Formosa Biomedical Technology, a subsidiary of Formosa Plastics Group, has been diversifying its business in recent years. On the 20th, it jointly announced with UWELL Biopharma a collaboration to advance the clinical development and commercialization of next-generation CAR-T cell therapy. UWELL’s anti-CD19 CAR-T therapy candidate, UWC19, is scheduled to begin a multicenter Phase II clinical trial in the fourth quarter of this year. Formosa Biomedical Technology will leverage its strengths in drug formulation and production to support the effort, aiming to bring Taiwan’s advanced cell therapy industry onto the global stage.
UWELL’s UWC19, targeting non-Hodgkin’s lymphoma (NHL) as its primary indication, demonstrated good safety and significant efficacy in Phase I trials.
Formosa Biomedical Technology noted that Taiwan’s National Health Insurance has approved reimbursement for international CAR-T therapies, with each dose costing around NT$8 million. If domestically developed CAR-T products can deliver both clinical efficacy and cost advantages, they would hold strong competitiveness. According to the Ministry of Health and Welfare’s 2022 cancer registry, NHL ranks as the tenth most common cancer in Taiwan, with about 4,900 new patients annually. Among them, the failure rate of conventional treatments is as high as 40–50%.
Sandy Wang, Chairperson of Formosa Biomedical Technology, stated that this collaboration not only addresses UWELL’s drug supply needs for its Phase II trial but also focuses on regulatory approval and future mass production. The partnership will integrate clinical-grade formulation production, GMP manufacturing, and quality management, establishing an internationally competitive model for cell drug production that ensures stable processes, consistent products, and long-term supply.
Liu Hui-chi, General Manager of Formosa Biomedical Technology, added that the company’s regenerative medicine facility in Taipei, built under the Regenerative Medicinal Products Act, fully complies with PIC/S GMP standards and is set to begin operations in 2026. The plant will host diversified production lines, including stem cells, exosomes, immune cells, and genetically modified cells, along with automated aseptic filling systems and seed bank management. Combined with advanced analytical laboratories, these capabilities will ensure product quality and stable supply, helping Taiwan’s cell therapy industry enter a stage of mature, large-scale development.
Dr. Cheng-Yi Kuo of UWELL Biopharma emphasized that UWC19 is an in-house innovation, with the company successfully establishing a complete process from laboratory research to clinical manufacturing. This collaboration brings together Taiwan’s innovative biopharmaceutical technologies and manufacturing strength, expected to enhance Taiwan’s international standing in the advanced cell therapy manufacturing chain.
Liu further noted that since the signing of the MOU in 2024, the partnership has progressed into the commercialization stage. UWC19 will be produced at Formosa Biomedical Technology’s PIC/S GMP regenerative medicine facility, while both parties jointly advance capacity expansion, quality control, and supply chain integration.
Resource: 台塑生醫攜手宇越生醫 打造新世代CAR-T藥物商業生產模式
