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CAR T-cell therapies 
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Product Candidate1
Technology
Target
Indication
Pre-clinical
Phase I
Phase II/III2
BLA/NDA

Zevor-cel (CT053)3
Zevor-cel (CT053)
fully-human BCMA CAR T for treatment of Multiple Myeloma
Product Candidate: Zevor-cel (CT053)
Technology:

Conventional

Target: BCMA
Indication: R/R MM

CT053 is a BCMA-specific CAR T product candidate, consists of autologous T cells genetically modified with a CAR incorporating a fully human anti-BCMA single chain fragment variant with high binding affinity that specifically recognizes BCMA.

Clinical studies

Investigator-Initiated Trial in China

Phase I/II Clinical Trial for MM in China (LUMMICAR STUDY 1)

  Phase 1b/2 Clinical Trial for MM in North America (LUMMICAR STUDY 2)

Designations

RMAT designation, FDA

for relapsed and/or refractory multiple myeloma (R/R MM)

PRIME designation, EMA

for relapsed and/or refractory multiple myeloma (R/R MM)

Breakthrough Therapy Designation, NMPA

for relapsed and/or refractory multiple myeloma (R/R MM)

Orphan Drug designation, FDA

for multiple myeloma (MM)

Orphan Drug designation, EMA

for multiple myeloma (MM)

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Technology:

Conventional

Target:
BCMA
BCMA
Indication
Pre-clinical
Phase I
Phase II/III2
BLA/NDA
R/R MM
LUMMICAR 1 (China)
R/R MM
LUMMICAR 2 (US, Canada)
R/R MM
IIT (China)

CT041
CT041
Claudin18.2 CAR T for treatment of Solid tumors
Product Candidate: CT041
Technology:

Conventional

Target: Claudin18.2
Indication: GC/GEJ, PC, etc.

CT041 is an autologous CAR T product candidate that targets Claudin18.2 (“CLDN18.2”), which is a stomach-specific isoform of CLDN18 and is highly expressed in gastric and pancreatic cancer cells.

Clinical studies

Investigator-initiated trials

Phase Ib clinical trial for advanced GC/GEJ and PC

Confirmatory Phase II clinical trial for advanced GC/GEJ

  Phase 1b/2 clinical trial for advanced gastric or pancreatic adenocarcinoma

Designations

RMAT designation, FDA

for advanced gastric /gastroesophageal junction adenocarcinoma (GC/GEJ) with Claudin18.2-positive tumor

PRIME designation, EMA

for advanced gastric cancer

Orphan Drug designation, FDA

for gastric /gastroesophageal junction cancer (GC/GEJ)

Orphan Drug designation, EMA

for advanced gastric cancer

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Technology:

Conventional

Target:
Claudin18.2
Claudin18.2
Indication
Pre-clinical
Phase I
Phase II/III2
BLA/NDA
GC/GEJ 
ST-01 (China)
GC/PC
ST-02 (US, Canada)
PC (adjuvant)
ST-05 (China)
GC/GEJ, PC, etc.
IIT (China)

CT011
CT011
GPC3 CAR T for treatment of Hepatocellular Carcinoma
Product Candidate: CT011
Technology:

Conventional

Target: GPC3
Indication: HCC

CT011 is an autologous CAR T product candidate that targets glypican-3 (GPC3), which is highly expressed in HCC and is suggested to be a prognostic marker for the disease.

Clinical studies

Investigator-Initiated Trial for HCC

Phase I Clinical Trial for HCC

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Technology:

Conventional

Target:
GPC3
GPC3
Indication
Pre-clinical
Phase I
Phase II/III2
BLA/NDA
HCC
(China)

CT0180
Product Candidate:
Technology:

sFv-ε

Target:
Indication:
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Technology:

sFv-ε

Target:
GPC3
Indication
Pre-clinical
Phase I
Phase II/III2
BLA/NDA
HCC
IIT (China)

CT0181
Product Candidate:
Technology:

sFv-ε

Target:
Indication:
More+
Technology:

sFv-ε

Target:
GPC3
Indication
Pre-clinical
Phase I
Phase II/III2
BLA/NDA
HCC
IIT (China)

CT0590
Product Candidate:
Technology:

THANK-uCAR®

Target:
Indication:
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Technology:

THANK-uCAR®

Target:
BCMA
Indication
Pre-clinical
Phase I
Phase II/III2
BLA/NDA
R/R MM
IIT(China)

CT048
Product Candidate:
Technology:

CycloCAR®

Target:
Indication:
More+
Technology:

CycloCAR®

Target:
Claudin18.2
Indication
Pre-clinical
Phase I
Phase II/III2
BLA/NDA
GC/GEJ and PC
IIT (China)

CT071
Product Candidate:
Technology:

Undisclosed

Target:
Indication:
More+
Technology:

Undisclosed

Target:
GPRC5D
Indication
Pre-clinical
Phase I
Phase II/III2
BLA/NDA
R/R MM
IIT(China)

KJ-C2113
Product Candidate:
Technology:

CycloCAR®

Target:
Indication:
More+
Technology:

CycloCAR®

Target:
Mesothelin
Indication
Pre-clinical
Phase I
Phase II/III2
BLA/NDA
Solid tumors

KJ-C2114
Product Candidate:
Technology:

THANK-uCAR®

Target:
Indication:
More+
Technology:

THANK-uCAR®

Target:
Undisclosed
Indication
Pre-clinical
Phase I
Phase II/III2
BLA/NDA
Solid tumors

KJ-C2320
Product Candidate:
Technology:

Undisclosed

Target:
Indication:
More+
Technology:

Undisclosed

Target:
Undisclosed
Indication
Pre-clinical
Phase I
Phase II/III2
BLA/NDA
AML
mAb
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Product Candidate1
Technology
Target
Indication
Pre-clinical
Phase I
Phase II/III2
BLA/NDA

AB011
AB011
Anti-Claudin18.2 mAb for treatment of solid tumors
Product Candidate: AB011
Technology:
Target: Claudin18.2
Indication: GC/GEJ and PC

AB011 is a humanized monoclonal antibody product candidate that targets Claudin18.2(“CLDN18.2”), which is a stomach-specific isoform of CLDN18 and is highly expressed in gastric and pancreatic cancer cells.

Clinical studies

Phase I Clinical Trial for CLDN18.2 Positive Advanced GC/GEJ and PC (AB011-ST-01)

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Technology:
Target:
Claudin18.2
Claudin18.2
Indication
Pre-clinical
Phase I
Phase II/III2
BLA/NDA
GC/GEJ and PC
Mono & Combo ( AB011+CAPOX) (China)
for hematologic malignancies
for solid tumors

R/R MM: relapsed / refractory multiple myeloma; GC: gastric cancer; GEJ: gastroesophageal junction cancer; PC: pancreatic cancer; HCC: hepatocellular carcinoma; AML: acute myeloid leukemia

1 All product candidates are self-developed with global rights

2 Phase II trials of some indications are pivotal studies

3 Core Product Candidate. Commercial rights in mainland China have been granted to Huadong Medicine (SZ: 000963). Rights in the South Korean market have been licensed out to HK Inno.N (KOSDAQ: 195940)