By Fineline Cube 
IASO Biotherapeutics, a China‑based biotherapeutics developer, today announced a strategic collaboration agreement with GC Cell Co., Ltd. to bring its BCMA‑targeted CAR‑T cell therapy Equecabtagene Autoleucel to the South Korean market for the treatment of multiple myeloma. GC Cell will spearhead the registration, regulatory approval, and commercialization of the product in South Korea.
Collaboration Highlights
- Joint Development & Commercialization – The partnership will progressively drive the full regulatory and commercial lifecycle of Equecabtagene Autoleucel in South Korea.
- Regulatory Milestones – The therapy has already received Orphan Drug Designation from the South Korean Ministry of Food and Drug Safety (MFDS) and was further designated as a Fast‑Track Advanced Regenerative Therapy in August 2025.
- Strategic Alignment – The deal positions GC Cell as the local commercial partner while leveraging IASO’s proven clinical platform and regulatory experience.
Product Profile – Equecabtagene Autoleucel
- Mechanism of Action – A BCMA‑targeted CAR‑T cell therapy independently developed by IASO, designed to eradicate malignant plasma cells in multiple myeloma patients.
- Regulatory Status – Approved for market by China’s National Medical Products Administration (NMPA) in June 2023.
- Clinical Development – Ongoing clinical data support its efficacy and safety profile, positioning it as a promising first‑in‑class therapy in the rapidly expanding CAR‑T market.
Strategic Impact
- Market Expansion – The collaboration opens a new growth avenue for IASO in the Korean biopharma landscape, while GC Cell expands its oncology portfolio with a cutting‑edge CAR‑T product.
- Accelerated Access – Fast‑Track designation and orphan status are expected to streamline the approval process, potentially delivering therapy to patients sooner.
Forward‑Looking Statements
This release contains forward‑looking statements that involve risks and uncertainties. Actual results may differ materially.-Fineline Info & Tech