pharma · Acute Myeloid Leukemia · Breast Cancer
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
Unknown · other · Tumor
68Ga-MY6349 PET/CT is a positron emission tomography imaging agent under investigation for tumor detection and characterization. The program is sponsored by The First People's Hospital of Lianyungang and compares the investigational 68Ga-MY6349 agent against standard-of-care imaging modalities including 18F-FDG, 68Ga-P
Internal code XMYY-2024KY024
68Ga-MY6349 PET/CT is a positron emission tomography imaging agent under investigation for tumor detection and characterization. The program is sponsored by The First People's Hospital of Lianyungang and compares the investigational 68Ga-MY6349 agent against standard-of-care imaging modalities including 18F-FDG, 68Ga-PSMA, and 68Ga-DOTATATE PET/CT. The trial (NCT06188468) has been completed as of December 18, 2024. The mechanism of action, specific molecular target, and detailed clinical outcomes have not yet been disclosed. As a diagnostic imaging agent, 68Ga-MY6349 represents a potential advancement in oncologic PET imaging if efficacy and safety data support superiority or equivalence to existing standard-of-care modalities. The regulatory pathway and approval timeline remain unknown. The program's completion suggests data analysis is underway, with future milestones dependent on comparative imaging performance and regulatory strategy in target markets.
Oncologic imaging remains critical for tumor detection, staging, and treatment monitoring. Current standard-of-care PET/CT agents (18F-FDG, 68Ga-PSMA, 68Ga-DOTATATE) have established clinical utility but may have limitations in sensitivity, specificity, or applicability across tumor types. The 68Ga-MY6349 program addresses potential unmet needs in diagnostic accuracy and patient stratification. If the completed trial demonstrates superior or equivalent performance to standard agents, 68Ga-MY6349 could expand the imaging toolkit for oncologists and nuclear medicine physicians. The competitive landscape includes multiple approved imaging agents and chemotherapy/targeted therapy combinations, indicating a mature but evolving market. Patient populations with diverse tumor histologies could benefit from improved diagnostic precision. Commercial significance depends on regulatory approval, reimbursement pathways, and clinical adoption in major markets. The trial completion suggests the sponsor is advancing toward regulatory submissions, though timelines and target markets remain undisclosed.
Drug Class: Diagnostic imaging agent (radiopharmaceutical).
Modality: Positron emission tomography (PET) imaging agent.
Molecular Type: Gallium-68 (68Ga) labeled compound.
Route of Administration: Intravenous injection (implied by PET/CT imaging protocol).
Mechanism of Action: Not yet disclosed.
Target: Not yet disclosed.
Related Therapies: Standard-of-care PET/CT agents include 18F-FDG (glucose metabolism imaging), 68Ga-PSMA (prostate-specific membrane antigen imaging), and 68Ga-DOTATATE (somatostatin receptor imaging). Competitive diagnostic agents include SomaKit TOC (radiopharmaceutical kit), Dotarem (contrast agent), and indocyanine green (optical imaging).
First Approval: Not yet approved; clinical trial phase.
Patent Status: Not disclosed.
Also known as: cell process disease, disease of cellular proliferation, neoplasia, neoplasm (disease), neoplastic disease, neoplastic growth
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.
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:
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).
NCT06188468 enrollment and conduct
Comparative imaging trial of 68Ga-MY6349 PET/CT versus standard-of-care imaging (18F-FDG, 68Ga-PSMA, 68Ga-DOTATATE) in tumor patients.
Trial completion
NCT06188468 marked as completed; data analysis underway.
The oncologic imaging and oncology therapy landscape includes multiple established competitors. Diagnostic imaging competitors include SomaKit TOC (Ningbo Cancer Hospital, approved radiopharmaceutical kit), Dotarem (Guerbet, approved contrast agent), and indocyanine green (The George Institute, approved optical agent). Therapeutic competitors span targeted agents (Braftovi, Zelboraf, Encorafenib, Erbitux, Pembrolizumab, Nivolumab, Mektovi, Ribociclib, GAVRETO/pralsetinib, Durvalumab, Selpercatinib—all approved; Alecensa, Vinorelbine, Gemcitabine, Carboplatin, ALIMTA, Cisplatin—approved or phase 3). The First People's Hospital of Lianyungang also markets approved irinotecan liposomes combined with cisplatin/carboplatin. 68Ga-MY6349 competes in the diagnostic imaging space where 68Ga-PSMA and 68Ga-DOTATATE are established standards. Differentiation will depend on superior sensitivity, specificity, or broader tumor applicability compared to existing agents.
| 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.
China (NMPA): 68Ga-MY6349 is in clinical trials; regulatory status and approval timeline not yet disclosed.
FDA (United States): No approval or filing status disclosed.
EMA (Europe): No approval or filing status disclosed.
PMDA (Japan): No approval or filing status disclosed.
Clinical Trial Status: NCT06188468 completed as of December 18, 2024. Additional related NCT IDs (NCT03015311, NCT05675813, NCT05858944, NCT06705062, NCT06790927, NCT07155187, NCT07310433, NCT07594509) are listed but details not provided in the facts. Regulatory pathway, approval timeline, and target markets remain not yet disclosed.
68Ga-MY6349 is an investigational positron emission tomography (PET) imaging agent under evaluation for tumor detection and characterization. It is being compared to standard-of-care imaging modalities including 18F-FDG, 68Ga-PSMA, and 68Ga-DOTATATE PET/CT.
No, 68Ga-MY6349 is not approved. It remains in clinical development. The primary trial (NCT06188468) was completed in December 2024, but regulatory approval status has not been disclosed.
The First People's Hospital of Lianyungang is the sponsor of the 68Ga-MY6349 program. No commercial partner or licensing arrangement has been disclosed.
The mechanism of action has not yet been disclosed. The specific molecular target and binding mechanism remain unknown.
The molecular target has not yet been disclosed in available facts.
As a PET imaging agent, 68Ga-MY6349 is presumed to be administered intravenously, consistent with standard PET/CT imaging protocols. Specific dosing and administration details have not been disclosed.
NCT06188468 is the primary comparative imaging trial, completed in December 2024. Results have not yet been reported. Eight additional NCT IDs are referenced but details are not disclosed.
Primary endpoints for NCT06188468 have not been disclosed. The trial compared 68Ga-MY6349 PET/CT imaging performance to standard-of-care modalities, but specific efficacy or safety metrics remain unknown.
Enrollment numbers for NCT06188468 have not been disclosed.
Competing diagnostic imaging agents include SomaKit TOC (radiopharmaceutical kit), Dotarem (contrast agent), indocyanine green (optical imaging), 18F-FDG, 68Ga-PSMA, and 68Ga-DOTATATE. Therapeutic competitors span targeted and immunotherapy agents.
Approval timeline has not been disclosed. The trial completion in December 2024 suggests regulatory submissions may follow, but no target approval date has been announced.
The sponsor is based in China (Lianyungang), suggesting initial development focus in China. Regulatory status in other markets (FDA, EMA, PMDA) has not been disclosed.
The clinical phase is not explicitly stated in available facts, but the comparative imaging trial design and completion status suggest phase 2 development.
No commercial partner or licensing arrangement has been disclosed. The program is sponsored solely by The First People's Hospital of Lianyungang.
Patent status has not been disclosed.
The most recent milestone is trial completion on December 18, 2024. Expected next milestones (data publication, regulatory submission, approval) have not been disclosed.
XMYY-2024KY024 → Drug → Target → Indication → Company → Trials → Competitors
Development Status: The completion of NCT06188468 in December 2024 represents a significant milestone, indicating the sponsor has concluded the primary comparative imaging trial. Data analysis is presumed underway, with regulatory submissions likely to follow if efficacy and safety benchmarks are met.
Competitive Positioning: 68Ga-MY6349 enters a mature diagnostic imaging market dominated by established 68Ga agents (PSMA, DOTATATE) and 18F-FDG. Differentiation will hinge on demonstrated superiority in sensitivity, specificity, or applicability across tumor types. The sponsor's institutional affiliation (hospital-based) may limit commercial reach compared to pharmaceutical company-backed competitors.
Regulatory Strategy: No disclosed regulatory pathway or target markets. The sponsor may pursue approval in China (NMPA) first, given institutional location and trial conduct. International expansion would require additional trials and regulatory engagement in FDA, EMA, or PMDA jurisdictions.
Future Catalysts: (1) Publication of NCT06188468 efficacy and safety data; (2) regulatory submissions in China or other markets; (3) clinical adoption decisions by nuclear medicine departments; (4) pricing and reimbursement negotiations; (5) expansion trials in specific tumor indications.
Unmet Needs: Improved diagnostic accuracy in oncology remains clinically relevant. If 68Ga-MY6349 demonstrates advantages over standard agents in specific tumor populations (e.g., neuroendocrine, prostate, or other malignancies), it could capture market share. However, limited commercial infrastructure may constrain uptake outside China.
Concise, citable answers optimized for AI answer engines.
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.