Yuhan Corporation "First Patient Dosed in US Phase 3 Trial of Degenerative Disc Disease Treatment 'YH14618'"

[Asia Economy Reporter Lee Gwan-ju] Yuhan Corporation announced on the 25th that the first patient has been dosed in the Phase 3 clinical trial of the degenerative disc disease treatment 'YH14618 (SB-01, Remedisk)'.

This clinical trial is being conducted under the leadership of the US-based Spine Biopharma, involving 400 patients with degenerative lumbar disc disease at over 30 clinical centers across the United States. The trial aims to evaluate the safety of YH14618 and to confirm improvements in persistent pain and related disabilities for six months following intradiscal administration. Including a 12-month follow-up period, clinical results are expected to be obtained in 2024.

Yuhan Corporation licensed the technology from Ensol Bio in 2009 and developed it domestically. In 2018, the development rights and global sales rights (excluding Korea) of YH14618 were licensed out to Spine Biopharma.

YH14618 is a peptide drug that induces disc regeneration by injection into the spinal area without surgery. It is expected to be a new drug that meets the unmet needs in the degenerative disc market, where there is currently no fundamental cause or treatment.

With the initiation of dosing the first patient in the Phase 3 clinical trial, Yuhan Corporation will receive a milestone technology fee of 2 million USD from Spine Biopharma.

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