Obigen Pharma, Taiwan’s first innovator in botulinum toxin type A (BoNT-A), announced on March 16 the completion of patient enrollment for its OBI-858 Phase III clinical trial for aesthetic applications.

• Integrated Value Chain: Apex attributes this efficiency to its "One-Stop" model, which integrates R&D with a PIC/S GMP certified biosecurity facility.
• Commercialization Timeline:
• Q3 2026: Completion of data collection and safety observation.
• End of 2026: Anticipated unblinding of trial results.
• 2027: NDA submission to the Taiwan FDA.
• Global Strategy: While the Taiwan trial enters its final observation phase, Apex is already recruiting for Phase II trials in the United States. The company plans a dual-track sales model involving both licensing to international big pharma and strategic alliances with leading aesthetic clinic chains.

Resource: 鼎晉進度超前 OBI-858台灣 TFDA 醫美三期臨床完成收案 啟動商業布局