• Meiji Seika Pharma-backed global Phase III trial of HBI-8000 (tucidinostat) in advanced melanoma met its primary endpoint.
• HBI-8000 with nivolumab delivered median PFS of 11.7 months vs 7.4 months for nivolumab with placebo in 404 patients.
• Meiji Seika Pharma plans to seek Japanese manufacturing and marketing approval for unresectable malignant melanoma.
• Japan’s health ministry granted orphan drug designation for the indication on Nov. 27, 2025.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Meiji Holdings Co. Ltd. published the original content used to generate this news brief on July 24, 2026, and is solely responsible for the information contained therein.