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东诚药业: 关于下属公司获得药物临床试验批准通知书的公告

Core Viewpoint - Yantai Dongcheng Pharmaceutical Group Co., Ltd. announced that its subsidiary LNC PHARMA PTE. LTD. received FDA approval for the clinical trial of 225Ac-LNC1011 injection, which will soon commence Phase I clinical trials [1][2]. Drug Information - The drug 225Ac-LNC1011 is an injectable formulation intended for the treatment of advanced prostate cancer expressing Prostate Specific Membrane Antigen (PSMA) [2]. - The drug utilizes alpha particle radiation therapy, which has a short range (<100 μm) and high energy deposition (80-100 keV/μm), providing stronger cell-killing effects on tumors while minimizing damage to surrounding healthy tissues [2]. - Previous animal and human trials have shown excellent pharmacokinetic properties and significant efficacy, indicating its potential as a more effective PSMA-targeted therapy for metastatic castration-resistant prostate cancer (mCRPC) [2]. Financial Investment - The total research and development expenses incurred for the 225Ac-LNC1011 project to date amount to approximately 14.1648 million yuan [3].