IASO Bio's Ixazomib-based CAR-T Therapy FUCASO Receives Approval from Singapore’s HSA, Marking Key Milestone in Global Commercialization

Jun 18, 2026 17:30 CST Updated 17:30

IASO Biotechnology

Cancer Treatment New Drug Developer

On June 18, 2026, IASO Bio announcedThe Health Sciences Authority (HSA) of Singapore has officially approved its independently developed fully human anti-BCMA CAR-T cell therapy product, equecabtagene autoleucel injection (approved name: FUCASO suspension for infusion; brand name in mainland China: Fukesu).^®) for the marketing authorization application of a new drug, indicated for the treatment of adult patients with relapsed or refractory multiple myeloma (r/r MM) who have experienced disease progression after at least three prior lines of therapy (including at least one proteasome inhibitor and one immunomodulatory agent). This marks the first successful international regulatory approval of a fully human CAR-T cell therapy product for commercial use globally. It represents a significant breakthrough in IASO Bio’s internationalization strategy and establishes a viable pathway for China-developed and manufactured cell therapies to compete globally and benefit patients worldwide.。

Multiple Myeloma (MM) is the second most common hematologic malignancy globally and in Singapore. According to Globocan 2022 data, the global incidence rate of MM is 1.8 per 100,000, with a 5-year prevalence rate of 6.8 per 100,000. In Singapore, both the incidence rate (2.2 per 100,000) and the 5-year prevalence rate (15.0 per 100,000) exceed the global averages, indicating a significant unmet clinical need.

As the first BCMA-targeted CAR-T product approved for marketing in SingaporeIcoCileucel Injection will address the current lack of comparable targeted cell therapies in the local and surrounding areas. Patients will be able to receive cutting-edge international cell therapy locally, eliminating the need for cross-border medical travel and potentially significantly reducing overall treatment costs and associated risks.

This approval marks the first overseas marketing authorization for Ikyocel Injection outside Greater China, following its approvals in mainland China, Macau, and Hong Kong.This milestone marks the official launch of the product’s global commercialization footprint. In terms of commercial supply, IASO Bio will adopt an innovative “Made in China, Supplying the World” model. Leveraging its manufacturing system compliant with international mainstream standards (including GMP) and a rigorous global cold-chain logistics network, IASO Bio will provide high-quality, consistently accessible innovative cell therapy medicines to patients in Singapore and Southeast Asia.

Ms. Zhang Jinhua

Founder, Chairman, and CEO of IASO Bio

Singapore is the first country where we submitted and obtained approval for an international new drug marketing authorization application, marking a key milestone in IASO Bio’s “global expansion” strategy. This approval serves as strong international endorsement of IASO Bio’s quality systems, manufacturing capabilities, and global cold-chain logistics accessibility for its CAR-T product. It signifies that China’s innovative strength in cell therapy has truly gone global, participating in international competition. With the product’s approval and launch in Singapore, patients can now access world-leading cell therapy within their own country and benefit from local medical insurance coverage, significantly improving drug accessibility and reigniting hope for life for more patients.

# About Multiple Myeloma

The global annual number of new multiple myeloma cases increased from approximately 164,300 in 2019 to approximately 197,200 in 2024, and is projected to reach 273,600 by 2040. Despite advances in current anti-myeloma therapies, multiple myeloma (MM) remains largely incurable, with a high propensity for multiple relapses and a tendency to develop resistance to multiple classes of drugs, posing significant challenges to treatment. Therefore, in addition to existing anti-myeloma therapies, there is an urgent need for new treatment options for relapsed or refractory MM to achieve deep and durable responses.

AboutIqirucel Injection

Iciloleucel Injection is a CAR-T cell therapy targeting B-cell maturation antigen (BCMA), which utilizes a lentiviral vector to transduce autologous T cells. The chimeric antigen receptor (CAR) comprises a fully human single-chain variable fragment (scFv), a CD8α hinge and transmembrane domain, a 4-1BB co-stimulatory molecule, and a CD3ζ activation domain. Based on rigorous molecular structure screening and comprehensive in vitro and in vivo functional evaluations, Iciloleucel Injection enables patients to achieve deep and durable remissions, with manageable adverse reactions.