Research & Development
Pipeline Research Capabilities Research Areas
CellBion's Radiopharmaceutical Pipeline Portfolio
Clinical Stage
Pipeline Target Indication Development Status Pre-clinical P1 P2 P3 177Lu-DGUL Prostate Cancer
Radiotherapy
(3rd line) 177
Lu-DGUL+
Pembrolizumab
 Prostate Cancer
Radiotherapy
(2nd line) 225
Ac-Antibody
(Novel Target)
 Multiple
cancer types 225Ac-DGUL Prostate Cancer
Radiotherapy 68Ga-Nota-MSA Cardiovascular
Disease Diagnosis 99mTc-MSA-ICG Lymphoscintigraphy
SLN mapping 68Ga-NGUL Prostate Cancer
Diagnosis Conditional approval is anticipated shortly following the completion of Phase 2 trials in Korea. Therapeutic agentDiagnostic agent
Preclinical Stage
Pipeline Target Indication Development Status Hit Lead Candidate Pre-IND 68Ga-FAP Solid Tumors
Diagnosis 225Ac-FAP Solid Tumors
Radiotherapy Peptide-Based
Radioligand
Therapy Undisclosed Antibody-
Radionuclide
Conjugates(ARC) Undisclosed
68Ga-NGUL

Confirmation of PET/CT Image Consistency for NGUL and PSMA-11 in the Same Patients

Bladder Absorption Dose Observed in Humans by NGUL

177Lu-PSMA-DGUL
Compared to Other PSMA Drugs: DGUL includes a very short linker containing a Thiourea bond, distinguishing it from other PSMA-targeting drugs.

Ⅰ. Superior Stability in Drug Metabolism

The absence of an amide bond renders the drug exceptionally stable within the body, ensuring its integrity and effectiveness throughout the metabolic process.

Ⅱ. Reduced Side Effects

The very short hydrophilic linker ensures that any drug not targeted at cancer cells is quickly expelled through the kidneys, minimizing side effects and enhancing patient safety.

Baseline
PSA level : 823

After 2nd Cycle
PSA level : 0.33

After 4th Cycle
PSA level : 0.2

Orphan Drug Designation

Global Innovative Products on Fast Track (GIFT) Designation

Clinical Trial(Pivotal) Enrollment Status
(as of August 28, 2024)

ORR(Evaluable) Lu-177-DGUL(%) n=61 PLUVICTO (%) n=385
CR 9.8 5.6
PR 37.7 24.1
ORR(Measurable) Lu-177-DGUL (%) n=43 PLUVICTO (%) n=184
CR 9.3 9.2
PR 53.5 41.8


99mTc-MSA-ICG
Intraoperative Color and Fluorescent Imaging System (ICFIS)
Image Verification 15 Minutes After Injection
Image Retention for Up to 4 Hours After Injection
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