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Table 1 Chimeric antigen receptor T-cell products developed in China

From: Redefining chimeric antigen receptor T-cell (CAR-T) regulation: China’s responses to address secondary cancer risks of CAR-T therapy

Product name

Generic name

Manufacturer

Target

Antigen-recognition domain

Approved indication

Approved by

Time of approval

Relevant studies

Zevor-cel

Zevorcabtagene Autoleucel

CARsgen Therapeutics, Shanghai, China

BCMA

a fully human BCMA-specific scFv (25C2)

Adult r/r MM progressed after at least 3 lines of systemic therapy, including a PI and an IMiD

NMPA

2024-02-23

[4]

CNCT19 (Inati-cel)

Inaticabtagene Autoleucel

Juventas Cell Therapy, Tianjin, China

CD19

a unique CD19 scFv derived from CD19 monoclonal antibody (HI19a)

Adult r/r B-ALL

NMPA

2023-11-07

[5]

Fucaso (Eque-cel)

Equecabtagene Autoleucel

IASO Bio, Nanjing, China

BCMA

a fully human scFv

Adult r/r MM progressed after at least 3 lines of systemic therapy, including a PI and an IMiD

NMPA

2023-06-30

[6]

Carvykti (Cilta-cel)

Ciltacabtagene Autoleucel

Janssen, New Jersey, US; Legend Biotech, Nanjing, China

BCMA

two llama (camelid) heavy chains (VH) as a scFv

Adult r/r MM after at least 4 lines of therapy, including a PI, an IMiD, and an anti-CD38 monoclonal antibody

FDA

2022-02-28

[7]

Relma-cel

Relmacabtagene Autoleucel

JW Therapeutics, Shanghai, China

CD19

scFv derived from a murine CD19-specific mAb (FMC63)

Adult r/r LBCL after at least 2 lines of systemic therapy

NMPA

2021-09-01

[8, 9]

Yescarta (Axi-cel)

Axicabtagene Ciloleucel

Fosun Kite Biotechnology, Shanghai, China

CD19

scFv derived from a murine CD19-specific mAb (FMC63)

Adult r/r LBCL after at least 2 lines of systemic therapy; adult LBCL fail to respond to first-line immunochemotherapy or relapse within 12 months after first-line immunochemotherapy

NMPA

2021-06-22

[10,11,12]

  1. BCMA, B cell maturation antigen; scFv, single chain variable fragment; VH, variable region of the heavy chain; r/r MM, relapsed and/or refractory multiple myeloma; PI, proteasome inhibitor; IMiD, immunomodulatory drug; r/r B-ALL, relapsed and/or refractory B-cell acute lymphoblastic leukemia; r/r LBCL, relapsed and/or refractory large B-cell lymphoma; LBCL, large B-cell lymphoma; NMPA, National Medical Products Administration; FDA, Food and Drug Administration