REPROCELL has submitted an application for manufacturing and marketing approval in Japan for Stemchymal, a regenerative medicine product intended to treat spinocerebellar ataxia.

• Target Indication: The application seeks approval for Stemchymal to suppress the progression of ataxia in patients with spinocerebellar ataxia types 3 and 6 (SCA3 and SCA6).
• Regulatory Status: Stemchymal received Orphan Regenerative Medicine Product designation from Japan’s Ministry of Health, Labour and Welfare in 2018.
• Commercial Arrangement: REPROCELL holds the exclusive commercialisation rights for Stemchymal in Japan, while Steminent Biotherapeutics will manufacture the product.

This summary is based on a news article published by BioSpectrum Asia.

Image for illustrative purposes only. Source: Canva.

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