Dingjin's Botulinum Toxin New Drug Aims for Year-End Unblinding, U.S. Clinical Trials to Begin This Year

Dingjin Biotechnology, Taiwan's first botulinum toxin new drug company, is accelerating the development of its innovative OBI-858, a 760 kDa long-acting botulinum toxin drug.

The company announced at a recent investor conference that Phase III human clinical trials for glabellar line treatment are on track for completion in the third quarter of 2026, with data unblinding anticipated by year-end. If successful, Dingjin aims to file for drug approval in Taiwan by the first half of 2027, targeting a market launch in 2028.

In parallel, Dingjin is actively pursuing international licensing and strategic partnerships, focusing on companies with strong medical aesthetics channels and regional market advantages. The company plans a dual approach of licensing and distribution to rapidly expand global market penetration.

Furthermore, OBI-858 has secured approval from the U.S. Food and Drug Administration (FDA) to utilize overseas (Taiwan) clinical data for its Phase II human clinical trials targeting glabellar lines in the U.S. Dingjin is collaborating with leading U.S. medical aesthetics experts to prepare for a Phase II trial exploring full dosage, with ambitions to directly advance to U.S. Phase III trials, significantly reducing time and cost in the competitive U.S. market.

CEO Chou Pei-fen also indicated that Dingjin is in discussions with over a dozen major international medical and aesthetics firms. The company plans a capital increase in the fourth quarter of 2026, aiming for an IPO by the end of 2027 as the new drug progresses.

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