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CAR T-cell therapies
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Product Candidates
Target
Global Rights
Pre-clinical
Phase I
Phase II/III1
BLA/NDA

CT0532
+
Target:
BCMA
Global Rights:

Global3

Pre-clinical
Phase I
Pivotal***
Phase II/III
BLA/NDA
R/R MM (China)
R/R MM (US, Canada )
R/R MM (IIT)
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CT053
fully-human BCMA CAR T for treatment of Multiple Myeloma
Product Candidate: CT053
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 Ib/II 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)

CT041
+
Target:
Claudin18.2
Global Rights:

Global

Pre-clinical
Phase I
Pivotal***
Phase II/III
BLA/NDA
GC/GEJ (China)
GC/PC (US, Canada )
PC (China)
GC/GEJ, PC and other GI tumors (IIT)
iconClose
CT041
Claudin18.2 CAR T for treatment of Solid tumors
Product Candidate: CT041
Target: Claudin18.2
Indication: GC/GEJ, PC and other GI tumors

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 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

CT011
+
Target:
GPC3
Global Rights:
Global
Pre-clinical
Phase I
Pivotal***
Phase II/III
BLA/NDA
HCC (China)
iconClose
CT011
GPC3 CAR T for treatment of Hepatocellular Carcinoma
Product Candidate: CT011
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

CT032
+
Target:
CD19
Global Rights:

Global3

Pre-clinical
Phase I
Pivotal***
Phase II/III
BLA/NDA
B-NHL (China)
iconClose
Product Candidate:
Target: CD19
Indication: B-NHL

CT01804
+
Target:
GPC3
Global Rights:

Global

Pre-clinical
Phase I
Pivotal***
Phase II/III
BLA/NDA
HCC (IIT)
iconClose
Product Candidate:
Target: GPC3
Indication: HCC

CT01814
+
Target:
GPC3
Global Rights:

Global

Pre-clinical
Phase I
Pivotal***
Phase II/III
BLA/NDA
HCC (IIT)
iconClose
Product Candidate:
Target: GPC3
Indication: HCC

CT05905
+
Target:
BCMA
Global Rights:

Global

Pre-clinical
Phase I
Pivotal***
Phase II/III
BLA/NDA
R/R MM (IIT)
iconClose
Product Candidate:
Target: BCMA
Indication: R/R MM
KJ-C2112
+
Target:
EGFR/EGFRvIII
Global Rights:
Global
Pre-clinical
Phase I
Pivotal***
Phase II/III
BLA/NDA
Glioblastoma
iconClose
Product Candidate:
Target: EGFR/EGFRvIII
Indication: Glioblastoma

KJ-C1807(CT048)6
+
Target:
Claudin18.2
Global Rights:

Global

Pre-clinical
Phase I
Pivotal***
Phase II/III
BLA/NDA
GC/GEJ and PC
iconClose
Product Candidate:
Target: Claudin18.2
Indication: GC/GEJ and PC

KJ-C21136
+
Target:
Mesothelin
Global Rights:

Global

Pre-clinical
Phase I
Pivotal***
Phase II/III
BLA/NDA
Solid tumor
iconClose
Product Candidate:
Target: Mesothelin
Indication: Solid tumor

KJ-C21145
+
Target:
Undisclosed
Global Rights:

Global

Pre-clinical
Phase I
Pivotal***
Phase II/III
BLA/NDA
Solid tumor
iconClose
Product Candidate:
Target: Undisclosed
Indication: Solid tumor
mAb
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Product Candidates
Target
Global Rights
Pre-clinical
Phase I
Phase II/III1
BLA/NDA

AB011
+
Target:
Claudin18.2
Global Rights:
Pre-clinical
Phase I
Pivotal***
Phase II/III
BLA/NDA
GC/GEJ and PC (China)
iconClose
AB011
Anti-Claudin18.2 mAb for treatment of solid tumors
Product Candidate: AB011
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 Solid Tumors

1 Phase II trials of some indications are pivotal studies

2 Core Product Candidate

3 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)

4 Developed with our sFv-ε-based T-cell therapy

5 Developed with our THANK-uCAR® technology

6 Developed with our CycloCAR® technology

R/R MM: relapsed / refractory multiple myeloma; GC: gastric cancer; GEJ: gastroesophageal junction cancer; PC: pancreatic cancer; B-NHL: B-cell non-Hodgkin lymphoma; HCC: hepatocellular carcinoma