Steminent Biotherapeutics has made significant progress in its overseas expansion, announcing that it has received certification from Japan's Ministry of Health, Labour and Welfare (MHLW) as a "foreign manufacturer of regenerative medical products." This certification marks Steminent as the only company in Taiwan currently recognized by Japan's MHLW in this category.
Chairperson Ling-Mei Wang stated that Steminent has been working for years to enter the Japanese market, and now, with the MHLW certification, it has become an officially approved regenerative medicine manufacturing facility in Japan. This achievement places Steminent alongside top-tier pharmaceutical companies in Europe and the U.S., setting a new milestone for Taiwan's cell therapy industry in Japan’s regulated market. The certification also lays a strong foundation for the company’s plan to apply for a temporary drug license in Japan next year.
With this MHLW certification, Steminent is now authorized to legally manufacture and sell its allogeneic adipose-derived mesenchymal stem cell product, Stemchymal®, intended for the treatment of spinocerebellar ataxia (SCA) in Japan. The company is also preparing for commercial activities in partnership with its Japanese licensee, REPROCELL, once a temporary drug license is obtained. Additionally, Steminent plans to pursue a temporary drug license in Taiwan, aiming to become the first company to apply allogeneic cell therapies under Taiwan's regenerative medicine regulatory framework for treating rare diseases.
Wang further highlighted that spinocerebellar ataxia affects over 350,000 people worldwide and currently lacks effective treatments, creating a substantial market opportunity for Stemchymal®. Stemchymal® has been granted orphan drug designation in Japan, and based on REPROCELL's projected sales, Steminent expects to capture an initial 10% share of the SCA treatment market upon securing temporary drug licenses in both Taiwan and Japan. This foothold is expected to propel the company's market expansion and accelerate operational growth, potentially reaching breakeven faster through revenue from product sales and royalties. In addition to sales, income is projected to grow from royalties, milestone payments, and licensing fees for additional indications.
According to a Marketresearch.biz report, the global spinocerebellar ataxia market was valued at $11.5 billion in 2023 and is projected to reach $20.7 billion by 2033.
Resource (mandarin): 台灣首例 仲恩細胞廠通過日本MHLW外國製造所認定
