SHANGHAI, NANJING, China, and PLEASANTON, Calif., June 18, 2026
IASO Bio has achieved a major international regulatory milestone with the approval of its New Drug Application (NDA) for Equecabtagene Autoleucel (FUCASO®) by the Singapore Health Sciences Authority (HSA) for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM). The approval marks the first overseas marketing authorization outside Greater China for the company’s fully human anti-BCMA CAR-T cell therapy and represents a significant advancement in IASO Bio’s global commercialization strategy. FUCASO is indicated for patients who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, and whose disease has progressed following treatment. As the world’s first commercialized fully human CAR-T cell therapy, the approval underscores the growing international recognition of innovative cell therapies developed and manufactured in China while creating new treatment opportunities for patients with advanced hematologic malignancies.
Singapore Approval Expands Access to Advanced Cell Therapy
The approval of Equecabtagene Autoleucel establishes the first anti-BCMA CAR-T therapy available in Singapore, addressing a significant unmet medical need for patients with relapsed or refractory multiple myeloma. Multiple myeloma remains the second most common hematologic cancer globally and continues to pose substantial treatment challenges despite advances in modern therapeutics. According to recent epidemiological data, Singapore experiences a higher incidence and prevalence of multiple myeloma than global averages, highlighting the importance of expanding access to innovative treatment options.
The approval will allow eligible patients to receive advanced CAR-T therapy within Singapore rather than traveling abroad for treatment, reducing logistical burdens, healthcare costs, and treatment delays. Industry experts view the decision as an important milestone for cell therapy adoption across Southeast Asia and a critical step toward improving outcomes for patients with heavily pretreated disease.
Fully Human Anti-BCMA CAR-T Demonstrates Innovation Leadership
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FUCASO® is a next-generation fully human anti-BCMA CAR-T cell therapy developed using autologous T cells genetically modified with a lentiviral vector. The therapy incorporates a fully human single-chain variable fragment (scFv), enabling highly targeted recognition of BCMA-expressing myeloma cells while potentially reducing immunogenicity concerns associated with non-human CAR constructs. Through extensive molecular optimization and preclinical evaluation, FUCASO demonstrated potent antitumor activity, durable persistence, and deep therapeutic responses in patients with multiple myeloma.
These characteristics have positioned the therapy as an important advancement in the rapidly evolving field of cellular immunotherapy. The successful approval by Singapore’s regulatory authority further validates IASO Bio’s scientific capabilities and highlights the growing competitiveness of China-developed cell therapies within the global biopharmaceutical landscape.
Global Commercialization Strategy Gains Momentum
The Singapore approval follows previous authorizations in Mainland China, Hong Kong, and Macau and represents a key milestone in IASO Bio’s international expansion efforts. The company plans to implement an innovative “Manufactured in China, Supplied Globally” commercial model supported by internationally compliant GMP manufacturing facilities and an advanced global cold-chain logistics infrastructure. This strategy is designed to ensure reliable supply, consistent product quality, and broader accessibility of cell therapies across international markets. Company leadership emphasized that the approval validates not only the therapeutic value of FUCASO but also the strength of IASO Bio’s manufacturing systems, regulatory capabilities, and global supply chain operations.
As demand for advanced cell therapies continues to rise worldwide, the approval positions IASO Bio to strengthen its presence in international oncology markets while expanding access to innovative CAR-T treatments for patients battling relapsed or refractory multiple myeloma. The milestone also demonstrates the increasing role of cell and gene therapies in shaping the future of precision oncology and hematologic cancer treatment.
Source: IASO Bio press release
