China's first approved CAR-T: axicabtagene ciloleucel
The approval that built China's CAR-T operating model — designated centres, apheresis capacity, a cold chain to the factory, and an ICU-backed safety protocol.
At a glance
- Generic name
- Axicabtagene ciloleucel
- Brand
- 奕凯达 / Yescarta
- Development code
- FKC876
- Regulatory status
- Approved in China (NMPA, 2021-06-22)
What happened
The NMPA approved axicabtagene ciloleucel injection, submitted by Fosun Kite, through priority review. It was the first cell therapy product approved in China.
The label covers adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL transformed from follicular lymphoma. The product is an autologous anti-CD19 CAR-T prepared with a retroviral vector.
Why it matters
Beyond being first, this approval created the operating model every later CAR-T in China depends on: designated cellular-therapy centres, apheresis capacity, a validated cold chain to a GMP manufacturing site, and a cytokine release syndrome protocol backed by intensive care.
That is why 'is CAR-T available in China' is the wrong question. The answerable one is whether that entire chain exists at a specific hospital on a specific date — and that is a hospital-level question no public list answers.
Access in China
Where it is available
Delivered only at hospitals with a cellular-therapy programme. Which centres are currently active, and which accept international self-pay patients, is not published; we confirm it during intake.
Language support
International departments at major public hospitals provide English support; ward-level care is in Chinese and requires interpretation.
Typical timeline
Leukapheresis, manufacture and release, lymphodepletion, infusion, then a monitored stay. Total time from first contact to infusion depends on slot availability and is not published.
Cost
No figure is published here. We do not publish a price we cannot back with a written quotation from a specific hospital — ask us and we will obtain it in writing before you commit to anything.
What we don't know
These are the questions patients actually ask, and the ones nobody publishes. We list them rather than filling them with guesses.
- •No published list price in China.
- •Which centres are currently active for new patients.
- •Manufacturing slot availability and vein-to-vein time.
- •Bridging therapy policy before lymphodepletion.
- •Whether prior CAR-T abroad disqualifies a patient at a given centre.
Sources
- NMPA — approval of axicabtagene ciloleucel injection
Original language: Chinese · Published 2021-06-23
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Published 2021-06-22 . This page is general information, not medical advice, diagnosis or a recommendation for any individual. Regulatory status, availability and price can change without notice — confirm with the treating hospital before making decisions.