Steminent Biotherapeutics announced on the 26th that its cell therapy manufacturing facility, built to PIC/S GMP standards in Neihu, Taipei, has been officially completed. The company will now apply for inspections from regulatory authorities in Taiwan and Japan to support the approval of its first stem cell product, Stemchymal®, which targets the treatment of spinocerebellar ataxia. The goal is to submit temporary drug license applications in Taiwan and Japan by 2025 to pave the way for product launches.
The design of the Steminent PIC/S GMP cell therapy facility was based on regulations from the U.S., EU, Japan, and Taiwan. In addition to its existing production equipment, the facility has incorporated Japan’s next-generation Isolator equipment to meet PIC/S GMP requirements. This new system is characterized by automation, a closed and modular design, and full digital recording of the production process, which minimizes human error and ensures product stability. This upgrade improves both production yield and quality. Initially, the facility will be used to manufacture Stemchymal® for the treatment of spinocerebellar ataxia, with plans to expand into other cell therapy product lines in the future.
In addition to the facility completion, Susan Perlman, a clinical professor of neurology at UCLA and an expert in neuro-medicine, shared positive outcomes at the 2024 Taiwan Society of Rare Neurological Diseases Annual Meeting and International Academic Conference on the 21st. Perlman discussed a clinical trial initiated by U.S. researchers in which a patient, who had not responded well to other investigational drugs, showed significant improvement after receiving Stemchymal®. This data offers hope for the treatment of spinocerebellar ataxia and other neurological diseases through cell therapy.
Ling-Mei Wang, Chairman of Steminent Biotherapeutics, stated that the company has begun discussions with its scientific advisory team regarding an IND (Investigational New Drug) application in the U.S., with plans to submit a Phase 2b clinical trial application to the FDA by 2025. Additionally, in July of this year, the FDA accepted a biologics license application (BLA) from Mesoblast for its allogeneic stem cell therapy to treat steroid-refractory acute graft-versus-host disease in children. This demonstrates the FDA’s supportive and open stance on regenerative medicine, particularly allogeneic stem cell therapies.
In terms of international market expansion, Steminent will join the Taiwanese delegation led by the Ministry of Economic Affairs at the 2024 Japan Biotechnology Exhibition in October. The aim is to strengthen ties with Japan's regenerative medicine and cell therapy industries, leveraging mutual strengths to develop new business opportunities and drive significant economic growth in the cell therapy sector.
Resource (mandarin): 仲恩細胞製劑廠完工 啟動美國臨床二期規劃
