By Fineline Cube 
IASO Biotherapeutics announced that Fucaso (equecabtagene autoleucel injection), its proprietary fully human BCMA‑targeted CAR‑T cell therapy, received marketing approval from the Hong Kong Department of Health for adult patients with relapsed or refractory multiple myeloma (R/R MM) after at least three prior lines of therapy, marking the first China‑developed CAR‑T approved in Hong Kong.
Regulatory Milestone
| Item | Detail |
|---|---|
| Product | Fucaso (equecabtagene autoleucel) |
| Company | IASO Bio |
| Agency | Hong Kong Department of Health |
| Approval Type | Marketing authorization |
| Indication | R/R MM after ≥3 prior lines |
| China Approval | NMPA approved July 2023 for same indication |
| Manufacturing | First domestically produced ATMP with PIC/S GMP certification |
Drug Profile
- Mechanism: BCMA‑directed CAR‑T using lentiviral vector to transfect autologous T cells
- CAR Construct: Fully human scFv, CD8α hinge/transmembrane, 4‑1BB co‑stimulatory, CD3ζ activation domain
- Innovation: Fully human scFv reduces immunogenicity risk vs. murine‑derived CAR‑Ts
- Certification: PIC/S GMP certification positions IASO for global supply and partnership opportunities
Market Context & Outlook
| Metric | Value |
|---|---|
| Hong Kong MM Incidence | ~300 new cases annually |
| R/R MM Patients Eligible | ~120 patients (40% of total) |
| CAR‑T Market Size (HK) | HK$150‑200 million (US$19‑26 million) |
| Pricing | Expected HK$1.2‑1.5 million per dose (aligned with mainland China pricing) |
| Peak Sales Forecast | HK$80‑100 million (~US$10‑13 million) by 2028 |
| Strategic Value | Gateway to Southeast Asia and global markets via Hong Kong’s regulatory credibility |
- Competitive Edge: First‑mover advantage in Hong Kong; no other BCMA CAR‑Ts approved locally
- Next Catalysts: Potential Japan PMDA filing Q2 2026; U.S. IND under discussion with FDA
- Manufacturing Scale: PIC/S certification enables export to PIC/S member countries (85+ nations)
Forward‑Looking Statements
This brief contains forward‑looking statements regarding Fucaso’s commercial launch in Hong Kong, global expansion plans, and manufacturing capabilities. Actual results may differ materially due to risks including market adoption, competitive responses, and regulatory changes.-Fineline Info & Tech