Pipeline

R&D PIPELINE · RADIOPHARMACEUTICALS

12 R&D Programs Spanning
6 Therapeutic Areas

 

From eight marketed TFDA-approved drug licenses to a diversified radionuclide portfolio in neurology, oncology, and the new Miaoli facility — PET Pharm Bio's R&D pipeline spans both diagnostics and therapeutics, representing the most complete pipeline among Taiwan's private radiopharmaceutical companies.

8
TFDA APPROVED LICENSES
Approved Licenses
18F-FDG (License R00033/R00043/R00045/R00050)
18F-FBB Neuraceq (License R00036)
18F-NaF (License R00040/R00042)
131I Sodium Iodide Capsules (License R00034)
2
IN CLINICAL TRIALS
In Clinical Trials
[161Tb] PSMA I&T — Phase 1
[18F] FBPA — Phase 2
6
THERAPEUTIC AREAS
Therapeutic Areas
Neurology (Alzheimer's Disease)
Neurology (Parkinson's Disease)
Oncology (Prostate Cancer / mCRPC)
Oncology (Brain Cancer / Osteosarcoma)
Oncology (Cancer Metabolic Imaging / FDG)
Oncology (Thyroid Cancer)
4
THERAPEUTIC NUCLIDES
Therapeutic Nuclides
177Lu — Exclusive Source
161Tb — Exclusive Source
64Cu/67Cu — In Development
225Ac — In Development
12+
TOTAL R&D PROGRAMS
Program Categories
New Drug R&D: 2 Programs
Partnership/CDMO: 3 Programs
NPM: 1 Program
Nuclide R&D: 4 Programs
Approved Products: 8 Licenses
APPROVED & MARKETED

Approved & Marketed Products

PET Pharm Bio currently holds 8 TFDA-approved drug licenses.

18F-FDG Fludeoxyglucose
License R00033 / R00043 / R00045 / R00050
Cancer metabolic PET imaging; routine supply to nuclear medicine centers nationwide
APPROVED
18F-FBB Neuraceq
License R00036
Alzheimer's disease Aβ imaging. Dual production sites in Taipei/Luzhu provide the industry's most stable supply.
APPROVED
18F-NaF Sodium Fluoride
License R00040 / R00042
Early detection imaging of bone metastasis, superior to conventional bone scans
APPROVED
131I Sodium Iodide Capsules
License R00034
Post-surgical thyroid remnant ablation and diagnostic scanning for thyroid cancer
APPROVED
THERANOSTICS PIPELINE

177Lu, 161Tb, 64Cu /67Cu, 225Ac
Taiwan's Only Four-Nuclide Therapeutic Radiopharmaceutical Portfolio

PET Pharm Bio is the only private radiopharmaceutical company in Taiwan simultaneously developing four therapeutic isotopes: 177Lu, 161Tb, 64Cu /67Cu, and 225Ac.

177Lu
NPM
PSMA I&T · Prostate Cancer (mCRPC)
Targeted Radiotherapy
161Tb
Clinical Trial
PSMA I&T · Prostate Cancer (mCRPC)
Next-Gen Targeted Therapy Nuclide
64Cu /67Cu
In Development
Cancer
Theranostics
225Ac
In Development
Cancer Alpha Therapy
New Nuclide Program
89Zr
In Development
Antibody / Cell Therapy Drugs
PET Precision Diagnosis
68Ga
In Development
Peptide-Based Cancer Therapy (Pre-Treatment)
PET Precision Diagnosis
Proprietary R&D Pipeline

PET Pharm Bio R&D Programs

Core R&D Technology
🧠

PET Pharm Bio's Uncontested Blue Ocean — Parkinson's Disease Imaging

FP-CIT (DAT-targeted) and AV-133 (VMAT2-targeted) are currently the only Parkinson's disease precision imaging diagnostic programs among Taiwan's local private radiopharmaceutical companies. As Taiwan's population ages, demand for precise Parkinson's disease diagnosis continues to grow, giving this drug series a significant first-mover advantage.

Candidate Molecular Profile Clinical Progression
Diagnosis
[18F] FP-CIT PPhB-F03
Parkinson's Disease Target: DAT  |  Isotope: 18F
 
Pre-Clin.Phase 1 Phase 2 Phase 3Reg. Filing
Diagnosis
[18F] AV-133 PPhB-F04
Parkinson's Disease Target: VMAT2  |  Isotope: 18F
 
Pre-Clin.Phase 1 Phase 2 Phase 3Reg. Filing
Partnership & CDMO Services

Partnership / CDMO Programs

Strategic Alliances & Contract Manufacturing
Candidate Molecular Profile Clinical Progression
Therapy
[161Tb] PSMA I&T PPhB-Tb01
Prostate Cancer (mCRPC) Target: PSMA  |  Isotope: 161Tb
 
Pre-Clin. Phase 1 Phase 2 Phase 3Reg. Filing
Diagnosis
[18F] FBPA PPhB-F01
Brain Cancer / Osteosarcoma Target: LAT  |  Isotope: 18F
 
Pre-Clin. Phase 1 Phase 2 Phase 3Reg. Filing
----
Honeybear / HB001
 
 
Pre-Clin. Phase 1 Phase 2 Phase 3Reg. Filing
Named Patient Manufacture (NPM)

Named Patient Manufacture

Project Manufacturing
Candidate Molecular Profile Clinical Progression
Therapy
[177Lu] PSMA I&T PPhB-Lu01
Prostate Cancer (mCRPC) Target: PSMA  |  Isotope: 177Lu
 
Pre-Clin. Phase 1 Phase 2 Phase 3Reg. Filing
NUCLIDE R&D PIPELINE

Medical Nuclide Development

4 Programs in Technical Development
Isotope / Half-life Application Area Development Phase
New Nuclide R&D
64Cu / 67Cu 12.7 hrs / 61.83 hrs
Cancer Theranostics (Dx + Tx)
 
In Development In Production DMF
New Nuclide R&D
225Ac 9.92 days
Cancer / RPTTargeted Alpha Therapy
 
In Development In Production DMF
New Nuclide R&D
89Zr 78.4 hrs
Antibody / Cell Therapy Drugs PET Precision Diagnosis
 
In Development In Production DMF
New Nuclide R&D
68Ga 68 min

Cancer

Peptide-Based Cancer Therapy (Pre-Treatment)

PET Precision Diagnosis
 
In DevelopmentIn Production DMF