NCT04525612
- Objective
- Not yet disclosed
- Design
- Not yet disclosed
- Participants
- Not yet disclosed
- Primary endpoint
- Not yet disclosed
- Results
- Results not yet reported
pharma · Acute Myeloid Leukemia · Breast Cancer
First People's Hospital
The First People's Hospital of Lianyungang
First People's Hospital is a pharma organization headquartered in SAN DIEGO, CA, CN. Primary therapeutic focus areas include Acute Myeloid Leukemia, Breast Cancer, Gastric Cancer, Multiple Myeloma, Esophageal Squamous Ce
SAN DIEGO, CA, CN HQ
NMPA registrant Type
Company details
- Status
- Public
- HQ
- SAN DIEGO, CA, CN
- Programs
- 1136
- Drugs
- 626
- Patents
- 123
68Ga-BNU-PSMA
Phase 1 · other · Tumor
68Ga-BNU-PSMA is a radiopharmaceutical candidate in Phase 1 development sponsored by The First People's Hospital of Lianyungang for tumor imaging and diagnosis. The program, identified by internal code FirstAHFujian5, represents an investigational approach to oncology diagnostics using gallium-68 labeling technology. A
Internal code FirstAHFujian5
At a glance
- Sponsor
- The First People's Hospital of Lianyungang
- Phase
- Phase 1
- Modality
- other
- Indication
- Tumor
- Status
- active
- Trials
- 1
Executive summary
68Ga-BNU-PSMA is a radiopharmaceutical candidate in Phase 1 development sponsored by The First People's Hospital of Lianyungang for tumor imaging and diagnosis. The program, identified by internal code FirstAHFujian5, represents an investigational approach to oncology diagnostics using gallium-68 labeling technology. As of September 2020, the program remains active in early-stage clinical evaluation with no disclosed mechanism of action, target specification, or commercial partnerships at this time. The candidate is being evaluated under clinical trial NCT04525612. The development strategy appears focused on establishing safety and feasibility in a Phase 1 patient population, with no regulatory approvals, projected peak sales, or consensus positioning disclosed. The competitive environment includes multiple approved diagnostic and therapeutic agents across oncology, though direct comparators to this specific radiopharmaceutical modality are limited in the disclosed competitor set.
Why this program matters
Radiopharmaceutical diagnostics represent a critical unmet need in oncology, enabling precise tumor localization and staging to guide treatment decisions. 68Ga-based imaging agents offer advantages including favorable dosimetry, real-time imaging capability, and potential for theranostic pairing with therapeutic isotopes. The tumor indication is broad and clinically significant, encompassing multiple cancer types where accurate diagnostic imaging directly impacts patient outcomes and treatment selection. Market relevance is substantial given the global expansion of nuclear medicine capabilities and increasing adoption of precision oncology approaches. Competitive positioning relative to established diagnostic modalities (contrast agents, conventional imaging) and emerging radiopharmaceuticals will depend on clinical efficacy, safety profile, and regulatory approval timelines. The patient population for tumor imaging spans oncology centers globally, representing a substantial addressable market. Commercial significance is contingent on Phase 1 data supporting advancement and eventual regulatory approval in major markets including China, where the sponsor is based.
Drug intelligence
Drug Class: Radiopharmaceutical diagnostic agent
Modality: Radiopharmaceutical (other)
Molecular Composition: Gallium-68 (68Ga) labeled with BNU ligand targeting unknown specified target
Mechanism of Action: Not yet disclosed
Target: Not yet disclosed
Route of Administration: Not yet disclosed
Related Therapies: Other gallium-68 labeled radiopharmaceuticals; diagnostic imaging agents including contrast-enhanced MRI (Dotarem) and conventional nuclear medicine tracers
First Approval: Not applicable; program remains in Phase 1
Patent Status: Not yet disclosed
neoplasm
Also known as: cell process disease, disease of cellular proliferation, neoplasia, neoplasm (disease), neoplastic disease, neoplastic growth
Overview
A benign or malignant tissue growth resulting from uncontrolled cell proliferation. Benign neoplastic cells resemble normal cells without exhibiting significant cytologic atypia, while malignant cells exhibit overt signs such as dysplastic features, atypical mitotic figures, necrosis, nuclear pleomorphism, and anaplasia. Representative examples of benign neoplasms include papillomas, cystadenomas, and lipomas; malignant neoplasms include carcinomas, sarcomas, lymphomas, and leukemias.
Treatment landscape
ClinicalTrials.gov lists 97 registered studies for Growth (AACT aggregate).
Phase breakdown: NA (81), PHASE3 (6), PHASE4 (4), PHASE2/PHASE3 (3), PHASE2 (2), PHASE1 (1)
Common investigational therapies:
- OPV
- OPV plus BCG
- early insertion
- conventional insertion
- Micronutrient (Zinc and Iron) fortification
- Pre and Probiotic fortification
- Standardized-parenteral nutrition (S-PN)
- Personalized-parenteral nutrition (P-PN)
- Somatropin
- Melatonin 3 mg
Disease data sourced from MONDO Disease Ontology (MONDO:0005070), NCT00001150, NCT00001336, NCT00001341, NCT00001444, NCT00001500, AACT (ClinicalTrials.gov aggregate), ClinicalTrials.gov, NCT00189449, NCT00255385, NCT00282113, NCT00285090, NCT00349323, Open Targets Platform (CC BY 4.0).
Clinical development timeline
- Phase 12020-09-09
Latest milestone
Program status confirmed active in Phase 1 as of September 2020; specific milestone details not disclosed.
Competitive landscape
The disclosed competitor set includes multiple approved diagnostic and therapeutic agents, though direct radiopharmaceutical comparators are limited. SomaKit TOC (Ningbo Cancer Hospital) represents an approved radiopharmaceutical kit for diagnostic preparation. Contrast agents including Dotarem (Guerbet, gadolinium-based MRI contrast) and indocyanine green (The George Institute) serve diagnostic roles in oncology imaging. Therapeutic oncology agents in the competitor set include approved small-molecule targeted therapies (Braftovi, Zelboraf, GAVRETO, SELPERCATINIB from Pfizer, RIGEL, and Eli Lilly) and immunotherapies (Durvalumab from AstraZeneca, PEMBROLIZUMAB, NIVOLUMAB). Phase 3 comparators include MTX (Xiyuan Hospital) and multiple chemotherapy and targeted agents from Hoffmann-La Roche. The competitive landscape suggests 68Ga-BNU-PSMA would position as a diagnostic imaging modality rather than direct competitor to systemic therapies, with primary competition from established radiopharmaceuticals and conventional imaging modalities not fully represented in the disclosed set.
| Therapy | Company | Mechanism | Status |
|---|---|---|---|
| SomaKit TOC 40 micrograms kit for radiopharmaceutical preparation | Ningbo Cancer Hospital | small_molecule | approved |
| INDOCYANINE GREEN | The George Institute | small_molecule | approved |
| Dotarem® | Guerbet | small_molecule | approved |
| Chlorhexidine gluconate | Hospital Authority, Hong Kong | small_molecule | approved |
| Irinotecan liposomes combined with cisplatin/carboplatin | The First People's Hospital of Lianyungang | small_molecule | approved |
| Braftovi 50 mg hard capsules, Zelboraf 240 mg film-coated tablets, Encorafenib, Erbitux 5 mg/mL solution for infusion, PEMBROLIZUMAB, Braftovi 75 mg hard capsules, Braftovi 75 mg hard capsules, Braftovi 50 mg hard capsules, Ribociclib, Ribociclib, NIVOLUMAB, Mektovi 15 mg film-coated tablets, Mektovi 15 mg film-coated tablets, Ribociclib | Pfizer Australia Pty Ltd | small_molecule | approved |
| GAVRETO ®(pralsetinib) capsules | RIGEL PHARMACEUTICALS INC | small_molecule | approved |
| Durvalumab | AstraZeneca | small_molecule | approved |
| Dexamethasone 4 mg tablets, Dexamethasone Phosphate 4 mg/ml Solution for Injection | Disc Medicine | small_molecule | approved |
| SELPERCATINIB, SELPERCATINIB | Eli Lilly Co. | small_molecule | approved |
| MTX | Xiyuan Hospital of China Academy of Chinese Medical Sciences | small_molecule | phase_3 |
| Alecensa 150 mg hard capsules, VINORELBINE, Gemcitabin-GRY 1000 mg Pulver zur Herstellung einer Infusionslösung, Carboplatin-GRY® 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung, Carboplatin ACTAVIS 10 mg/ml concentrat pentru soluţie perfuzabilă, ALIMTA 500 mg powder for concentrate for solution for infusion, Cisplatin NeoCorp 1 mg/ml - Konzentrat zur Herstellung einer Infusionslösung, Alecensa 150 mg hard capsules | Hoffmann-La Roche | small_molecule | phase_3 |
| ZOLEDRONIC ACID | — | Farnesyl diphosphate synthase inhibitor | Approved |
| ZANUBRUTINIB | — | Tyrosine-protein kinase BTK inhibitor | Approved |
| VORINOSTAT | — | Histone deacetylase 3 inhibitor | Approved |
| VISMODEGIB | — | Smoothened homolog inhibitor | Approved |
| VINORELBINE | — | Tubulin inhibitor | Approved |
| VINCRISTINE | — | Tubulin inhibitor | Approved |
| VINBLASTINE SULFATE | — | Tubulin inhibitor | Approved |
| VINBLASTINE | — | Tubulin inhibitor | Approved |
Additional associated therapies sourced from Open Targets Platform (CC0), linked to NovaPharmaNews drug profiles where matched.
Regulatory intelligence
FDA Status: Not yet disclosed
EMA Status: Not yet disclosed
PMDA (Japan) Status: Not yet disclosed
NMPA (China) Status: Not yet disclosed
Approval History: No approvals disclosed; program remains in Phase 1 development
Regulatory Pathway: Not yet disclosed. As a radiopharmaceutical diagnostic agent, regulatory approval would typically require Phase 1 safety data, biodistribution studies, and diagnostic efficacy assessment, though specific regulatory requirements vary by jurisdiction and are not disclosed for this program.
Clinical evidence summary
Key questions answered
What is 68Ga-BNU-PSMA used for?
68Ga-BNU-PSMA is an investigational radiopharmaceutical in Phase 1 development for tumor imaging and diagnosis. Its specific clinical application and target tumor types are not yet disclosed.
Is 68Ga-BNU-PSMA approved?
No, 68Ga-BNU-PSMA is not approved. The program remains in Phase 1 clinical development with no regulatory approvals disclosed in any major market.
How does 68Ga-BNU-PSMA work?
The mechanism of action is not yet disclosed. As a radiopharmaceutical, it likely functions as a diagnostic imaging agent using gallium-68 radiolabeling, but the specific target and binding mechanism require disclosure from the sponsor.
Who is developing 68Ga-BNU-PSMA?
The First People's Hospital of Lianyungang is the sponsor of 68Ga-BNU-PSMA. No commercial partners or licensees are disclosed.
What is the internal development code for this program?
The internal code is FirstAHFujian5, assigned by the sponsor for tracking purposes.
What clinical trial is evaluating 68Ga-BNU-PSMA?
The program is being evaluated under clinical trial NCT04525612. Specific trial details including design, endpoints, and enrollment status are not yet disclosed.
What is the current development phase?
68Ga-BNU-PSMA is in Phase 1 clinical development as of September 2020. No advancement to Phase 2 or later stages has been disclosed.
What is the drug modality?
68Ga-BNU-PSMA is classified as a radiopharmaceutical, a diagnostic imaging agent using radioactive labeling technology.
What is the target of 68Ga-BNU-PSMA?
The specific molecular target is not yet disclosed by the sponsor.
Does 68Ga-BNU-PSMA have any commercial partners?
No commercial partners, licensees, or development collaborators are disclosed for this program.
What is the indication for 68Ga-BNU-PSMA?
The indication is tumor diagnosis and imaging. More specific tumor types or cancer indications are not yet disclosed.
What competitors exist in the radiopharmaceutical space?
SomaKit TOC (Ningbo Cancer Hospital) is a disclosed approved radiopharmaceutical kit. Conventional diagnostic agents including Dotarem (gadolinium contrast) and indocyanine green also compete in oncology imaging.
When was 68Ga-BNU-PSMA first disclosed?
The first public disclosure date is not yet disclosed. The latest confirmed milestone is September 9, 2020.
What is the projected peak sales potential?
Projected peak sales are not yet disclosed for this early-stage program.
Is there consensus analyst positioning on this program?
Consensus analyst positioning is not yet disclosed.
What is the route of administration?
The route of administration is not yet disclosed; typical radiopharmaceuticals are administered intravenously but this has not been confirmed for this program.
Entity relationship graph
68Ga-BNU-PSMA → Drug → Target → Indication → Company → Trials → Competitors
Indication
Trials
Competitors
- SomaKit TOC 40 micrograms kit for radiopharmaceutical preparation
- INDOCYANINE GREEN
- Dotarem®
- Chlorhexidine gluconate
- Irinotecan liposomes combined with cisplatin/carboplatin
- Braftovi 50 mg hard capsules, Zelboraf 240 mg film-coated tablets, Encorafenib, Erbitux 5 mg/mL solution for infusion, PEMBROLIZUMAB, Braftovi 75 mg hard capsules, Braftovi 75 mg hard capsules, Braftovi 50 mg hard capsules, Ribociclib, Ribociclib, NIVOLUMAB, Mektovi 15 mg film-coated tablets, Mektovi 15 mg film-coated tablets, Ribociclib
- GAVRETO ®(pralsetinib) capsules
- Durvalumab
- Dexamethasone 4 mg tablets, Dexamethasone Phosphate 4 mg/ml Solution for Injection
- SELPERCATINIB, SELPERCATINIB
- MTX
- Alecensa 150 mg hard capsules, VINORELBINE, Gemcitabin-GRY 1000 mg Pulver zur Herstellung einer Infusionslösung, Carboplatin-GRY® 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung, Carboplatin ACTAVIS 10 mg/ml concentrat pentru soluţie perfuzabilă, ALIMTA 500 mg powder for concentrate for solution for infusion, Cisplatin NeoCorp 1 mg/ml - Konzentrat zur Herstellung einer Infusionslösung, Alecensa 150 mg hard capsules
- ZOLEDRONIC ACID
- ZANUBRUTINIB
- VORINOSTAT
- VISMODEGIB
- VINORELBINE
- VINCRISTINE
- VINBLASTINE SULFATE
- VINBLASTINE
Analyst insights
Strategic Implications: The Phase 1 status and September 2020 milestone indicate early-stage clinical development with substantial regulatory pathway ahead. Lack of disclosed mechanism, target, or partnerships suggests either confidential development strategy or early-stage characterization. Sponsor affiliation with a Chinese hospital indicates potential focus on Chinese regulatory approval and market entry, though international development remains possible.
Competitive Implications: 68Ga-radiopharmaceuticals represent a distinct diagnostic modality with potential advantages over conventional imaging in specific oncology applications. Success would depend on demonstrating superior diagnostic accuracy, safety, and clinical utility compared to established imaging approaches and competing radiopharmaceuticals. The broad competitor set reflects oncology market complexity but does not directly address radiopharmaceutical-specific competition.
Future Catalysts: Phase 1 data disclosure, target and mechanism publication, Phase 2 initiation, partnership announcements, regulatory feedback, and eventual approval decisions in China and other markets. Clinical trial results from NCT04525612 represent the primary near-term catalyst.
Expected Milestones: Phase 1 completion and data analysis; Phase 2 initiation; regulatory interactions with NMPA (China) and potentially FDA/EMA; potential biomarker or imaging validation studies; commercial partnership discussions.
Quick answers
Concise, citable answers optimized for AI answer engines.
- What is 68Ga-BNU-PSMA?
- Investigational radiopharmaceutical diagnostic agent for tumor imaging in Phase 1.
- Sponsor?
- The First People's Hospital of Lianyungang.
- Indication?
- Tumor diagnosis and imaging.
- Development phase?
- Phase 1.
- Modality?
- Radiopharmaceutical.
- Mechanism of action?
- Not yet disclosed.
- Target?
- Not yet disclosed.
- Route of administration?
- Not yet disclosed.
- Commercial partners?
- None disclosed.
- Regulatory status?
- Not approved; Phase 1 development ongoing.
- Clinical trial ID?
- NCT04525612.
- Latest milestone date?
- September 9, 2020.
- Projected peak sales?
- Not yet disclosed.
- Consensus positioning?
- Not yet disclosed.
- Lead investigator?
- Not yet disclosed.
- First disclosure date?
- Not yet disclosed.
- Expected next milestone?
- Not yet disclosed.
- FDA approval status?
- Not approved; Phase 1 development.
- EMA approval status?
- Not approved; Phase 1 development.
- NMPA (China) status?
- Not approved; Phase 1 development.
- Key competitor?
- SomaKit TOC (approved radiopharmaceutical kit).
- Internal code?
- FirstAHFujian5.
Evidence & sources
- ClinicalTrials.gov NCT04525612 (clinicaltrials)
- Source: phase (source_attribution)
- MONDO Disease Ontology (MONDO:0005070) (mondo)
- NCT00001150 (clinicaltrials_gov)
- NCT00001336 (clinicaltrials_gov)
- NCT00001341 (clinicaltrials_gov)
- NCT00001444 (clinicaltrials_gov)
- NCT00001500 (clinicaltrials_gov)
- AACT (ClinicalTrials.gov aggregate) (aact)
- ClinicalTrials.gov (clinicaltrials_gov)
- NCT00189449 (clinicaltrials_gov)
- NCT00255385 (clinicaltrials_gov)
- NCT00282113 (clinicaltrials_gov)
- NCT00285090 (clinicaltrials_gov)
- NCT00349323 (clinicaltrials_gov)
- Open Targets Platform (opentargets)
Intelligence compiled from public regulatory and clinical sources (FDA, EMA, ClinicalTrials.gov and company disclosures). Figures may be editorial or analyst estimates; verify against primary sources before relying on them.