NANJING / SHANGHAI, China — November 27, 2025 — IASO Bio announced today that it has secured a landmark regulatory approval from the Hong Kong Department of Health for its fully-human anti-BCMA CAR-T therapy Fucaso (Equecabtagene Autoleucel), intended for adult patients with relapsed or refractory multiple myeloma (R/R MM) who have previously undergone at least three lines of therapy.
Global Milestone: Fucaso Gains BLA Approval
This approval marks the first time a CAR-T therapy developed by IASO Bio in mainland China has been authorized in Hong Kong — a major achievement that elevates the company’s global presence and underscores confidence in its manufacturing standards. The green light was granted under Hong Kong’s “1+” regulatory pathway, which recognizes prior approvals and clinical data as part of a streamlined review.
Under this new approval, Fucaso becomes the first China-developed Advanced Therapy Medicinal Product (ATMP) to achieve certification under the international standard Pharmaceutical Inspection Co‑operation Scheme (PIC/S) GMP guidelines following a successful inspection by Hong Kong’s regulators.
IASO Bio has announced its intention to extend its “Manufactured in Nanjing, Supplied Globally” model, paving the way for broader access to CAR-T therapy across key Asian markets — subject to local regulatory requirements. 2iasobio.com+2
Why IASO Bio’s Approval Matters
1. Expanding Access to Novel CAR-T Therapy
Multiple myeloma (MM) remains one of the most challenging hematological malignancies, especially in relapsed or refractory cases where patients have failed several prior therapies. The approval of Fucaso in Hong Kong provides a new, globally accepted therapeutic option for such patients, expanding the treatment landscape in Asia.
2. Regulatory and Manufacturing Confidence
The PIC/S GMP recognition underscores the robustness of IASO Bio’s manufacturing processes — including its GMP-compliant facilities, vector production capabilities, and quality-control standards.
3. Strategic Step in Internationalization
With regulatory approval beyond mainland China, IASO Bio strengthens its global development strategy. This move — combined with recent clinical-trial notifications and regulatory filings in jurisdictions like Japan — positions the company as a serious global contender in cell therapy.
4. Validation of a Diversified Pipeline
Fucaso is part of a broader pipeline that includes CAR-T candidates targeting CD19/CD22 (for B-cell lymphomas), GPRC5D (for MM), and antibody-based therapies for autoimmune diseases — demonstrating IASO Bio’s breadth in both oncology and immunology.
What’s Next: Commercialization & Global Expansion
With BLA approval secured:
- IASO Bio plans to begin regulatory and reimbursement discussions in Hong Kong, aiming to enable access to eligible MM patients as soon as possible.
- The company’s manufacturing center in Nanjing — licensed for CAR-T production and capable of producing up to 3,000 batches annually — is expected to support scaled-up supply for global markets.
- Regulatory strategies are underway for other regions: Fucaso’s applications in Singapore, Saudi Arabia and other markets remain under review, while ongoing IND-approved trials and CAR-T research expand the global footprint of IASO Bio’s therapies.
- Continued R&D: Parallel to commercialization efforts, IASO Bio will continue advancing its pipeline — including CD19/CD22 dual-target CAR-T for lymphoma, GPRC5D-targeted therapies, and antibody-based immunotherapies, reinforcing its long-term innovation strategy.
About IASO Bio — At the Forefront of Next-Gen Cell Therapies
Founded in 2017, IASO Bio is a pioneering biopharmaceutical company dedicated to the discovery, development, manufacturing, and commercialization of advanced cell therapies and biologics targeting hematologic malignancies and autoimmune diseases.
With a robust product pipeline encompassing more than ten innovative candidates — including CAR-T therapies, monoclonal antibodies and biologics — the company leverages integrated capabilities spanning early research, clinical development, GMP manufacturing, and global regulatory submission.
The company operates multiple R&D and manufacturing sites in Nanjing, Shanghai and the U.S. San Francisco Bay Area, staffed by a global team of approximately 500 employees. This infrastructure supports IASO Bio’s dual commitment: delivering breakthrough therapies and expanding patient access worldwide.
Strategic Significance for Stakeholders & the Oncology Ecosystem
- Patients & Clinicians: Fucaso’s approval offers hope to MM patients with limited options, especially in Hong Kong and broader Asia — and may shorten the time between relapse and access to CAR-T therapy.
- Healthcare Providers & Payers: With a China-developed therapy achieving international regulatory recognition, healthcare providers may gain cost-effective, regionally produced alternatives to imported cell therapies — potentially improving access and affordability.
- Investors & Industry Watchers: IASO Bio’s trajectory — from R&D startup to global-stage biotech — highlights the growing maturity and global competitiveness of Chinese cell-therapy companies. The Hong Kong approval may serve as a template for market expansion across Asia and beyond.
- Global Biopharma Landscape: The success of IASO Bio demonstrates that innovative biologics and cell therapies can emerge outside traditional Western biotech hubs, possibly reshaping global supply chains, licensing strategies and collaborative research.
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