Kringle Pharma (4884) · InitiativeRestatedLatest Financial Results Presentation (2026-05-18): "Advanced"
Using orphan drug designation for acute spinal cord injury
First written in FY2020. 3 of 5 entries say "Advanced", first in 2026-04-24. Latest entry: 2026-05-18.
5entries
7years
3from disclosures
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Use of Orphan Drug Designation for Acute-Phase Spinal Cord InjuryA theme 1 companies write about · 0 as a headwind · 1 as a tailwind
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- FY2022RestatedAnnual report
「After obtaining proof of concept, the company can receive orphan drug designation from the Ministry of Health, Labour and Welfare and accelerate activities through to filing by using development cost subsidies and priority review.」
希少疾病用医薬品指定、開発費助成、優先審査の活用を承認申請の加速手段として引き続き位置付けている。 - FY2020First statedAnnual report
「After obtaining proof of concept, the company can receive orphan drug designation from the Ministry of Health, Labour and Welfare and accelerate activities through to filing by using development cost subsidies and priority review.」
Orphan drug designation, development cost subsidies and priority review are positioned as ways to accelerate the marketing approval application.