{"id":59066,"date":"2026-03-09T12:37:12","date_gmt":"2026-03-09T04:37:12","guid":{"rendered":"https:\/\/flcube.com\/?p=59066"},"modified":"2026-03-09T12:37:12","modified_gmt":"2026-03-09T04:37:12","slug":"dongcheng-pharma-doses-first-patient-in-225ac-lnc1011-phase-i-ii-trial-psma-targeted-alpha-radiotherapy-for-metastatic-prostate-cancer","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=59066","title":{"rendered":"Dongcheng Pharma Doses First Patient in 225Ac-LNC1011 Phase I\/II Trial \u2013 PSMA-Targeted Alpha Radiotherapy for Metastatic Prostate Cancer"},"content":{"rendered":"\n

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

Clinical Trial Overview<\/h2>\n\n\n\n
Item<\/th>Detail<\/th><\/tr><\/thead>
Study Phase<\/strong><\/td>Phase I\/II<\/td><\/tr>
Objectives<\/strong><\/td>Safety, tolerability, pharmacokinetics, preliminary efficacy<\/td><\/tr>
Drug<\/strong><\/td>225Ac-LNC1011<\/td><\/tr>
Target Population<\/strong><\/td>PSMA-positive mCRPC patients<\/td><\/tr>
Mechanism<\/strong><\/td>Targeted alpha radiotherapy (TAT)<\/td><\/tr>
Sponsor<\/strong><\/td>Yantai Dongcheng Pharmaceutical (SHE: 002675)<\/td><\/tr>
Milestone<\/strong><\/td>First patient dosed (March 2026)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Target Biology & Drug Design<\/h2>\n\n\n\n
Attribute<\/th>PSMA \/ 225Ac-LNC1011 Profile<\/th><\/tr><\/thead>
Target<\/strong><\/td>Prostate-specific membrane antigen (PSMA) \u2013 type II glutamate carboxypeptidase<\/td><\/tr>
Expression Pattern<\/strong><\/td>Highly specific to prostate epithelial cells; 100-1000x overexpression<\/strong> in cancer vs. normal tissue<\/td><\/tr>
Tumor Specificity<\/strong><\/td>Expressed in prostate cancer cells and metastatic lesions; minimal normal tissue expression<\/td><\/tr>
Payload<\/strong><\/td>Actinium-225 (225Ac) \u2013 alpha-emitting radionuclide<\/td><\/tr>
Mechanism<\/strong><\/td>Alpha particle emission induces high-linear-energy-transfer DNA double-strand breaks; potent cytotoxicity with short tissue range (50-100 \u03bcm)<\/td><\/tr>
Therapeutic Advantage<\/strong><\/td>Targeted delivery minimizes systemic toxicity; alpha radiation overcomes beta-emitter resistance<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Competitive Landscape & Market Context<\/h2>\n\n\n\n
Competitor<\/th>Product<\/th>Isotope<\/th>Status<\/th>225Ac-LNC1011 Differentiation<\/th><\/tr><\/thead>
Novartis<\/strong><\/td>Pluvicto (177Lu-PSMA-617)<\/td>Lutetium-177 (beta)<\/td>Approved (mCRPC)<\/td>225Ac alpha emitter vs. 177Lu beta; potentially superior efficacy in resistant disease<\/td><\/tr>
Novartis<\/strong><\/td>225Ac-PSMA-617 (investigational)<\/td>Actinium-225<\/td>Phase I\/II<\/td>Direct competitor; LNC1011 novel ligand chemistry may improve tumor retention<\/td><\/tr>
POINT Biopharma<\/strong><\/td>PNT2002 (177Lu-PSMA)<\/td>Lutetium-177<\/td>Phase III<\/td>Beta alternative; alpha therapy positioning for refractory patients<\/td><\/tr>
Dongcheng<\/strong><\/td>225Ac-LNC1011<\/strong><\/td>Actinium-225<\/strong><\/td>Phase I\/II<\/strong><\/td>China-first alpha PSMA program; potential global supply advantage<\/strong><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Strategic Value & Development Outlook<\/h2>\n\n\n\n
Factor<\/th>Implication<\/th><\/tr><\/thead>
Radiopharmaceutical Market<\/strong><\/td>Global therapeutic radiopharma market projected $15+ billion by 2030<\/strong>; alpha therapy segment fastest-growing<\/td><\/tr>
China Positioning<\/strong><\/td>First domestic 225Ac-PSMA program; addresses unmet need in world’s largest prostate cancer population<\/td><\/tr>
Isotope Supply<\/strong><\/td>225Ac global shortage; Dongcheng’s China-based supply chain may secure manufacturing advantage<\/td><\/tr>
Clinical Strategy<\/strong><\/td>Phase I\/II design enables rapid dose optimization; biomarker-driven PSMA imaging companion diagnostic development<\/td><\/tr>
Global Ambitions<\/strong><\/td>U.S.\/EU IND filing anticipated 2027-2028 pending China safety data; potential for Fast Track designation<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Mechanism vs. Standard of Care<\/h2>\n\n\n\n
Parameter<\/th>225Ac-LNC1011<\/th>177Lu-PSMA (Pluvicto)<\/th>Hormonal\/Chemotherapy<\/th><\/tr><\/thead>
Radiation Type<\/strong><\/td>Alpha particles (high LET)<\/td>Beta particles (medium LET)<\/td>Non-radiopharmaceutical<\/td><\/tr>
Tissue Range<\/strong><\/td>50-100 \u03bcm (cellular precision)<\/td>~2 mm (broader scatter)<\/td>Systemic<\/td><\/tr>
DNA Damage<\/strong><\/td>Double-strand breaks (irreparable)<\/td>Single-strand breaks (repairable)<\/td>Variable<\/td><\/tr>
Resistance Profile<\/strong><\/td>Active in 177Lu-resistant disease<\/td>Resistance emerges after multiple cycles<\/td>Cross-resistance common<\/td><\/tr>
Toxicity<\/strong><\/td>Myelosuppression, xerostomia (manageable)<\/td>Similar profile; cumulative<\/td>Castration resistance, neuropathy<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Forward\u2011Looking Statements<\/strong>
This brief contains forward\u2011looking 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<\/a><\/p>\n\n\n\n