JCR Pharmaceuticals Co., Ltd.
Briefing on the Agreement with Italfarmaco
Entered into an exclusive license agreement with Italfarmaco for the Duchenne Muscular Dystrophy treatment Givinostat in Japan, initiating a strategic partnership in rare disease therapeutics.
Key Figures
- Domestic DMD Patient Population: Approximately 3,500
- Givinostat US Approval: March 2024
- Givinostat EU Conditional Approval: June 2025
AI要約
Overview of the Agreement
JCR Pharmaceuticals Co., Ltd. has entered into an exclusive license agreement with Italfarmaco for the Duchenne Muscular Dystrophy (DMD) treatment Givinostat in Japan. This expands the rare disease treatment portfolio and promotes the joint exploration of opportunities in R&D pipelines and core technologies of both companies. Givinostat is a histone deacetylase (HDAC) inhibitor and is expected to be a non-steroidal treatment for DMD.
Current Status and Future Outlook of the Treatment
Givinostat was approved in the US in March 2024 and received conditional approval in the EU in June 2025, but it is not yet approved in Japan. The domestic DMD patient population is approximately 3,500, with an estimated over 1,000 patients aged six and older who are ambulatory, indicating significant commercial potential. The goal is to obtain marketing authorization by 2028, with Phase III clinical trials (EPIDYS Study) currently underway.
