Looking Statements
This brief contains forward‑looking statements regarding regulatory filings, market potential, and revenue projections for BAT3306. Actual results may differ due to regulatory review outcomes, competitive dynamics, and market adoption rates.-Fineline Info & Tech