By Fineline Cube 
Fosun Kairos, a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (SHA: 600196, HKG: 2196), announced today that the China National Medical Products Administration (NMPA) has accepted the marketing application for its second CAR‑T therapy, brexucabtagene autoleucel (FKC889). The product is indicated for adult patients with relapsed or refractory precursor B‑cell acute lymphoblastic leukemia (ALL).
Key Highlights
- Domestic Production – FKC889 is a CD19‑targeted CAR‑T cell therapy manufactured locally in Mainland China, Hong Kong and Macau via technology transfer and licensing from Kite Pharma, Inc., a Gilead Sciences subsidiary.
- Regulatory Milestone – NMPA approval places Fosun Kairos among the few Chinese companies capable of delivering a fully regulated, high‑complexity cell therapy within its borders.
- Market Context – The global CAR‑T market is projected to exceed $10 billion by 2027, with China expected to capture 25‑30 % of sales as domestic manufacturing and reimbursement frameworks mature.
Clinical Positioning
| Aspect | Detail |
|---|---|
| Indication | Adult relapsed/refractory precursor B‑cell ALL |
| Reference Product | Tecartus (Kite Pharma) – approved in the U.S. (Jul 2020) and EU (Dec 2020) |
| Bridge Trials | Ongoing trials for relapsed/refractory mantle cell lymphoma (r/r MCL) with ≥ 2 prior lines of therapy |
Strategic Implications
- First‑Mover Advantage – By leveraging a proven Kite platform and local manufacturing, Fosun Kairos can reduce supply‑chain risk and potentially lower costs for Chinese patients.
- Reimbursement Pathway – NMPA approval is a prerequisite for inclusion in China’s national health insurance schemes, which could accelerate patient access and generate revenue streams.
- Expansion Potential – Success in ALL may pave the way for FKC889’s indication expansion into MCL, solidifying Fosun Kairos’ position as a leading domestic CAR‑T developer.-Fineline Info & Tech