Dongcheng Pharma Doses First Patient in 225Ac-LNC1011 Phase I/II Trial – PSMA-Targeted Alpha Radiotherapy for Metastatic Prostate Cancer

Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) announced first subject enrollment in a Phase I/II clinical study evaluating 225Ac-LNC1011 in PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). The targeted alpha radiotherapeutic leverages actinium-225 (225Ac) conjugated to a PSMA-binding ligand, positioning Dongcheng Pharma in the rapidly expanding radiopharmaceutical oncology market targeting the highly specific prostate cancer antigen PSMA.

Clinical Trial Overview

ItemDetail
Study PhasePhase I/II
ObjectivesSafety, tolerability, pharmacokinetics, preliminary efficacy
Drug225Ac-LNC1011
Target PopulationPSMA-positive mCRPC patients
MechanismTargeted alpha radiotherapy (TAT)
SponsorYantai Dongcheng Pharmaceutical (SHE: 002675)
MilestoneFirst patient dosed (March 2026)

Target Biology & Drug Design

AttributePSMA / 225Ac-LNC1011 Profile
TargetProstate-specific membrane antigen (PSMA) – type II glutamate carboxypeptidase
Expression PatternHighly specific to prostate epithelial cells; 100-1000x overexpression in cancer vs. normal tissue
Tumor SpecificityExpressed in prostate cancer cells and metastatic lesions; minimal normal tissue expression
PayloadActinium-225 (225Ac) – alpha-emitting radionuclide
MechanismAlpha particle emission induces high-linear-energy-transfer DNA double-strand breaks; potent cytotoxicity with short tissue range (50-100 μm)
Therapeutic AdvantageTargeted delivery minimizes systemic toxicity; alpha radiation overcomes beta-emitter resistance

Competitive Landscape & Market Context

CompetitorProductIsotopeStatus225Ac-LNC1011 Differentiation
NovartisPluvicto (177Lu-PSMA-617)Lutetium-177 (beta)Approved (mCRPC)225Ac alpha emitter vs. 177Lu beta; potentially superior efficacy in resistant disease
Novartis225Ac-PSMA-617 (investigational)Actinium-225Phase I/IIDirect competitor; LNC1011 novel ligand chemistry may improve tumor retention
POINT BiopharmaPNT2002 (177Lu-PSMA)Lutetium-177Phase IIIBeta alternative; alpha therapy positioning for refractory patients
Dongcheng225Ac-LNC1011Actinium-225Phase I/IIChina-first alpha PSMA program; potential global supply advantage

Strategic Value & Development Outlook

FactorImplication
Radiopharmaceutical MarketGlobal therapeutic radiopharma market projected $15+ billion by 2030; alpha therapy segment fastest-growing
China PositioningFirst domestic 225Ac-PSMA program; addresses unmet need in world’s largest prostate cancer population
Isotope Supply225Ac global shortage; Dongcheng’s China-based supply chain may secure manufacturing advantage
Clinical StrategyPhase I/II design enables rapid dose optimization; biomarker-driven PSMA imaging companion diagnostic development
Global AmbitionsU.S./EU IND filing anticipated 2027-2028 pending China safety data; potential for Fast Track designation

Mechanism vs. Standard of Care

Parameter225Ac-LNC1011177Lu-PSMA (Pluvicto)Hormonal/Chemotherapy
Radiation TypeAlpha particles (high LET)Beta particles (medium LET)Non-radiopharmaceutical
Tissue Range50-100 μm (cellular precision)~2 mm (broader scatter)Systemic
DNA DamageDouble-strand breaks (irreparable)Single-strand breaks (repairable)Variable
Resistance ProfileActive in 177Lu-resistant diseaseResistance emerges after multiple cyclesCross-resistance common
ToxicityMyelosuppression, xerostomia (manageable)Similar profile; cumulativeCastration resistance, neuropathy

Forward‑Looking Statements
This brief contains forward‑looking statements regarding clinical development timelines, radiopharmaceutical manufacturing, and competitive positioning for 225Ac-LNC1011. Actual results may differ due to isotope supply constraints, regulatory requirements, and trial outcomes in the radioligand therapy space.-Fineline Info & Tech