Beyond licensing, five major players—PharmaEssentia, Belite Bio, Medeon Biodesign, Tanvex BioPharma-KY, and Handa Pharmaceuticals—are targeting US commercial launches starting in Q2 2026.

• PharmaEssentia: Their flagship drug, Ropeg, for Polycythemia Vera (PV) drove cumulative revenue to NT$13.71 billion (+59.38% YoY). The company is now pursuing a second indication for Essential Thrombocythemia (ET). Following a successful Application Orientation Meeting (AOM) with the FDA on December 8, approval is expected in 1H 2026.
• Belite Bio (subsidiary of Lin Bio): Following the successful Phase III unblinding of LBS-008 for adolescent Stargardt Disease, the company aims for US approval by December 2026. Notably, Belite Bio intends to self-distribute in the US rather than out-license, given the lack of competing drugs and their strong relationships with specialized medical experts.
• Tanvex BioPharma-KY: Following its acquisition by the Bora Group, the company plans to resubmit the US FDA application for its breast cancer biosimilar, TX-05, by late December, targeting a mid-2026 approval.
• Handa Pharmaceuticals: Their new formulation anti-cancer drug, HND-039, is targeted for approval by July 2026.

Resource: 生技五業者拚新品在美上市