Taiwan’s biomedical sector is reporting strong momentum, with a massive "licensing wave" expected next year. Several domestic biotech companies have successfully achieved clinical unblinding for Phase II and III trials this year or have secured market approvals. Based on recent institutional investor briefings, at least eight biomedical companies are projected to finalize international licensing deals in the first half of 2026, ushering in a new wave of investment interest.

Companies poised to complete licensing for US and European markets starting in Q1 2026 include Oneness Biotech, Taiho Pharma, AP Biosciences, BRIM Biotechnology, Anji Therapeutics, TaiMed Biologics, Medeon Biodesign, and HanchorBio-KY.

K.M. Lu, Chairman of the MicroBio Group, recently emphasized that when competing with global Big Pharma, Taiwan’s breakthrough strategy should not be a "vertical integration" model from R&D to global sales, but rather a focused "Out-licensing" strategy targeting market vacuums.

• Oneness Biotech: Their innovative wound care medical device, Bonvadis (ON101) cream, received US FDA clearance for chronic full-thickness wounds in late 2025. Licensing negotiations with US pharmacy chains, hospitals, and distributors are expected to conclude in 1H 2026.
• Taiho Pharma: Their anticoagulant oral soluble film, TAH3311 (BEQIA), received an Information Request (IR) letter from the US FDA but expects to resubmit in Q1 2026. Meanwhile, the EMA (Europe) has already accepted the marketing application. Chairman Lee Shih-jen noted that licensing efforts remain unaffected, with European licensing likely finalized in Q2, followed by the US market.
• Medeon Biodesign (益安生醫): Their minimally invasive prostate device, Urocross Expander System, applied for US FDA approval in November. A 510(k) clearance is anticipated as early as Q1 2026.
• Others: Anji Therapeutics is progressing with AJ201 for Kennedy’s Disease, and AP Biosciences is advancing IBI302, a bispecific antibody for wet Age-related Macular Degeneration (nAMD).

Resource: 生醫族群 新藥授權一波波…合一、泰合等明年歐美市場有進展