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Yokohama, JapanJune 24, 2026 /PRNewswire/ — REPROCELL Inc. today announced that it has submitted a manufacturing and marketing authorization application for the regenerative medicine product Stemchymal® to Japanese regulatory authorities. The company holds exclusive commercialization rights for this product in Japan. The application seeks approval for the use of Stemchymal® to suppress the progression of ataxia in patients with spinocerebellar ataxia (SCA3 and SCA6).
Under the established framework, Stemchymal® will be manufactured by Steminent Biotherapeutics Inc. in Taiwan, China, with REPROCELL responsible for all sales and distribution activities within Japan.
Notably, Stemchymal® was granted Orphan Regenerative Medicine Product Designation (*1) by Japan’s Ministry of Health, Labour and Welfare (MHLW) in December 2018. As a result, the product is eligible for priority review by the Pharmaceuticals and Medical Devices Agency (PMDA), with a target regulatory review period of nine months from the date of application acceptance (*2).
Chikafumi Yokoyama, CEO of REPROCELL, commented:
“We are very pleased to announce the submission of the manufacturing and marketing authorization application for Stemchymal® for the treatment of spinocerebellar ataxia (SCA3 and SCA6). Spinocerebellar ataxia is a rare disease characterized by the progressive loss of motor function. Given the limited availability of effective treatments currently, there is an unmet medical need for new therapeutic options. We firmly believe that Stemchymal® has the potential to significantly slow symptom progression and improve the quality of life (QOL) for these patients. Looking ahead, our entire company is unwavering in its commitment to obtaining approval as quickly as possible and delivering this breakthrough therapy to patients.”
Financial Outlook
Although this regulatory filing is expected to have a limited impact on the company’s consolidated financial results for the fiscal year ending March 31, 2027, REPROCELL considers this milestone to be strategically important. It is expected to significantly drive the company’s further development in the medium to long term and continuously enhance corporate value. The company will promptly disclose any material developments that arise in the future.
*1: Orphan Regenerative Medicine Product Designation
A regenerative medicine product designated by the Ministry of Health, Labour and Welfare that meets specific criteria regarding “target patient population,” “medical need,” and “development feasibility.” To qualify, the product must target a disease with a patient population of fewer than 50,000 in Japan, with no suitable alternative therapies, or it must demonstrate significantly higher expected efficacy or safety compared to existing treatments. Products granted this designation are eligible for comprehensive support measures, including priority clinical trial consultations and priority PMDA review.
*2: PMDA Review Timeline
For more information on the PMDA’s priority review process and target review timelines for regenerative medicine products, please visit the PMDA website:
https://www.pmda.go.jp/review-services/drug-reviews/about-reviews/ctp/0008.html