CAR-T细胞疗法 在华治疗
自2021年以来,中国国家药监局(NMPA)已批准至少八款CAR-T产品,其中包括2026年6月获批的satri-cel,这是首款获批用于实体瘤的CAR-T产品。其中两款(axi-cel和cilta-cel)也获得了美国FDA批准。患者可通过医院血液科或肿瘤科团队获取治疗,通常经由国际部,或通过临床试验。
已核验最后核验
可用疗法
| 可用疗法 | 在华状态 | 在美状态 | 信息来源 |
|---|---|---|---|
| Axicabtagene ciloleucel (Yikaida in China, Yescarta in US) | 在中国已获批 | 在中国已获批 | PubMed CentralNMPA (English) |
| Relmacabtagene autoleucel (Carteyva) | 在中国已获批 | 未获批 | PubMed CentralNMPA (English) |
| Equecabtagene autoleucel (Fucaso) | 在中国已获批 | 未获批 | Xinhua (English)JW TherapeuticsNMPA (English) |
| Inaticabtagene autoleucel | 在中国已获批 | 未获批 | Xinhua (English)NMPA (English) |
| Zevorcabtagene autoleucel | 在中国已获批 | 未获批 | Xinhua (English)JW TherapeuticsNMPA (English) |
| Ciltacabtagene autoleucel (Carvykti) | 在中国已获批 | 在中国已获批 | Nature Reviews Drug DiscoveryNMPA (English) |
| Ranicabtagene autoleucel (HICARA) | 在中国已获批 | 未获批 | Alliance for Regenerative MedicineShanghai Hengrun Dasheng (Harin Bio)NMPA (English) |
| Satricabtagene autoleucel (satri-cel), Claudin18.2 CAR-T for gastric/GEJ cancer | 在中国已获批 | 未获批 | China Economic Net / CailiansheCARsgen TherapeuticsNMPA (English) |
| Dual-target and allogeneic CAR-T (investigational) | 临床试验 | 临床试验 |
有公开项目的医院
以下为有来源的公开信息,不构成推荐。
Nanjing泰康仙林鼓楼医院Taikang Xianlin Drum Tower HospitalInternational deptVerified
Nanjing南京鼓楼医院Nanjing Drum Tower HospitalNo public intl deptReported
Shanghai上海交通大学医学院附属瑞金医院Ruijin Hospital, Shanghai Jiao Tong University School of MedicineInternational deptVerified
Shanghai上海嘉会国际医院Shanghai Jiahui International HospitalInternational deptJCIVerified
Hangzhou浙江大学医学院附属第一医院The First Affiliated Hospital, Zhejiang University School of Medicine (FAHZU)International deptVerified
临床试验
465项研究正在中国招募(ClinicalTrials.gov,截至 2026-10-26). 查看列表
我们只提供试验链接;是否入组由试验团队决定。据 AFP 报道,自 2026 年 5 月起中国禁止向患者收取临床研究费用。
常见问题
CAR-T在中国是否已获批?
是的。NMPA自2021年开始批准(axi-cel和relma-cel)。瑞基奥仑赛于2025年7月成为第七款获批产品,satri-cel用于Claudin18.2阳性胃癌,于2026年6月获批,依据为NMPA关联企业公告。
[1] China Economic Net /…[2] CARsgen Therapeutics中国的获批名单与美国相比如何?
截至2026年9月,FDA已批准七款CAR-T产品。只有axi-cel和cilta-cel在两国均获批;中国批准的其他产品尚未获FDA批准。
[1] BioInformantCAR-T在中国的价格是多少?
一份期刊表格列出axi-cel(益基利仑赛,阿基仑赛注射液)每次输注约116.6万元。法新社2026年6月报道治疗价格约为15万至18万美元。2026年6月国家医保局文件显示,淋巴瘤CAR-T产品尚未纳入国家基本医保药品目录。
[1] PubMed Central[2] AFP / Free Malaysia …[3] National Healthcare …外国人能否在中国接受CAR-T治疗?
已有外国患者接受治疗并被公开报道,例如上海的一位新西兰淋巴瘤患者。获取途径为医院国际部或临床试验;由医院临床团队逐例评估决定。
[1] AFP / Free Malaysia …信息来源
- Redefining CAR-T regulation: China's responses to address secondary cancer risks of CAR-T therapy (Table 1)
“Table 1 lists zevor-cel (NMPA, 2024-02-23), inati-cel (NMPA, 2023-11-07) and eque-cel/Fucaso (NMPA, 2023-06-30).”
- A New Outcomes-Based Payment Plan From a Chinese Company to Improve Patient Affordability of CAR-T Product
“Lists Yikaida (axicabtagene ciloleucel) at about 1.166 million yuan per infusion and inaticabtagene at about 0.999 million yuan.”
- NMPA acceptance of sBLA for Carteyva as second-line treatment in r/r LBCL
“Carteyva has been approved by NMPA for three indications.”
- Harin Bio's CD19 CAR-T HICARA (Ranicabtagene Autoleucel Injection) Approved for Marketing
“On July 30, 2025, the National Medical Products Administration formally approved the New Drug Application for Ranicabtagene Autoleucel Injection (HICARA).”
- Fourth CD19 CAR-T approved in China (seventh CAR-T overall)
“Ranicabtagene became the seventh CAR-T product approved in China.”
- CARsgen Announces Approval of Satri-cel, the World's First CAR T-Cell Therapy Product for Solid Tumors
“Satri-cel is the world's first approved CAR T-cell therapy product for the treatment of solid tumors.”
- Ciltacabtagene Autoleucel Injection Approved for Marketing by China NMPA
“It is indicated for the treatment of adults with relapsed or refractory multiple myeloma after three or more prior lines of therapy and progressed, including a proteasome inhibitor and an immunomodulatory agent.”
- 16 CAR-T Therapies and Counting
“Seven therapies have been approved by the U.S. FDA.”
- 2026 National Reimbursement Drug List application: ranicabtagene autoleucel (public version)
“In r/r large B-cell lymphoma, four CAR-T products are marketed in China (axicabtagene, relmacabtagene, ranicabtagene, inaticabtagene), none yet in the national basic medical insurance drug list.”
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