IASO Bio Hosts FUCASO Singapore Launch Event, Marking the Official Commercial Landing of China's Original Fully Human BCMA CAR-T Cell Therapy in Southeast Asia's Healthcare Hub

IASO Bio and its Singapore partner Pills and Pokes jointly hosted the FUCASO launch event in Singapore on November 3, marking the official commercial arrival of the world's first fully human BCMA-targeted CAR-T cell therapy in Singapore. FUCASO was approved by Singapore's Health Sciences Authority (HSA) in June 2026 for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who have progressed after at least three prior lines of therapy (including at least one proteasome inhibitor and one immunomodulatory agent).

SHANGHAI, NANJING, China, and PLEASANTON, Calif., Nov. 3, 2026 /PRNewswire/ -- IASO Bio, a biopharmaceutical company dedicated to the discovery, development, manufacturing and commercialization of innovative cell therapies and biologics for hematologic malignancies and autoimmune diseases, today announced that it has jointly hosted a launch event with its local partner Pills and Pokes in Singapore to celebrate the commercial launch of FUCASO (approved name: FUCASO suspension for infusion), marking the official commercialization of the world's first fully human BCMA-targeted CAR-T cell therapy in Singapore.

FUCASO was approved by Singapore's Health Sciences Authority (HSA) in June 2026 for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who have progressed after at least three prior lines of therapy, including at least one proteasome inhibitor and one immunomodulatory agent. It is the first BCMA-targeted CAR-T cell therapy approved in Singapore.

Experts from China and Singapore Discuss the R/R MM Treatment Landscape, Witnessing the Launch of FUCASO in Singapore

Held under the theme 'Expanding New Possibilities in the Treatment of Relapsed/Refractory Multiple Myeloma,' the launch event brought together leading clinical experts in hematology-oncology from Singapore, local partners and investors.

Professor Chng Wee Joo of the Department of Haematology-Oncology, National University Cancer Institute, Singapore, delivered the welcome address and closing remarks. In the scientific session, Professor Chandramouli from the Department of Haematology, Singapore General Hospital, presented on the evolving treatment landscape and unmet needs in R/R MM, analyzing the current status and pain points of regional clinical practice. Professor Chen Wenming from Beijing Chaoyang Hospital, Capital Medical University, discussed treatment sequencing optimization in R/R MM and patient selection for BCMA-targeted therapy. During the Q&A session, attendees engaged in in-depth discussions on the clinical application of FUCASO and patient management.

From Approval to Infusion: Full Commercialization Chain Validated in Real-World Settings

Just two months after its approval, the first commercial patient infusion of FUCASO was completed at Parkway Cancer Centre in Singapore. The patient, an adult with R/R MM who had received four prior lines of therapy, has achieved complete response and remains in good condition.

This milestone is significant: it demonstrates that FUCASO's 'In China, For Global' model — spanning regulatory approval, patient screening and leukapheresis, cross-border cold-chain logistics, manufacturing and release at IASO Bio's China facility, and cold-chain return to Singapore for infusion — has been fully validated in a real-world commercial setting. This not only lays the foundation for sustained patient access in Singapore, but also provides a replicable model for expansion into other markets in Southeast Asia and beyond.

In Singapore, IASO Bio partners with Pills and Pokes, a local specialty pharmaceutical importer and distributor, leveraging its capabilities in specialty drug importation, supply and marketing to ensure the stable supply of and patient access to FUCASO.

Reimbursement Access: FUCASO's Accessibility Strategy Fully Established in Singapore

Following evaluation by the Agency for Care Effectiveness (ACE) under Singapore's Ministry of Health, FUCASO has been successfully included in Singapore's Cancer Drug List (CDL), effective December 1, 2026. From that date, eligible local patients will be able to obtain coverage for treatment costs through a healthcare financing network comprising public and commercial funds, significantly reducing their out-of-pocket burden and extending the benefits of this innovative CAR-T therapy to more patients in Singapore.

This inclusion marks an important milestone in FUCASO's overseas reimbursement journey: it not only substantially improves access for patients in Singapore, but also provides valuable, replicable experience for securing inclusion in local reimbursement systems in additional overseas markets.

Efficacy and Safety Validated by Pivotal and Real-World Data

The efficacy and safety of FUCASO have been validated in the pivotal registrational study FUMANBA-1. Among patients receiving CAR-T therapy for the first time, the overall response rate (ORR) reached 98.9%, the stringent complete response/complete response (sCR/CR) rate reached 88.4%, and the median progression-free survival (mPFS) was 35.9 months. In terms of safety, the incidence of Grade 3 or higher cytokine release syndrome (CRS) was only 0.9%; no Grade 3 or higher immune effector cell-associated neurotoxicity syndrome (ICANS) was observed, and no parkinsonism-like manifestations or second primary malignancies were reported.

Real-world data further corroborate these findings. In a retrospective study of 281 patients with R/R MM presented at the 2026 International Myeloma Society (IMS) Annual Meeting, the ORR was 95.9%, the sCR/CR rate was 77.2%, and the 12-month PFS rate was 71.5%. The overall safety profile was favorable, with adverse events predominantly of low grade and managed through well-established clinical protocols.

Anchored in Singapore, Radiating Across Southeast Asia: A New Starting Point for Regional Access

Singapore is widely recognized as the healthcare hub of Southeast Asia, with region-leading hematology-oncology expertise and a well-established cell therapy infrastructure. It attracts a large number of patients from neighboring countries and regions each year, and HSA's regulatory decisions carry significant influence across the region. The commercial launch of FUCASO in Singapore not only delivers direct benefits to local patients, but also establishes a regional anchor point from which this innovative therapy can reach the entire Southeast Asian market.

With a population of over 600 million, Southeast Asia faces a growing multiple myeloma disease burden, while advanced cell therapies such as CAR-T remain largely inaccessible in most regional markets. For patients in countries where FUCASO is not yet available, seeking treatment in Singapore offers a well-established and convenient pathway — substantially reducing the time and financial burden of cross-border care compared to traveling to Europe or the United States.

"The launch event in Singapore marks the full commercial take-off of FUCASO at the healthcare hub of Southeast Asia. Working closely with our local partner Pills and Pokes, and backed by our mature cross-border supply chain and local medical affairs capabilities, we are committed to providing stable and accessible treatment options for patients in Singapore and the wider region, and to continuously advancing clinical exchange and drug accessibility in the region," said Mr. Zhang Hua, Chief Business Officer and Senior Vice President of IASO Bio.

"At Pills and Pokes, our purpose is to bring tomorrow's therapies to today's patients. From my many years on the clinical ground, I know how much timely access matters. FUCASO is the first BCMA CAR-T cell therapy approved in Singapore, and Singapore is its first market outside Greater China. As a Singaporean, I am proud to help bring this innovation from China to patients here and across Southeast Asia," said Ms. Gail Chang, Co-founder and Chief Executive Officer of Pills and Pokes.

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