# REPROCELL Submits Application for Manufacturing and Marketing Approval in Japan for Stem Cell Therapy Stemchymal® for Spinocerebellar Ataxia (SCA3 and SCA6)

- Link: https://www.thailand-business-news.com/pr-news/reprocell-submits-application-for-manufacturing-and-marketing-approval-in-japan-for-stem-cell-therapy-stemchymal-for-spinocerebellar-ataxia-sca3-and-sca6
- Published: 2026-06-24T20:30:00+07:00
- Author: PR Newswire

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YOKOHAMA, Japan, June 24, 2026 /PRNewswire/ — REPROCELL Inc. today announced the
submission of an application for manufacturing and marketing approval in Japan for
the regenerative medicine product Stemchymal®, for which the company holds exclusive
commercialization rights 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 Taiwan-based
Steminent Biotherapeutics Inc., with REPROCELL overseeing 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. Consequently,
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 acceptance
of the application (*2).

**Chikafumi Yokoyama, CEO of REPROCELL, commented:**

"We are highly pleased to announce the submission of the application for manufacturing
and marketing approval for Stemchymal® for the treatment of spinocerebellar ataxia(
SCA3 and SCA6). Spinocerebellar ataxia is a designated intractable disease characterized
by the progressive loss of motor function. With currently limited effective treatments
available, there has been a profound unmet medical need for new therapeutic options.
We firmly believe that Stemchymal® has the potential to significantly contribute
to slowing symptom progression and improving the quality of life (QOL) for these
patients. Moving forward, our entire organization remains steadfast in our commitment
to securing approval and delivering this groundbreaking therapy to patients as quickly
as possible."

**Financial Outlook**

While the impact of this regulatory submission on the company’s consolidated financial
performance for the current fiscal year ending March 31, 2027, is expected to be
minimal, REPROCELL views this milestone as a significant catalyst that will substantially
contribute to the company’s further growth and the sustainable enhancement of corporate
value over the medium to long term. The company will promptly disclose any future
material developments as they arise.

***1: Orphan Regenerative Medicine Product Designation**

A regenerative medicine product designated by the MHLW that meets specific criteria
regarding the "number of target patients," "medical need," and "feasibility of development."
To qualify, the product must target a disease affecting fewer than 50,000 patients
in Japan, with either no appropriate alternative treatments available or the expectation
of significantly higher efficacy or safety compared to existing therapies. Products
receiving this designation are eligible for comprehensive support measures, including
priority clinical trial consultations and PMDA priority review.

***2: PMDA Review Schedule**

For further information regarding PMDA’s priority review process and target review
timeline for regenerative medicine products, please refer to the PMDA website:

[https://www.pmda.go.jp/review-services/drug-reviews/about-reviews/ctp/0008.html](https://edge.prnewswire.com/c/link/?t=0&l=en&o=4716663-1&h=1005484006&u=https%3A%2F%2Fwww.pmda.go.jp%2Freview-services%2Fdrug-reviews%2Fabout-reviews%2Fctp%2F0008.html&a=https%3A%2F%2Fwww.pmda.go.jp%2Freview-services%2Fdrug-reviews%2Fabout-reviews%2Fctp%2F0008.html)

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**Read the original article :** [REPROCELL Submits Application for Manufacturing and Marketing Approval in Japan for Stem Cell Therapy Stemchymal® for Spinocerebellar Ataxia (SCA3 and SCA6) ](http://www.prnasia.com/story/archive/4989053_AE89053_0?rand=184833)