TOKYO, Apr 24 (Pulse News Wire) – Kringle Pharma,inc. (4884.T) announced today that its recombinant human hepatocyte growth factor protein, oremepermin alpha, has received orphan medicinal product designation (Orphan Medicinal Product Designation) from the European Medicines Agency (EMA).
This marks the third such designation for the drug, which was previously granted in Japan in September 2019 and in the United States in June 2025. The orphan drug status in the EU provides up to ten years of market exclusivity, fee reductions, and specialized advice and support from the EMA. The designation targets diseases affecting fewer than five people per 100,000 population and offers significant therapeutic benefits compared to existing treatments. In Japan, development of oremepermin alpha for acute spinal cord injury has completed Phase III clinical trials and preparations are underway to initiate additional clinical trials within 2026.
In the US, the company plans to prepare for an Investigational New Drug (IND) application in 2026 ahead of initiating Phase III clinical trials. "We are delighted to secure orphan drug designations across three major markets," said Kiyoshi Ando, President and CEO of Kringle Pharma. "This recognition underscores the potential and medical value of our homegrown pharmaceutical innovation, oremepermin alpha. It will significantly enhance our partnerships and funding opportunities, allowing us to accelerate global development and contribute to improving healthcare worldwide." HGF, known for promoting cell proliferation and tissue regeneration, also exhibits neuroprotective properties and shows promise in treating various conditions, including ALS and vocal cord scarring.
Kringle Pharma continues to advance HGF-based therapies through late-stage clinical pipelines aimed at addressing spinal cord injuries and vocal cord scars.
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