IASO Bio Announces NDA Approval of Equecabtagene Autoleucel by the Singapore Health Sciences Authority (HSA) for the Treatment of Relapsed or Refractory Multiple Myeloma, Marking a Key Milestone in International Commercialization

SHANGHAI, NANJING, and PLEASANTON, Calif., June 18, 2026 /PRNewswire/ -- IASO Biotechnology ("IASO Bio"), a commercial-stage biopharmaceutical company focused on the discovery, development, manufacturing, and commercialization of novel cell therapies and biologics for hematologic malignancies and autoimmune diseases, today announced that the New Drug Application (NDA) for its independently developed, fully human anti-BCMA CAR-T therapy Equecabtagene Autoleucel (FUCASO suspension for infusion) has been approved by the Singapore Health Sciences Authority (HSA). The therapy is indicated for adult patients with relapsed or refractory multiple myeloma, after at least three prior lines of therapy, (including a proteasome inhibitor and an immunomodulatory agent), and have demonstrated disease progression on the last therapy. This marks the successful international approval of the world's first commercialized fully human CAR-T cell therapy product. It represents not only a major milestone in IASO's "go global" strategy but also establishes a feasible pathway for China-developed and manufactured cell therapies to compete globally and benefit patients worldwide.

Multiple myeloma (MM) is the second most common hematological malignancy both globally and in Singapore. According to Globocan 2022 data, the global incidence of MM was 1.8 per 100,000 people, with a 5-year prevalence of 6.8 per 100,000. In Singapore, the incidence of MM reached 2.2 per 100,000 people, with a 5-year prevalence of 15.0 per 100,000, which are both higher than the global averages, underscoring a critical unmet clinical need in the region.

As the first approved anti-BCMA CAR-T product in Singapore, Equecabtagene Autoleucel is set to transform the local and regional treatment landscape, addressing the historical lack of similar targeted cell therapy. Patients will now be able to access cutting-edge, world-class cell therapy locally, eliminating the need for the burden of cross-border medical travel while significantly reducing overall treatment costs and associated risks.

This approval marks the first overseas marketing authorization outside Greater China for Equecabtagene Autoleucel, following its prior approvals in Mainland China, Macau, China and Hong Kong, China. This milestone signifies the official launch of its global commercial footprint. In terms of commercial supply, IASO Bio will adopt an innovative model of "Manufactured in China, Supplied Globally". Leveraging a manufacturing system that complies with major international standards (including GMP) and a rigorous global cold-chain logistics network, IASO Bio is poised to deliver high-quality, stable, and accessible innovative cell therapies to patients across Singapore and Southeast Asia.

Ms. Jinhua Zhang, Founder, Chairwomen, and CEO of IASO Bio, commented: "Singapore is the first country where we submitted an international NDA and received approval, marking a critical milestone in IASO Bio's 'go global' strategy. This approval serves as a powerful international validation of IASO Bio's CAR-T product quality system, manufacturing capabilities, and global cold-chain logistics reach. It signifies that China's innovation capabilities in cell therapy have truly gone global, further integrating into the global innovative healthcare ecosystem. Once the product is launched in Singapore, patients will not only have access to world-leading cell therapy in their own country but will also benefit from local health insurance coverage, significantly improving drug accessibility, bringing renewed hope to more patients and their families."

About Multiple Myeloma (MM)

The global annual incidence of MM increased from 164,300 cases in 2019 to 197,200 cases in 2024, and is projected to reach 273,600 cases by 2040. Despite significant progress in modern anti-myeloma treatments, MM remains largely incurable with multiple relapses and tendency to develop refractoriness to several drug classes, presenting a major therapeutic challenge. Thus, there remains an urgent unmet clinical need for novel treatment options beyond current therapies that can achieve deep, durable and sustained responses.

About Equecabtagene Autoleucel (FUCASO)

Equecabtagene Autoleucel (FUCASO) is an innovative fully human anti- BCMA CAR-T cell therapy which uses lentivirus as a gene vector to transfect autologous T cells. The CAR contains a fully human scFv, CD8a hinge and transmembrane, and 4-1BB co-stimulatory and CD3ζactivation domains. Based on rigorous molecular structure screening and comprehensive in vitro and in vivo functional evaluations, FUCASO demonstrates rapid and potent efficacy, accompanied by exceptional long-term persistence in vivo, enabling patients to achieve higher and deeper responses, providing continuous protection and care for patients with multiple myeloma.

About IASO Bio

Founded in 2017, IASO Bio is one of the few commercial-stage biopharmaceutical companies in the Advanced Therapy Medicinal Product (ATMP) sector bringing China's breakthrough innovations to the global market. We specialize in developing cell therapies and biologics for hematological malignancies and autoimmune diseases. Our industry-leading, fully integrated platforms leverage cutting-edge technologies that span the entire product lifecycle—from discovery and development to manufacturing and commercialization.

We have established a robust and synergistic pipeline, reflecting our commitment to making transformative cell therapies broadly accessible to patients worldwide. Our current portfolio includes ten products and product candidates, anchored by our core product, Equecabtagene Autoleucel (eque-cel). The CAR-T therapy Eque-cel has been approved in China for the treatment of relapsed or refractory multiple myeloma (r/r MM) in patients who have progressed after at least three prior lines of therapy. It is also being developed for use in earlier lines of r/r MM treatment and for autoimmune diseases, including myasthenia gravis (MG), multiple sclerosis (MS), and systemic lupus erythematosus (SLE)/lupus nephritis (LN). Beyond eque-cel, we are developing nine additional therapeutic candidates—including three autologous chimeric antigen receptor T-cell (CAR-T) therapies, five in vivo CAR-T cell therapies, and one antibody product candidate.

We collaborate with leading biotechnology and biopharmaceutical companies such as Innovent, Sana, Cabaletta, and Umoja, as well as top-tier academic institutions and hospitals, to strengthen our product development capabilities.

Leveraging our strong execution capability, an integrated and experienced management team in ATMPs, a robust pipeline, and advanced manufacturing and CMC capabilities, IASO Bio remains committed to making transformative cell therapies broadly accessible to patients worldwide.

SOURCE IASO Bio