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Nanjing, China; Shanghai, China; and Pleasanton, USAJune 18, 2026 /PRNewswire/ — IASO Biologics, 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 the Health Sciences Authority (HSA) of Singapore has officially approved the New Drug Application (NDA) for its independently developed, fully human BCMA-targeted CAR-T cell therapy product, Equecabtagene Autoleucel Injection (approved name: FUCASO suspension for infusion; trade name in Mainland China: Fucaso®), for the treatment of adult patients with relapsed or refractory multiple myeloma (r/r MM) who have received at least three prior lines of therapy and have shown disease progression (including at least one proteasome inhibitor and one immunomodulatory agent). This marks the first international approval of a commercially available, fully human CAR-T cell therapy product globally, representing not only a major breakthrough in IASO Biologics’ internationalization strategy but also paving a viable path for China’s self-developed and self-manufactured cell therapies to compete globally and benefit patients worldwide.
Multiple myeloma (MM) is the second most common hematologic malignancy in terms of incidence 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 of 6.8 per 100,000; Singapore’s MM incidence rate (2.2 per 100,000) and 5-year prevalence (15.0 per 100,000) are both higher than the global average, indicating significant unmet clinical needs.
As the first approved BCMA-targeted CAR-T product in Singapore, Equecabtagene Autoleucel Injection will transform the current lack of similar targeted cell therapies in the region. Patients can now receive cutting-edge cell therapy locally, eliminating the need for cross-border medical travel, which is expected to significantly reduce overall treatment costs and associated risks.
This approval marks the first overseas marketing authorization for Equecabtagene Autoleucel Injection outside Greater China, following its approvals in Mainland China, Macau, and Hong Kong. This milestone signifies the official launch of the product’s global commercialization footprint. For commercial supply, IASO Biologics will adopt an innovative “Made in China, Supplied Globally” model. Leveraging its production system that meets internationally recognized standards (including GMP) and a rigorous global cold-chain logistics network, IASO Biologics will provide high-quality, stable, and accessible innovative cell therapy drugs to patients in Singapore and Southeast Asia.
Ms. Zhang Jinhua, Founder, Chairwoman, and CEO of IASO Biologics, stated: “Singapore is the first country where we submitted an international NDA and received approval, marking a key milestone in IASO Biologics’ ‘going global’ strategy. This approval serves as a strong international endorsement of our CAR-T product’s quality system, manufacturing capabilities, and global cold-chain logistics accessibility, signifying that China’s innovative strength in the cell therapy field has truly stepped onto the global stage and entered international competition. With the product’s approval and launch in Singapore, patients can not only receive world-leading cell therapy within their own country but also benefit from local medical insurance coverage, significantly enhancing drug accessibility and rekindling hope for more patients.“